Sex: U
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: partially administered vaccine/ Underdose; product leaked out onto the patients' arm; product leaked out onto the patients' arm/ accidental Exposure; syringes had cracked at the syringe hub; Product Complaint/ syringes had cracked at the syringe hub; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T7245, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced accidental underdose (Verbatim: partially administered vaccine/ Underdose), exposure via skin contact (Verbatim: product leaked out onto the patients' arm), inadvertent exposure to vaccine (Verbatim: product leaked out onto the patients' arm/ accidental Exposure), syringe broken (Verbatim: syringes had cracked at the syringe hub) and pharmaceutical product complaint (Verbatim: Product Complaint/ syringes had cracked at the syringe hub). The outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine, syringe broken and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe broken to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe broken to be related to Fluarix 2024-2025 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: 24-SEP-2024 The pharmacist reported that 15 Fluarix syringes had cracked at the syringe hub and because of the crack, product leaked out onto the patients' arm. All 15 syringes were from the same lot. The reporter did not have the information of which type of needle was used. The reporter was unable to describe how the needle was attached. PQC (product quality complaint) related questions from content were unable to be fully answered by the reporter. The reporter stated that the step of the defect discovered was unknown as unknown amount were noticed during preparation for administration and an unknown amount were noticed during administration. It was unknown if any of the suspect syringes were after partial use of the multipack or end of the multipack. The reporter was not able to specify how may suspect syringes were administered or partially administered but was only aware of partially administered vaccine due to the vaccine running down the patient's arm, which led to an accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The box or carton or blister tray were not damaged upon receipt. It was unknown if there were any evidence of leakage or product in box or carton. The product was still present in the syringe. The reporter was told (by the nurse) crack or breakage was at the hub of the syringe. It was unknown if the syringe hubs came broken; with the information that was given to the reporter, at least 1 cracked while attaching the needle, and 1 cracked when injecting the vaccine into the patient. The syringe hub cracked.  The pharmacist believed that none of the suspect syringes were available to return PQC filed. It was unknown how many patients were involved with underdose (partially administered vaccine) or how many patients were involved with accidental exposure.