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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||EL1491 / 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 INC2021191681
Write-up: the fatal outcome; This is a spontaneous report from a non- contactable physician downloaded from the regulatory authority- DE-PEI-PEI2021002724 A female patient of an unspecified received the second dose of bnt162b2 (COMIRNATY; Lot # EL1491) vaccine, via an unspecified route of administration on 23Jan2021 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On 31Dec2020, the patient received the first dose of COMIRNATY. The patient died on 04Feb2021. The cause of death was unknown. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) assessed Inconsistent causal association by regulatory authority. No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer 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.; Reported Cause(s) of Death: Unknown cause of death
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