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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: hemorrhagic stroke; This is a spontaneous report from a contactable physician (patient''s wife) via a Pfizer sales representative. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation and rivaroxaban (XARELTO), route of administration, start and stop date, batch/lot number and dose were not reported for atrial fibrillation. The patient''s medical history included atrial fibrillation and concomitant medications were not reported. The patient experienced hemorrhagic stroke on an unspecified date. The patient consulted the physician (his wife) due to slight malaises and dizziness and the physician thought that it was due to rivaroxaban. She prescribed him an MRI (results not yet available). The patient then died of a hemorrhagic stroke. As the patient was also vaccinated, the physician did not know if the event was due to bnt162b2 or rivaroxaban. The action taken in response to the event for rivaroxaban is not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Considering the patient was administrated with rivaroxaban for atrial fibrillation, the reported event hemorrhagic stroke is likely due to rivaroxaban, based on the bleeding risk of the suspected drug. The latency of the event to administration of BNT162B2 is unknown, the event is unrelated to BNT162B2 based on the very limited information. 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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