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Life Threatening? No
Write-up: SEPSIS; cholecystitis; FEVER; Blood cultures positive for E. Coli; A regulatory authority report was received from a physician concerning a 95-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sepsis and fever. The patient''s medical history, as provided by the reporter, included polyneuropathy, prostatic cancer, atrial fibrillation, urinary tract infection, and living in a nursing home. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for the prophylaxis of COVID-19 infection. On 20 Jan 2021, a blood culture showed positive for E. coli and an abdominal ultrasound showed findings compatible with cholecystitis. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 22 Jan 2021. The cause of death was reported as sepsis, fever, and cholecystitis. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 95-year-old male, who experienced a serious unexpected fatal events of sepsis and pyrexia, with blood culture positive for E. coli and ultrasound with cholecystitis. Events began the same day as the first dose of mRNA-1273. Autopsy not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sepsis; fever; cholecystitis
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