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Life Threatening? No
Write-up: SIADH; Respiratory failure; Tachycardia; Hypotension; Aspiration pneumonia; Sputum pseudomonas; Guillain-Barre syndrome; Death; This is a spontaneous case initially reported by other health professional to Administration (reference number: AU-TGA-0000477321) and initially retrieved on 11-Oct-2019, concerning a 75-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 13-May-2019, the patient was administered Fluad [influenza virus haemagglutinin; route of administration: intramuscular, dose, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 20-May-2019, the patient was administered co-suspect vaccine, Pneumovax 23 [pneumococcal purified capsular polysaccharides; dose 2 (as reported), route of administration intramuscular, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 04-Jul-2019, 1 month and 21 days after flu vaccination, the patient developed Guillain-Barre syndrome (GBS). On 11-Jul-2019, the patient presented to general practitioner (GP), complaining of unsteady gait, walking very slowly and pain in lower back and hips. Patient''s wife had reported the change in gait, shuffling and walking very, very slowly, plus hip and lower back pain had commenced 1-2 months prior to GP presentation. On the same date, the patient was sent to emergency department (ED) by GP and then transferred to hospital intensive care unit (ICU) for respiratory support due to aspiration pneumonia and suspicion on GBS. On an unspecified date, the patient underwent lumbar puncture, electroencephalogram (EEG) and nerve conduction studies which confirmed diagnosis of GBS. Computerized tomogram (CT) of brain, chest, abdomen and pelvis showed nothing abnormal detected (NAD). Cerebrospinal fluid (CSF) test showed albumino-cytologic dissociation. On an unspecified date early August, the patient acutely worsened. The patient developed autonomic complications: SIADH (inappropriate antidiuretic hormone secretion), blood pressure fluctuations/autonomic dysfunction (tachycardia, hypotension), respiratory deterioration due to difficulty clearing secretions, weak cough and poor peak flows and lower tract respiratory infection (LRTI). On 11-Aug-2019, the patient was transferred from Ward to ICU. On 14-Aug-2019 the patient was transferred to Hospital Neuro Ward and later to ICU for respiratory failure which resolved quickly with HFNP (high flow nasal prong therapy), and transferred back to ward. On 16-Aug-2019 the patient underwent nerve conduction studies which documented stable appearances - no significant improvement or deterioration was noted, and findings remained consistent with demyelinating motor neuropathy. On 06-Sep-2019, the patient underwent nerve conduction studies which documented stable appearances - no significant improvement or deterioration was noted, and findings remained consistent with demyelinating motor neuropathy On 10-Sep-2019 the patient was transferred back to hospital for rehabilitation for ongoing lower limb proximal myopathy, poor cough and difficulty clearing sputum and some autonomic dysfunction (tachycardia, hypotension) whilst an inpatient at hospital. On 12-Sep-2019, the patient was diagnosed with Pseudomonas in sputum culture and was treated with Tazocin (piperacillin sodium, tazobactam sodium) for 5 days. On 25-Sep-2019, after further deterioration his care was changed to comfort only, and the patient died. It was unknown whether autopsy was performed. The patient was treated with Privigen (immunoglobulin human normal) [from 13-Aug-2019 to 18-Aug-2019], Augmentin Duo Forte (amoxicillin trihydrate, clavulanate potassium), atenolol [stop date 09-Sep-2019], fludrocortisone, furosemide, fluid restriction and with physio treatment. Requiring chest physio had good results but failing to thrive on ward, the patient remained generally deconditioned. The outcome of the event respiratory failure was resolved on an unspecific date. The outcome of all other events was not provided, at the time of this report. This case was assessed as serious and the reporter did not provide causality assessment to Fluad.; Sender''s Comments: The patient experienced pneumonia aspiration, pseudomonas infection, inappropriate antidiuretic hormone secretion, respiratory failure, tachycardia, hypotension, Guillain-Barre syndrome and death after vaccination with the suspect product Fluad. Chronology is plausible. Causality was confounded by co suspect vaccine, Pneumovax 23 (pneumococcal purified capsular polysaccharides). No medical history, exact cause of death and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reported Cause(s) of Death: Unknown cause of death
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