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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Blood culture positive, Chills, Headache, Inflammation, Injection site erythema
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Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on 7/31/25 for lump on left deltoid, 6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site induration, Injection site mass, Nausea, Pyrexia, Ultrasound scan abnormal
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Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on 7/31/25 for lump on left deltoid, 6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: White blood cell count increased
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Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on 7/31/25 for lump on left deltoid, 6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
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No adverse reactions noted before, during, nor after administration of vaccine. Minor kept for post vaccination observation for 15 minutes and then released.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
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Minor received 0.3 mL of Pfizer dose labeled for use to children ages 6 months to 4 years old. No adverse reactions noticed before, during, nor after receiving vaccine. Client kept for post vaccination observation for 15 minutes and then released from vaccine clinic.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX
Symptoms: Cardiac ablation, Respiratory syncytial virus infection, Supraventricular tachycardia, Traumatic lung injury, Vaccination failure
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had it; Permanent lung damage; supraventricular tachycardia needing an ablation; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: had it) (serious criteria hospitalization), lung injury (Verbatim: Permanent lung damage) (serious criteria hospitalization) and supraventricular tachycardia (Verbatim: supraventricular tachycardia needing an ablation) (serious criteria hospitalization). The outcome of the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. The patient had it and after that hospitalized for10 days. The patient had permanent lung damage and supraventricular tachycardia needing an ablation and now on permanent nocturnal oxygen. The patient had the vaccine too late. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. A case of Respiratory syncytial virus infection, Traumatic lung injury and Supraventricular tachycardia, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
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a patient had been given an Infanrix dose that expired on 13th July 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 31-JUL-2025, the patient received Infanrix. On 31-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: a patient had been given an Infanrix dose that expired on 13th July 2025 ). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JUL-2025 Medical assistant called to request information about what to do after a patient had been given an Infanrix dose that expired on 13th July 2025 which led to expired vaccine used. The dose was given to patient on 31st July 2025.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
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started a two-dose pre-exposure series but never received her second dose with no reported ae; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 53-year-old female patient who started a two-dose pre-exposure series of Rabies (HDC) vaccine [IMOVAX Rabies] but never received her second dose with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Jun-2025, the patient received a first dose of 0.5ml of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (lot Y1A8CP1, standard strength, frequency once, and expiry date-28-Feb-2025) via intramuscular route in unknown administration site for Immunization and was to receive two-doses of pre-exposure series but never received her second dose with no reported ae (routine immunisation schedule not administered). Reportedly-Patient missed the second dose they wanted to know if they can get the second dose or they need to restart. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Product administered at inappropriate site
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Mobility issues; Shoulder pain; Needle goes into the tendon instead of the muscle when administering Afluria PFS; This spontaneous case, initially received on 25-Jul-2025, was reported by a health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date in 2025, the patient received Afluria (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: No batch number available would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in 2025, the patient experienced Mobility issues (outcome: Not Reported), Shoulder pain (outcome: Not Reported), Needle goes into the tendon instead of the muscle when administering Afluria PFS (outcome: Not Reported). Healthcare professional (HCP) inquired about any records of adverse events where needle went into the tendon instead of the muscle when administering Afluria Prefilled syringe (PFS). When asked if there was a patient involved in this question, Healthcare professional (HCP states that they are still investigating and event was not yet confirmed; therefore, they did not wish to report any details yet. She mentioned a situation involving a patient who received Afluria 6 months ago and has been experienced shoulder pain and mobility issues. Caller stated that patient was given the 2023-2024 season formula, but mentions that this occurred last winter, in Jan (Sic!). Healthcare professional (HCP stated not knowing the size of the needle and that they were trying to figure out if the needle was long enough to go that deep; also mentions not having that much of clinical knowledge about the situation to share any details Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment for the events Mobility issues, Shoulder pain and Needle goes into the tendon instead of the muscle when administering Afluria PFS.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. There is insufficient information regarding events for meaningful causal assessment (events onset dates, temporality, site of vaccination and shoulder pain, route of administration, etc.). Of note, wrong technique in product usage process might be considered as confounding factors for the events occurrence.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Dizziness, Migraine, Photophobia, Pyrexia
