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Life Threatening? No
Write-up: routine rapid tests was positive; routine rapid tests was positive; This is a spontaneous report from a contactable physician. A 94-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The 94-year-old woman who died in the days that followed in 2021, routine rapid tests was positive 2021. The patient underwent lab tests and procedures which included coronavirus test: positive on 2021. The patient died in 2021. It was not reported if an autopsy was performed. It was reported that: residents and staff in a nursing home were administered the first dose of Comirnaty on 27Jan2021. During routine rapid tests in the days that followed, a large number of residents and staff were positive. Most of these were asymptomatic or with only minor symptoms of illness, and none required hospitalization. In the end, there was a 94-year-old woman who died in the days that followed. The physician assume that the germ was already in the house in the run-up to the vaccination. In his/her opinion, the vaccination had the effect that there were no severe courses. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information available, a causal association between BNT162b2 and the reported event cannot be excluded. The patient''s immunocompromised state due to age and the current pandemic may provide an alternative explanation for the events. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: there was a 94-year-old woman who died in the days that followed; there was a 94-year-old woman who died in the days that followed
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