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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Dizziness, Drug ineffective, Fatigue
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fatigue; dizziness; fogginess; covid again the past Jun; covid again the past Jun; 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 included: "covid", start date: Jul2020 (unspecified if ongoing). The patient's 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), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "covid again the past Jun"; FATIGUE (hospitalization), outcome "unknown"; DIZZINESS (hospitalization), outcome "unknown"; BRAIN FOG (hospitalization), outcome "unknown", described as "fogginess". Clinical Course: Patient reported taking 4 pfizer vaccines and covid again the past Jun. Currently on leave because of neurological and vestibular symptoms due to covid. Patient was in the hospital diagnosed with fatigue, dizziness and fogginess and is interested in participating in a trial. 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: F
Vaccine: FLU3
Symptoms: Breast pain, Injection site pain, Pain
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It hurt like a normal vaccine, but after two or three hours it started getting even worse; It was from her elbow to shoulder, the vaccine was on the right hand side/ The pain went to entire upper arm; The pain went down almost to waist and the right side of upper torso; The pain landed in the breast; This spontaneous case, initially received on 30-Jul-2025, was reported by a non health professional and concerns an elderly female patient. Past medical history included biopsy. Concomitant Medications reported as unknown Administration of company suspect drug: On an unknown date in Nov-2022, the patient received Fluad (TIV) for influenza prophylaxis. Dose regimen: Not reported. Route of administration: Not reported. Anatomical location: right hand side. Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2022, the patient experienced It hurt like a normal vaccine, but after two or three hours it started getting even worse (Medically Significant, outcome: Recovered/resolved), It was from her elbow to shoulder, the vaccine was on the right hand side / The pain went to entire upper arm (Medically Significant, outcome: recovered/resolved), The pain went down almost to waist and the right side of upper torso (Medically Significant, outcome: recovered/resolved), The pain landed in the breast (Medically Significant, outcome: recovered/resolved). Patient stated that she received Fluad back in Nov-2022 and blew up in her arm and upper torso. When asked if the adverse reaction started right after taking the vaccine, caller states: Not really. It hurt like a normal vaccine, but after two or three hours it started getting even worse. Through the night, it was from her elbow to shoulder, the vaccine was on the right hand side. The pain went to entire upper arm, and down almost to waist and the right side of upper torso. No hives, no breathing issues, it was just severe pain. When asked if there was any treatment associated with the adverse reaction, patient mentioned that once she got a hold of her doctor, the pain had already subsided except for the upper half portion of her torso. Transcribed from call: The pain lasted and eventually, she ended up going to the doctor, because the pain landed in the breast, and eventually went to the breast surgeon. Nobody could see anything but they could recognize that she was in a lot of pain. It went away everywhere else, except there. Patient ended up going to two different breast surgeons, two different hospitals, because everybody acknowledged that she was in pain but nobody could find anything. Gradually, it took about a year for the pain to finally dimmish. After the fact, she was hospitalized to get a biopsy done when she told her doctor about the symptoms she had experienced following vaccination; patient was then told by the doctor that due to the severity of the reaction, she should have gone directly to the emergency room. When asked to confirm if the hospitalization was due to the adverse reactions from the vaccine, caller said not for that. Stated that after consulting with two different breast surgeons, she was referred to an allergist so she could be tested for every component in the vaccine. Stated needing the PI for the 2022-2023 season so the doctors could be made aware of which ingredients to test for. Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter (patient), reporting 30-Jul-2025, on considered the events as serious (Medically Significant) and did not provide the causality assessment.; Reporter's Comments: Causality : Due to the spontaneous nature of the case, the events are considered related for reporting purposes. Related for events vaccination site pain, pain in extremity and radiating pain due to close temporal association and anatomical proximity (after2-3 hours of vaccine). Related for breast pain due to plausible temporal association (reported as "eventually pain landed in breast"). However there is insufficient information on biopsy details.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
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Gillian Barre; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Gillian Barre) (serious criteria death and GSK medically significant). The reported cause of death was guillain barre syndrome. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a consumer via interactive digital media. Reporter did not get the shingles vaccine. He/she had a friend who got it, and she died from Guillain-Barre syndrome. Look it up.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a 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.; Reported Cause(s) of Death: 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: 78.0
Sex: M
Vaccine: UNK
Symptoms: Atrial fibrillation, Cardiac pacemaker insertion, Magnetic resonance imaging head abnormal, Sinus node dysfunction, Syncope
