Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
it sprayed out from the tip onto the patient skin; it sprayed out from the tip onto the patient skin; sprayed out from the tip; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) 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 exposure via skin contact (Verbatim: it sprayed out from the tip onto the patient skin), inadvertent exposure to vaccine (Verbatim: it sprayed out from the tip onto the patient skin), syringe leak (Verbatim: sprayed out from the tip) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak 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: 03-FEB-2025 The other health professional reported that Boostrix vaccine was administered by a experienced nurse. The nurse states that as the medication was being administered it sprayed out from the tip onto the patient skin which led to inadvertent exposure to vaccine.