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Life Threatening? No
Write-up: Obtunded; Ventilator-aquired pneumonia; Respiratory failure; Guillain-Barre syndrome; This is a serious spontaneous case reported from other health care professional to TGA (reference number: AU-TGA-0000469653) and initially retrieved on 26-Jul-2019, concerning an 80-year-old female patient. The patient''s medical history included dyslipidaemia, gastroesophageal reflux disease (GORD), chronic obstructive pulmonary disease (COPD), cholecystectomy and anaemia. On 14-May-2019, the patient administered Fluad [influenza virus haemagglutinin, dose reported as: 1 dose unspecified, route of administration intramuscular, anatomical location, batch number, expiry date: not reported] for vaccination. On 09-Jun-2019, the patient developed Guillain-Barre syndrome. On 12-Jun-2019, the patient was admitted to intensive care unit (ICU) with respiratory failure and was obtunded. The patient was intubated on admission and underwent on following procedures: chest x-ray, magnetic resonance imaging (MRI) and lumbar puncture, however results were not provided. During ICU admission the patient developed ventilator-acquired pneumonia and escalation of antimicrobial therapy. The patient died on 25-Jun-2019. As reported, nerve conduction studies were ordered but patient died before it was performed. The outcome of the events of respiratory failure, obtundation and ventilator-acquired pneumonia was unknown. The reporter assessed the case as serious (death, hospitalization) and possibly related to Fluad.; Sender''s Comments: The patient developed Guillain-Barre syndrome, respiratory failure, depressed level of consciousness and pneumonia bacterial after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient died due to Guillain-Barre syndrome. Medical history of chronic obstructive pulmonary disease and advanced age (80) may have contributed to development of the events. More information regarding autopsy and concomitant drugs is needed. Based on provided information, causality is assessed as related for all events except for pneumonia bacterial (reported as ventilator-acquired pneumonia).; Reported Cause(s) of Death: Guillain-Barre syndrome
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