instruction
stringclasses 1
value | input
stringlengths 19
390
| output
stringlengths 1
32k
|
|---|---|---|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
|
As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27), 2021. Immediately after the COVID19 Vaccine, I had a LARGE HUMERUS on my left arm. As the years past, I had pain in my LEFT ARM. My LEFT ARM became progressively WEAK that I couldn't USE and/or RAISE my LEFT ARM to pick up an empty cup. I was hospitalized on July 12, 2025 for (congestive heart failure/hypertension). While I was hospitalized, I give TWO BLOOD THINNERS in my stomach. Immediately, shrunk to half the size on my LEFT ARM. 9% of the PAIN on the LEFT ARM has gone. I can USE my LEFT ARM again "I think the COVID19 Pfizer Vaccine that I received in my LEFT ARM gave me a TINY BLOOD CLOT in my LEFT ARM which DIDN'T SHOW UP my MRI RESULTS. When I received the BLOOD THINNER while I was in the hospital, the BLOOD THINNER REMOVED the TINY BLOOD CLOT in my LEFT ARM!" I thought that I would have to live with the PAIN in my LEFT ARM after the COVID19 Vaccine. Please research if BLOOD THINNER is the SOLUTIONS to some of the PATIENTS that received COVID 19 Vaccine, and they are in PAIN.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle spasms
|
Reported Symptoms: 10041408:SPASMS; Narrative: Other Relevant HX: Other: SPASMODIC MOVEMENT
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19
Symptoms: Rash
|
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Cough, Decreased appetite, Lethargy
|
Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a couple days after the vaccine was administered on 4/11/25 and said the patient was experiencing lethargic, weak, decreased appetite, and confusion after getting the vaccine and the plan was to just monitor over the weekend and a provider would check back in after the weekend and if anything got worse they were advised to seek medical attention. Patient has received several doses previously but all were Moderna, this was the first time the patient received Pfizer. Other Relevant HX: Other: COUGH; MALAISE
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
|
Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a couple days after the vaccine was administered on 4/11/25 and said the patient was experiencing lethargic, weak, decreased appetite, and confusion after getting the vaccine and the plan was to just monitor over the weekend and a provider would check back in after the weekend and if anything got worse they were advised to seek medical attention. Patient has received several doses previously but all were Moderna, this was the first time the patient received Pfizer. Other Relevant HX: Other: COUGH; MALAISE
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
|
Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: COVID19
Symptoms: Retinal vascular thrombosis
|
Has developed blood clots in one of their eyes just days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) (seriousness criterion medically significant). At the time of the report, RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient took the vaccine and had developed blood clots in one of their eyes just days after receiving the vaccine back in 2021. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788794 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788794:Reporter case
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: COVID19
Symptoms: Visual impairment
|
a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) (seriousness criterion medically significant). At the time of the report, VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that patient took the Covid-19 vaccine back in Fall of 2021 due to it being mandated by their job. After the patient took vaccine, a rapid decline in their vision was noticed and had slowly been losing their eyesight ever since to the point where they were seeing just glows of white. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788797 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788797:case for family member
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
|
felt achy/felt under the weather; lethargic/felt under the weather; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (he had slight fever and "could feel his immune system working). Past adverse reactions to the above products included Slight fever with Pfizer. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather). At the time of the report, PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was stated patient had better reaction to Moderna's vaccine over Pfizer's. It was stated with Moderna's vaccine he had no fever but "felt under the weather". Probed was asking for details then it was stated patient felt achy and lethargic. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Cerebral haemorrhage, Computerised tomogram
|
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fall, Head injury, Influenza, Loss of consciousness
|
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary thrombosis, Pyrexia, Sepsis, Thrombosis
|
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary bladder haemorrhage, Weight
|
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
|
spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis. Clinical course: Medication was Pfizer covid vaccination from 2021. She has lots of things that happened after the vaccination that has now caused her lots of health problems and was on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine. She did not have immediate issues after the first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there are hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she did not know what its called. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
|
not clarify when caller was diagnosed with Type 1 diabetes in relation to receiving vaccine.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 71-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. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant), outcome "unknown", described as "not clarify when caller was diagnosed with Type 1 diabetes in relation to receiving vaccine.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Clinical Course:It was reported that the patient had Type 1 Diabetes. She also mentioned that last year she got the Pfizer COVID 19 vaccine. Agent did not clarify that when patient was diagnosed with Type 1 diabetes in relation to receiving vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
|
Didn't pay attention to the vaccine age limit. Patient was given the 12+ years Pfizer vaccine.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
|
vaccine was expired on 5/17/2025
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Death
|
Resident expired
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block left, Electrocardiogram abnormal
|
New onset Left Bundle branch block
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
|
RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
|
RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Erythema, Gait disturbance, Guillain-Barre syndrome
|
Patient is having extreme difficulty walking. Has tingling in feet and legs, and swelling in ankles and feet. He is experiencing pain/weakness with walking; unsteady gait. He has redness on bottom of feet. His wife states that at the doctor's office today, he had no reflexes in his legs. Wife states that doctor has ordered for the patient to go to the hospital and be admitted for evaluation. Wife said dr. suspects that pt has Guillian Barre Syndrome.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Pain, Paraesthesia, Peripheral swelling
|
Patient is having extreme difficulty walking. Has tingling in feet and legs, and swelling in ankles and feet. He is experiencing pain/weakness with walking; unsteady gait. He has redness on bottom of feet. His wife states that at the doctor's office today, he had no reflexes in his legs. Wife states that doctor has ordered for the patient to go to the hospital and be admitted for evaluation. Wife said dr. suspects that pt has Guillian Barre Syndrome.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
|
None stated.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
|
RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
|
RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Ammonia, Chest X-ray abnormal, Full blood count, Hypotension
|
Admitted to Nursing Home on Monday 8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit. Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid. Friday 8/22/25 she was hypotensive, lethargic. Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovolaemia, Lethargy, Leukocytosis, Metabolic function test, Pneumonia
|
Admitted to Nursing Home on Monday 8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit. Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid. Friday 8/22/25 she was hypotensive, lethargic. Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Treatment failure, Urine analysis, White blood cell count increased
|
Admitted to Nursing Home on Monday 8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit. Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid. Friday 8/22/25 she was hypotensive, lethargic. Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Bipolar disorder, Depression, Echocardiogram, Electrocardiogram
|
PFIZER #1 3/13/2021 PFIZER #2 4/5/2021 PFIZER #3 12/29/2021 DEVELOPED WORSENED ANXIETY DEPRESSION BIPOLAR SYMPTOMS REQUIRING VENLAFAXINE AND LAMICTAL. DEVELOPED DYSFUNCTIONAL UTERINE BLEEDING AND POST EXERTIONAL MALAISE. DIAGNOSIS POST VACCINE INJURY SYNDROME.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging heart, Malaise, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
|
PFIZER #1 3/13/2021 PFIZER #2 4/5/2021 PFIZER #3 12/29/2021 DEVELOPED WORSENED ANXIETY DEPRESSION BIPOLAR SYMPTOMS REQUIRING VENLAFAXINE AND LAMICTAL. DEVELOPED DYSFUNCTIONAL UTERINE BLEEDING AND POST EXERTIONAL MALAISE. DIAGNOSIS POST VACCINE INJURY SYNDROME.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
|
Patient lost consciousness about 15mintues after getting the covid vaccine. Her parents were standing right next to her and caught her and lay her on the pharmacy waiting area floor. She regained consciousness in a few seconds and was back to normal. She was given water and later her father got her gatorade. She rested in the pharmacy waiting area for about 15minutes and said she was feeling much better and left with her parents afterwards.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment, Retinal tear, Vitrectomy, Vitreous detachment
|
I?ve had viscous separation and retinal tear and detachments in both eyes followed by a vitrectomy in both eyes.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Malaise, Urticaria
|
I got a large welt ("COVID Arm") on the left arm at the site of injection. It was warm to the touch and itchy and has lasted for at least 3 days. I also felt very ill (similar to when I had COVID) on the day after my vaccine.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Angina pectoris, Electrocardiogram, Mechanical urticaria, Urticaria
|
Urticaria, dermatographia, heart pain, heat interested, hives
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria thermal
|
Urticaria, dermatographia, heart pain, heat interested, hives
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Brain fog, Constipation, Dizziness, Fatigue
|
Rapid heart rate, sudden drop of blood pressure, lightheadedness, headaches, nausea, constipation, fatigue, spinal tumor, brain fog
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Nausea, Neoplasm
|
Rapid heart rate, sudden drop of blood pressure, lightheadedness, headaches, nausea, constipation, fatigue, spinal tumor, brain fog
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
|