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sick sinus syndrome; Intermittent Syncope; Atrial Fibrillation; This 79-year-old male subject was enrolled in an open label study titled A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. The subject received the 3rd dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) 120 µg on 19-APR-2023, for prophylaxis. In DEC-2023, between 7 and 9 months after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 sick sinus syndrome (Verbatim: sick sinus syndrome) in DEC-2023 with serious criteria of hospitalization and moderate - grade 2 syncope (Verbatim: Intermittent Syncope) in DEC-2023 with serious criteria of hospitalization. The outcome of atrial fibrillation was not resolved. The outcome(s) of the additional event(s) included sick sinus syndrome (resolved in FEB-2024) and syncope (resolved in APR-2025). Relevant Tests: On Unk/Dec/2023, Subject reported a brain MRI (Magnetic resonance imaging) showed 2 posterior vessels were obstructed.. The investigator considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2024051986, US2025100252 GSK receipt date: 23-Apr-2024 Hospital records pending Hospital records still pending as of 5/28/2024 Subject admitted to hospital for syncope. In February 2024, he had atrial fibrillation and a sick sinus syndrome for which a pacemaker was placed 14FEB2024. This was an AESI. 6/19/2024: Hospital records had not been received. Intermittent Syncope began unDEC2023 for which he was treated for as well during hospitalization. 11/13/2024: Hospital records had not been received. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 07-MAY-2024 Summary of change : Narrative updated. Follow up information received on 28-MAY-2024 On 28-May-2024, the case US2024051986 was identified as duplicate of US2024051985. The case US2024051986 was prepared for deletion and all future correspondence will be added to the case US2024051985. Summary of change : Narrative updated, Event term updated from Atrial Fibrillation to Atrial Fibrillation and Intermittent Syncope Follow-up information received on :- 10-Jul-2024 Summary of changes:- SAE term updated to Atrial Fibrillation from Atrial Fibrillation and Intermittent Syncope. AESI sentence updated in narrative. Follow up information received on 18 Jul 2024 and 19 Jul 2024 Summary of changes: General narrative was updated. Follow up information received 25-JUL-2024 Summary of changes: New events sick sinus syndrome, Intermittent Syncope and narrative updated. Follow up information received 18-Sep-2024. Summary of changes: "The subject withdraw from study due to event of Atrial Fibrillation" sentence removed and narrative was updated. Follow up information received 13-NOV-2024 Summary of changes: General narrative was updated. Follow up information received on 04-Aug-2025. Summary of changes: Outcome of events sick sinus syndrome and intermittent syncope updated from not recovered to recovered.; Sender's Comments: A case of Atrial fibrillation, Sinus node dysfunction and Syncope, between 7 and 9 months after receiving 3rd dose of RSVPreF3 vaccine + AS01E in a 79-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor for atrial fibrillation and sinus node dysfunction (age) and (brain MRI showed 2 posterior vessels were obstructed) for event syncope. US-GSK-US2024051986: US-GSK-US2025100252:
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Guillain-Barre syndrome, Mobility decreased
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I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome; Bedridden; I can't move at all; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome) (serious criteria GSK medically significant), bedridden (Verbatim: Bedridden) and mobility decreased (Verbatim: I can't move at all). The outcome of the guillain barre syndrome, bedridden and mobility decreased were not resolved. It was unknown if the reporter considered the guillain barre syndrome, bedridden and mobility decreased to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the bedridden and mobility decreased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-AUG-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome. He or she also reported that become so weak and can't move at all, and the treatment for Gillian Barre had started to affect my kidneys. He or she was now completely bedridden. The follow-up could not be possible as no contact details were available.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a 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.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
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Chronic hives treated biweekly Xolair and daily Xyzal
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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: PNC21
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis
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Patient received PCV21 vaccine on 05 August 25 and woke up on 06 Aug 25 with sweating, left arm pain, chills, light headedness, loss of control of bladder, fatigue, hip pain, right arm pain and generalized inflammation in the area of vaccination. Patient was seen in clinic 08 Aug 2025, and treated with the following medications for the next seven days: Zyretc 10mg, Pepcid 20mg, Hydrocortisone cream 1% , Decadron 4mg IM.
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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: PNC21
Symptoms: Injection site inflammation, Injection site pain, Pain in extremity, Urinary incontinence
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Patient received PCV21 vaccine on 05 August 25 and woke up on 06 Aug 25 with sweating, left arm pain, chills, light headedness, loss of control of bladder, fatigue, hip pain, right arm pain and generalized inflammation in the area of vaccination. Patient was seen in clinic 08 Aug 2025, and treated with the following medications for the next seven days: Zyretc 10mg, Pepcid 20mg, Hydrocortisone cream 1% , Decadron 4mg IM.
