Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | N733B | — |
started leaking on the side of it, and the needle and everything was attached correctly; Pharmaceutical product complaint; half of it, not sure, probably more; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 67-year-old male patient who received HBV (Engerix B) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. This case was associated with a product complaint. On 20-JUN-2025, the patient received Engerix B. On 20-JUN-2025, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: half of it, not sure, probably more). On an unknown date, the patient experienced syringe leak (Verbatim: started leaking on the side of it, and the needle and everything was attached correctly) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the underdose, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related to Engerix B and Engerix B 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: 23-JUN-2025 Other HCP was giving Engerix-B vaccine on 20th June 2025 on Friday, and then as reporter was administering the vaccine half of it or they were not sure, probably more, just started leaking on the side of it, and the needle and everything was attached correctly. Reporter stated that liquid leaked out from the syringe, not from the site of injection.