COVID 2x; COVID 2x; COVID 2x; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoker" (ongoing), notes: long time. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID 2x". Clinical course: The patient had COVID 2x but had only 1 shot. The reporter asked if it is possible to get 2nd, 3rd & booster shots. Also, the patient lives in a personal care home with a lot of disabled folks who always seem to be sick. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
|
poor covid performance; poor covid performance; 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 "poor covid performance". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
|
I have COVID and I wanted to get Paxlovid but I can't afford it; I have COVID and I wanted to get Paxlovid but I can't afford it; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID and I wanted to get Paxlovid but I can't afford it". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
|
Caused vomiting for one day afterwards. Reporting for safety reasons.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Bradycardia, Brain natriuretic peptide, C-reactive protein, Cardiac monitoring abnormal
|
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chills, Dyspnoea, Echocardiogram normal, Fatigue
|
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Positron emission tomogram, Positron emission tomogram normal, Pulse abnormal
|
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Troponin, Ventricular extrasystoles, Ventricular tachycardia
|
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC15, UNK
Symptoms: Bed sharing, Death, Decreased appetite, Infant irritability, Pyrexia
|
DEATH; INFANT IRRITABILITY; UNRESPONSIVE TO STIMULI; DECREASED APPETITE; PYREXIA; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (Agency #2839201-1) on 17-JUL-2025. This spontaneous report and refers to an infant (age reported as 0.75-year-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with the third dose of pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection, administered intramuscularly in left leg, lot #Y010032, expiration date was not reported, however upon internal validation determined as 17-FEB-2027, for prophylaxis (exact dose was not reported); on the same day, she was vaccinated with 3rd dose of diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (MRC 5) (+) tetanus vaccine toxoid) (PENTACEL), administered intramuscularly in right leg, lot #UK196AA, for prophylaxis (exact dose and expiration date were not reported). On 09-APR-2025, in the evening, the child had fever and fussiness; fever resolved on 10-APR-2025 (discrepancy, outcome reported as fatal), however, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 10-APR-2025, her mother reported that the child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 11-APR-2025 and they activated Emergency Medical Services (EMS). Child was transported to hospital. She did not survive and was pronounced dead in the hospital (conflicting information, the onset date of the events of infant irritability, decreased appetite, pyrexia, unresponsive to stimuli, and death was reported as 11-APR-2025; she was treated at emergency room and hospitalized due to the events; she was also treated at emergency room/department or urgent care). The patient died because of the events of infant irritability, unresponsive to stimuli, decreased appetite, and pyrexia. It was unknown whether an autopsy was performed. Causality assessment was not provided. Follow up information has been received on 21-AUG-2025. Investigation summary for VAXNEUVANCE, Batch/Lot #Y010032: Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V114 0.5ML 1DOSE SYR Batch number 0001759288 material number 2016658 at MSD Carlow which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. A supporting investigation was requested from the drug substance (DS) manufacturing site MSD (Inv-012951). The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of the Drug Substance batches consumed in Drug product batch 0001759288. The investigation concluded that the Drug Substance batches conform to all release specifications. A supporting investigation was also completed by the MSD packaging site (Inv-012952). Based on their investigation, no systemic packaging inadequacy of package batch Y010032 were identified at the Merck manufacturing facility that could impact the quality attributes of the product. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. There have been no additional requests for information or additional testing relating to this Adverse Event.; Reported Cause(s) of Death: DECREASED APPETITE; INFANT IRRITABILITY; PYREXIA; UNRESPONSIVE TO STIMULI
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC15, UNK
Symptoms: Unresponsive to stimuli
|
DEATH; INFANT IRRITABILITY; UNRESPONSIVE TO STIMULI; DECREASED APPETITE; PYREXIA; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (Agency #2839201-1) on 17-JUL-2025. This spontaneous report and refers to an infant (age reported as 0.75-year-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with the third dose of pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection, administered intramuscularly in left leg, lot #Y010032, expiration date was not reported, however upon internal validation determined as 17-FEB-2027, for prophylaxis (exact dose was not reported); on the same day, she was vaccinated with 3rd dose of diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (MRC 5) (+) tetanus vaccine toxoid) (PENTACEL), administered intramuscularly in right leg, lot #UK196AA, for prophylaxis (exact dose and expiration date were not reported). On 09-APR-2025, in the evening, the child had fever and fussiness; fever resolved on 10-APR-2025 (discrepancy, outcome reported as fatal), however, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 10-APR-2025, her mother reported that the child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 11-APR-2025 and they activated Emergency Medical Services (EMS). Child was transported to hospital. She did not survive and was pronounced dead in the hospital (conflicting information, the onset date of the events of infant irritability, decreased appetite, pyrexia, unresponsive to stimuli, and death was reported as 11-APR-2025; she was treated at emergency room and hospitalized due to the events; she was also treated at emergency room/department or urgent care). The patient died because of the events of infant irritability, unresponsive to stimuli, decreased appetite, and pyrexia. It was unknown whether an autopsy was performed. Causality assessment was not provided. Follow up information has been received on 21-AUG-2025. Investigation summary for VAXNEUVANCE, Batch/Lot #Y010032: Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V114 0.5ML 1DOSE SYR Batch number 0001759288 material number 2016658 at MSD Carlow which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. A supporting investigation was requested from the drug substance (DS) manufacturing site MSD (Inv-012951). The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of the Drug Substance batches consumed in Drug product batch 0001759288. The investigation concluded that the Drug Substance batches conform to all release specifications. A supporting investigation was also completed by the MSD packaging site (Inv-012952). Based on their investigation, no systemic packaging inadequacy of package batch Y010032 were identified at the Merck manufacturing facility that could impact the quality attributes of the product. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. There have been no additional requests for information or additional testing relating to this Adverse Event.; Reported Cause(s) of Death: DECREASED APPETITE; INFANT IRRITABILITY; PYREXIA; UNRESPONSIVE TO STIMULI
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
|
Unknown. Report is made after review of medical record by medical examiner. Unknown if recent vaccination had any effect of cause of death which is reported as Atherosclerotic and Hypertensive Cardiovascular Disease with Other significant conditions: diabetes mellitus, hypothyroidism, smoking, and chronic ethanol use. No autopsy was performed.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: COVID19, DTPIHI, PNC20, RV5, RVX
Symptoms: Body temperature, Irritability, Pyrexia, Somnolence
|
sleepy; irritable/ cranky; fever; This spontaneous report was received from a Consumer or other non health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported. The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months (same as other vaccines received on 11 Jul-2025). On 11-Jul-2025, the was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form administered by oral route (exact dose, lot # and expiration date were not reported) for prophylaxis (indication reported as unknown but by default changed to prophylaxis). On the same day, the patient started therapy with clesrovimab (ENFLONSIA) (reported as RSV vaccine) prefilled syringe, 1 dosage form administered by unknown route for unknown indication (exact dose, lot # and expiration date were not reported). On the same day, he was vaccinated with a dose of COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) dose 1 administered intramuscularly (lot # and expiration date were not reported) for COVID-19; with a dose of Pneumococcal vaccine conj 20v (CRM197) 1 dosage form administered by unknown route for unknown indication (expiration date, and lot # were not reported); and with a dose of Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine 1 dosage form administered by unknown route for unknown indication (indication, expiration date, and lot # were not reported). It was reported that the patient received first dose of Moderna Covid vaccine at 6-month checkup along with RSV, rotavirus, and other standard vaccines. The patient received the vaccine at noon. On 11-Jul-2025, the patient experienced somnolence (sleepy). On the same day at 5:00 PM, the patient experienced irritability (irritable/ cranky) and pyrexia (fever). On that day at 5:00 PM, body temperature was 101 F. It was also reported that, post vaccination, the patient developed fever and he was sleepy with irritable symptom which started about two hours after vaccination. He was feverish and cranky until mid-day on 13-Jul-2025. The fever never reached over 101 F. From 11-Jul-2025 to 13-Jul-2025, the patient was treated with paracetamol (TYLENOL) (oral use) at a dose of 2.5 milliliter every four hours. Paracetamol (TYLENOL) significantly improved the symptoms. The patient did not experience any additional symptoms or events. On 12-Jul-2025, somnolence had resolved. On 13-Jul-2025, irritability and pyrexia had resolved. The action taken with COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) was unknown (by default changed to not applicable). The action taken with clesrovimab (ENFLONSIA) was not reported. The action taken with Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine, Pneumococcal vaccine conj 20v (CRM197) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not applicable. The causal relationship between the reported adverse events and the suspect therapies was not reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-07-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : MOD-2025-788098 , Central date : 2025-07-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
|
Upper L arm red, swollen, and painful
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid cyst, Eyelid cyst removal, Eyelid discolouration, Oedema peripheral, Swelling of eyelid
|
Armpit swelled the size of an orange after dose 1. After does 2 I developed cysts on both eyelids. They swelled up and turned purple. I had to get the cysts surgically removed. Terrible reaction to Covid vaccine in BOTH eyes. Surgery needed.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Photopsia, Product administered at inappropriate site, Visual impairment