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severe migraine >10, fever, dizziness, loss of depth perception for <10 hours, fever, light sensitivity.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 RNA undetectable
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severe migraine >10, fever, dizziness, loss of depth perception for <10 hours, fever, light sensitivity.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Bell's palsy, Facial paralysis, Guillain-Barre syndrome, Muscle spasms, Respiratory disorder
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patient started having leg cramps, and vomiting about 1 week after vaccine pt went to emergency room first was diagnosed with bell's palsy with one side of his face dropping - patient was not getting better then went to primary care doctor that said go to University and they diagnosed him with Gillian barre syndrome (patient has issues with his face, legs, and breathing )
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Vomiting
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patient started having leg cramps, and vomiting about 1 week after vaccine pt went to emergency room first was diagnosed with bell's palsy with one side of his face dropping - patient was not getting better then went to primary care doctor that said go to University and they diagnosed him with Gillian barre syndrome (patient has issues with his face, legs, and breathing )
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrophy, Fatigue, Incorrect route of product administration
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Patient think that administrator gave her with shorter needle with let to SQ. So she had atrophy on her arm.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Sensitive skin, Swelling face, Tenderness
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Patient describes spontaneous facial bruising below the right eye with swelling and tenderness. Additionally, she reports scalp sensitivity.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Coronary artery bypass, Dialysis, End stage renal disease, Herpes zoster, Pain in extremity
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Coronary artery bypass, Dialysis, End stage renal disease, Herpes zoster, Pain
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Vaccination failure
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness, Osteoarthritis
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray abnormal
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chondropathy, Condition aggravated
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Joint stiffness, Lip disorder, Lip pain, Magnetic resonance imaging
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Meniscus injury, Mobility decreased, Muscle tightness, Muscular weakness, Musculoskeletal stiffness
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Osteoarthritis, X-ray, X-ray abnormal
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Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: White blood cells urine positive
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Agitation, Asthenia, Death, General physical health deterioration, Toxic encephalopathy
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Urine analysis, Urine analysis abnormal, White blood cells urine positive
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more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection. The patient's family history included Bladder cancer with Bladder Surgery. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia. Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole. On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation). On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence) (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal) (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula. On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present) (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula. Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024: [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024: [>60 mL/min]; on 13-Oct-2024: [>60 mL/min]; on 14-Oct-2024: [>60 mL/min]; on 15-Oct-2024: [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024: [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024: [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs] Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy. Action taken was not applicable. The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan). At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy), was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy), was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy), No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy. Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy). This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swollen tongue, Tongue oedema
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Reported Symptoms: 10014257:EDEMA TONGUE; 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING; SWELLING OF TONGUE
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: FLU3
Symptoms: Rash
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Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Viral infection
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Reported Symptoms: 10016797:FLU-LIKE SYMPTOMS; Narrative: a 67yo male reported he can't get influenza vaccine due to experiencing severe flu-like symptoms previously. Other Relevant HX: Patient reported had a severe viral illness after flu vaccines. Other: severe flu-like symptom
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Guillain-Barre syndrome
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Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: A 39yo female reported to physician unable to get flu vaccines due to Guillain-Barre syndrome with prior vaccines. Patient reported had allergies to influenza vaccine back in March, 2017 with no sx listed, then August 22,2022 reported sx of dyspnea when received influenza vaccine. Other Relevant HX: 39yo female reported a severe sx of Guillain-Barre when received influenza vaccine. Looking back to patient history, had also reported allergies to flue vaccine with no specific symptom listed back in March 16, 2017, Then later reported with sx of dyspnea when received influenza vaccine back in August 22, 2022. Other: Guillain-Barre syndrome