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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: F
Vaccine: FLU3
Symptoms: Diarrhoea, Inflammation, Urticaria, Vertigo
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Patient reported getting a whelt, nausea, diarrhea, inflammation and vertigo symptoms during the night after vaccine.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
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Patient had itching following administration
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head abnormal, Electroencephalogram abnormal, Epilepsy, Hyperventilation, Magnetic resonance imaging head normal
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She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncopal episode, then subsequently in the ED that same day for seizures. She was admitted to the hospital and has been managed with neurology for epilepsy since then. Dad is unsure if incident was reported through the vaccine adverse events system at the time of the event, but would like to make sure it is.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Scalp haematoma, Seizure, Syncope, Ultrasound abdomen normal
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She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncopal episode, then subsequently in the ED that same day for seizures. She was admitted to the hospital and has been managed with neurology for epilepsy since then. Dad is unsure if incident was reported through the vaccine adverse events system at the time of the event, but would like to make sure it is.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
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The patient received an adult dose of Moderna.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered, No adverse event
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Patient was given two doses of Prevnar 20. One was given on 02/14/2025 and the other on 08/06/2025. No adverse symptoms were reported by patient.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain, Vaccination site urticaria
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Body aches and pains; Chest pain within 48 hours. A 5/10 on pain. Tightness; raised warm welt at injection site within 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) in a 24-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Aug-2025, the patient experienced PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours). At the time of the report, PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had body aches and pains, raised warm welt at injection site within 24 hours, chest pain within 48 hours, A 5/10 on pain, and tightness. It was unknown if she experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. There were no lab data/results available. Treatment medication was not 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: COVID19
Symptoms: Breakthrough COVID-19, Polymerase chain reaction
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Got Covid about 9 months after getting Novavax, last August 2024; This non-serious initial spontaneous report was reported by a Physician via contact center (MI No. NOV25-00560) and concerns a 69-year-old Female who experienced "GOT COVID ABOUT 9 MONTHS AFTER GETTING NOVAVAX, LAST AUGUST 2024" on an unspecified date in August 2024 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on an unknown day. At the time of the report, the outcome of the Breakthrough COVID-19 was Unknown.; Sender's Comments: This 69-year-old Female experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Breakthrough COVID-19 was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Insomnia, Pain
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Upper Back pain; excruciating pain; unable to sleep consistently through the night; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 at 12:30 as dose 3, single (Lot number: SENG6198) at the age of 57 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Hypersensitivity". The following information was reported: BACK PAIN (non-serious), outcome "recovering", described as "Upper Back pain"; PAIN (non-serious), outcome "recovering", described as "excruciating pain"; INSOMNIA (non-serious), outcome "recovering", described as "unable to sleep consistently through the night". Additional information: the pain starts on the right side of his ribs.
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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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tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP. A 65-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Aug2025, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes simplex, Pyrexia, Vomiting
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diagnosed with COVID-19; diagnosed with COVID-19; broke out with "herpes simplex" virus all over her face; fever; threw up; This is a spontaneous report received from a Consumer or other non HCP. A 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series completed), for covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "broke out with "herpes simplex" virus all over her face"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "threw up". Clinical course: Caller is a consumer, calling to report AE after receiving COVID-19 booster shots. After receiving booster shots she broke out with herpes simplex virus all over her face, had a fever, threw up and was diagnosed with COVID-19. Needs patient assistance for Paxlovid. Patients have government funded insurance. 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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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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Their Covid shot failed; Their Covid shot failed; 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 "Their Covid shot failed". Clinical course: The reporter stated that Pfizer's Covid shot failed. 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
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COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. During an inbound call for financial assistance, the patient wanted to know what she has to do to try to lower the cost of COVID-19 medicine, because she currently has COVID. The patient got COVID and got to take a break from work. The patient remembers when this stuff was free. The patient had nirmatrelvir/ritonavir (PAXLOVID) before for COVID. Per patient, it didn't feel like this time. The patient was sicker than she was last time. But the patient had a couple shots and boosters, but then she hadn't had it in a long time. The patient had been in the patient assistance program before. The patient inquired if she could go take that COVID shot.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: Malaise
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Perhaps too effective because it made me feel horrible; 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 number unknown, 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: MALAISE (non-serious), outcome "unknown", described as "Perhaps too effective because it made me feel horrible". Additional information: Patient reported that yes, the covid shot was incredibly effective. Perhaps too effective because it made me feel horrible. 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: RSV
Symptoms: Nervous system disorder, Respiratory failure
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respiratory failure; neurological distress; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY FAILURE (hospitalization, medically significant), 30 days after the suspect product(s) administration, outcome "unknown"; NERVOUS SYSTEM DISORDER (hospitalization), 30 days after the suspect product(s) administration, outcome "unknown", described as "neurological distress". No prior symptoms or diagnosis before the vaccine. Patient has been in the hospital/long term care (LTC) for over 100 days. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v 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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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated; the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, 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) all with onset 2024, outcome "unknown" and all described as "the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated". The clinical course was reported as follows: Patient was a teacher working in a fitness facility and they felt vulnerable. The patient didn't know if they should get another dose before school started or wait until the new version was available, but that might be after school started. The patient asked if they could get another dose every 6 months. Two years ago, the patient's superintendent urged them to get vaccinated before they came to school because of the likelihood of a surge with kids coming back into the classroom. The following year, patient did get COVID and got pretty sick with it even though they did get vaccinated. 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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Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Death, Pyrexia
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Fever, 2 days later death occurred
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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: F
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Dizziness, Fatigue, Heart rate decreased
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Fell ill - high fever. Extremely body aches, dizziness, extremely fatigue, nausea, brain fog and extreme pain, ended up in the ER after a week from getting the vaccine. They claimed it was because I caught covid. O2 levels dropped to 86. Heart rate dropped to 38. Fever 104.
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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: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oxygen saturation decreased, Pain, Pyrexia
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Fell ill - high fever. Extremely body aches, dizziness, extremely fatigue, nausea, brain fog and extreme pain, ended up in the ER after a week from getting the vaccine. They claimed it was because I caught covid. O2 levels dropped to 86. Heart rate dropped to 38. Fever 104.
