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Write-up: Pneumonia aspiration; Pyrexia; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21107080. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) at 92-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: pyrexia (non-serious). On 12May2021, the patient experienced: pneumonia aspiration (death, hospitalization, medically significant). The patient was hospitalized for pneumonia aspiration from 12May2021 to an unknown date. The clinical course was reported as follows: The patient was a 92-year and 10-month-old male. Body temperature before vaccination was not provided (reported as uncertain). No information on medical history, concomitant medications, or family history was provided (reported as uncertain). On 11May2021, the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date was not reported). On an unspecified date, the patient experienced pyrexia. On 12May2021 (1 day after the vaccination), the patient experienced pneumonia aspiration, and was hospitalized. On 15May2021 (4 days after the vaccination), the patient died of pneumonia aspiration (dysphagia), although treatment was provided. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed that there was no causal relationship with BNT162b2. Dysphagia was reported as another possible cause of the event. The reporting physician commented as follows: It was considered that there was no causal relationship with BNT162b2. The patient underwent lab tests and procedures which included body temperature: reported as uncertain on 11May2021, body temperature: pyrexia on an unspecified date. Therapeutic measures were taken as a result of pneumonia aspiration. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the event, pneumonia aspiration, was fatal. The patient died on 15May2021 due to pneumonia aspiration and dysphagia. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up. ; Reported Cause(s) of Death: pneumonia aspiration; dysphagia
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