|
Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots; Tiredness; vaccine was given too high on the shoulder/ it was given just below the shoulder bone; This serious case was reported by a consumer via call center representative and described the occurrence of posterior vitreous detachment in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine (received a dose on an unknown date). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 02-AUG-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 02-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: vaccine was given too high on the shoulder/ it was given just below the shoulder bone). On 03-AUG-2025, the patient experienced tiredness (Verbatim: Tiredness). On 08-AUG-2025, the patient experienced posterior vitreous detachment (Verbatim: Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots) (serious criteria GSK medically significant). The outcome of the posterior vitreous detachment and tiredness were unknown and the outcome of the vaccine administered at inappropriate site was not applicable. The reporter considered the posterior vitreous detachment to be possibly related to Shingrix. It was unknown if the reporter considered the tiredness to be related to Shingrix. The company considered the posterior vitreous detachment to be unrelated to Shingrix. It was unknown if the company considered the tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient self-reported this case for herself. The patient received the first dose of Shingrix on 31-MAY-2025. The patient further received the second dose of Shingrix on Saturday morning. The afternoon of Sunday 03-AUG-2025, 1 days after vaccination, the patient saw a bright flash on the right side of her right eye. The patient stated she felt crummy and tired. When asked to expand on felt crummy, the patient stated she felt like she did after a COVID vaccine. On Thursday, 07-AUG-2025, 5 days after vaccination, the patient saw 1000 poppy seed like dots in her right eye. The patient was seen by an eye physician on Friday 08-AUG-2025, 6 days after vaccination, and was diagnosed with posterior vitreous detachment (PVD). The patient was told by the physician that it was possible this (PVD) was related to the vaccine. The patient had no personal history or family history of eye problems, and the patient stated that the vaccine was given too high on the shoulder, it was given just below the shoulder bone, the placement of the vaccine seemed wrong to her, which led to vaccine administered at inappropriate site.; Sender's Comments: A case of Vitreous detachment, 6 days after receiving 2nd dose of Shingrix, in a 65-year-old female subject. and Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor(age)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitreous detachment
|
Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots; Tiredness; vaccine was given too high on the shoulder/ it was given just below the shoulder bone; This serious case was reported by a consumer via call center representative and described the occurrence of posterior vitreous detachment in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine (received a dose on an unknown date). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 02-AUG-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 02-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: vaccine was given too high on the shoulder/ it was given just below the shoulder bone). On 03-AUG-2025, the patient experienced tiredness (Verbatim: Tiredness). On 08-AUG-2025, the patient experienced posterior vitreous detachment (Verbatim: Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots) (serious criteria GSK medically significant). The outcome of the posterior vitreous detachment and tiredness were unknown and the outcome of the vaccine administered at inappropriate site was not applicable. The reporter considered the posterior vitreous detachment to be possibly related to Shingrix. It was unknown if the reporter considered the tiredness to be related to Shingrix. The company considered the posterior vitreous detachment to be unrelated to Shingrix. It was unknown if the company considered the tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient self-reported this case for herself. The patient received the first dose of Shingrix on 31-MAY-2025. The patient further received the second dose of Shingrix on Saturday morning. The afternoon of Sunday 03-AUG-2025, 1 days after vaccination, the patient saw a bright flash on the right side of her right eye. The patient stated she felt crummy and tired. When asked to expand on felt crummy, the patient stated she felt like she did after a COVID vaccine. On Thursday, 07-AUG-2025, 5 days after vaccination, the patient saw 1000 poppy seed like dots in her right eye. The patient was seen by an eye physician on Friday 08-AUG-2025, 6 days after vaccination, and was diagnosed with posterior vitreous detachment (PVD). The patient was told by the physician that it was possible this (PVD) was related to the vaccine. The patient had no personal history or family history of eye problems, and the patient stated that the vaccine was given too high on the shoulder, it was given just below the shoulder bone, the placement of the vaccine seemed wrong to her, which led to vaccine administered at inappropriate site.; Sender's Comments: A case of Vitreous detachment, 6 days after receiving 2nd dose of Shingrix, in a 65-year-old female subject. and Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor(age)
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Loss of personal independence in daily activities
|
Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. 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: 12-AUG-2025 This case was reported by the patient's friend's wife via interactive digital media. A healthy friend had just got guillain barre syndrome after the first shot. He could not even put on his own socks.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a male 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.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Deafness
|
tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe headache; muscle pain; lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days; can barely walk/ not being able to walk; Fatigue; This serious case was reported by a physician via call center representative and described the occurrence of tunnel vision in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date, refer case US2025AMR109704). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. In AUG-2025, 2 days after receiving Bexsero, the patient experienced tunnel vision (Verbatim: tunnel vision) (serious criteria GSK medically significant), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), presyncope (Verbatim: almost passing out/ she was almost passed out this morning) (serious criteria GSK medically significant), headache (Verbatim: severe headache), muscle pain (Verbatim: muscle pain), supraclavicular lymph nodes enlarged (Verbatim: lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days), unable to walk (Verbatim: can barely walk/ not being able to walk) and fatigue (Verbatim: Fatigue). The outcome of the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue were not resolved. The reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. The company considered the tunnel vision, hearing loss and presyncope to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR109704 Additional Information: GSK Receipt Date: 18-AUG-2025 On 18 August 2025, a physician called to inform her college-aged daughter just starting freshman year on last Monday took her for a Bexsero second vaccine, she got it at a pharmacy, and on Tuesday was brought to her to school. She did fine with the first dose, but the arm was very sore way back. However, within two days of receiving the second dose, she began experiencing severe systemic symptoms. She developed a severe headache, headache, fatigue, lymphadenopathy. The reporter stated as she walks feels like almost passing out, she started to get tunnel vision, muscle pain and her lymph nodes are all dilated and painful supraclavicular even, like out of the blue. The reporter enquired if patient was having cancer as the lymph were enlarged, she ended up going, her roommate took her to the hospital, yesterday emergency (not hospitalized) She had a CAT scan of the neck, head and chest because she got lymphadenopathy up the wazoo, huge, painful in the sentinel area/ supraclavicular. She was going to student services they may have to put her in the hospital as she had almost passed out this morning with tunnel vision and hearing loss. The reporter stated that her daughter (patient) was not immunocompromised and did not have any weight loss or fatigue. There were no signs of lymphoma (like she was getting some signs of issues before). Her daughter was a healthy and happy kid. The patient had sentinel area with huge lymph nodes and then another hard lymph node. The patient had severe headaches and, all of a sudden, upon getting up, was unable to walk, requiring her to lie back down. She experienced fatigue and muscle aches in her legs and the back of her shoulders. Today, this morning, a mono test that was run came back negative. The patient was going to try to get a TB test since she had been out of the country. She has no coughing or respiratory condition. The reporter stated it was all systemic and when she looked at GlaxoSmithKline list of things it included fatigue, severe headaches, muscle aches, and maybe even lymphadenopathy, she feels like it was all related. The reporter mentioned that now, a week later, the patient was still experiencing symptoms. They were continuing to evaluate what steps needed to be taken next. The patient was not immunocompromised.; Sender's Comments: A case of Tunnel vision, Deafness and Presyncope, 2 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device in a 18-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. US-GSK-US2025AMR109704:same reporter
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Gait disturbance, Headache, Lymph node pain, Lymphadenopathy
|
tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe headache; muscle pain; lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days; can barely walk/ not being able to walk; Fatigue; This serious case was reported by a physician via call center representative and described the occurrence of tunnel vision in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date, refer case US2025AMR109704). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. In AUG-2025, 2 days after receiving Bexsero, the patient experienced tunnel vision (Verbatim: tunnel vision) (serious criteria GSK medically significant), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), presyncope (Verbatim: almost passing out/ she was almost passed out this morning) (serious criteria GSK medically significant), headache (Verbatim: severe headache), muscle pain (Verbatim: muscle pain), supraclavicular lymph nodes enlarged (Verbatim: lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days), unable to walk (Verbatim: can barely walk/ not being able to walk) and fatigue (Verbatim: Fatigue). The outcome of the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue were not resolved. The reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. The company considered the tunnel vision, hearing loss and presyncope to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR109704 Additional Information: GSK Receipt Date: 18-AUG-2025 On 18 August 2025, a physician called to inform her college-aged daughter just starting freshman year on last Monday took her for a Bexsero second vaccine, she got it at a pharmacy, and on Tuesday was brought to her to school. She did fine with the first dose, but the arm was very sore way back. However, within two days of receiving the second dose, she began experiencing severe systemic symptoms. She developed a severe headache, headache, fatigue, lymphadenopathy. The reporter stated as she walks feels like almost passing out, she started to get tunnel vision, muscle pain and her lymph nodes are all dilated and painful supraclavicular even, like out of the blue. The reporter enquired if patient was having cancer as the lymph were enlarged, she ended up going, her roommate took her to the hospital, yesterday emergency (not hospitalized) She had a CAT scan of the neck, head and chest because she got lymphadenopathy up the wazoo, huge, painful in the sentinel area/ supraclavicular. She was going to student services they may have to put her in the hospital as she had almost passed out this morning with tunnel vision and hearing loss. The reporter stated that her daughter (patient) was not immunocompromised and did not have any weight loss or fatigue. There were no signs of lymphoma (like she was getting some signs of issues before). Her daughter was a healthy and happy kid. The patient had sentinel area with huge lymph nodes and then another hard lymph node. The patient had severe headaches and, all of a sudden, upon getting up, was unable to walk, requiring her to lie back down. She experienced fatigue and muscle aches in her legs and the back of her shoulders. Today, this morning, a mono test that was run came back negative. The patient was going to try to get a TB test since she had been out of the country. She has no coughing or respiratory condition. The reporter stated it was all systemic and when she looked at GlaxoSmithKline list of things it included fatigue, severe headaches, muscle aches, and maybe even lymphadenopathy, she feels like it was all related. The reporter mentioned that now, a week later, the patient was still experiencing symptoms. They were continuing to evaluate what steps needed to be taken next. The patient was not immunocompromised.; Sender's Comments: A case of Tunnel vision, Deafness and Presyncope, 2 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device in a 18-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. US-GSK-US2025AMR109704:same reporter
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mononucleosis heterophile test negative, Myalgia, Presyncope, Tunnel vision
|
tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe headache; muscle pain; lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days; can barely walk/ not being able to walk; Fatigue; This serious case was reported by a physician via call center representative and described the occurrence of tunnel vision in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date, refer case US2025AMR109704). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. In AUG-2025, 2 days after receiving Bexsero, the patient experienced tunnel vision (Verbatim: tunnel vision) (serious criteria GSK medically significant), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), presyncope (Verbatim: almost passing out/ she was almost passed out this morning) (serious criteria GSK medically significant), headache (Verbatim: severe headache), muscle pain (Verbatim: muscle pain), supraclavicular lymph nodes enlarged (Verbatim: lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days), unable to walk (Verbatim: can barely walk/ not being able to walk) and fatigue (Verbatim: Fatigue). The outcome of the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue were not resolved. The reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. The company considered the tunnel vision, hearing loss and presyncope to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR109704 Additional Information: GSK Receipt Date: 18-AUG-2025 On 18 August 2025, a physician called to inform her college-aged daughter just starting freshman year on last Monday took her for a Bexsero second vaccine, she got it at a pharmacy, and on Tuesday was brought to her to school. She did fine with the first dose, but the arm was very sore way back. However, within two days of receiving the second dose, she began experiencing severe systemic symptoms. She developed a severe headache, headache, fatigue, lymphadenopathy. The reporter stated as she walks feels like almost passing out, she started to get tunnel vision, muscle pain and her lymph nodes are all dilated and painful supraclavicular even, like out of the blue. The reporter enquired if patient was having cancer as the lymph were enlarged, she ended up going, her roommate took her to the hospital, yesterday emergency (not hospitalized) She had a CAT scan of the neck, head and chest because she got lymphadenopathy up the wazoo, huge, painful in the sentinel area/ supraclavicular. She was going to student services they may have to put her in the hospital as she had almost passed out this morning with tunnel vision and hearing loss. The reporter stated that her daughter (patient) was not immunocompromised and did not have any weight loss or fatigue. There were no signs of lymphoma (like she was getting some signs of issues before). Her daughter was a healthy and happy kid. The patient had sentinel area with huge lymph nodes and then another hard lymph node. The patient had severe headaches and, all of a sudden, upon getting up, was unable to walk, requiring her to lie back down. She experienced fatigue and muscle aches in her legs and the back of her shoulders. Today, this morning, a mono test that was run came back negative. The patient was going to try to get a TB test since she had been out of the country. She has no coughing or respiratory condition. The reporter stated it was all systemic and when she looked at GlaxoSmithKline list of things it included fatigue, severe headaches, muscle aches, and maybe even lymphadenopathy, she feels like it was all related. The reporter mentioned that now, a week later, the patient was still experiencing symptoms. They were continuing to evaluate what steps needed to be taken next. The patient was not immunocompromised.; Sender's Comments: A case of Tunnel vision, Deafness and Presyncope, 2 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device in a 18-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. US-GSK-US2025AMR109704:same reporter
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
|
Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 024M20A, 017E21A and 033K21-2A) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-788866 (Patient Link).
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
|
after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7180B) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788866 (Patient Link).
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
|
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient received six different vaccines in past and patient had COVID. Patient received the older strain vaccines, but he wanted the new one. It was reported that patient inquired about obtaining the most current Moderna COVID-19 vaccine before traveling internationally and he would be taken treatment medication Paxlovid if require. No treatment medications provided by the reporter.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
|
Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 02-Oct-2024. At the time of the report, the outcome of the Arthritis was Recovered/Resolved. A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Arthritis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Arthritis is considered Possible.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Abdominal pain upper, Back pain, Chills, Decreased appetite, Erythema
|
stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pain in arm at site and down arm; lump; redness at injection site; loss of appetite; low grade fever; chills; tired; lethargic; back ache; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in arm for immunisation; hepatitis B vaccine rhbsag (yeast) (ENGERIX B), on 12Aug2025 as dose 2, single, in right arm for immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: recovery; "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Engerix b (DOSE 1, SINGLE), for Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Aug2025, outcome "not recovered", described as "Swollen arm"; BACK PAIN (non-serious) with onset 13Aug2025, outcome "not recovered", described as "back ache"; CHILLS (non-serious) with onset 13Aug2025, outcome "not recovered"; LETHARGY (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "loss of appetite"; PYREXIA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lump"; NAUSEA (non-serious) with onset 13Aug2025, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 13Aug2025, outcome "not recovered" and all described as "pain in arm at site and down arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "redness at injection site"; FATIGUE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "tired"; ERYTHEMA (non-serious) with onset 16Aug2025, outcome "not recovered", described as "redness spreading down arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Aug2025, outcome "not recovered", described as "stomach ache". Therapeutic measures were taken as a result of peripheral swelling, nausea, vaccination site pain, pain in extremity, vaccination site mass, vaccination site erythema, decreased appetite, pyrexia, chills, fatigue, lethargy, back pain, abdominal pain upper, erythema. Causality for "swollen arm", "nausea", "pain in arm at site and down arm", "lump", "redness at injection site", "loss of appetite", "low grade fever", "chills", "tired", "lethargic", "back ache", "stomach ache" and "redness spreading down arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Swollen arm, nausea, pain in arm at site and down arm, lump, redness at injection site, loss of appetite, low grade fever, chills, tired, lethargic, back ache. Day 4 stomach ache, redness spreading down arm, back ache, chills. Antibiotic treatment received for the adverse events. It was reported that patient did not received any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The patient wasn't receiving any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Fatigue, Injection site erythema, Injection site pain, Lethargy, Mass
|
stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pain in arm at site and down arm; lump; redness at injection site; loss of appetite; low grade fever; chills; tired; lethargic; back ache; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in arm for immunisation; hepatitis B vaccine rhbsag (yeast) (ENGERIX B), on 12Aug2025 as dose 2, single, in right arm for immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: recovery; "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Engerix b (DOSE 1, SINGLE), for Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Aug2025, outcome "not recovered", described as "Swollen arm"; BACK PAIN (non-serious) with onset 13Aug2025, outcome "not recovered", described as "back ache"; CHILLS (non-serious) with onset 13Aug2025, outcome "not recovered"; LETHARGY (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "loss of appetite"; PYREXIA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lump"; NAUSEA (non-serious) with onset 13Aug2025, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 13Aug2025, outcome "not recovered" and all described as "pain in arm at site and down arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "redness at injection site"; FATIGUE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "tired"; ERYTHEMA (non-serious) with onset 16Aug2025, outcome "not recovered", described as "redness spreading down arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Aug2025, outcome "not recovered", described as "stomach ache". Therapeutic measures were taken as a result of peripheral swelling, nausea, vaccination site pain, pain in extremity, vaccination site mass, vaccination site erythema, decreased appetite, pyrexia, chills, fatigue, lethargy, back pain, abdominal pain upper, erythema. Causality for "swollen arm", "nausea", "pain in arm at site and down arm", "lump", "redness at injection site", "loss of appetite", "low grade fever", "chills", "tired", "lethargic", "back ache", "stomach ache" and "redness spreading down arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Swollen arm, nausea, pain in arm at site and down arm, lump, redness at injection site, loss of appetite, low grade fever, chills, tired, lethargic, back ache. Day 4 stomach ache, redness spreading down arm, back ache, chills. Antibiotic treatment received for the adverse events. It was reported that patient did not received any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The patient wasn't receiving any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 60.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia