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
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Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Nausea, Vomiting
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Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10013573:DIZZINESS; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Other Relevant HX: Other: NAUSEA AND VOMITING; CHEST PAIN; DIZZINESS
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia
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Reported Symptoms: 10019211:HEADACHE; 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MUSCLE PAIN; HEADACHE; MALAISE
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: FLUX
Symptoms: Cough, Malaise
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Reported Symptoms: 10011232:COUGHING; Narrative: a 52yr male with PMH of Allergic Rhinitis, GERD, Asthma, Migraine, Plantar Fascial Fibromatosis, Knee Pain, Shoulder Pain, low Back pain, ED and Exposure to potentially hazardous substance. On February 20, 2025, staff RN @ 17:43 reported the patient had a history of influenza vaccine induced ADR of sever cough. The report included, "he became very sick after taking the Flu vaccine and had not taken the vaccine since 2009." No other information was provided regarding the vaccine and where, when and by who it was administered. Other Relevant HX: Other: COUGH
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
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Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
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Reported Symptoms: 10003239:ARTHRALGIA; 10023222:JOINT PAIN; Narrative: Other Relevant HX: Other: JOINT PAIN
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Wheezing
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Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: per provider note: 72-year-old female who states that at about 9:00 a.m. this morning she got a flu shot and shortly after started having difficulty swallowing. She denies tightness in the chest, shortness of breath or wheezing. She denies inability to handle her own secretions. She denies diffuse itch or rash. Patient presented to ED and was offered treatment with Benadryl IV, steroids but patient refused. Also offered epi, patient refused. Patient's sx improved without treatment while in ED. She had not no respiratory involvement at this time and I believe the difficulty swallowing is probably esophageal/GI. There was no signs of angioedema or airway inclusion. No stridor. The lungs are clear to auscultation all fields and she was moving air well. Other Relevant HX: Other: ANAPHYLAXIS
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: FLUX
Symptoms: Contraindication to vaccination
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Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 69yo female with PMH of Osteopenia, Environmental Allergies, Osteoarthritis, Breast Cancer, long term use of anticoagulant, Atrial Flutter, Cardiomyopathy, Colonic Polyp and Cerebrovascular Accident s/p Arrhythmia. On February 8, 2025, PCC/WHC attending physician reported the patient had a historical ADR of Influenza vaccine induced Anaphylaxis classified as severe and updated the patient's ADR/Allergy profile. PCC attending physician also added an addendum note regarding influenza vaccine contraindication as "severe reaction in previous dose/contraindicated" No other detailed information was provided regarding reaction treatment, the product, when and where it occurred, who administered the vaccine, vaccine manufacturer, Expiration date, lot number etc. Unable to find on patient immunization profile. Other Relevant HX: Other: ANAPHYLAXIS
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Myalgia
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Reported Symptoms: 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MALAISE; MUSCLE PAIN
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: HEPAB, PNC21, TDAP
Symptoms: Blood pressure decreased, Death, Palpitations
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BLOOD PRESSURE DECREASED; PALPITATIONS; Information has been received from a health authority (agency # 2836036-1). This spontaneous report refers to a(n) 51-year-old female patient. The patient's medical history included Past Stroke and blood pressure control with triptans. The patient's concurrent conditions included Blood pressure control. Concomitant medications included Trazodone hydrochloride, Pantoprazole, Oxybutynin, Ropinirole, Famotidine, Meloxicam, Atorvastatin. On 26-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXVIVE) Injection, lot #Y019158, expiration date was not reported but upon internal validation was established as 20-MAY-2026, administered by Intramuscular route; Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot #M4834, administered by Intramuscular route (expiration date was not reported); along with Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX); all vaccines were administered for prophylaxis. On the same date, soon after vaccination but already at home, the patient experienced blood pressure went down and the hear stater racing (palpitations). On 09-APR-2025, the patient died due to the events. It was unknown whether an autopsy was performed. The causal relationship between the events of and the suspect vaccines were not reported. Executive summary received on 29-JUL-2025. Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V116 0.5ML 1DOSE SYR Batch number 0001791496 material number 2017970 at MSD which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. Due to the nature of this AE-QIR, a drug substance (DS) review was performed by DS manufacturing site MSD. The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of these Drug Substance batches. The investigation concluded that the Drug Substance batches conform to all release specifications. There have been no additional requests for information or additional testing relating to this Adverse Event.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2836036 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :; Reported Cause(s) of Death: BLOOD PRESSURE DECREASED; PALPITATIONS
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
