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Write-up: fatal arrhythmia; patient in cardio-respiratory arrest; fever of over 37.5 degrees Centigrade; This is a spontaneous report from a contactable physician received via the Agency and from the Regulatory Authority, via regulatory authority report number is v21117492. The patient was a 22-year-old and 2-month-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient had neither medical history nor allergies to drugs including other vaccines. On 26May2021 at 15:45, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization (at the age of 22 years old). On 16Jun2021 at 15:45 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital (at the age of 22 years old). On 19Jun2021 (3 days after the vaccination), the patient experienced fatal arrhythmia. The event resulted in death on 19Jun2021. The outcome of the event was fatal on 19Jun2021 without treatment. An autopsy was performed. The cause of death confirmed by autopsy was fatal arrhythmia. It was unknown if the patient has been tested for COVID-19 since the vaccination. The course of the events was as follows: Body temperature before vaccination was 36.8 degrees Centigrade (first dose) and 36.5 degrees Centigrade (second dose) and no abnormalities were noted, so it was considered possible for him to receive the vaccination. On 17Jun2021 (1 day after the second dose vaccination), the patient had a fever of over 37.5 degrees Centigrade. He was a student and took a class online on that day. On 18Jun2021 (2 days after the second dose vaccination), he went to a school to take a class as usual. On 19Jun2021 in the morning (3 days after the second dose vaccination), the patient did not get up, so his family went to woke him up, his family found the patient in cardio-respiratory arrest and they called an ambulance and he was transferred to an emergency medical facility, he was immediately transferred to a hospital by an ambulance, but resuscitation did not work. The reporter was informed that he died on that day. In consideration of the causal relationship with BNT162b2, an autopsy was performed at a hospital with his family''s consent. The reporter did not receive the result directly. After the 2nd dose of vaccination, he did not ask the reporter about adverse reactions. Three days after the vaccination, this case resulted in unfortunate outcome, and so it was reported. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. No follow-up attempts are possible; information about batch number was already obtained.; Autopsy-determined Cause(s) of Death: patient in cardio-respiratory arrest; fatal arrhythmia
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