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Life Threatening? No
Write-up: Drowsiness/waardoor suf worden en uiteindelijk overlijden; Decreased appetite/verminderde intake; Malaise/algehele malaise zonder koorts; Herpes zoster; A regulatory report was received from a physician concerning a 101-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced drowsiness/waardoor suf worden en uiteindelijk overlijden, decreased appetite/verminderde intake, malaise/algehele malaise zonder koorts and herpes zoster. The patient''s medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. On 1 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042722) intramuscularly for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced drowsiness, decreased appetite, malaise and herpes zoster. As per the report, drowsiness, decreased appetite, malaise and herpes zoster resulted in patient death. The patient died on 10 Mar 2021. Autopsy information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events, drowsiness, decreased appetite, malaise and herpes zoster, were considered fatal.; Reporter''s Comments: This fatal case concerns a 101 Y/O F with serious unexpected events of somnolence, malaise, decreased appetite, and herpes zoster. Event onset 4 days after first dose mRNA-1273. Event outcome death. Autopsy information not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: algehele malaise zonder koorts; waardoor suf worden; verminderde intake; herpes zoster
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