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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: COVID19, FLU3
Symptoms: Pain in extremity
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THe patient reported that she has been having pain in her arms since last October. She states she is unable to lift more than 15 pounds and that her arms fall asleep often.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
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Missed period 10+ days, no pregnancy. Unusual as it is always on time.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
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Missed period 10+ days, no pregnancy. Unusual as it is always on time.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pyrexia
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Large red spot, taking up most of the upper arm. Fever and signs of high immune activity. Started the next day and continued for several days with the red injection site growing every day until it stopped. it is now beginning to go down and the flu like symptoms are resolving.
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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: Fatigue, Injection site pain, Injection site swelling, Myalgia, Pain
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Swollen and sore at shot sight hour after shot I felt tired drowsy and sore
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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: Somnolence
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Swollen and sore at shot sight hour after shot I felt tired drowsy and sore
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid infection, Fatigue, Feeling abnormal, Hordeolum, Immune system disorder
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After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so bad, Then My eyelid becomes Swallen and infected and few days later I had about 25000 stye under my upper eyelid, and I went to Employee Healths, they sent me home, my doctor had prescribed me antibiotics and a lot of other treatment. I was stayed out of work for about 2 weeks, until all inflammation and infections healed. And until they cleared me to back to work. All this record in my doctor's office chart and in hospital Employees health as well. I paid out of my packet for all medication, and for my sick days-its was took out of my vacation PTO time. And this medication was not by my choices-its was mandatory for hospital workers. My immune system never come back to Normal.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Inflammation, Swelling of eyelid
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After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so bad, Then My eyelid becomes Swallen and infected and few days later I had about 25000 stye under my upper eyelid, and I went to Employee Healths, they sent me home, my doctor had prescribed me antibiotics and a lot of other treatment. I was stayed out of work for about 2 weeks, until all inflammation and infections healed. And until they cleared me to back to work. All this record in my doctor's office chart and in hospital Employees health as well. I paid out of my packet for all medication, and for my sick days-its was took out of my vacation PTO time. And this medication was not by my choices-its was mandatory for hospital workers. My immune system never come back to Normal.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 47.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Hypoaesthesia, Paraesthesia
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patient says that the next day after receiving the TWINRIX and FLUBLOK vaccine he started to experience numbness and tingling in his left arm and fingers
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimuli
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On 8/13/2023 Police was called to do a wellness check on patient because she did not report to work or answer multiple phone calls which was very unusual. Upon entering patient's home, she was found unresponsive with no sign of life. EMS was dispatched to the home where they confirmed that she was deceased. She was transported to Coroner's office where an autopsy was performed to determine the exact cause of death. The report indicated that she had passed from multiple Pulmonary Embolism and multiple Deep Vein Thrombosis. We believe her death was directly related the Pfizer Covid-19 SARS injections since she was otherwise a very healthy person who worked in the health system.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Continuous glucose monitoring, Diarrhoea, Eczema, Feeding disorder, Insomnia
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in September 2022, i ate a bag of M&Ms and started violently puking, diarrheaing, and passing out. because i had not received a diagnosis yet, i thought it was normal. in February 2024, i was diagnosed with type one diabetes. my pancreas is now dead and i have to take insulin shots and constantly monitor my sugar (i cant eat, i cant sleep, years are taken off my life). in addition to this, i have also developed eczema.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pancreatic disorder, Type 1 diabetes mellitus, Vomiting
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in September 2022, i ate a bag of M&Ms and started violently puking, diarrheaing, and passing out. because i had not received a diagnosis yet, i thought it was normal. in February 2024, i was diagnosed with type one diabetes. my pancreas is now dead and i have to take insulin shots and constantly monitor my sugar (i cant eat, i cant sleep, years are taken off my life). in addition to this, i have also developed eczema.
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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: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Carotid endarterectomy, Cerebrovascular accident, Inflammation
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Heart disease, stroke, carotid surgery, flammatory complications.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Chills, Condition aggravated, Continuous glucose monitoring, Headache
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With the headache, muscle aches, and chills my blood sugar has been consistently higher than usual with extreme highs with food
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Type 2 diabetes mellitus
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With the headache, muscle aches, and chills my blood sugar has been consistently higher than usual with extreme highs with food
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Myalgia, Pyrexia
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Chills, low headache, minor muscle ache, low temperature, general malaise
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Seizure
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The immunizer stated that the patient started to have a seizure about 7-110 minutes after the flu shot was given. It last less than 1 minute. She stayed in the immunization room for about 20 minutes with the store manager. PT stated that she has a history of seizures and wasn't sure it was related to vaccine.
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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: Fatigue
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my husband and I have received all Moderna Covid Shots - we never got covid - the problem is we are both physically exhausted all the time started about a year ago and we wanted to know if this could be a long term side effect of all the shots
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
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Guillaine Barre Syndrome
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 89.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
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Patient had previously received RSV (Arexvy) on 9/28/23. Per patient, she did not experience any adverse effects.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 93.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
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Patient had previously received RSV (Arexvy) on 9/28/23. Per patient, he did not experience any adverse effects.
