Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | JST7414 | — |
Pain in injection site; Swelling; Itchy arm; the vaccine did not push out the air from the PFS; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number JST7414) for prophylaxis. On 02-OCT-2025, the patient received Fluarix 2025-2026 season. On 02-OCT-2025, less than a day after receiving Fluarix 2025-2026 season, the patient experienced injection site pain (Verbatim: Pain in injection site), injection site swelling (Verbatim: Swelling), itchy upper limbs (Verbatim: Itchy arm) and wrong technique in product usage process (Verbatim: the vaccine did not push out the air from the PFS). The outcome of the injection site pain, injection site swelling and itchy upper limbs were not resolved and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the injection site pain, injection site swelling and itchy upper limbs to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site swelling and itchy upper limbs 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: 02-OCT-2025 The Licensed Vocational Nurse stated that the person (nurse) who administered the vaccine did not expel the air from the pre-filled syringe (PFS) and administered the vaccine as it was. The nurse who administered the vaccine informed them that she did not prime the vaccine or push out the air, and that the vaccine was much more painful that way. She said that was the correct method. The patient experienced swelling and pain at injection site and noted that it had never been painful before. However, her arm immediately started to become very itchy. The patient mentioned that it was more painful to receive the vaccine without expelling the air bubble, compared to when it was pushed out. The batch number was not provided upon follow- up with the reporter.