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This pharmacist reported that a 40 year old male patient received his first dose of Gardasil on 23-Feb-2024. His next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist wondered if he has to restart his series.; This spontaneous report was received from a Pharmacist and refers to a 40-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-Feb-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, units and route of administration were not reported) lot #W007026, which was confirmed to be valid and the expiration date was verified to be 12-Apr-2024, for prophylaxis. It was reported that the patient's next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist wondered if he had to restart his series (Inappropriate schedule of product administration).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
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Pharmacist reported that a patient received first dose (w014513 exp 1/26/2025) of GARDASIL 9 on 7/18/2024 and the second dose (z018414 exp 12/11/2025) on 7/15/2025. No additional AEs were reported, no further information provided. No PQC.; no additional adverse event; Information has been received from Business Partner/CRO on 15-Jul-2025. This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Jul-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #W014513, expiration date: 26-Jan-2025), dose number 1, for an unknown indication. On 15-Jul-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Unknown), dose number 2, (indication and expiration date were not reported) (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
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two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable. The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316283).; Reporter's Comments:
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
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two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable. The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316262).; Reporter's Comments:
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: FLUX, VARZOS
Symptoms: Erythema
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Angry Red Shoulder; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of localized erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patients received Shingrix (unknown arm) and Flu vaccine. On an unknown date, an unknown time after receiving Shingrix and Flu vaccine, the patients experienced localized erythema (Verbatim: Angry Red Shoulder). The outcome of the localized erythema was resolved. The reporter considered the localized erythema to be related to Shingrix. It was unknown if the reporter considered the localized erythema to be related to Flu vaccine. The company considered the localized erythema to be related to Shingrix. It was unknown if the company considered the localized erythema to be related to Flu vaccine. Additional Information: GSK Receipt Date: 18-JUL-2025 A Population Health Pharmacist at a top 200 healthcare system wanted to know if certain patients had a genetic predisposition to experience more severe local reactions with Shingrix. She shared that some patients experienced an angry red shoulder, while others could barely tell where the vaccination had been given. She had seen the same thing when patients received an adjuvanted flu vaccine. When asked about the age of the patients in whom she had noticed this difference more often, she shared that it was usually not the elderly, but patients in their 40s and 50s.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Skin lesion, Vaccination failure
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mild shingles outbreak two months ago; suspected vaccination failure/Lack of drug effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (experienced 20 years ago, treated with one round of Prednisone and it resolved.). Previously administered products included Prednisone (polymyalgia rheumatica treated with one round of Prednisone). Concurrent medical conditions included hypercholesterolemia and atrial fibrillation. Concomitant products included lovastatin and apixaban (Eliquis). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix (intramuscular, unknown deltoid). In MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: mild shingles outbreak two months ago). In MAY-2025, the outcome of the shingles was resolved. The outcome of the vaccination failure was not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 23-JUL-2025 The patient reported that he had received both doses of Shingrix about 10 years ago, stating it had been confirmed to be "the new vaccine." He experienced a mild shingles outbreak two months prior. He had only a few lesions on his right back and side, accompanied by tingling on the right side and right front of his trunk. This was treated and resolved quickly. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
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suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 09-AUG-2022, the patient received the 2nd dose of Shingrix. On 12-MAR-2022, the patient received the 1st dose of Shingrix. On 21-JUL-2025, 1077 days after receiving Shingrix and 1227 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with mupirocin (Bactroban). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-JUL-2025 The patient received first and second dose of Shingrix and a week ago (Monday from reporting date), the patient developed shingles. The rash was on his left side near his hip and on his left side center back. His doctor prescribed an antiviral and Bactroban (mupirocin) ointment 2 percent. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 39.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
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had two outbreaks of shingles since then and one in July; Suspected vaccination failure; had two outbreaks of shingles since then One in March; 39 years patient received Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 39-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included renal disease. In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 years patient received Shingrix). In MAR-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two outbreaks of shingles since then One in March). In JUL-2025, the patient experienced shingles (Verbatim: had two outbreaks of shingles since then and one in July). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JUL-2025 The patient received the Shingrix vaccine in December and had two outbreaks of shingles since then which was one in March and one in July. The patient was very disappointed. The patient thought it was supposed to prevent future outbreaks and had to go on medication for them and was not supposed to take it because of his/her kidney disease. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure?is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
