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Write-up: Nervous system disorder; Hemorrhagic stroke; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The Regulatory Authority report number is BE-FAMHP-DHH-N2021-79017. This report originated from the Regulatory Authority. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. Medical history included paranoid schizophrenia, benign prostatic hyperplasia, and mild aortic and mitral insufficiency. Concomitant medications included procyclidine hydrochloride (KEMADRIN), vitamin D, haloperidol (HALDOL), lormetazepam, cyanocobalamin, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (BEFACT), bisoprolol, and tamsulosin; all taken from an unspecified date for an unspecified indication. Nutritional supplement included Easy-Transil. The patient experienced nervous system disorder and hemorrhagic stroke, both on 29Jan2021 with fatal outcome. There was no treatment received for the adverse events. The patient died on 01Feb2021. It was unknown if an autopsy was performed. Events were assessed by FAMHP as unclassifiable. Reporter comment: Patient was of a thin corpulence. He had a correct general condition before and after vaccination. On 29Jan2021, neurological problems appeared: agitation, mutism, swallowing disorders, falls,..linked with a cerebral haemorrhage. Follow-up attempts are not needed. No further information is expected.; Reported Cause(s) of Death: Nervous system disorder; Hemorrhagic stroke
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