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Life Threatening? No
Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, batch number: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death
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