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Write-up: Acute myocardial infarction/Chest discomfort; Arrhythmia; This is a spontaneous report from a contactable physician received via the Agency. The patient was a 56-year-old male. The patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EP9605, Expiration Date: 30Jun2021) (at the age of 56-years-old) intramuscular in the arm right on 21Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received NU-LOTAN tablet 50MG, CRESTOR tablet 2.5MG and RABEPRAZOLE NA tablet 10MG within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had allergies to medications, food, or other products or not. Other medical history included Hypertension. On 12May2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31-AUG-2021) (at the age of 56-years-old) intramuscular in the arm right for COVID-19 immunization. On 31May2021 at 13:00 (19 days and 13 hours after the vaccination), the patient experienced Acute myocardial infarction, Arrhythmia and Chest discomfort. The event resulted in Clinic/Emergency room/department or urgent care. The outcome of the events was death with treatment including BOSMIN Injection 1MG, MEYLON Injection 7%, DOPAMINE HYDROCHLORIDE Injection 600mg. The reporting physician assessed the events as serious (death). An autopsy was not performed. The PCR test with nasal swab was performed on 31May2021, which showed negative results. The clinical course was as follows: On 31May2021, the patient complained of Chest discomfort during the work on the farm and, visited reporter''s hospital. After arrival to the outpatient, Cardiac/Respiratory arrest were noted and, cardiopulmonary resuscitation was performed. A diagnosis of Myocardial infarction and Arrhythmia were made and, treatment was given. 1 hour and 30 minutes after his arrival, death of the patient was confirmed.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. 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: Acute myocardial infarction/Chest discomfort; Arrhythmia
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