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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||- / 2||- / -|
Administered by: Other Purchased by: ??
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
Diagnostic Lab Data:
CDC 'Split Type': DEPFIZER INC2021050589
Write-up: after second dose vaccination the patient died; This is a spontaneous report based on information received by Pfizer from LLP- BioNtech, license party for COMIRNATY. A contactable physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received second dose of bnt162b2 (COMIRNATY), on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 28Dec2020 at single dose for COVID-19 immunisation. Several hours after second dose vaccination the patient died. The patient died on an unspecified date in Jan2021. It was unknown if an autopsy was performed. Information on the batch number has been requested; Sender''s Comments: Lacking information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the COVID 19 vaccine, BNT162B2, and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. More information (patient age group, underlying medication conditions, relevant lab tests, autopsy results) is required for the Company to make a more meaningful causality assessment. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021050519 same reporter/drug/event, different patient; Reported Cause(s) of Death: after second dose vaccination the patient died
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