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Life Threatening? Yes
Write-up: Vomiting blood; Bloody stool; Generelized discomfort since vaccination; Melena; Haemodynamic instability; Coffee ground colored vomiting; positive COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number DK-DKMA-WBS-0055221. A 82-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 02Mar2021 (Lot Number: ER2659; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included apoplexy cerebral on 2010, ongoing hypercholesterolaemia, apoplexy cerebral on 2009, ongoing hypertension, ongoing atrial fibrillation, ongoing urinary tract infection, ongoing renal failure, apoplexy cerebral on 2008, back surgery, ongoing diabetes mellitus, ongoing dementia, ongoing wheelchair user. There is no information regarding past medication. Concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation from 2018. The patient experienced vomiting blood on 02Mar2021, bloody stool on 02Mar2021, generelized discomfort since vaccination on 02Mar2021, melena on 02Mar2021, haemodynamic instability on 02Mar2021, coffee ground colored vomiting on 02Mar2021. The ADRs were reported by the physician as causing acute hospitalisation on 11Mar2021, as being fatal (all besides from general discomfort) on 11Mar2021 and being life threatening. No treatment or medical procedure due to the ADRs were reported. General discomfort was not recovered. Bloody stool, coffee ground vomiting, haemodynamic instability, melena and vomiting blood were all fatal. Patient died on 11Mar2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021 (outcome unknown). No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Melena; Bloody stool; Coffee ground vomiting; Vomiting blood; Haemodynamic instability
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