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Write-up: Aortic dissection; pyrexia; cardiac tamponade; This is a spontaneous report from a contactable pharmacist received via a Company sales representative. The patient''s age and gender were not provided. Body temperature before vaccination was not provided. The patient family history and medical history were not provided.On 17May2021 at (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular at a dose of 0.3 mL, single for COVID-19 immunization. On 17May2021 (the day of the vaccination), the patient experienced pyrexia and aortic dissection. On 17May2021 (the day of the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 17May2021 (the day of vaccination), after the patient received BNT162b2 vaccination at the institution where she was admitted to, she experienced an adverse event of pyrexia, and she was emergently transferred to another hospital. While the patient was being treated in the hospital, she experienced an adverse event of aortic dissection and cardiac tamponade occurred. Thereafter, the patient died. Cause of death was reported as cardiac tamponade; aortic dissection, pyrexia also reported as fatal. Unknown whether autopsy was performed or not. The causality between the event and BNT162b2 was not provided. Information on the lot/batch 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 event pyrexia cannot be excluded. However, the events of Aortic dissection and Cardiac tamponade are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. 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: Aortic dissection; pyrexia; cardiac tamponade
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