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Life Threatening? No
Write-up: Death; melaena; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00439484). A 92-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history included decompensation cardiac and aortic valve stenosis (recently diagnosed as severe and symptomatic with life expectancy between 0.5 - 1 year). Concomitant medications included carbasalate calcium (CARBASALAATCALCIUM), furosemide (MANUFACTURER UNKNOWN), and pantoprazole (PANTOPRAZOL). The patient experienced melaena on 03Feb2021. The patient also experienced death on 05Feb2021, which was reported as fatal. The clinical course was reported as: The reporter described that the patient was recently diagnosed with a severe symptomatic aortic valve stenosis, with a life expectancy between 0.5 - 1 year. At time of vaccination, melaena was suspected. The patient deceased 44 hours after vaccination. The clinical outcome of melaena was unknown. The cause of death was reported as unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
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