Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
patient presented seizures/convulsions after getting flu shot; This serious case was reported by a pharmacist via call center representative and described the occurrence of seizure in a elderly male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced seizure (Verbatim: patient presented seizures/convulsions after getting flu shot) (serious criteria GSK medically significant). The outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the seizure to be unrelated to Fluarix 2024-2025 season and Fluarix 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: 10-OCT-2025 Reporter asked regarding the Arexvy vaccine and a possible adverse reaction. According to the reporter, an adult patient was suggested by his Physician to get the Arexvy vaccine, but the patient presented seizures /convulsions after getting a flu vaccine (not specified) in the past (unknown date). The patient wanted to know if there was a possibility of having these adverse reactions after getting the shot of Arexvy.; Sender's Comments: A case of Seizure, unknown time after receiving a dose of Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE in a male subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.