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Life Threatening? No
Write-up: Cerebral infarction; Depressed level of consciousness; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21114221. The patient was an 83-year-old female. Body temperature before vaccination was 36.7 degrees centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 26Apr2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17May2021 at 08:50 (21 days after the vaccination), the patient experienced cerebral infarction. Depressed level of consciousness was noted. JCS was III-300. Head CT revealed extensive cerebral infarction in the right cerebral hemisphere. Oxygen 5 L/min and infusion of GLYCEOL 200 mL twice daily were initiated. On 05Jun2021 at 0:45 (40 days after the vaccination), the patient died. It was not provided if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was deep vein thrombosis. The reporting physician commented as follows: Causality between the vaccine and cerebral infarction was unknown. Therapeutic measures were taken as a result of the events and included Oxygen and GLYCEOL. The outcome of the event cerebral infarction was fatal; outcome of other event was unknown. The cause of death was cerebral infarction.; Reported Cause(s) of Death: Cerebral infarction
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