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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 1||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Death, Electrocardiogram, Electroencephalogram, Malaise, Presyncope, Seizure, Neurological examination, Scan brain, Blood test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2
Write-up: Death unexplained; Vasovagal reaction/lipothymia; Convulsion; Felt unwell; This is as spontaneous report received from a contactable Physician downloaded from a regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BR20210969. An 87-year-old female patient received the first dose of BNT162b2 (COMIRNATY), via intramuscular route on 18Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypoacusis, hypothyroidism, coronary angioplasty, cerebral ischaemia from 2020, sigmoid polyp (resected). Concomitant medications included perindopril; bisoprolol; apixaban (ELIQUIS); ezetimiba; furosemide; spironolactone; atorvastatin; levothyroxine sodium (LEVOTHYROX); mianserin; bromazepam; alendronic acid; cholecalciferol; potassium chloride (DIFFU-K), all from an unspecified date for unspecified indication. On the way back home after first dose of Comirnaty, in the car with her daughter, the patient felt unwell. At the history, she described prodromal symptoms followed by lipothymia then convulsions. In the emergency room, the patient presented a normal neurological examination, without confusional syndrome, without focal signs. A brain scan, a blood test, an Electroencephalogram (EEG) and an Electrocardiogram (ECG) were carried out: they were all normal, not allowing to identify a particular somatic cause for the malaise. The patient was kept under surveillance in the Short Stay Unit (SSU). The day after her admission, there was no recurrence of the malaise or convulsive seizure. On reviewing the events, it appears that the patient had not eaten breakfast in the morning and that a priori, she would have presented prodromal symptoms before the seizure, and given her more or less forced sitting position in the vehicle, which prevented her from decubitus during the seizure, the convulsions are probably related to a drop in blood pressure of the vagal malaise type. Conclusion: very likely vagal malaise. On 20Mar2021, the patient returns home. On 20Mar2021 at 17:00, the nurse finds the patient dead on the floor (as if she had tipped over from her chair). The outcome of the event felt unwell was unknown. The patient died on 20Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death unexplained
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