Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 37R35 | — |
vaccine leaked underneath the syringe and needle causing the patient to not receive the full dose; vaccine leaked underneath the syringe and needle; Product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 47-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 37R35, expiry date 21-OCT-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: vaccine leaked underneath the syringe and needle causing the patient to not receive the full dose), device connection issue (Verbatim: vaccine leaked underneath the syringe and needle) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the device 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: 25-JUL-2025 Medical assistant was giving a tetanus tdap Boostrix confirmed to the patient and the needle was on the syringe like normally screwed on but when she injected it leaked underneath the syringe and needle and she was not able to finish up and if it was a defect with syringe or needle or something like that, which led to accidental underdose. The leak had occurred between the leur lock and needle and no damage at the box. The defect was discovered during the administration of the vaccine. They did everything that was required by our office standards but then one of our pharmacist said to call manufacturer and find out. It had happened in the past in other clinic thought like that happen if the needle was not correctly place. But she said everything was good but it kind of exploded on there. Could it have been a defective vial or she did wrong, like you guys heard about that happening. The partial vaccine was administered to the patient. Patient was given another dose as per office but making sure everything was ok and it was not a defect vial and concerned. Not splashed into the eye.