|
stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pain in arm at site and down arm; lump; redness at injection site; loss of appetite; low grade fever; chills; tired; lethargic; back ache; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in arm for immunisation; hepatitis B vaccine rhbsag (yeast) (ENGERIX B), on 12Aug2025 as dose 2, single, in right arm for immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: recovery; "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Engerix b (DOSE 1, SINGLE), for Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Aug2025, outcome "not recovered", described as "Swollen arm"; BACK PAIN (non-serious) with onset 13Aug2025, outcome "not recovered", described as "back ache"; CHILLS (non-serious) with onset 13Aug2025, outcome "not recovered"; LETHARGY (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "loss of appetite"; PYREXIA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lump"; NAUSEA (non-serious) with onset 13Aug2025, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 13Aug2025, outcome "not recovered" and all described as "pain in arm at site and down arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "redness at injection site"; FATIGUE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "tired"; ERYTHEMA (non-serious) with onset 16Aug2025, outcome "not recovered", described as "redness spreading down arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Aug2025, outcome "not recovered", described as "stomach ache". Therapeutic measures were taken as a result of peripheral swelling, nausea, vaccination site pain, pain in extremity, vaccination site mass, vaccination site erythema, decreased appetite, pyrexia, chills, fatigue, lethargy, back pain, abdominal pain upper, erythema. Causality for "swollen arm", "nausea", "pain in arm at site and down arm", "lump", "redness at injection site", "loss of appetite", "low grade fever", "chills", "tired", "lethargic", "back ache", "stomach ache" and "redness spreading down arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Swollen arm, nausea, pain in arm at site and down arm, lump, redness at injection site, loss of appetite, low grade fever, chills, tired, lethargic, back ache. Day 4 stomach ache, redness spreading down arm, back ache, chills. Antibiotic treatment received for the adverse events. It was reported that patient did not received any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The patient wasn't receiving any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain
|
Passed in an ICU; Severe pneumonia; Congestive heart failure; Damaged kidneys (later diagnosed with Stage 3 kidney failure); Atrial fibrillation (AFib); Intolerance/allergy to egg protein and autoimmune issues; Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack; Palpitations; This spontaneous case, initially received on 15-Aug-2025, was reported by a non-health professional and concerns an elderly female patient. Past medical history included Fall, rehab for 2 months. At the time of the event the patient had rheumatoid arthritis, Irritable bowel syndrome (IBS), previous cancers, MTHFR Vitamin deficiencies, depression, bruised rib from a fall, egg allergy. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 04-Nov-2024 17:00, the patient received Fluad (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 390224. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2024, the patient experienced Atrial fibrillation(AFib) associated symptoms of Palpitations and chest pain. On 01-Dec-2024, the patient experienced Severe pneumonia (Hospitalized, outcome: Recovered / Resolved). On Dec-2024, the patient experienced Congestive heart failure (Hospitalized, outcome: Not Reported), Damaged kidneys (later diagnosed with Stage 3 kidney failure) (Hospitalized, outcome: Not Reported). On an unknown date, the patient experienced Intolerance/allergy to egg protein and autoimmune issues (outcome: Not reported). On 25-May-2025, the patient passed in an ICU (Hospitalized, outcome: Fatal). The patient died on 25-May-2025. The cause of death and autopsy details were not provided. On 04-Nov-2024, the patient got the Fluad 65 vaccine at 17:00, and within an hour she grabbed her chest for the first time, in panic. Within 30 hours after the vaccine, she went into the Emergency room (ER) for about 6-8 hours complaining of chest pain feeling like a heart attack. They found nothing wrong except for a bruised rib from a fall she had on 31-Oct-2024. The bruised rib was helped with ice packs and a heating pad, but all they said about the heart was that she had palpitations and a newly diagnosed Atrial fibrillation (AFib). Later that same day, 06-Nov-2024, we went to another ER that has a great cardiology wing of the hospital but they still couldn't find anything wrong, just mentioning that she had AFib, which had never been an issue in the past, was now active and showing signs of being unstable. There was nothing they felt needed to be done at the time. She went home with an unstable heart and laid in bed with rib pain and heart issues, going back to the ER several more times in Nov-2024. On 12-Nov-2024, the patient went back into the ER for a whole day with her Afib very unstable and uncontrolled by medication. The ER preformed a cardio version on her. It helped her AFib stabilize temporarily but then she was still in and out of the ER several more times. She then began going to a cardiologist and had several tests run on her heart. On 01-Dec-2024, she went into the hospital with severe pneumonia and AFib that was out of control. She spent 10 days in the hospital as they cleared the pneumonia, gave her 2 stints, and controlled the AFib fully with meds, but she was left with congestive heart failure and damaged kidneys (later diagnosed with Stage 3 kidney failure). She continued living with us for the next 5 months, and a rehab for 2 months, in and out of hospitals and ER's, getting weaker and weaker until she eventually passed in an Intensive Care Unit (ICU) on 25-May-2025. Once they realized the connection to the timing of the vaccine and all of her health issues, they began to look into exactly which vaccine she got and what were possible reasons for her body to react in the way it did. We found a precaution warning not take Fluad65 if a person has an intolerance/allergy to egg protein, which she did. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event passed in an ICU as serious (Hospitalized, Death) and did not provide the causality assessment. The reporter assessed events AFib, Severe pneumonia, Congestive heart failure, Damaged kidneys (later diagnosed with Stage 3 kidney failure) as serious (Hospitalized) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the events Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack, Palpitations, Rib pain, Getting weaker and weaker and Intolerance/allergy to egg protein and autoimmune issues.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, all events are considered related for reporting purposes. Related for event atrial fibrillation considering implied temporal relationship (symptom of chest pain started within one hour after vaccine administration). Furthermore, the contraindicated product administration (intolerance/allergy to egg protein) could have contributed to the event atrial fibrillation. The events pneumonia, congestive cardiac failure, chronic kidney disease are considered coincidental with no biological plausibility for the product to cause/contribute. The medical history of previous cancers (unspecified) is considered as risk factors for events reported. Related for the event death, due to the lack of the information (cause of death, autopsy details). However, the events of atrial fibrillation, pneumonia, congestive cardiac failure, chronic kidney disease could have contributed to the event death.; Reported Cause(s) of Death: Passed in an ICU
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Coronary arterial stent insertion, Death, Intensive care, Palpitations, Pneumonia
|
Passed in an ICU; Severe pneumonia; Congestive heart failure; Damaged kidneys (later diagnosed with Stage 3 kidney failure); Atrial fibrillation (AFib); Intolerance/allergy to egg protein and autoimmune issues; Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack; Palpitations; This spontaneous case, initially received on 15-Aug-2025, was reported by a non-health professional and concerns an elderly female patient. Past medical history included Fall, rehab for 2 months. At the time of the event the patient had rheumatoid arthritis, Irritable bowel syndrome (IBS), previous cancers, MTHFR Vitamin deficiencies, depression, bruised rib from a fall, egg allergy. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 04-Nov-2024 17:00, the patient received Fluad (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 390224. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2024, the patient experienced Atrial fibrillation(AFib) associated symptoms of Palpitations and chest pain. On 01-Dec-2024, the patient experienced Severe pneumonia (Hospitalized, outcome: Recovered / Resolved). On Dec-2024, the patient experienced Congestive heart failure (Hospitalized, outcome: Not Reported), Damaged kidneys (later diagnosed with Stage 3 kidney failure) (Hospitalized, outcome: Not Reported). On an unknown date, the patient experienced Intolerance/allergy to egg protein and autoimmune issues (outcome: Not reported). On 25-May-2025, the patient passed in an ICU (Hospitalized, outcome: Fatal). The patient died on 25-May-2025. The cause of death and autopsy details were not provided. On 04-Nov-2024, the patient got the Fluad 65 vaccine at 17:00, and within an hour she grabbed her chest for the first time, in panic. Within 30 hours after the vaccine, she went into the Emergency room (ER) for about 6-8 hours complaining of chest pain feeling like a heart attack. They found nothing wrong except for a bruised rib from a fall she had on 31-Oct-2024. The bruised rib was helped with ice packs and a heating pad, but all they said about the heart was that she had palpitations and a newly diagnosed Atrial fibrillation (AFib). Later that same day, 06-Nov-2024, we went to another ER that has a great cardiology wing of the hospital but they still couldn't find anything wrong, just mentioning that she had AFib, which had never been an issue in the past, was now active and showing signs of being unstable. There was nothing they felt needed to be done at the time. She went home with an unstable heart and laid in bed with rib pain and heart issues, going back to the ER several more times in Nov-2024. On 12-Nov-2024, the patient went back into the ER for a whole day with her Afib very unstable and uncontrolled by medication. The ER preformed a cardio version on her. It helped her AFib stabilize temporarily but then she was still in and out of the ER several more times. She then began going to a cardiologist and had several tests run on her heart. On 01-Dec-2024, she went into the hospital with severe pneumonia and AFib that was out of control. She spent 10 days in the hospital as they cleared the pneumonia, gave her 2 stints, and controlled the AFib fully with meds, but she was left with congestive heart failure and damaged kidneys (later diagnosed with Stage 3 kidney failure). She continued living with us for the next 5 months, and a rehab for 2 months, in and out of hospitals and ER's, getting weaker and weaker until she eventually passed in an Intensive Care Unit (ICU) on 25-May-2025. Once they realized the connection to the timing of the vaccine and all of her health issues, they began to look into exactly which vaccine she got and what were possible reasons for her body to react in the way it did. We found a precaution warning not take Fluad65 if a person has an intolerance/allergy to egg protein, which she did. