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Write-up: Melaena; Breast haematoma; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-800382. A 98-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (lot number: EP2163) as 0.3 mL, single for COVID-19 immunisation; and acenocoumarol (SINTROM), oral from 07Dec2020 (Batch/Lot number was not reported) to 17Mar2021, at unspecified dose for atrial fibrillation. Medical history included ischaemic stroke from 2009 to an unknown date, urinary tract infection from 21Feb2020 to an unknown date, atrial fibrillation from an unknown date and unknown if ongoing, and dyslipidaemia from an unknown date and unknown if ongoing. Concomitant medications included bisoprolol fumarate taken for atrial fibrillation from 01Aug2012 to 17Mar2021; fluoxetine hydrochloride (DEPRAX) taken for an unspecified indication from 29Nov2019 to 17Mar2021; hydrochlorothiazide, valsartan (VALSARTAN + HIDROCLOROTIAZIDA) taken for an unspecified indication from 18May2012 to 17Mar2021. On 18Feb2021, patient''s INR= 5.4. On 04Mar2021, the patient received the first dose of Comirnaty. On 08Mar2021, urine culture negative. 09Mar2021, patient had lesions/wounds on both lower limbs, treatment with EII with betatul + velban + crepe, and EID povidone iodine + aquacel foam. On 17Mar2021, sudden deterioration in general condition with difficulty swallowing in the last 24 hours, and black stools (melaena). Patient bedridden, sleepy, calm. Still on 17Mar2021, patient had spontaneous opening of eyes, no speech; GCS (Glasgow Coma Scale): 8. BP: 10/60; generalized crackles. Patient had no respiratory distress. Extensive haematoma in the left mammary and inframammary region (breast haematoma on 17Mar2021). Sintron and other medication were suspended except paracetamol if necessary. The patient died on 18Mar2021. Causes of death were melaena and breast hematoma. An autopsy was not performed. Time interval between beginning of Comirnaty administration and start of both events was 14 days; between beginning of Valsartan + Hydrochlorothiazide administration and start of both events was 1 day; between beginning of Sintrom administration and start of both events was 101 days; between beginning of Deprax administration and start of both events was 475 days; between beginning of Bisoprolol administration and start of both events was 3151 days; and time interval between last dose of Deprax, Bisoprolol, Sintrom, Valsartan+Hydrochlorothiazide and start of both events was 1 day. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Breast haematoma; Melaena
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