Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 2LY39 | — |
Rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 6-month-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 2LY39, expiry date 30-JUN-2026) for prophylaxis. The patient's past medical history included eczema. Concomitant products included cetirizine. On 20-JAN-2026, the patient received the 1st dose of Fluarix 2025-2026 season. On 20-JAN-2026, less than a day after receiving Fluarix 2025-2026 season, the patient experienced rash (Verbatim: Rash). On 20-JAN-2026, the outcome of the rash was resolved. The reporter considered the rash to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. The company considered the rash to be related to Fluarix 2025-2026 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: 20-JAN-2026 The reporter stated that they would like to provide additional information about the report: they had no increase respiratory rate, no retractions, no increase work of breathing or no nasal flaring. The reporter stated that the rash extended from the nose to the ears and down to the torso and arms but did not include the abdomen or back. The reporter would like to share about the primary disease: strong history of eczema. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Eczema
CETIRIZINE