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Life Threatening? No
Write-up: Fainted; Blood pressure 95/47; Suspected infection/pneumonia; Suspected infection/pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-007688). A 95-year-old male patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) in Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pain, dementia, anxiety, depressed mood and renal failure; all unknown if ongoing. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE) from 19Nov2020 to an unspecified date; memantine hydrochloride (EBIXA) from Jan2021 to an unspecified date; tranexamic acid (CYKLOKAPRON) from 19Nov2020 to an unspecified date; paracetamol (PARACETAMOL NET) from 19Nov2020 to an unspecified date; risperidone (RISPERIDON ACTAVIS) from 19Nov2020 to an unspecified date; oxazepam (OXASCAND) from 05Nov2020 to an unspecified date; and mirtazapine (MIRTAZAPIN ACTAVIS) from 19Nov2020 to an unspecified date. In Jan2021, 22 days after the vaccination, the patient had fainted while sitting on a chair; and blood pressure was at 95/47 mmHg. The events were reported to be serious (medically significant). The patient''s COVID-19 virus test in Jan2021 came back negative. A few days later, on an unspecified date in 2021, the patient had died, and the cause of death was suspected infection/pneumonia according to the death certificate. No autopsy was performed. The outcome of the events, ''fainted'' and ''blood pressure was at 95/47 mmHg'', was unknown. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Suspected infection/pneumonia; Suspected infection/pneumonia
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