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Life Threatening? Yes
Write-up: acute leukemia; cerebral haemorrhage; This is a spontaneous report from a contactable physician received via Regulatory Authority portal. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10May2021 (Batch/Lot Number: Unknown) (at the age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included arterial hypertension from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. Concomitant medications included ramipril (RAMILICH) and atorvastatin, both taken for an unspecified indication, start and stop date were not reported. The patient experienced acute leukemia on 14May2021 and died of it on 27may2021, cause of death was reported as cerebral haemorrhage. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included intensive therapy (as reported). An autopsy was not performed. The information on the lot/batch number has been requested.; Sender''s Comments: Events acute leukemia and cerebral haemorrhage represent intercurrent medical conditions and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral hemorrhage; acute leukemia
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