Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Potential administration after a temperature excursion; Potential administration after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On an unknown date, the patient received Fluarix 2025-2026 season. On an unknown date, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Potential administration after a temperature excursion) and product storage error (Verbatim: Potential administration after a temperature excursion). The outcome of the circumstance or information capable of leading to medication error and product storage error were not applicable. 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: 21-OCT-2025 Registered pharmacist had a general question if there was a timeframe that the Fluarix vaccine could be out of the fridge at room temperature and after could be returned to the fridge and a stated that some patients were not aware if the vaccine can be left out of the fridge and if it can be returned to the fridge afterwards because they were not aware if it was okay to do so. No vaccination dates, no vaccine details and no patient demographics were provided. Adverse event was raised due to the risk scenario of potential administration after a temperature excursion. The reporter did not reactively confirm any specific real case scenario.