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Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received via a regulatory authority and a other healthcare professional received from another regulatory authority. Regulatory authority report number is v21113307. The patient was a 79 years and 5 months old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received rivaroxaban (XARELTO) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was not reported as to whether the patient had allergies to medications, food, or other products. Body temperature before vaccination was 36.0 degrees Centigrade. Other medical history chronic idiopathic pseudointestinal obstruction, hypoproteinaemia, ascites retention, pleural effusion, and platelets decreased and dementia. On 07Jun2021 at 10:59 (the day of vaccination, at age of 79-year-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. Between 27May2021 (11 days before the vaccination) and 07Jun2021 (the day of the vaccination), the patient was hospitalized. On 07Jun2021 at 18:40, the patient experienced respiratory arrest. (However, it was also reported that the start time of the event was 18:45). The course of the event was as follows: There was no particular change immediately after the vaccination. The patient was an inpatient. It was a serious case (disseminated intravascular coagulation (DIC) onset case) that should not have been vaccinated in view of the general condition. The event resulted in hospitalization and death. The outcome of the events was fatal without treatment. Since the vaccination, the patient has not been tested for COVID-19. The patient died of disseminated intravascular coagulation syndrome on 07Jun2021. An autopsy was not performed. At 14:30 (4 hours and 31 minutes after the vaccination), SpO2 was 98% (room air). At 18:40 (7 hours and 41 minutes after the vaccination), a nurse found that the patient was in respiratory arrest. The nurse contacted a duty doctor and the patient''s death was confirmed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was disseminated intravascular coagulation syndrome. The reporting physician commented as follows: The report on examination (platelets decreased) had not been confirmed before the vaccination.; Reported Cause(s) of Death: Disseminated intravascular coagulation syndrome
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