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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: Death, COVID-19, SARS-CoV-2 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
Diagnostic Lab Data: Test Date: 202104; Test Name: Covid-19 test; Test Result: Positive
CDC 'Split Type': DEPFIZER INC2021404402
Write-up: patient died approximately 1 week after first vaccination; Covid-19 test positive; This is a spontaneous report based on information received by Pfizer from a company [manufacturer control number: 38084], license party for Comirnaty. A non-contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in Apr2021 at SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient has been vaccinated with bnt162b2 during Easter holidays. A few days later the COVID-19 test was positive in Apr2021. The patient died approximately 1 week after first vaccination according to the daughter in Apr2021. It was not reported if an autopsy was performed. The outcome of the event COVID-19 test was positive was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause 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. COVID-19 is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information 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: patient died approximately 1 week after first vaccination
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