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Life Threatening? No
Write-up: respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is HU-OGYI-287121. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular, administered in left arm on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml single for covid-19 immunization. Medical history included ongoing arteriosclerosis obliterans, ongoing hypothyroidism. The patient''s concomitant medications were not reported. The patient was under in-patient care at the time of the vaccinations, the hospitalization started on 08Feb2021. The Covid-19 PCR test was negative. The occurrence of respiratory arrest after the administration of Comirnaty on 28Mar2021. On 28Mar2021, the patient died. Autopsy was not performed. According to the patient''s death certificate, the direct cause of death was respiratory arrest, indirect causes were general atherosclerosis. The patient''s hospitalization was prolonged as a result of respiratory arrest. In the reporter physician''s opinion, the patient''s death was related to his underlying diseases. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Feb2021, on 11Feb2021, on 23Feb2021 and on 08Mar2021. The outcome of the event was fatal. Sender Comment: The 90-year-old patient died 26 days after Comirnaty vaccination. The cause of death was respiratory arrest. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of respiratory arrest. The reported event likely appears associated with intercurrent medical conditions in this elderly 90 year old patent. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.; direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.
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