Received Mar 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected Vaccination failure; Patient diagnosed with Flu A; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On an unknown date, the patient received the 1st dose of Fluarix 2025-2026 season (unknown arm). On an unknown date, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: Patient diagnosed with Flu A). The outcome of the vaccination failure was not reported and the outcome of the influenza was resolving. The reporter considered the vaccination failure and influenza to be unrelated to Fluarix 2025-2026 season. It was unknown if the reporter considered the vaccination failure and influenza to be related to Fluarix Pre-Filled Syringe Device. The company considered the vaccination failure and influenza to be unrelated to Fluarix 2025-2026 season. It was unknown if the company considered the vaccination failure and influenza to be related to 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: 24-FEB-2026 Patient received her first dose of Fluarix in the 20252026 season and was later diagnosed with Flu A. Patient was treated with an antiviral. This case was considered as confirmed vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming Influenza. A virus were known at the time of reporting. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Fluarix 2025-2026 season, in a elderly female patient. 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.