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Life Threatening? No
Write-up: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl; This is a spontaneous report from a non-contactable physician. A 85-year-old female patient received second dose of bnt162b2 (COMIRNATY) intramuscular on 15Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. Medical history included arterial hypertension, state after rectum carcinoma from 2008, heart failure from 2008, chronic renal insufficiency from 2008, absolute arrhythmia from 2008. Historical vaccine included first dose of bnt162b2 (COMIRNATY) intramuscular on 16Feb2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. Concomitant medications included furosemide (FUROSEMID); sodium picosulfate; candesartan; bisoprolol; apixaban; amlodipine; all taken for an unspecified indication, start and stop date were not reported. The patient experienced thrombocytopenia until 2/nl on 30Mar2021. Event seriousness criteria was death. Treatment received for the adverse event included imungglobulines and romiplostim. The lab test included sars-cov-2 test: negative on 25Mar2021. The patient died on 25Apr2021. Cause of death was reported as suspicion on intracerebral bleeding. An autopsy was not performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on chronological connection to the vaccine, a causal relationship between events thrombocytopenia and intracerebral bleeding and BNT162B2 (COMIRNATY) vaccine cannot be excluded. 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: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl
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