Symptomtext
20 lb weight loss; she cannott walk, becoming bed bound; gastrointestinal issues; not eating; worsened dementia; Guillain-Barre Syndrome; Initial information received on 04-Mar-2021 regarding an unsolicited valid serious case from pharmacist on behalf of a consumer. This case involves a 100 year elderly female patient who had worsened dementia (dementia), Guillain Barre syndrome (Guillain-Barre syndrome), 20 lb. (pound) weight loss (weight decreased), was unable to walk, had become bed bound (gait inability), had gastrointestinal issues (gastrointestinal disorder) and was not able to eat (feeding disorder), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included SODIUM (NA). On an unknown date in January 2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ500AB and expiry date: 30-Jun-2021] via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date in January, 2021, the patient developed possible Guillain-Barre Syndrome (Guillain-Barre syndrome) (as reported it began the day after getting the vaccine in Jan, 2021), worsening of dementia (dementia), (serious events) and had gastrointestinal issues (gastrointestinal disorder) resulting in not eating (feeding disorder), had 20 lb. weight loss (weight decreased), unable to walk, became bed bound (gait inability) (non-serious), (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Guillain-Barre syndrome and dementia were assessed as medically significant. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the patient did not recover from the reported events.; Sender's Comments: This case concerns a 100 years elderly female patient who presented with worsened dementia, Guillain-Barre syndrome, gastrointestinal disorder, weight decrease, gait inability and feeding disorder after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Concomitant medication included Sodium for unknown indication. There is, moreover, no information regarding patient's condition at time of vaccination, past history and laboratory test. Based upon the reported information and advanced age of the patient, the role of the suspect vaccine cannot be assessed.