Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | RA |
fatigue; sore throat; headache; coughing up mucus; tightness in lungs; This non-serious case was reported by a consumer via sales rep and described the occurrence of sore throat in a 57-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On 15-SEP-2025, the patient received the 1st dose of Fluarix 2025-2026 season (right deltoid). On 18-JAN-2026, 125 days after receiving Fluarix 2025-2026 season, the patient experienced sore throat (Verbatim: sore throat), headache (Verbatim: headache), productive cough (Verbatim: coughing up mucus) and lung tightness (Verbatim: tightness in lungs). On an unknown date, the patient experienced fatigue (Verbatim: fatigue). The outcome of the sore throat, headache, productive cough and lung tightness were not resolved and the outcome of the fatigue was not reported. The reporter considered the sore throat, headache, productive cough and lung tightness to be related to Fluarix 2025-2026 season. It was unknown if the reporter considered the fatigue to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the reporter considered the sore throat, headache, productive cough and lung tightness to be related to Fluarix Pre-Filled Syringe Device. The company considered the sore throat, headache, productive cough and lung tightness to be related to Fluarix 2025-2026 season. It was unknown if the company considered the fatigue to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the sore throat, headache, productive cough and lung tightness 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: 18-JAN-2026 The reporter asked the provider to share the batch number and expiry date. There was nothing the reporter would like to share about the primary disease and complicating disease. The reporter stated that they would like to provide additional information about the report: they had just thought of another symptom- fatigue. The batch number was not provided and a request for this information has been made.