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Life Threatening? No
Write-up: Death/poor general condition; fall; fall; This is a spontaneous report from a contactable physician downloaded from a regulatory authority HU-OGYI-394021 This spontaneous, serious, medically confirmed case was reported on 27May2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 04May2021 the 87-years-old female patient received the second dose of 0.3 ml BNT162B2 (COMIRNATY) concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) to prevent Covid-19. Medical history included NYHA class IV heart failure, bacterial pneumonia and atherosclerosis, pertrochanteric fracture of femur, closed. Concomitant drugs were not reported. The patient was hospitalized on 09May2021 after a fall. Examinations showed a pertrochanteric fracture which required surgery, but as the patient general condition was bad, she was unfit to have the surgery. Despite treatment, the patient passed away on 13May2021 at 06:10. Autopsy was performed. Further information is not expected. Sender Comment: As the patient was hospitalized because of a fall and then passed away due to her poor general condition, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: poor general condition
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