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Life Threatening? No
Write-up: died on 14Mar2021 due to cachexia and heart insufficiency; died on 14Mar2021 due to cachexia and heart insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB HU-OGYI-291421. This is a report received from the administrative authority (AA). A 83-year-old female patient received second dose BNT162B2 (COMIRNATY, lot/batch number EJ0725), intramuscular on 18-FEB-2021 at 0.3 ml single dose for COVID-19 immunization. Medical history included ischemic heart disease, Parkinson''s disease, hypertension and cerebral infarction. The concomitant medications were not reported.The Historical Vaccine was first dose COMIRNATY on 28JAN-021(batch number: EL6134 ,0.3 ml single) intramuscular for COVID-19 immunization. The patient died on 14Mar2021 due to cachexia and heart insufficiency. According to the reporter physician''s opinion the patient''s death was caused by her underlying diseases. The event and the vaccination were not related. The patient died on 14Mar2021. The autopsy was not performed. The cause of death was cachexia and heart insufficiency. The outcome of the events was fatal. Sender comments: The patient died due to cachexia and heart insufficiency 26 days after vaccination with COMIRNATY. The event and the vaccination are not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the clinical information currently provided, the company concurs with the causality assessment expressed by the reporter, considering there is not a reasonable possibility that the reported events are related to the suspect drug Comirnaty.; Reported Cause(s) of Death: cachexia; heart insufficiency
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