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Write-up: Pulmonary artery thromboembolism due to deep vein thrombosis leg; Pulmonary artery thromboembolism due to deep vein thrombosis leg; This is a spontaneous report from a contactable physician received via regulatory authority. A 34-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 21Apr2021 at 12:00 (Batch/Lot Number: ER9480; Expiration Date: 31Jul2021) at 34-years-old as a single dose for COVID-19 immunization. The patient''s medical history was reported as none. Concomitant medications were not reported. On an unspecified date, the patient experienced: pulmonary artery thromboembolism due to deep vein thrombosis leg (death, medically significant). The clinical course was reported as follows: The patient was a 34-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient had no other medical history. On 21Apr2021 at 12:00 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER9480, Expiration date 31Jul2021) intramuscularly for COVID-19 immunization. On an unspecified date, the patient experienced pulmonary artery thromboembolism due to deep vein thrombosis leg. The event resulted in death. The outcome of the events was fatal. No treatment was given. The reported narrative was as follows: On 10May2021 (19 days after the vaccination), the patient was found dead in a car. The estimated date of death according to the police was 05May2021. Forensic autopsy results revealed pulmonary artery thromboembolism due to deep vein thrombosis leg. Date of death was reported as May2021. Cause of death was pulmonary artery thromboembolism. Autopsy remarks included pulmonary artery thromboembolism. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was fatal. The patient died on an unspecified date in May2021 due to pulmonary artery thromboembolism. An autopsy was performed that revealed pulmonary artery thromboembolism due to deep vein thrombosis leg.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of pulmonary artery thromboembolism and deep vein thrombosis leg, due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including complete autopsy results, serum toxicology screen and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: Pulmonary artery thromboembolism; Autopsy-determined Cause(s) of Death: Pulmonary artery thromboembolism due to deep vein thrombosis leg; Pulmonary artery thromboembolism due to deep vein thrombosis leg
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