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Write-up: Ischamic cardiac death; Ischamic cardiac death; cardio-respiratory arrest; This is a spontaneous report from a contactable physician via COVID-19. The patient was a 90-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cancer of sigmoid colon from 1999 and lumbar spine compression fracture from Jan2021. On 08Jun2021 at 16:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, solution for injection, Lot number FA5829, Expiration date 31Aug2021), intramuscular in the left arm for COVID-19 immunisation. After that, there was no skin symptoms or no problem in vital signs. On 11Jun2021 (3 days after the vaccination), the patient''s family member and a caregiver found the patient in cardio-respiratory arrest in the bathroom. Since drowning was suspected, an external examination was given by a medical examiner. As a result, the cause of death was diagnosed as ischemic cardiac death (estimated). On 12Jun2021 at 08:30, ischemic cardiac death was confirmed. Autopsy was not performed. The reporting physician assessed the event as serious (death). Causality was not provided by the reporting physician. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of ischemic cardiac death and cardio-respiratory arrest. The reported events may likely represent intercurrent medical conditions in this elderly patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Ischemic cardiac death; cardio-respiratory arrest; Ischemic cardiac death
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