Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | d2d49 | IM |
medication squirted out/medication got on thigh; medication squirted out/medication got on thigh; PFS broke during injection; uncertain how much medication was injected; Pharmaceutical product complaint; This non-serious case was reported by a other health professional and described the occurrence of exposure via skin contact in a 4-month-old male patient who received HBV (Engerix B pediatric) (batch number d2d49, expiry date 24-SEP-2027) for prophylaxis. Concomitant products included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Dtap), POLIO VACCINE and HIB VACCINE. On an unknown date, the patient received Engerix B pediatric (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced exposure via skin contact (Verbatim: medication squirted out/medication got on thigh), inadvertent exposure to vaccine (Verbatim: medication squirted out/medication got on thigh), needle broken (Verbatim: PFS broke during injection), underdose (Verbatim: uncertain how much medication was injected) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, needle broken, underdose and pharmaceutical product complaint were not applicable. 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: 07-APR-2026 The healthcare professional (HCP) stated that during the injection of Engerix-B prefilled syringe (PFS) the PFS broke off at the hub during the injection. The reporter stated that the medication squirted out and did get on the skin of the patients thigh. The box or carton or tray was not damaged upon receipt. There was not any evidence of leakage or product in box or carton. The product was still present in the syringe. The crack or breakage was observed on the hub of the syringe The syringe broke during the injection. Broke completely off. The HCP was uncertain how much medication was injected but made the decision not to re-dose.