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numbness and tingling in his fingers started this morning; numbness and tingling in his fingers started this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Concurrent medical conditions included Arthritis. Concomitant products included Cyclobenzaprine hydrochloride (Cyclobenzaprine), Duloxetine hydrochloride (Duloxetine), Tamsulosin hydrochloride (Tamsulosin), Tadalafil and Tadalafil (Cialis) for an unknown indication. On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 01-Aug-2025, the patient experienced HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning). At the time of the report, HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The HCP was not aware of any other vaccines administered 4 weeks prior to Spikevax. The patient received most of his vaccines and had some pain medications at the pharmacy. The HCP enquired about a side effect one of their patients experienced after receiving the COVID-19 vaccine the previous day. On the morning of 01-Aug-2025, a patient contacted the pharmacy to report experiencing numbness in their fingers following administration of the COVID-19 vaccine the previous day. The pharmacist spoke with the patient over the phone. The HCP believed the numbness and tingling in his fingers began that same morning and had not yet resolved. After conducting some research, the HCP was unable to find substantial information on this side effect and sought to learn whether similar cases had been reported. She was particularly interested in understanding the outcomes of those cases and whether there is a typical timeline for resolution. It was unknown if the patient experienced any additional symptoms or events.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
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Patient received Fluzone HD on 7/22/25 and again on 8/4/25. Patient reports no adverse events or side effects.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 59.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Peripheral swelling
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Patient describes waking up the next morning with a swollen arm, with two knots at the injection site, the entire area red and hot to touch. She reports that the two knots when the injections were given disappeared the next day. This morning she contacted the pharmacy to report that her arm was still red from the shoulder to elbow and hot to touch.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
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Back to school event, 9 yr. old was given Pfizer (6 mths-4yrs) vaccine. Minor sent to post vaccination observation and after 15 minutes monitoring minor was dismissed.Noticed the vial closely when entering vaccine information to database, wrong vaccine was given,notified clinic lead on site.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
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resident passed away
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
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7/29/25 at 1200pm patient received his 3rd Twinrix vaccine. Administered into right deltoid with a 25G x1 inch safety hypodermic needle. As this RN was pushing in vaccine, employee stated it was painful compared to the other 2 doses. Complained of continued pain while in health center. Employee given Ibuprofen 200 mg (2 tablets) at 1207pm. Advised to keep arm moving. Denied any numbness or tingling. Employee stated he had minimal discomfort and left department at 1218pm. 8/5/25 1339 employee came back into health center complaining of right arm pain. "I can raise my arm to about shoulder height, then I have to push through the pain. And it gets stiff, and I have to work it out to loosen it up." Reports taking Ibuprofen 200 mg x3 tabs twice a day. Denies any pain into shoulder or down into bicep/arm. Recommended alternate ice/heat, alternate Tylenol/Ibuprofen and follow package direction.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: Product container issue
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the vial of the glass breaking while we were giving the vaccine; the vial of the glass breaking while we were giving the vaccine; administered to the patient; This is a spontaneous report received from a Consumer or other non HCP. A 6-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2025 as dose number unknown, single (Lot number: LP4946, Expiration Date: Aug2026) at the age of 6 months intramuscular, in left vastus lateral. for immunisation, Device Lot Number: LP4946, Device Expiration Date: Aug2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine"; POOR QUALITY DEVICE USED (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine; administered to the patient". Additional information: Reporter stated that medication issue they had this morning(31Jul2025) of a vial breaking while giving a vaccine. Packaging sealed and intact. It was administered to the patient and the patient got the full vaccine. Lab working (Past 2 week) was Unknown. The "lab was no" but reporter was not sure. Causality for "the vial of the glass breaking while we were giving the vaccine" and "the vial of the glass breaking while we were giving the vaccine; administered to the patient" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Loss of consciousness, Mobility decreased
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12+ hours after receiving the vaccine patient reported that she began to feel like she couldn't move, also felt like she was having trouble breathing. Father states she lost consciousness briefly. Symptoms resolved, then the following day, 8/5/25 around 3:00pm patient stated she began feeling like she couldn't move her arms and legs.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: [ICH-Unidentifiable patient]. Upon receipt of follow-up information on (24Jul2025), this case now contains all required information to be considered valid. This is a literature report. A 26-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 3 (booster), single and on 27Mar2023 as dose 4 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "dysfunctional uterine bleeding" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "Attention-deficit hyperactivity disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia; LEVONORGESTREL taken for contraception; TESTOSTERONE taken for hypogonadism; BUSPIRONE taken for anxiety; SERTRALINE taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "recovered" (14Apr2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: There is not a reasonable possibility that the reported event covid-19 was related to the suspect product event most likely due to patient underlying contributory factors.,Linked Report(s) : US-PFIZER INC-PV202500078537 Same article, drug, event and different patient;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: PNC20