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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: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Erythema, Inflammation
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THIS WAS THE VACCINE THAT CAUSED AN ADVERSE REACTION. WITH RED AND INFLAMED AREA.
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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: FLU3, PNC21
Symptoms: Fatigue, Injection site rash, Injection site warmth, Malaise, Mobility decreased
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THE PATIENT EXPERIENCED SEVERE MALAISE AND FATIGE. SHE COULD NOT GET OUT OF THE BED FOR 2 DAYS. SHE SLSO HAD A HUGE RASH ON HER LET ARM AT THE INJECTION SITE AND SURROUNDING AREA. IT WAS HOT TO THE TOUCH
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Anaphylactic reaction, Hypopnoea, Loss of consciousness, Urticaria
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Patient was administered the above vaccinations and within a few minutes, patient developed anaphylactic reaction which includes shallow breathing, hives and unconscious. I administered Epipen to the right thigh and within a few seconds, patient breathing was better and consciousness returned.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot
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PATIENT SCHEDULED 4 VACCINATIONS. THE PATIENT WAS IMMUNIZED FIRST WITH FLUARIX AND THEN GARDASIL. AFTER GARDASIL SHE FELT LIGHTHEADED AND OVERHEATED. THE IMMUNIZING INTER CALLED ME (RPH) INTO THE ROOM AND THE PATIENT APPEARED TO BE ON THE VERGE OF SYNCOPE BUT STATED SHE WAS JUST VERY AFRAID OF NEEDLES. SHE WAS GIVEN WATER AND PAPER TOWELS TO WIPE HER FACE. PATIENT AND HER PARENTS DECLINED OFFER TO CALL EMS. RECOMMENDED THE PATIENT NOT GET THE OTHER 2 VACCINATIONS (MENINGITIS AND TDAP) AT THIS TIME, BUT THE PATIENT STATED SHE FELT BETTER AFTER DRINKING WATER AND RESTING FOR 15 MINUTES AND PATIENT/PARENTS DECIDED TO CONTINUE WITH THE IMMUNIZATIONS. PATIENT REMAINED SEATED FOR 30 MINTUES WITH NO FURTHER ADVERSE EFFECTS.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Biopsy colon abnormal, Blood test abnormal, Colitis microscopic, Colonoscopy abnormal
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1. Severe recurring diarrhea, gas, bloating - diagnosed by Dr. 06/28/2022 via colonoscopy and biopsy; no previous history prior to COVID-19 vaccines; treated with budesonide, temporary relief only; condition worsened - treated with prednisone 10mg starting 12/2022 with some relief; recurring episodes of severe diarrhea treated with prednisione to current date. 2. Immune system no longer protective - CVID diagnosed 1/12/2024 by Dr.; no previous history prior to COVID-19 vaccines; currently treated with subcutaneous infusion of HyQvia.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Immunodeficiency common variable
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1. Severe recurring diarrhea, gas, bloating - diagnosed by Dr. 06/28/2022 via colonoscopy and biopsy; no previous history prior to COVID-19 vaccines; treated with budesonide, temporary relief only; condition worsened - treated with prednisone 10mg starting 12/2022 with some relief; recurring episodes of severe diarrhea treated with prednisione to current date. 2. Immune system no longer protective - CVID diagnosed 1/12/2024 by Dr.; no previous history prior to COVID-19 vaccines; currently treated with subcutaneous infusion of HyQvia.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac failure congestive, Cardioversion, Echocardiogram
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patient was in hospital for new onset afib; Congestive heart failure; Pleural effusion; Fever; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included escitalopram oxalate (Lexapro). On 23-AUG-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, less than a month after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: patient was in hospital for new onset afib) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and pleural effusion (Verbatim: Pleural effusion) (serious criteria hospitalization). On an unknown date, the patient experienced fever (Verbatim: Fever). The patient was treated with amiodarone, furosemide (Lasix), potassium and oxygen. The outcome of the atrial fibrillation, congestive heart failure and pleural effusion were not resolved and the outcome of the fever was resolved. It was unknown if the reporter considered the atrial fibrillation, congestive heart failure, pleural effusion and fever to be related to Shingrix. The company considered the atrial fibrillation, congestive heart failure and pleural effusion to be unrelated to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JUL-2025 and 30-JUL-2025 The patient went to the emergency room on 9 September 2023 and was admitted for a week to 10 days and was diagnosed with new onset atrial fibrillation, pleural effusion, and congestive heart failure after receiving the Shingrix vaccine. She went home with 5 different medications on discharge which were Amiodarone, Lasix, a beta blocker, potassium and oxygen. She also mentioned having a fever for a week or 2 weeks after hospitalization. The patient had a cardioversion 4 weeks after her discharge. She had an ICD implant, ablation and an echocardiogram. Further the patient had difficult experience with the Shingrix vaccine which was still ongoing two years later The patient appreciated the support from the GlaxoSmithKline representative which made this difficult experience with the Shingrix vaccine much easier to talk about; Sender's Comments: A case of Atrial fibrillation, Cardiac failure congestive and Pleural effusion, less than a month after receiving Shingrix, in a 71-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Implantable defibrillator insertion, Pleural effusion, Pyrexia
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patient was in hospital for new onset afib; Congestive heart failure; Pleural effusion; Fever; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included escitalopram oxalate (Lexapro). On 23-AUG-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, less than a month after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: patient was in hospital for new onset afib) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and pleural effusion (Verbatim: Pleural effusion) (serious criteria hospitalization). On an unknown date, the patient experienced fever (Verbatim: Fever). The patient was treated with amiodarone, furosemide (Lasix), potassium and oxygen. The outcome of the atrial fibrillation, congestive heart failure and pleural effusion were not resolved and the outcome of the fever was resolved. It was unknown if the reporter considered the atrial fibrillation, congestive heart failure, pleural effusion and fever to be related to Shingrix. The company considered the atrial fibrillation, congestive heart failure and pleural effusion to be unrelated to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JUL-2025 and 30-JUL-2025 The patient went to the emergency room on 9 September 2023 and was admitted for a week to 10 days and was diagnosed with new onset atrial fibrillation, pleural effusion, and congestive heart failure after receiving the Shingrix vaccine. She went home with 5 different medications on discharge which were Amiodarone, Lasix, a beta blocker, potassium and oxygen. She also mentioned having a fever for a week or 2 weeks after hospitalization. The patient had a cardioversion 4 weeks after her discharge. She had an ICD implant, ablation and an echocardiogram. Further the patient had difficult experience with the Shingrix vaccine which was still ongoing two years later The patient appreciated the support from the GlaxoSmithKline representative which made this difficult experience with the Shingrix vaccine much easier to talk about; Sender's Comments: A case of Atrial fibrillation, Cardiac failure congestive and Pleural effusion, less than a month after receiving Shingrix, in a 71-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state
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Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia
