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Life Threatening? No
Write-up: Miller Fisher''s syndrome; Flaccid tetraparesis; Cranial nerve deficit; Decompensation cardiac; Acute respiratory failure; This is a spontaneous case reported by a physician to Regulatory Authority (regulatory reference number: IT-MINISAL02-535338) and initially retrieved on 11-Mar-2019, concerning an 85-year-old, elderly female patient. The patient''s current conditions included chronic renal failure with secondary anaemia. The concomitant medications included Congescor (bisoprolol fumarate), Aranesp (darbepoetin alfa) and Xanax (alprazolam). On 13-Nov-2018 at 15:00, 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: 1030A1A, anatomical location and expiry date: not reported] for flu prevention. On 14-Nov-2018, one day after vaccination, the patient experienced cranial nerve deficit, flaccid tetraparesis and probable Miller Fisher''s syndrome (as reported). On 03-Dec-2018, the patient died. It was unknown whether autopsy was performed. The cause of death was reported as decompensation cardiac and acute respiratory failure. The reporter assessed the case as serious (death).; Reporter''s Comments: An 85-year-old female patient with concurrent medical condition chronic renal failure and secondary anaemia experienced symptoms of Miller Fisher''s syndrome, 1 day after receipt of Fluad TIV. Considering the plausible temporal relationship between vaccination and reported event, plausible immunological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event Miller Fisher''s syndrome as possibly related to suspect vaccine. The patient died, 19 days post vaccination and the cause of death was reported as decompensation cardiac and acute respiratory failure. Despite the plausible temporal relationship, the event acute respiratory failure can be alternately explained by the Miller Fisher''s syndrome syndrome, rather than suspect vaccine. The event decompensation cardiac can be alternately explained by underlying medical condition chronic renal failure, anaemia and precipitated by acute respiratory failure. Hence, causality of these events assessed as not related to suspect vaccine. The company assessed the event ''acute respiratory failure'' as serious (medically significant).; Reported Cause(s) of Death: Decompensation cardiac; Acute respiratory failure
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