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Life Threatening? No
Write-up: Consciousness decreased; Cerebral thrombosis (died on 31Jan2021); This is a spontaneous report downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0030642]. The case was received from a contactable physician via The Agency. A 97-years-old female patient started to receive bnt162b2 (COMIRNATY,Batch numbers: EJ6797, Exp date: 30Apr2021) , intramuscular on 23Jan2021 at 1 DF, single dose for covid-19 immunisation. Medical history included ongoing heart failure, heart rate irregular and pain. She was in Diuretic therapy and Anticoagulant therapy. She was living in a nursing home. She was well before the vaccination on 23Jan2021. Concomitant medication included furosemide (FURIX [FUROSEMIDE]) oral from 09Jun2020 at 40 mg, daily for diuretic therapy, digoxin (DIGOXIN DAK) oral from 09Jun2020 at 62.5 ug, daily for heart rate irregular, paracetamol (PAMOL) oral from 27Dec2018 at 1000 mg, as needed for Pain, acetylsalicylic acid (HJERTEMAGNYL [ACETYLSALICYLIC ACID]) oral from 09Jun2020 at 75 mg, daily for Anticoagulant therapy. On 01Jan2021, the patient was vaccinated with first dose of COMIRNATY(Batch numbers: EJ6136, exp date 30Apr2021). On 24Jan2021, the day after the second vaccination the patient developed cerebral thrombosis and consciousness decreased. The ADRs were by the reporter reported as fatal and resulting in hospitalisation (24Jan2021). She is discharged to loving care at the nursing home and dies on 31Jan2021 at 00:51. The outcome of Cerebral thrombosis was fatal and the outcome of Consciousness decreased was unknown. Reported cause of death was cerebral thrombosis. Usual confirmation of death was performed on 31Jan2021 and here rigor mortis and livor mortis were found, nothing else. There is no information regarding test results. Causality: The physician does not know if it is an adverse reaction related to the vaccine, but due to the time context the physician is probably in doubt to report. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral thrombosis
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