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Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased
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Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive
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Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes
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Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
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Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.; This is a spontaneous report received from an Other HCP. A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Jul2025 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 03Jul2025 as dose 2, single, in left arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Mmr (Dose 1, single), for Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 30Jul2025, outcome "unknown", described as "Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.". Therapeutic measures were not taken as a result of menstruation delayed. Additional information: the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) being reported. 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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Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
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Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.; This is a spontaneous report received from an Other HCP. A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Jul2025 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 03Jul2025 as dose 2, single, in left arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Mmr (Dose 1, single), for Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 30Jul2025, outcome "unknown", described as "Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.". Therapeutic measures were not taken as a result of menstruation delayed. Additional information: the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) being reported. 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: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
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pregnant patient received Arexvy instead of Abrysvo; pregnant patient received Arexvy instead of Abrysvo within the health system; pregnant patient received Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy. The patient did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Arexvy instead of Abrysvo), wrong vaccine administered (Verbatim: pregnant patient received Arexvy instead of Abrysvo within the health system) and product use in unapproved population (Verbatim: pregnant patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 28-JUL-2025 The pregnant patient received Arexvy instead of Abrysvo within the health system which led to wrong vaccine administered, product use in unapproved population and vaccine exposure during pregnancy. No negative outcomes apparent at the time of reporting provided.
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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: Brain fog
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brain fogging issues related to this specific vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN FOG (brain fogging issues related to this specific vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (brain fogging issues related to this specific vaccine). At the time of the report, BRAIN FOG (brain fogging issues related to this specific vaccine) had not resolved. No concomitant medication was reported. She was confused about if she had reactions upon getting the second vaccine and she had brain fogging issues related to this specific vaccine. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme abnormal, Condition aggravated, Electromyogram, Epstein-Barr virus infection reactivation, Epstein-Barr virus test
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Neuropathy, Chronic pain, Reactivated EBV, abnormal Angiotensin Converting Enzyme
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, SARS-CoV-2 antibody test
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Neuropathy, Chronic pain, Reactivated EBV, abnormal Angiotensin Converting Enzyme
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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: Death, Guillain-Barre syndrome, Hypoaesthesia
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FBE calling on behalf of HCP to submit an AE for a patient who was given CAPVAXIVE. The experience happened "over the last month" where the patient was given CAPVAXIVE, then developed numbness "about a week later" and was diagnosed with severe Guilla; Death; Information has been received from Business Partner/CRO on 05-Aug-2025. This spontaneous report was received from a physician and refers to a 61-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine 0.5 mL administered by Intramuscular route (lot # and expiration date were not reported). The patient started therapy with for the treatment of pneumonia prevention. The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine for the treatment of pneumonia prevention. On an unknown date, the patient developed numbness and was diagnosed with severe Guillain-Barre. The patient was hospitalized due to those events. On unknown date, the patient died for unknown reason. At the reporting time, the patient had not recovered from Guillain-Barre syndrome. On an unspecified date, the patient died because of the event of death. It was unknown whether an autopsy was performed. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between all of the events and Pneumococcal 21-valent Conjugate Vaccine was not provided. The reporter considered the event of Guillain-Barre to be life-threatening and disabling/incapacitating.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 70.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of product administration
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Patient received Havrix 2nd dose one month early in series. First dose was given 03/11/25 and second dose was given 08/09/25 rather than 09/09/25
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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: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vitiligo
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I had 3 shots of Moderna over the course of 2021. It is hard to identify Vitiligo until summer and I start to tan The following summer 2022 I noticed the backside of my leg at the bend was developing what I know now was Vitiligo. It seemed to be getting larger as the summer went on. Summer of 2023 the area on the back of my leg was larger and a few more spots on the front of my leg and the inside of the right forearm. Summer of 2024. I went to the dermatologist and they identified it as Vitiligo. The summer of 2025 the area on my legs and right forearm are larger and now it is on the left forearm.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 97.0
Sex: F
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: 81.0
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: 47.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Pericardial drainage, Pericardial effusion
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2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Hospital and was misdiagnosed with heartburn and sent home due to excessive COVID 19 patients . Chest pain continued to progress so went to a different emergency room many months later, hospital ,and was admitted with 8 liters of fluid around heart and pericarditiis. Emergency surgery to remove fluid.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Pericarditis, Ultrasound scan
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2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Hospital and was misdiagnosed with heartburn and sent home due to excessive COVID 19 patients . Chest pain continued to progress so went to a different emergency room many months later, hospital ,and was admitted with 8 liters of fluid around heart and pericarditiis. Emergency surgery to remove fluid.
