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Life Threatening? No
Write-up: Death was probable caused by cardiac reasons (death during defecation).; Weakness; Very severe musculoskeletal pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority PL-URPL-3-108-2021. An 85-year-old patient received first dose bnt162b2 (COMIRNATY, lot number: EJ6136, expiration date: 30Jan2021), via an unspecified route of administration, at left arm on 29Jan2021 10:20 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 at 8:00 am, very severe muscular and bone pain (very severe musculoskeletal pain), weakness. Death on 01Feb2021 at 13.15, most likely for cardiac reasons (during defecation). The family refused to consent to the proposed post-mortem examination. The reporting person classified them as severe. The URPL also classified the report as severe (death). The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. The outcome of the event very severe musculoskeletal pain, weakness were unknown, of the other events was fatal. The patient died on 01Feb2021. An autopsy was not performed. Causality assessment was reported as Relatedness of drug to reaction Weakness , Musculoskeletal pain/ One agency /Another agency / possible for Unwitnessed cardiac death NCA / Agency / possible Sender Comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). Bone and joint pain, fatigue is an expected side effect, included in the Summary of Product Characteristics for Corminaty, with a frequency of very common. There is a time relationship between drug administration and the occurrence of side effects. Due to insufficient information, it cannot be assessed whether the cardiac event, if it occurred at all ("possibly" was the cause of death), was related to vaccination. The reporting person classified them as severe. The URPL also classified the report as severe due to the nature of the adverse reaction resulting in death (possibly cardiac cause of death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death was probable caused by cardiac reasons (death during defecation).
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