Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M77CC | — |
Product complaint; medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle; underdose; vaccine leaked onto patient's arm; vaccine leaked onto patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. This case was associated with a product complaint. On 07-MAY-2025, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: underdose), exposure via skin contact (Verbatim: vaccine leaked onto patient's arm) and accidental exposure while administering drug (Verbatim: vaccine leaked onto patient's arm). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint) and syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle). The outcome of the underdose, exposure via skin contact, accidental exposure while administering drug, pharmaceutical product complaint and syringe connection issue were not applicable. It was unknown if the reporter considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix 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: 09-MAY-2025 14-MAY-2025 Other HCP reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to Accidental exposure while administering drug and exposure via skin contact. Needle was securely attached to the syringe. Return of needle used was not available. This case is linked with US2025AMR059513 reported by same reporter.; Sender's Comments: US-GSK-US2025AMR059513:Same reporter/Diffrent patient