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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope; This is a spontaneous cas, reported by physician to Agency (reference number: IT-MINISAL02-594481) and initially retrieved on 23-Dec-2019 with additional information (being processed together) retrieved on 24-Dec-2019, concerning a 103-year-old, female patient. The patient''s current condition included cardiac decompensation and cardiomyopathy. The patient''s concomitant medications included Triatec (ramipril), Cardioaspirin (acetylsalicylic acid), Zyloric (allopurinol), Lasix (furosemide sodium) and lansoprazole, all for an unknown indication. On 15-Nov-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: A031840034; dose reported as one dosage form; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 19-Nov-2019, four days after vaccination, it was suspected that the patient experienced cerebral stroke. The patient also experienced aphasia, inappetence, asthenia and presyncope. On an unknown date in Nov-2019, the patient had slight recovery of her state. On 24-Nov-2019, the patient experienced new worsening. On 26-Nov-2019, the patient died. It was unknown if autopsy was done. The events of inappetence, aphasia, asthenia, presyncope and stroke were considered serious due to fatal outcome. The reporter did not provide causality assessment. Company comment: All events are considered as related to Fluad (TIV).; Sender''s Comments: All events are considered as related to Fluad (TIV).; Reported Cause(s) of Death: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope
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