Symptoms: Product container issue
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this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.". Additional information: The reporter stated, all the liquid was still in the vaccine. The vaccine was not administered to any patient, as they got another dose and we used that to administer the dose. The reporter considered "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Product Quality Group provided investigational results on 01Aug2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 24Jul2025, this case now contains all required information to be considered valid. This is a literature report. A 40-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 4 (booster), single and on 30Mar2023 as dose 5 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chronic low back pain" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "gastroesophageal reflux disease" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "Migraine without aura" (unspecified if ongoing); "Nausea associated with migraines" (unspecified if ongoing); "Peripheral sensory neuropathy" (unspecified if ongoing); "Muscle pain" (unspecified if ongoing); "Headache" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease; PROCHLORPERAZINE taken for anxiety; SUMATRIPTAN taken for migraine without aura; CLONAZEPAM taken for depression; INTRAUTERINE CONTRACEPTIVE DEVICE taken for contraception; DESVENLAFAXINE taken for depression; GABAPENTIN taken for depression; EPTINEZUMAB taken for migraine without aura, headache; PARACETAMOL taken for myalgia; NAPROXEN taken for myalgia; BREXPIPRAZOLE taken for depression. Past drug history included: Bactrim, reaction(s): "bactrim allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Apr2023, outcome "recovered" (01May2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event covid-19 based on the known safety profile and temporal association.,Linked Report(s) : US-PFIZER INC-202500156631 Same article, drug, event and different patient;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: HEP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
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adacel was administered to a newborn instead of hepatitis b with no reported adverse event; adacel was administered to a newborn instead of hepatitis b with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 day old male patient who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to a newborn instead of Hepatitis B Vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Aug-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (Lot U8274AA, expiry date 31-Aug-2026, strength standard and frequency once) via intramuscular route in unknown administration site for Immunisation and it was administered to a newborn instead of Hepatitis B Vaccine with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
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Expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 28-JUL-2025, the patient received Infanrix. On 28-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-JUL-2025 A Nurse Practitioner mentioned he did not realize that he gave a Infanrix vaccine that was a little bit past the expiration date which led to expired vaccine used.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I contracted covid 4 times, I stopped taking vaccines as it was not protecting me". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal
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About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad; Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious), outcome "unknown", described as " About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me". Additional information patient went to get the vaccine (Pfizer COVID-19 Vaccine) about like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed and I think they are related. Consumer stated, Ever since I, this is very related to the vaccine. So, I told you ever since I got the vaccine (Pfizer COVID-19 Vaccine), I have been a little sad but along or soon I also kind of feel like I have hamster and for some reason I had it (hamster) for years and he's just been a really pet of mine and I loved them but I got this vaccine shot for COVID about two weeks ago and ever since then I can't stop thinking about putting this hamster in my butt hole, so weird, I don't know have you had any report about that or I might be the only one? I felt like getting my hamster doing that and it's been bothering me, and I feel like it has to do with the vaccine (Pfizer COVID-19 Vaccine) Consumer stated, I am sorry, I have 'pauperism autism' (further not clarified). So, some times I say retracted things. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: MNP
Symptoms: Headache, Pain in extremity
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having like under other arm she did not get injection, she felt heavy on her other arm; sore arm; Having headache everyday; This is a spontaneous report received from a Consumer or other non HCP. A female patient received meningococcal group abcwy vaccine (PENBRAYA), in Jul2025 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jul2025, outcome "unknown", described as "Having headache everyday"; LIMB DISCOMFORT (non-serious) with onset Jul2025, outcome "recovered" (2025), described as "having like under other arm she did not get injection, she felt heavy on her other arm"; PAIN IN EXTREMITY (non-serious) with onset Jul2025, outcome "unknown", described as "sore arm". Additional information: The reporter stated, "Yes, my daughter get a vaccine for Penbraya the meningitidis vaccine like a week ago and then she had, at the beginning the first two days sore arm which is normal and then while she took the vaccine, she was on her menstrual period too, right and then she started having like under other arm she did not get injection, she felt heavy on her other arm and then for one or two days and it went away but after her period was over and like Sunday, on Sunday last week after that she started having headache every day. So, I was wondering is this related to the Penbraya vaccine or?" When paraphrased the above concern: Reporter stated, "Last Wednesday and then she was having sore arm under that she got the shot and then the first two days and then next two days she started having the other arm feeling heavy." