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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: Aortic dissection
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)? Yes
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Syncope; Terminal state
Diagnostic Lab Data:
CDC 'Split Type': JPPFIZER INC2021807618
Write-up: Aortic dissection; This is a spontaneous report from a contactable physician received a company representative. The patient was an 83-year-old female. Medical history included dementia, hypertension, and occasional onsets of syncope, and she was dying of old age and was on end-of-life care. Concomitant medications were not reported. On 04Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 23Jun2021 at unknown time (19 days after the vaccination), the patient experienced aortic dissection. On 23Jun2021 (19 days after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The patient had dementia, hypertension, and occasional onsets of syncope. She was dying of old age and was on end-of-life care. On 04Jun2021 (the day of vaccination), the patient received the first BNT162b2 vaccination. On 23Jun2021 (19 days after the vaccination), the patient''s condition suddenly changed during the meal, and she died at the hospital where she was transported. The cause of death was aortic dissection. It was said that the causal relationship could not be denied, but no further follow-ups could be accepted considering the end-of-life care and the privacy of the bereaved family. The seriousness of the event was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Aortic Dissection cannot be fully assessed/excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic dissection
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