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event passed in an ICU as serious (Hospitalized, Death) and did not provide the causality assessment. The reporter assessed events AFib, Severe pneumonia, Congestive heart failure, Damaged kidneys (later diagnosed with Stage 3 kidney failure) as serious (Hospitalized) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the events Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack, Palpitations, Rib pain, Getting weaker and weaker and Intolerance/allergy to egg protein and autoimmune issues.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, all events are considered related for reporting purposes. Related for event atrial fibrillation considering implied temporal relationship (symptom of chest pain started within one hour after vaccine administration). Furthermore, the contraindicated product administration (intolerance/allergy to egg protein) could have contributed to the event atrial fibrillation. The events pneumonia, congestive cardiac failure, chronic kidney disease are considered coincidental with no biological plausibility for the product to cause/contribute. The medical history of previous cancers (unspecified) is considered as risk factors for events reported. Related for the event death, due to the lack of the information (cause of death, autopsy details). However, the events of atrial fibrillation, pneumonia, congestive cardiac failure, chronic kidney disease could have contributed to the event death.; Reported Cause(s) of Death: Passed in an ICU
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Renal failure, Renal injury
|
Passed in an ICU; Severe pneumonia; Congestive heart failure; Damaged kidneys (later diagnosed with Stage 3 kidney failure); Atrial fibrillation (AFib); Intolerance/allergy to egg protein and autoimmune issues; Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack; Palpitations; This spontaneous case, initially received on 15-Aug-2025, was reported by a non-health professional and concerns an elderly female patient. Past medical history included Fall, rehab for 2 months. At the time of the event the patient had rheumatoid arthritis, Irritable bowel syndrome (IBS), previous cancers, MTHFR Vitamin deficiencies, depression, bruised rib from a fall, egg allergy. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 04-Nov-2024 17:00, the patient received Fluad (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 390224. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2024, the patient experienced Atrial fibrillation(AFib) associated symptoms of Palpitations and chest pain. On 01-Dec-2024, the patient experienced Severe pneumonia (Hospitalized, outcome: Recovered / Resolved). On Dec-2024, the patient experienced Congestive heart failure (Hospitalized, outcome: Not Reported), Damaged kidneys (later diagnosed with Stage 3 kidney failure) (Hospitalized, outcome: Not Reported). On an unknown date, the patient experienced Intolerance/allergy to egg protein and autoimmune issues (outcome: Not reported). On 25-May-2025, the patient passed in an ICU (Hospitalized, outcome: Fatal). The patient died on 25-May-2025. The cause of death and autopsy details were not provided. On 04-Nov-2024, the patient got the Fluad 65 vaccine at 17:00, and within an hour she grabbed her chest for the first time, in panic. Within 30 hours after the vaccine, she went into the Emergency room (ER) for about 6-8 hours complaining of chest pain feeling like a heart attack. They found nothing wrong except for a bruised rib from a fall she had on 31-Oct-2024. The bruised rib was helped with ice packs and a heating pad, but all they said about the heart was that she had palpitations and a newly diagnosed Atrial fibrillation (AFib). Later that same day, 06-Nov-2024, we went to another ER that has a great cardiology wing of the hospital but they still couldn't find anything wrong, just mentioning that she had AFib, which had never been an issue in the past, was now active and showing signs of being unstable. There was nothing they felt needed to be done at the time. She went home with an unstable heart and laid in bed with rib pain and heart issues, going back to the ER several more times in Nov-2024. On 12-Nov-2024, the patient went back into the ER for a whole day with her Afib very unstable and uncontrolled by medication. The ER preformed a cardio version on her. It helped her AFib stabilize temporarily but then she was still in and out of the ER several more times. She then began going to a cardiologist and had several tests run on her heart. On 01-Dec-2024, she went into the hospital with severe pneumonia and AFib that was out of control. She spent 10 days in the hospital as they cleared the pneumonia, gave her 2 stints, and controlled the AFib fully with meds, but she was left with congestive heart failure and damaged kidneys (later diagnosed with Stage 3 kidney failure). She continued living with us for the next 5 months, and a rehab for 2 months, in and out of hospitals and ER's, getting weaker and weaker until she eventually passed in an Intensive Care Unit (ICU) on 25-May-2025. Once they realized the connection to the timing of the vaccine and all of her health issues, they began to look into exactly which vaccine she got and what were possible reasons for her body to react in the way it did. We found a precaution warning not take Fluad65 if a person has an intolerance/allergy to egg protein, which she did. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event passed in an ICU as serious (Hospitalized, Death) and did not provide the causality assessment. The reporter assessed events AFib, Severe pneumonia, Congestive heart failure, Damaged kidneys (later diagnosed with Stage 3 kidney failure) as serious (Hospitalized) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the events Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack, Palpitations, Rib pain, Getting weaker and weaker and Intolerance/allergy to egg protein and autoimmune issues.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, all events are considered related for reporting purposes. Related for event atrial fibrillation considering implied temporal relationship (symptom of chest pain started within one hour after vaccine administration). Furthermore, the contraindicated product administration (intolerance/allergy to egg protein) could have contributed to the event atrial fibrillation. The events pneumonia, congestive cardiac failure, chronic kidney disease are considered coincidental with no biological plausibility for the product to cause/contribute. The medical history of previous cancers (unspecified) is considered as risk factors for events reported. Related for the event death, due to the lack of the information (cause of death, autopsy details). However, the events of atrial fibrillation, pneumonia, congestive cardiac failure, chronic kidney disease could have contributed to the event death.; Reported Cause(s) of Death: Passed in an ICU
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain
|
Patient stopped by the pharmacy on 08/26/2025 and asked to me to report his side effects of Spikevax vaccine given on 08/17/2025. Patient states he had sever exhaustion, headache, body aches, and loss of appetite. Side affects subsited without medical intervention.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Diarrhoea, Hallucination, Nausea, Vomiting
|
Patient husband stopped by the pharmacy and expressed that both him and his wife experienced side affects post receiving Spikevax vaccine on 08/14/2025. Per husband patient experienced diarrhea, and nausea accompanied by throwing up. In addition, patient had some cognitive side effects, per husband, patient had "loss of time and reality". Patient was hilucinating and talking about their daughter as if she was still 3 years old. Patient states that the side affects subsited without any medical intervention.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headache
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pain, Pain, Protein urine present, Pyrexia, Pyuria
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Urine abnormality, White blood cells urine positive
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Back pain, Bacterial test positive, Blood creatinine normal, Blood urine present
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chromaturia, Condition aggravated, Haematuria, Headache, Injection site pain
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Pain, Protein urine present, Pyrexia, Pyuria, Urinary squamous epithelial cells increased
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Urine abnormality, White blood cells urine positive
|
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Arrhythmia, Injected limb mobility decreased, Injection site oedema, Pain in extremity
|
patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; This spontaneous report was received from an Office manager and refers to a 27-year-old female patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were reported as none. On 03-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE 0.5 mL administered by Intramuscular route, lot # Y016291 has been verified to be valid, expiration date reported as 31-DEC-2026 but upon internal validation established as 06-DEC-2026, given for Low IG level vaccination [Immunoglobulins decreased (Considered as concurrent condition)]. On 05-Jun-2025, the patient was evaluated at an urgent care clinic on with arrythmia, edema at the injection site (Vaccination site edema), and arm soreness (Vaccination site pain) to the point the patient could not lift their arm (Injected limb mobility decreased). Unspecified treatment was given for the adverse events and on an unspecified date in 2025, the patient recovered from all the events. The causal relationship between all the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE was not reported. Upon internal review, the event of arrythmia was considered medically significant. This is one of four reports from the same reporter.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: ADAMTS13 activity decreased, Activated partial thromboplastin time normal, Acute respiratory failure, Alanine aminotransferase normal, Aspartate aminotransferase increased
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Asterixis, Back pain, Bilirubin conjugated increased, Blood bilirubin increased, Blood creatinine increased
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Blood electrolytes normal, Blood fibrinogen normal, Blood lactate dehydrogenase increased, Chest X-ray abnormal, Complement factor C3
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Complement factor C4, Complement factor normal, Coombs test negative, Crepitations, Eastern Cooperative Oncology Group performance status