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid". The clinical course was reported as follows: The patient was diagnosed with COVID-19 and he found a pack of nirmatrelvir;ritonavir (PAXLOVID) dates Sep2022 and he also got Pfizer COVID-19 vaccines shot twice before but still got COVID-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; This is a spontaneous report received from a Consumer or other non HCP,. A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cataracts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated, "The doctor just prescribed Paxlovid for me. I got COVID. I can't afford the medicine, Paxlovid. I have cataracts, and I am old. Well, I do want to say that I do like the Pfizer medication program. I've always used the Pfizer shots, and all that stuff, I can appreciate this." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID". The events "she had the vaccine 6 times, and the last one being in october, and this is the first time having covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was vaccinated 6 times against COVID, counting the recommended boosters. The last one was on 15Oct2024 and it would be one year since the last COVID vaccination. It was the patient's first time having COVID. Doctor ordered a prescription at a pharmacy and was told that she would be given a voucher for Paxlovid. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
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Patient reported to pharmacy #5619 where she received her vaccination 2 days ago, and showed that her upper left arm around the vaccination site was visibly red and bruised. Reported that there was pain and a burning sensation that's been progressing since she received her vaccine. Patient was advised to treat any symptoms and discomfort with ibuprofen and/or acetaminophen and to ice around the site, and that the pharmacist will check with her tomorrow and see how she is feeling. Will also reach out to her physician if anything progresses.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin irritation
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Pharmacy was contacted by physician stating patient's left arm was irritated and itchy
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Retching, Tremor
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In the middle of the night after receiving the vaccine, patient started getting shakes, dray heaves, and felt freezing cold. Symptoms lasted for about 2 days
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
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I got shingles a week after the Covid 19 vaccine. It was early onset (I was in my young 40s) and I believed it to be directly related to the vaccine. I?ve heard from others that shingles activation is not uncommon.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Coronary artery bypass, Dialysis, End stage renal disease, Herpes zoster, Pain in extremity
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Coronary artery bypass, Dialysis, End stage renal disease, Herpes zoster, Pain
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Vaccination failure
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open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos. On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2018GSK223654 Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient. The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018. At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024. The patient did not developed blisters from the Shingles but has pain which she has not had any relief since. The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain. The patient was currently on Dialysis due to End Stage Renal Disease. The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atypical pneumonia, Bronchitis, Chills, Deafness, Diarrhoea
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loss of hearing; Walking pneumonia; swelling around the injection site; soreness around the injection site; ear infection; bronchitis; dry skin; wrinkling skin; 2nd dose not yet received; shingles on the left leg above the knee; This serious case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive 2nd dose of Shingrix. In JUL-2020, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the left leg above the knee). On an unknown date, the patient experienced hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant), walking pneumonia (Verbatim: Walking pneumonia) (serious criteria GSK medically significant), injection site swelling (Verbatim: swelling around the injection site), injection site pain (Verbatim: soreness around the injection site), ear infection (Verbatim: ear infection), bronchitis (Verbatim: bronchitis), dry skin (Verbatim: dry skin), skin wrinkling (Verbatim: wrinkling skin) and incomplete course of vaccination (Verbatim: 2nd dose not yet received). The outcome of the hearing loss, injection site swelling, injection site pain, shingles, ear infection, bronchitis and dry skin were resolved and the outcome of the walking pneumonia was not reported and the outcome of the skin wrinkling was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the hearing loss, walking pneumonia, injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix. The company considered the hearing loss and walking pneumonia to be unrelated to Shingrix. It was unknown if the company considered the injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix. Additional Information: GSK Receipt Date: 03-DEC-2020 The reporter reported that the patient received the first dose of Shingrix vaccine on 10-DEC-2019 and had not received the second dose yet (Inappropriate schedule of vaccine). Patient reported the day after receiving the vaccine she was achy, had a headache, was exhausted, had soreness around the injection site, had chills, had swelling around the injection site, diarrhea, shivering, and muscle pain. Patient reported these events lasted 3 to 4 days and then resolved. Patient reported she was diagnosed