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Write-up: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism; Cardiac decompensation with suspected pulmonary embolism; Respiratory distress; This is a spontaneous report downloaded from the Agency Regulatory Agency-WEB [FR-AFSSAPS- RN20210588] and received via the Agency . A contactable physician reported that an 89-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6789), intramuscularly in right arm on 05Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing mild neurocognitive disorder/ moderate neurocognitive disorder, ongoing heart failure, ongoing ischaemic cardiomyopathy under pacemaker, ischemic heart disease under pacemaker, dysrhythmic. The patient had no history of COVID-19. Concomitant medications were not reported. The patient experienced acute respiratory decompensation, dyspnea, cardiac decompensation with suspected pulmonary embolism, respiratory distress on 17Feb2021. On 18Feb2021, a COVID-19 test was performed, and it was negative. The patient condition required urgent medical intervention. The events acute respiratory decompensation, dyspnea, cardiac decompensation were considered as serious (death) by the physician. The outcome of the events pulmonary embolism, respiratory distress was unknown and fatal for the other events. The patient died on 22Feb2021. It was not reported if an autopsy was performed or not. Comment: Case from a report via the portal (# 20210222150517211), medically confirmed. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism
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