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Ecchymosis, Echocardiogram, Echocardiogram normal, Ejection fraction normal, Fibrin D dimer increased
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Genetic testing, Haemodialysis, Haemoglobin decreased, Haptoglobin decreased, Immature platelet fraction increased
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Jugular vein distension, Karnofsky scale, Mental status changes, Metabolic encephalopathy, Metabolic function test normal
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Microangiopathic haemolytic anaemia, Multiple organ dysfunction syndrome, Oedema peripheral, Plasmapheresis, Platelet count decreased
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Platelet factor 4 decreased, Prothrombin time normal, Pulmonary oedema, Red blood cell burr cells present, Red blood cell schistocytes present
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: RSV
Symptoms: Renal failure, Soluble fibrin monomer complex increased, Thrombotic microangiopathy, Urinary retention, White blood cell count normal
|
respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia; metabolic encephalopathy; anuric renal failure; multi-organ failure; acute hypoxic respiratory failure; This serious case was reported in a literature article and described the occurrence of thrombotic microangiopathy in a 91-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included low back pain, coronary artery disease (status post bypass grafting), coronary artery bypass graft, aortic valve replacement, sick sinus syndrome (status post pacemaker placement), cardiac pacemaker insertion, hypertension, paroxysmal atrial fibrillation, cardiac failure (with preserved ejection fraction), thoracic aortic aneurysm, chronic anemia, prostate cancer stage iv (status post retro pelvic prostatectomy), prostatectomy, radiation therapy, bone metastases (extensive), crackles lung, jugular vein distension, pedal edema, asterixis, ecchymosis (in the left upper extremity), pulmonary edema and urinary retention. Additional patient notes included Patient had not recently started any other new medications or herbal supplements. Concomitant products included abiraterone acetate, prednisone, leuprorelin acetate (Leuprolide Acetate), ELASOMERAN (MODERNA COVID-19 VACCINE), INFLUENZA VACCINE and rituximab. On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced thrombotic microangiopathy (Verbatim: respiratory syncytial virus vaccine induced thrombotic microangiopathy/vaccine-induced thrombotic microangiopathy/microangiopathic hemolytic anemia) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), metabolic encephalopathy (Verbatim: metabolic encephalopathy) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), anuric renal failure (Verbatim: anuric renal failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), multi-organ failure (Verbatim: multi-organ failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and acute hypoxic respiratory failure (Verbatim: acute hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with prednisone. The outcome of the thrombotic microangiopathy and anuric renal failure were resolved and the outcome of the metabolic encephalopathy, multi-organ failure and acute hypoxic respiratory failure were resolving. The reporter considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. The company considered the thrombotic microangiopathy, metabolic encephalopathy, anuric renal failure, multi-organ failure and acute hypoxic respiratory failure to be related to Arexvy. Additional Information: GSK Receipt Date 21-AUG-2025. Author reported a patient presented to hospital with severe low back pain and urinary retention. Patient received the new adjuvant RSV vaccine, known as Arexvy, the day prior at a local pharmacy. His past medical history included coronary artery disease status post bypass grafting, bovine aortic valve replacement, sick sinus syndrome status post pacemaker placement, hypertension, paroxysmal atrial fibrillation, heart failure with preserved ejection fraction, chronic thoracic aortic aneurysm, chronic anemia, and stage IV prostate cancer status post retro pelvic prostatectomy followed by radiation therapy with subsequent recurrence with extensive bony metastases. Pertinent outpatient medications included abiraterone acetate, prednisone (5 mg daily), and leuprolide acetate. Patient had not recently started any other new medications or herbal supplements. Patient had received the coronavirus-19 (COVID-19) Moderna vaccine booster 1 month prior to admission and patient had received the Influenza vaccine 3 weeks prior to admission. Patient had baseline Karnofsky and Eastern Cooperative Oncology Group performance scores of 90 percent and 0, respectively. Patient was found to have metabolic encephalopathy and renal failure. His initial labs showed white blood cell count of 7.7 x 10e9 /L, hemoglobin 12.4 g/dL, and platelet count of 112 x 10e9 /L. His complete metabolic profile was normal, except for a creatinine 1.3 mg/dL, and total bilirubin of 2.2 mg/dL. Baseline labs from seven weeks prior were normal including a hemoglobin of 13 g/dL and a platelet count 201x10e9 /L. His last available total bilirubin three months prior was normal. During his hospitalization, his renal failure (Cr 4.1 mg/dL) and encephalopathy worsened, his hemoglobin and platelets continued to decrease, and his AST increased to 95 U/L with normal ALT at 36 U/L. Due to clinical deterioration with no clear diagnosis. Patient was afebrile with pulse rate 60 bpm, respiratory rate 19/min, blood pressure 191/ 108 mmHg, and acute hypoxic respiratory failure requiring 5 L Oxymask to maintain SpO2 more than 90percent. The physical exam was significant for bibasilar crackles in the lungs, jugular venous distention, trace pedal edema, asterixis, ecchymosis in the left upper extremity, and acute metabolic encephalopathy (Glascow Coma Score 9). Laboratory findings include the following (reference ranges listed parenthetically): hemoglobin, 9 g/dL (13.2-16.6 g/ dL); platelet count, 10 x 10e9 /L (135-317x10e9 /L); white blood cell count, 7.1x10e9 /L (3.4-9.6 x 10e9 /L); creatinine, 5.15 mg/ dL (0.75-1.34 mg/dL); total bilirubin, 2.5 mg/dL (less than 1.2 mg/dL); direct bilirubin, 1.0 mg/dL (0-0.3 mg/dL); lactate dehydrogenase, 3080 U/L (122-222 U/L); D-dimer, 33,652 ng/mL (less than 500 ng/mL); haptoglobin, less than 14 mg/dL (30-200 mg/ dL); immature platelet fraction, 15.7percent (1-7percent). Prothrombin time, activated partial thromboplastin time, and fibrinogen were within normal limits. Soluble fibrin monomer was positive. Complement levels on admission included a normal C3 and C4. Chest x-ray revealed bilateral pulmonary edema. Transthoracic echocardiography (TTE) was obtained to assess for the Waring Blender effect, which revealed no prosthetic or periprosthetic regurgitation. The differential diagnosis on admission for this patient with new-onset microangiopathic hemolytic anemia with anuric renal failure and metabolic encephalopathy included TTP, aHUS, disseminated intravascular coagulation (DIC), Waring-Blender syndrome secondary to paravalvular regurgitation, vaccine-induced thrombotic microangiopathy (TMA), or other causes of TMA. Non-TMA etiologies to explain the thrombocytopenia included vaccine-induced immune thrombotic thrombocytopenia (VITT) and heparin-induced thrombocytopenia (HIT). Heparin platelet factor 4 (PF4) antibody and Coombs test were negative. Peripheral smear revealed schistocytes (more than 10/hpf) and burr cells. ADAMTS13 and aHUS/TMA panels were obtained. Due to concern for TTP with multiorgan failure, plasma exchange (PLEX) and hemodialysis were promptly initiated. Given his stable respiratory status and no severe electrolyte abnormalities, PLEX initiation was prioritized over hemodialysis. After the initial PLEX session, the patient demonstrated significant improvement in mental status. Intermittent hemodialysis and prednisone (60 mg daily) were started subsequently. Rituximab therapy was held pending the ADAMTS13 result. The patient received eight sessions of PLEX in total with complete recovery of mental status to baseline within 48 hours. Prednisone (60 mg daily) was administered daily with PLEX until platelets reached 150x10e9 /L for 3 days, after which steroids were tapered over the next few weeks. ADAMTS13 activity results sent before PLEX returned at 67percent (normal more than 70percent) essentially ruling out a diagnosis of TTP, so rituximab was not administered. AHUS/TMA/complement panel returned with the following lab values: total complement 60 (normal 30-75 U/mL), C3 84 (normal 75-175 mg/dL) C4 28 (normal 14-40 mg/dL), factor B complement antigen 36 (normal 30-75 mg/dL), factor H complement antigen 24.7 (normal 18.5-40.8 mg/dL), alternate complement pathway function more than 110percent (normal more than 46percent), SC5b-9 complement 597 (normal less than 251 ng/dL). CBb complement more than 6 (normal less than 1.7 mcg/dL), and C4d complement 2.7 (normal less than 9.9 mcg/dL). Since this panel was not consistent with active alternative complement pathway activation and given the clinical improvement with PLEX, the patient was not started on eculizumab. On the day of discharge (day 11), platelet count was normal at 267x10e9 /L. By discharge, his renal function had not improved, and patient still required hemodialysis. After discharge, his atypical HUS gene panel results showed a double heterozygote status for CFHR1 exon 2-6 deletion, and CFHR3 exon 1-6 deletion. These specific mutations were not well-characterized and were of unclear clinical significance. After discharge, his clinical status continued to improve. Patient completed his course of prednisone, and his renal function improved to the point that patient came off hemodialysis. His most recent labs at 9 weeks post-discharge showed LDH within normal limits at 188 U/L, Hb of 11.4 g/dL, and platelets of 289x10e9 /L. ALT and AST within normal limits at 27 U/L and 33 U/L, respectively. Total bilirubin within normal limits at 0.5 mg/dL with no indirect hyperbilirubinemia. Creatinine normalized at 0.65 mg/dL. Author presented the case of a patient with microangiopathic hemolytic anemia, anuric renal failure and metabolic encephalopathy within 24 hours of administration of the new Arexvy RSV vaccine. Arexvy RSV vaccine data sheets do not report thrombocytopenia or microangiopathic hemolytic anemias to be known adverse events. The patient was heterozygous for a large deletion involving the CFHR1 and CFHR3 genes, strongly suggesting the presence of a contiguous deletion of the full CFHR1 and CFHR3 genes. Specifically, it was noted that the complement factor H (CFH)-CFHR gene cluster was prone to structural variation resulting in large deletions, duplications, and hybrids of genes within the cluster. Currently, the clinical significance of heterozygous copy number variation impacting the CFHR1 and CFHR3 genes was not well-characterized, and the clinical significance of deletions and duplications impacting other genes within the CFHR cluster was not well-delineated. The patient's complement levels were within normal range, except for elevations in CBb and SC5b-9. These complement-level abnormalities indicate activation of the alternative complement pathway, and in the absence of other complement abnormalities this was most likely secondary to post-blood draw activation. Of note, the expected a-HUS lab findings (low factor H, normal C4 and low AH50) were not present. However, prior studies have reported that complement levels may remain normal in aHUS.4 Classically, aHUS was not effectively treated with PLEX, although it was a first-line treatment for Factor H deficiency. RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion. High dose corticosteroids with PLEX resolved the patient's microangiopathic hemolytic anemia and thrombocytopenia and, in conjunction with intermittent hemodialysis, resolved the patient's acute renal failure.; Sender's Comments: A case of Thrombotic microangiopathy, Metabolic encephalopathy, Renal failure, Multiple organ dysfunction syndrome and Acute respiratory failure, less than a day after receiving Arexvy, in a 91-year-old male patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and etiology (RSV vaccine-induced thrombotic microangiopathy with associated multi-organ failure was a diagnosis of exclusion) based on medical history.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Electromyogram, Laboratory test, Nerve conduction studies, Postural orthostatic tachycardia syndrome
