Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 2GZ34 | — |
Adult dose administered to pediatric patient; Adult dose administered to pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) suspension for injection in pre-filled syringe (batch number 2GZ34 with expiry date 14-AUG-2028) for prophylaxis. On 03-JUN-2026, the patient received the 1st dose of Engerix B adult. On 03-JUN-2026, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose administered to pediatric patient) and overdose (Verbatim: Adult dose administered to pediatric patient). The outcome of the adult product administered to child and overdose 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: 02-JUL-2026 The reporter called to report that an adult dose of Engerix-B was administered to a pediatric patient. This was the patient first dose of Engerix-B. No further details were provided.