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Life Threatening? No
Write-up: Fever 38.0 - 38.4 centigrade persisting for 48 hours; Diarrhea; Vomiting; Lung oedema; Suspected pneumonia; This is a spontaneous report downloaded from the Agency Regulatory Authority -WEB, Regulatory Authority number PL-URPL-3-96-2021. A contactable physician reported that an 89 years old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, Lot. EL1491, expiration date: 22Jan2021) intramuscularly, at single dose, on 20Jan2021 at 15:53, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 27Jan2021 at 17:15, the patient experienced fever at 38.0 - 38.4 Centigrade persisting for 48 hours, diarrhea and vomiting. Complications occurred: lung oedema and suspected pneumonia. The patient died on 29Jan2021. Clinical outcome of all events was reported as fatal. It was unknown if autopsy was done. Sender''s comments: fever is an expected side effect for the vaccine. The fever started one week after vaccination with diarrhea and vomiting, so the cause could not be vaccine-related. Pulmonary edema, suspected pneumonia in an elderly person, which led to death, most likely occurred in the time coincidence until vaccination, although the role of the vaccine cannot be completely ruled out. There is a time relationship between vaccination and the occurrence of side effects. The person reporting ADR qualified it as severe. Assessed the ADR as heavy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever 38.0 - 38.4 centigrade persisting for 48 hours; Diarrhea; Vomiting; Lung oedema; Pneumonia
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