with shingles in July 2020. Patient reported shingles on the left leg above the knee, had itching, redness, and pain around the area of shingles. Patient reported dry skin, wrinkling skin, and peeling skin around the area of shingles. Patient reported these events lasted a couple of weeks with the exception of the wrinkling skin which was still ongoing at this time. Patient reported her doctor prescribed an antiviral medication for the shingles. Patient reported she had bronchitis and an ear infection in January 2020 and these have resolved. Patient reported she was prescribed steroids for the bronchitis. Patient reported she had a loss of hearing around January 2020 that lasted for 30 days and resolved. Follow up information received on: 22-JUL-2025 The reporter states she received her first dose of Shingrix vaccine in January or February of 2020. Consumer states she was never informed that she needed to have a second dose administered, therefore, she did not have the second dose of Shingrix vaccine (missed dose.) Consumer states she had a small case of shingles after having the first dose (date not disclosed / lack of effect.) The consumer states after having the first dose of Shingrix she was lethargic, achy, and had a fever. The consumer stated that there was no record of her having had the first dose administered as the doctor's office where the vaccine was administered failed to record/report the injection. During the call the consumer stated she will speak with her doctor about having the second dose administered but was worried about the potential adverse events she may have and worried about efficacy. The consumer states that she has recently been diagnosed with walking pneumonia. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. Summary of changes: Patient tab, product tab, event details and narrative were updated.; Sender's Comments: A case of Deafness and Atypical pneumonia, an unknown time after receiving Shingrix, in a 68-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GLAXOSMITHKLINE-US2020239776:same reporter
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry skin, Ear infection, Erythema, Fatigue, Headache
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loss of hearing; Walking pneumonia; swelling around the injection site; soreness around the injection site; ear infection; bronchitis; dry skin; wrinkling skin; 2nd dose not yet received; shingles on the left leg above the knee; This serious case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive 2nd dose of Shingrix. In JUL-2020, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the left leg above the knee). On an unknown date, the patient experienced hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant), walking pneumonia (Verbatim: Walking pneumonia) (serious criteria GSK medically significant), injection site swelling (Verbatim: swelling around the injection site), injection site pain (Verbatim: soreness around the injection site), ear infection (Verbatim: ear infection), bronchitis (Verbatim: bronchitis), dry skin (Verbatim: dry skin), skin wrinkling (Verbatim: wrinkling skin) and incomplete course of vaccination (Verbatim: 2nd dose not yet received). The outcome of the hearing loss, injection site swelling, injection site pain, shingles, ear infection, bronchitis and dry skin were resolved and the outcome of the walking pneumonia was not reported and the outcome of the skin wrinkling was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the hearing loss, walking pneumonia, injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix. The company considered the hearing loss and walking pneumonia to be unrelated to Shingrix. It was unknown if the company considered the injection site swelling, injection site pain, shingles, ear infection, bronchitis, dry skin and skin wrinkling to be related to Shingrix. Additional Information: GSK Receipt Date: 03-DEC-2020 The reporter reported that the patient received the first dose of Shingrix vaccine on 10-DEC-2019 and had not received the second dose yet (Inappropriate schedule of vaccine). Patient reported the day after receiving the vaccine she was achy, had a headache, was exhausted, had soreness around the injection site, had chills, had swelling around the injection site, diarrhea, shivering, and muscle pain. Patient reported these events lasted 3 to 4 days and then resolved. Patient reported she was diagnosed with shingles in July 2020. Patient reported shingles on the left leg above the knee, had itching, redness, and pain around the area of shingles. Patient reported dry skin, wrinkling skin, and peeling skin around the area of shingles. Patient reported these events lasted a couple of weeks with the exception of the wrinkling skin which was still ongoing at this time. Patient reported her doctor prescribed an antiviral medication for the shingles. Patient reported she had bronchitis and an ear infection in January 2020 and these have resolved. Patient reported she was prescribed steroids for the bronchitis. Patient reported she had a loss of hearing around January 2020 that lasted for 30 days and resolved. Follow up information received on: 22-JUL-2025 The reporter states she received her first dose of Shingrix vaccine in January or February of 2020. Consumer states she was never informed that she needed to have a second dose administered, therefore, she did not have the second dose of Shingrix vaccine (missed dose.) Consumer states she had a small case of shingles after having the first dose (date not disclosed / lack of effect.) The consumer states after having the first dose of Shingrix she was lethargic, achy, and had a fever. The consumer stated that there was no record of her having had the first dose administered as the doctor's office where the vaccine was administered failed to record/report the injection. During the call the consumer stated she will speak with her doctor about having the second dose administered but was worried about the potential adverse events she may have and worried about efficacy. The consumer states that she has recently been diagnosed with walking pneumonia. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. Summary of changes: Patient tab, product tab, event details and narrative were updated.; Sender's Comments: A case of Deafness and Atypical pneumonia, an unknown time after receiving Shingrix, in a 68-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GLAXOSMITHKLINE-US2020239776:same reporter
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