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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: ??
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
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Diagnostic Lab Data:
CDC 'Split Type': ROPFIZER INC2021385965
Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19
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