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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: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Catheterisation cardiac abnormal, Contrast echocardiogram, Dyspnoea, Ejection fraction decreased
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very weaked heart & short of breath, especially outside in the heat
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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: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Left ventricular enlargement
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very weaked heart & short of breath, especially outside in the heat
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 65.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Nausea, Syncope
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Fainting, nausea.
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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: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocytopenia, Mobility decreased
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in 2018 I resulted positive for ANA, dsDNA and being treatment for the possibility of Lupus (SLE). I received the COVID vaccine as a result of my medical conditions including that of asthma. However, after the second/third dose of the vaccination my autoimmune issues seemed to begin to worsen, and it has only been until now that I have been able to place to two together. After, I received the second/third dose of the vaccine I was unable to sit upright, I was extremely tired and slept for approximately two days and was unable to move from the bed. Ever since, it seems that my autoimmune issues have become more profound and recently I discovered I have a high Factor VIII/autoimmune thrombocytopenia.
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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: M
Vaccine: COVID19
Symptoms: Arthritis infective, Bacterial infection, Bone atrophy, Carpal tunnel syndrome, Computerised tomogram
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Dyspnoea, Electrocardiogram, Laboratory test, Magnetic resonance imaging
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle atrophy, Muscle injury, Muscular weakness, Musculoskeletal stiffness
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Protein total increased, Respiratory disorder, Retinal detachment
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19
Symptoms: Rotator cuff repair, Scan brain, Trigger finger, Viral infection, Weight decreased
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19
Symptoms: X-ray
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pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Blood test abnormal, Cardiac monitoring normal, Cardiolipin antibody positive
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I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo. I felt sick to my stomach. The room was spinning. I was nauseous. I was at a restaurant with my wife at the time. After about 15 minutes, it dissipated. I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening. 2 days later on Sunday morning, February 3, I went for my bike ride. After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me. Once again, they dissipated about 15 minutes later. My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out. We discussed possible treatment for vertigo. But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5. The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER. In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound. Those tests both were negative. My arteries in my neck and the back of my head were also checked through an ultrasound with dye. Those tests showed my arteries were clear. I was released from the hospital about 48 hours after admittance. I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision. The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB. I visited my opthamologist re the double vision. She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed. She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes. She thought over time the double vision would disappear. As of today I still have permanent double vision. I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily). I am also required to take aspirin every day (81 mg). And, I worry about a possible future stroke and so does my wife of 45 years.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Cerebellar stroke, Diplopia, Dizziness, Echocardiogram, Magnetic resonance imaging head abnormal
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I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo. I felt sick to my stomach. The room was spinning. I was nauseous. I was at a restaurant with my wife at the time. After about 15 minutes, it dissipated. I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening. 2 days later on Sunday morning, February 3, I went for my bike ride. After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me. Once again, they dissipated about 15 minutes later. My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out. We discussed possible treatment for vertigo. But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5. The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER. In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound. Those tests both were negative. My arteries in my neck and the back of my head were also checked through an ultrasound with dye. Those tests showed my arteries were clear. I was released from the hospital about 48 hours after admittance. I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision. The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB. I visited my opthamologist re the double vision. She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed. She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes. She thought over time the double vision would disappear. As of today I still have permanent double vision. I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily). I am also required to take aspirin every day (81 mg). And, I worry about a possible future stroke and so does my wife of 45 years.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Scan with contrast normal, Ultrasound Doppler, Ultrasound head, Ultrasound scan normal
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I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo. I felt sick to my stomach. The room was spinning. I was nauseous. I was at a restaurant with my wife at the time. After about 15 minutes, it dissipated. I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening. 2 days later on Sunday morning, February 3, I went for my bike ride. After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me. Once again, they dissipated about 15 minutes later. My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out. We discussed possible treatment for vertigo. But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5. The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER. In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound. Those tests both were negative. My arteries in my neck and the back of my head were also checked through an ultrasound with dye. Those tests showed my arteries were clear. I was released from the hospital about 48 hours after admittance. I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision. The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB. I visited my opthamologist re the double vision. She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed. She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes. She thought over time the double vision would disappear. As of today I still have permanent double vision. I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily). I am also required to take aspirin every day (81 mg). And, I worry about a possible future stroke and so does my wife of 45 years.
