COVID-19 (COrona VIrus Disease-2019) Тема - 8

fatal arrhythmia; cardio-respiratory arrest; this is a spontaneous report from a contactable pharmacist received from the regulatory authority. regulatory authority report number is v21116654. the patient was an 81-year-old male. body temperature before vaccination was not reported. medical history included cardiac failure chronic, arrhythmia and copd (chronic obstructive pulmonary disease). concomitant medications and family history were not provided. on 10jun2021 at 13:30 (the day of vaccination), the patient received the first dose of bnt162b2 (comirnaty, solution for injection, lot# ex3617, expiration date 31aug2021) an unspecified route of administration as a single dose for covid-19 immunization. on 24jun2021 at 06:00 (14 days after the vaccination), the patient experienced fatal arrhythmia. on 24jun2021 at 09:48, he died. it was not reported if an autopsy was performed. the course of the events was as follows: he was a housebound patient and was receiving home oxygen therapy. on 10jun2021, a physician made a home visit and gave the first dose of vaccination to the patient. no adverse reaction was seen during acute period. on 22jun2021 (12 days after the vaccination), the patient looked fine when visiting nurse. on 24jun2021 in early morning, the patient was found sitting on a seat chair in a state of cardio-respiratory arrest. at 09:48, the patient's death was confirmed. the reporting pharmacist classified the event as serious (fatal outcome) and assessed the causality between the event and bnt162b2 as unassessable. other possible cause of the event was reported as follows: the patient had a medical history of cardiac disease, so the causal relationship with bnt162b2 was uncertain. the reporting pharmacist commented as follows: although the causal relationship with bnt162b2 was uncertain, the event occurred within 2 weeks from the vaccination, therefore, this case was reported.; reported cause(s) of death: fatal arrhythmia