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Write-up: COVID-19 pneumonia; COVID-19; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-349921. This spontaneous, serious case was reported on 13May2021 by a physician via the national competent authority for vaccines and concerns the occurrence of Covid-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. An 84-year old female patient received her first dose of BNT162B2 (COMIRNATY) intramuscularly on 20Mar2021 (batch/Lot number ET1831) at 0.3 mL single for Covid-19 immunization. Relevant medical history included hypertension, NIDDM, chronic kidney failure, osteoporosis, glaucoma, Covid-19 and Covid-19 pneumonia. Concomitant medications were not reported. The patient was admitted in the hospital on 13Apr2021 because she has been experiencing coughing and breathing difficulty for the last 3-4 days. Chest X-ray confirmed Covid-19 pneumonia. The patient had to be intubated because her oxygen saturation worsened and had tachypnea. Despite the therapy, the patient passed away on 15Apr2021 at 22:18 due to ARDS, multiple organ failure and tissue hypoxia caused by the Covid-19 infection. The case was investigated by the national competent authority for vaccines, the investigator did not find any irregularities regarding the transportation and storage of the vaccine. Sender Comment: As the patient got infected with Covid-19 after the first dose, immunity may have not developed yet, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The investigator via the national competent authority for vaccines also assessed the events as not related to the vaccine. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Covid-19 pneumonia
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