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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: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
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I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo. I felt sick to my stomach. The room was spinning. I was nauseous. I was at a restaurant with my wife at the time. After about 15 minutes, it dissipated. I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening. 2 days later on Sunday morning, February 3, I went for my bike ride. After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me. Once again, they dissipated about 15 minutes later. My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out. We discussed possible treatment for vertigo. But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5. The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER. In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound. Those tests both were negative. My arteries in my neck and the back of my head were also checked through an ultrasound with dye. Those tests showed my arteries were clear. I was released from the hospital about 48 hours after admittance. I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision. The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB. I visited my opthamologist re the double vision. She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed. She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes. She thought over time the double vision would disappear. As of today I still have permanent double vision. I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily). I am also required to take aspirin every day (81 mg). And, I worry about a possible future stroke and so does my wife of 45 years.
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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: F
Vaccine: COVID19
Symptoms: Bedridden, Blindness, Headache, Herpes zoster, Neuralgia
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shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for 4 months-2 months in the dark, headaches and nerve pain still ongoing today.
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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: F
Vaccine: COVID19
Symptoms: Rash, Scar, Weight decreased
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shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for 4 months-2 months in the dark, headaches and nerve pain still ongoing today.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Furuncle, Impaired work ability, Localised infection, Pain, Wound
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My arm swelled up like a boil and a week and a half later white spots showed up a day later the boil burst i went to the emergency room 08/08/2025 theybsaid was infected gave mw anitibiotics i called off work 08/09/2025 due to pain and pus, now i have two holes in my shot, no one cleaned tge infection or packed at facility. Im still in pain and going back today 08/11/2025
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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: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Hallucination, auditory, Mobility decreased, Palpitations
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Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went to Hospital 2-3 times. States he spent weeks on the couch unable to get up off of it due to weakness and heart palpations. He also experienced psychosis/mental illness episodes of hearing voices. Client is now able to work and states he is pretty much back to normal.
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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: M
Vaccine: COVID19
Symptoms: Psychotic disorder
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Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went to Hospital 2-3 times. States he spent weeks on the couch unable to get up off of it due to weakness and heart palpations. He also experienced psychosis/mental illness episodes of hearing voices. Client is now able to work and states he is pretty much back to normal.
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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: Incorrect route of product administration, Injection site indentation, Vaccination failure
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created an indent on the injection site; Patient is claiming that the vaccine was given sub-Q rather than intramuscularly; Patient believes that the vaccine was ineffective; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use) .5 milliliter. On an unknown date, the patient experienced INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective). At the time of the report, INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. No other vaccines within the past 4 weeks and no relevant medical history were reported as per HCP. According to the HCP, after the vaccination, the patient reported that the vaccine was given subcutaneously instead of intramuscularly and noted an indent at the injection site. The patient believed that the vaccine was ineffective and subsequently requested a second dose of Spikevax. HCP inquired whether administering another dose would be appropriate. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results available. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Back pain, COVID-19, Ear disorder, Eczema
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small nodes were found in lungs and one or two in her trachea; had a fungal infection on hand; GI problems; had a drug reaction on hand. Also one side of hand had eczema; had a problem with eye; taking Bactroban for ear; scalp got extremely itchy/immune response to the vaccine; had a drug reaction on hand. Also one side of hand had eczema; COVID; Last fall after the vaccine had different kinds of pains in back and check and in different places; Last fall after the vaccine had different kinds of pains in back and check and in different places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand) and GASTROINTESTINAL DISORDER (GI problems) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places). On an unknown date, the patient experienced PRURITUS (scalp got extremely itchy/immune response to the vaccine), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID). The patient was treated with Mupirocin (Bactroban) for Ear disorder, at an unspecified dose and frequency and Melaleuca alternifolia oil (Tea tree oil) for Eye disorder, at an unspecified dose and frequency. At the time of the report, PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID) had resolved and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: small nodes were found in lungs and one or two in trachea. Concomitant medication was not reported. It was stated that patient held off on one her boosters and got covid last spring or summer. She had gotten every single COVID vaccine and booster. Either last fall or the fall before HCP stated she had immune response to the vaccine. Her scalp got extremely itchy which went away on it was own. Last fall after the vaccine she had different kinds of pains in her back and check and in different places. It was also reported that she had gastrointestinal problems, and she skipped the vaccine prior the summer because she had a drug reaction on her hand. Also, one side of her hand had eczema. She had a fungal infection on her hand. She had a problem with her eye and used liquid eye drops. HCP did an IG something at one point because of a reaction to medication but she was not sure what medication.
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