|
Severe Dysautonomia, Postural Orthostatic Tachycardia, Neurally Mediated Syncope
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
|
Severe Dysautonomia, Postural Orthostatic Tachycardia, Neurally Mediated Syncope
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperacusis, Tinnitus
|
My tinnitus definitely got worse and my ears more sensitive--an increase in hyperacusis. I'm still feeling it 8 months later.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Documented hypersensitivity to administered product, Hypoaesthesia, Malaise
|
Patient was allergic to dtap per documentation patient was feeling body numbness and feeling sick medical assistant administered TDAP before provider order. Patient not feeling well patient was send to emergency room per provider per provider direction.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 79.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Death, Nausea, Unresponsive to stimuli, Vomiting
|
Resident developed nausea and vomiting on 08/23/2025 at 1500, resident vomited x2 Ordered zofran from MD PRN. Resident still monitored every shift with no episodes noted for the ff shift. Resident still eating her meals for dinner and breakfast. Around shower time the next day resident noted to be non responsive while up on the shower chair. Transferred to bed, no vitals obtained. Resident is DNR.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Loss of employment, Malaise
|
I got dizzy and then i got brain fog, and i have a list of the symptoms, I am better but some do linger. I was hoping it would go away and i got to see my new doctor 3 weeks after the vaccine, and it took him by surprise. I went to facility twice. I lost my job over this and i have been sick ever since, I had over 35 symptoms.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
|
Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 23-Oct-2023. At the time of the report, the outcome of the event Arthritis was Recovered/Resolved. A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Arthritis 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 Arthritis is considered Possible.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: VARZOS
Symptoms: Deafness
|
could not hear the sound; This serious case was reported by a consumer via interactive digital media and described the occurrence of deafness in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced deafness (Verbatim: could not hear the sound) (serious criteria GSK medically significant). The outcome of the deafness was not reported. It was unknown if the reporter considered the deafness to be related to Herpes Zoster vaccine. The company considered the deafness to be unrelated to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. Patient could not hearth the sound.; Sender's Comments: A case of Deafness, on an unknown time after receiving Herpes Zoster vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Condition aggravated, Heavy menstrual bleeding, Hypersensitivity
|
premature ovarian failure/severe night sweats/mood swings/difficulty sleeping/restless nights/migraines/early onset menopause/allergies worsen/abdominal cramping/chest pains, a heavy menstrual cycle; autoimmune injuries; vomiting; Plaintiff was 34 years when she received three dosages of Gardasil; Information has been received from a lawyer regarding a case in litigation and referred to a currently adult female patient (pt) (exact age not provided). Her other medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (at the age of 34 years old), the pt was vaccinated with three dosages of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her health care provider/ doctor with her consent, for prophylaxis (reported as for preventing cervical cancer) (Product administered to patient of inappropriate age). Pt had no symptoms following the first quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. Following the second and third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt began to have severe night sweats, mood swings, restless nights, difficulty sleeping, and migraines. Her allergies worsened. Following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, her doctor suspected premature ovarian failure and had her stop Depo-Provera so he could get accurate testing results as Depo-Provera could mask the symptoms of premature ovarian failure and impact the results. Pt's menstrual period started two weeks prior to stopping Depo-Provera and was ongoing at the time she stopped the shot. After she stopped the Depo-Provera, she had severe abdominal cramping, chest pains, night sweats, migraines that led to vomiting, and a heavy menstrual cycle which lasted for nine weeks steady. Pt's doctor suspected premature ovarian failure, as well as early onset menopause (Premature menopause). Pt contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune injuries (Autoimmune disorder), including but not limited to Premature ovarian failure/premature menopause, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. The outcome of all events (except for Product administered to patient of inappropriate age) was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events (except for Product administered to patient of inappropriate age) to be disabling/incapacitating.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Insomnia, Migraine, Mood swings, Night sweats, Premature menopause
|
premature ovarian failure/severe night sweats/mood swings/difficulty sleeping/restless nights/migraines/early onset menopause/allergies worsen/abdominal cramping/chest pains, a heavy menstrual cycle; autoimmune injuries; vomiting; Plaintiff was 34 years when she received three dosages of Gardasil; Information has been received from a lawyer regarding a case in litigation and referred to a currently adult female patient (pt) (exact age not provided). Her other medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (at the age of 34 years old), the pt was vaccinated with three dosages of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her health care provider/ doctor with her consent, for prophylaxis (reported as for preventing cervical cancer) (Product administered to patient of inappropriate age). Pt had no symptoms following the first quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. Following the second and third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt began to have severe night sweats, mood swings, restless nights, difficulty sleeping, and migraines. Her allergies worsened. Following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, her doctor suspected premature ovarian failure and had her stop Depo-Provera so he could get accurate testing results as Depo-Provera could mask the symptoms of premature ovarian failure and impact the results. Pt's menstrual period started two weeks prior to stopping Depo-Provera and was ongoing at the time she stopped the shot. After she stopped the Depo-Provera, she had severe abdominal cramping, chest pains, night sweats, migraines that led to vomiting, and a heavy menstrual cycle which lasted for nine weeks steady. Pt's doctor suspected premature ovarian failure, as well as early onset menopause (Premature menopause). Pt contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune injuries (Autoimmune disorder), including but not limited to Premature ovarian failure/premature menopause, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. The outcome of all events (except for Product administered to patient of inappropriate age) was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events (except for Product administered to patient of inappropriate age) to be disabling/incapacitating.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Restlessness, Vomiting
|
premature ovarian failure/severe night sweats/mood swings/difficulty sleeping/restless nights/migraines/early onset menopause/allergies worsen/abdominal cramping/chest pains, a heavy menstrual cycle; autoimmune injuries; vomiting; Plaintiff was 34 years when she received three dosages of Gardasil; Information has been received from a lawyer regarding a case in litigation and referred to a currently adult female patient (pt) (exact age not provided). Her other medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (at the age of 34 years old), the pt was vaccinated with three dosages of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her health care provider/ doctor with her consent, for prophylaxis (reported as for preventing cervical cancer) (Product administered to patient of inappropriate age). Pt had no symptoms following the first quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. Following the second and third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt began to have severe night sweats, mood swings, restless nights, difficulty sleeping, and migraines. Her allergies worsened. Following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, her doctor suspected premature ovarian failure and had her stop Depo-Provera so he could get accurate testing results as Depo-Provera could mask the symptoms of premature ovarian failure and impact the results. Pt's menstrual period started two weeks prior to stopping Depo-Provera and was ongoing at the time she stopped the shot. After she stopped the Depo-Provera, she had severe abdominal cramping, chest pains, night sweats, migraines that led to vomiting, and a heavy menstrual cycle which lasted for nine weeks steady. Pt's doctor suspected premature ovarian failure, as well as early onset menopause (Premature menopause). Pt contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune injuries (Autoimmune disorder), including but not limited to Premature ovarian failure/premature menopause, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. The outcome of all events (except for Product administered to patient of inappropriate age) was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events (except for Product administered to patient of inappropriate age) to be disabling/incapacitating.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
|
Suspected vaccination failure; shingles in my right eye again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles on scalp) and ophthalmic herpes zoster (had shingles in right eye, eyelid was affected). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in my right eye again) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. The patient said that his/her physician told him/her once you have had shingles it was in your system, and the shot would not help. The patient had shingles on his/her scalp and in right eye, finally recovered after a few months but his/her eyelid was affected, got the 2 Shingles shots and 2 years later, in his/her right eye again. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of ophthalmic herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). A case of Ophthalmic herpes zoster, 2 years 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.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.