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Life Threatening? No
Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uwzpr3. A 71-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EX2405) via an unspecified route of administration, administered in left arm on 14Apr2021 at 12:00 as single dose for covid-19 immunisation. Medical history included breast cancer from 2019 and lung cancer from 2016, both not ongoing (as reported). The patient did currently not have any active cancerous disease or other known diseases. The patient''s concomitant medications were not reported. The patient experienced sudden death on 03May2021. The patient had not had any symptoms following vaccination. The patient died on 03May2021. An autopsy was not performed. The reporter stressed the uncertainty as to whether or not the death could be associated with vaccination, due to the death occurring more than two weeks after vaccination. Thus, Causality by reporter was also registered and set to Uncertain. The clinical investigation did not establish any clear cause of a sudden death. Due to the vaccine being administered some weeks before the sudden death, death as a possible adverse reaction to vaccination could not be ruled out, although the physician was uncertain whether to report it or not. The Regulatory Authority assessed the causal relationship between BNT162B2 and sudden death as possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH
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