Sex: F
Vaccine: FLU4
Symptoms: Bowel movement irregularity, Cognitive disorder, Decreased appetite, Diarrhoea, Food intolerance
Clinical narrative: Nausea gravidarum; had trouble thinking and making decision; "could not tolerate any type of sauce with salt"; One week later I was nauseous/nauseousness lasted for 2 weeks; diarrhea; my cognitive abilities were affected/had trouble thinking and making decisions; bowel movements were not normal for 3 weeks; appetite for about 2 weeks after the onset of the nauseousness; This serious case was reported by a consumer and described the occurrence of difficulty thinking in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number U8084AB, expiry date 30-JUN-2024) for prophylaxis.   On 12-OCT-2023, the patient received Fluarix Tetra 2023-2024 season. In OCT-2023, 1 week after receiving Fluarix Tetra 2023-2024 season, the patient experienced difficulty thinking (Verbatim: had trouble thinking and making decision) (serious criteria GSK medically significant), nausea (Verbatim: One week later I was nauseous/nauseousness lasted for 2 weeks), diarrhea (Verbatim: diarrhea), cognitive function abnormal (Verbatim: my cognitive abilities were affected/had trouble thinking and making decisions), bowel movement irregularity (Verbatim: bowel movements were not normal for 3 weeks) and food intolerance (Verbatim: "could not tolerate any type of sauce with salt"). On 19-OCT-2023, the patient experienced nausea gravidarum (Verbatim: Nausea gravidarum). On an unknown date, the patient experienced appetite lost (Verbatim: appetite for about 2 weeks after the onset of the nauseousness). In OCT-2023, the outcome of the nausea was resolved (duration 2 weeks). The outcome of the difficulty thinking and food intolerance were not reported and the outcome of the nausea gravidarum was resolving and the outcome of the diarrhea and bowel movement irregularity were resolved (duration 3 weeks) and the outcome of the cognitive function abnormal and appetite lost were resolved (duration 2 weeks).   It was unknown if the reporter considered the difficulty thinking, nausea gravidarum, nausea, diarrhea, cognitive function abnormal, bowel movement irregularity, appetite lost and food intolerance to be related to Fluarix Tetra 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the difficulty thinking, nausea gravidarum, nausea, diarrhea, cognitive function abnormal, bowel movement irregularity, appetite lost and food intolerance to be related to Fluarix Tetra 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-NOV-2023  The reporter reported that the patient received Fluarix for flu vaccine shot. the patient was nauseousness lasted for 2 weeks with cognitive abilities and abnormal bowel movements for 3 weeks.  The reporter stated that there must had been a sodium type preservative in the vaccine.  One week later I was nauseous, could not tolerate any type of sauce with salt, cognitive abilities were affected, had trouble thinking and making decisions.  The patient had diarrhea and my bowel movements were not normal for 3 weeks later. The patient did not had an appetite for about 2 weeks after the onset of the nauseousness.  The patient's co-workers could told by the patient facial expression something was wrong with the patient.  One of the patient's coworkers did not want to get a flu shot since the patient had such a bad reaction.  The patient was making mistakes at work for about 2 weeks. The symptoms were not treated. The patient never had an allergic reaction to a flu shot and will never get another one manufactured by GlaxoSmithKline. The reporter consented to follow up.