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Life Threatening? No
Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable pharmacist. An 83-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY), via intramuscular in Apr2021 (at an unknown age) at 0.3 mL, single for COVID-19 immunisation. Medical history included diabetes, hypercholesterolemia, and hypertension arterial. Concomitant medications included unspecified medications for treatment of diabetes, hypercholesterolemia, and hypertension arterial. The patient previously received the first dose of BNT162B2 (COMIRNATY) (lot number: unknown) in Mar2021 at the age of 82-year-old via intramuscular for COVID-19 immunisation. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It is unknown if since the vaccination, the patient was tested for COVID-19. On 30Apr2021 at 06:00, the patient was found lying on the floor. She had experienced hemorrhagic stroke and was taken to the hospital on 30Apr2021 at 06:00. She remained hospitalized and died on 06May2021. Autopsy was performed. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available and currently known drug safety profile, it is unlikely that event hemorrhagic stroke was related to BNT162B2. The patient''s underlying risk factors/predisposing conditions diabetes, hypercholesterolemia, and hypertension arterial and the advanced age have been assessed to have played a contributory role toward the event. 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: Hemorrhagic stroke
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