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Life Threatening? No
Write-up: Nausea; Not feeling well; Generalized joint pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00485901. An 84-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: ER7812) via an unspecified route of administration, on 24Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included open lateral clavicle resection (left) on 03Mar2021 and procedural pain. Concomitant medications included levothyroxine, naproxen from 04Mar2021 taken for procedural pain, colecalciferol, and pantoprazole. On 25Mar2021, the patient contacted her physician at 6:00 with complaints of nausea, malaise, and generalized joint pain. Physician gave her advice for managing her nausea. On 8:00 home care saw the patient. And on 20:00 home care found patient deceased in her bed. Outcome of the events was fatal. Causes of death were reported as generalized joint pain, nausea, and malaise. It was unknown if an autopsy was performed. Sender Comment: Since it is obvious from the case report that the reported drug naproxen was incorrectly reported as suspect drug, the drug characterization has been changed from suspect to concomitant drug by the agency. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): unknown, Previous COVID-19 infection: No. Diagnostic procedures: Patient has received 24Mar2021 vaccine. Report 25Mar2021 at 6:00 that she is nauseous and unwell. Had advice regarding nausea. Seen around 8 am by home care. Found dead in bed by home care at 8 PM. 3Mar2021 underwent left open lateral clavicle resection. For this use NSAID and PPI. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: nausea; malaise; generalized joint pain
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