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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||- / -|
Administered by: Other Purchased by: ??
Symptoms: Cardiac failure, Cardio-respiratory arrest, Chest X-ray, Electrocardiogram, Sudden death, Investigation
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: 3
Write-up: Suspected cardiac failure; suspected cardio-respiratory arrest; Sudden death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory Authority report number v21110380. A 102-year-old female patient received the first dose of BNT162b2 (COMIRNATY) via an unspecified route of administration on 20May2021 (at the age of 102-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was a 102-year and 11-month-old female. Body temperature before vaccination was unknown. The patient had no particular family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 24May2021 at 11:00 (4 days, and 11 hours after the vaccination), the patient experienced suspected cardiac failure. On 21May2021 (one day after the vaccination), the patient was admitted to the hospital. On 24May2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 12May2021, chest X-ray showed no significant changes. ECG showed only supraventricular premature beats (rare). The biochemical examination included white cell nucleated (WNR). On 20May2021 (the day of vaccination), in the afternoon, the patient received mass vaccination of BNT162b2. On 21May2021 (one day after vaccination), the patient was admitted to the reporting hospital for short stay. On 24May2021, 07:30 (4 days, 7 hours, and 30 minutes after vaccination), during the short stay, the patient had no pain on defecation, and when the staff member visited her room for preparation for going home, the patient had suspected cardio-respiratory arrest. The patient was emergently transferred to another hospital, where she was confirmed death. The date of death was 24May2021. Cardiac failure was suspected. Head CT was not performed because the family member did not wish to. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the patient had no underlying disease which was the cause of the sudden death, and she was healthy for her age. However, since the patient was oldest old, the causality between the event and BNT162b2 was unknown. The information on the batch number has been requested.; Reported Cause(s) of Death: Suspected cardiac failure; Sudden death; suspected cardio-respiratory arrest
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