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Write-up: Sepsis; Macrophage activation syndrome; This is a spontaneous case, initially reported by a physician to regulatory authority (regulatory reference number: GB-MHRA-EYC 00195313) and initially retrieved by Seqirus on 04-Mar-2019, concerning a 66-year-old, elderly, male patient. The patient''s current condition included hypertension. The patient did not have any known allergies and otherwise was very well. The patient''s concomitant medication included atorvastatin. On 25-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, batch number: 254682, route of administration: intramuscular, anatomical location and expiry date: not reported] as flu vaccination. On 26-Jan-2019, one day after vaccination, the patient experienced macrophage activation syndrome and on unspecified date, the patient experienced sepsis. The patient was hospitalised and died on 28-Jan-2019. The autopsy was done. The cause of death was reported as macrophage activation syndrome. The reporter assessed this case as serious (fatal and hospitalization).; Reporter''s Comments: A 66-year-old male patient experienced macrophage activation syndrome (MAS), one day after vaccination with Fluad TIV. Considering the plausible temporal relationship between vaccination to event onset, possible autoimmune inflammatory basis of the event, the company assessed causality of MAS as related to suspect vaccine. The patient also had sepsis, unspecified period after receipt of suspect vaccine. However, considering the inactivated nature of vaccine and infective nature of the event, the causal role of suspect vaccine can be ruled out. The sepsis could have contributed to MAS.; Reported Cause(s) of Death: Macrophage activation syndrome
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