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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||RA / -|
Administered by: Other Purchased by: ??
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Chills, Pyrexia, Vomiting, Illness
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: Stroke (previous stroke in May 2017)
Diagnostic Lab Data:
CDC 'Split Type': CAPFIZER INC2021498435
Write-up: sick; fever; chills; vomiting; stroke; brain bleed; This is a spontaneous report from a contactable other health care professional (patient''s niece). A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 23Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 91 years old) at 2nd dose, single for COVID-19 immunisation. Medical history included previous stroke in May2017. The patient was not pregnant at the time of vaccination. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021 at 03:00, the patient became extremely sick. On 24Apr2021, she had fever, chills and vomiting. Later that evening (24Apr2021), she passed away from a stroke and brain bleed. The adverse events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event sick was not recovered, and unknown outcome for fever, chills and vomiting. The patient died on 24Apr2021. It was unknown if an autopsy was performed. Information on batch/lot number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. Medical history of previous stroke may provided a plausible alternative explanation for the events of Stroke and Cerebral bleeding. 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: Stroke; brain bleed
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