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Life Threatening? No
Write-up: COVID-19 virus test was positive; COVID-19 virus test was positive; Patient died on 04Feb2021 with pneumonia; This is a spontaneous report downloaded from the Regulatory Authority -WEB DK-DKMA-WBS-0032249. The case was received from a contactable physician via The Regulatory Authority. An 81-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; lot number; EJ679) via Intramuscular route on 03Jan2021 and second dose (lot number; EJ6136, expiry date; 30Apr2021) via intramuscular route, on 24Jan2021, and both were at single dose for COVID-19 immunisation. Medical history included ongoing dementia. Concomitant medications were not reported. The patient underwent COVID-19 virus test on 26Jan2021 and resulted as positive. On an unknown date in 2021, patient had pneumonia. On 04Feb2021 the patient died due to pneumonia. There are no other ADRs to COMIRNATY. An autopsy has not been performed. The test was positive when the patient died. No treatment or medical procedure due to the ADRs was reported. Seriousness of the event pneumonia was fatal. Outcome of the event pneumonia was fatal and for other events it was unknown. Causality: The hospital believes that the patient has died from Pneumonia. The reporting physician does not believe that there is a causal relationship between pneumonia and COMIRNATY, but he sticks to reporting the case due to the temporal correlation. No follow-up attempts are possible, batch number already obtained.; Sender''s Comments: The association between the event fatal pneumonia and lack of effect (COVID-19 virus test positive) with COMIRNATY use can not be fully excluded.; Reported Cause(s) of Death: Patient died on 04Feb2021 with pneumonia
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