Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 9G523 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9G523 | — |
50 plus years old were administered the pediatric dose; 50 plus years old were administered the pediatric dose; 50 plus years old were administered the pediatric dose; 50 plus years old were administered the pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) (batch number 9G523, expiry date 20-MAY-2027) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) (batch number 9G523, expiry date 20-MAY-2027) for prophylaxis. On 07-NOV-2025, the patient received the 2nd dose of Engerix B pediatric .5 ml. In OCT-2025, the patient received the 1st dose of Engerix B pediatric .5 ml. In OCT-2025, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 50 plus years old were administered the pediatric dose) and underdose (Verbatim: 50 plus years old were administered the pediatric dose). On 07-NOV-2025, the patient experienced adult use of a child product (Verbatim: 50 plus years old were administered the pediatric dose) and underdose (Verbatim: 50 plus years old were administered the pediatric dose). The outcome of the adult use of a child product, underdose, adult use of a child product and underdose 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-NOV-2025, 11-NOV-2025 Physician assistant called to know if a lot number corresponded to Engerix b adult dose or pediatric dose. After the match in the database, it was identified that 50 plus years old adult patient was administered with the pediatric dose in the vaccine series, first dose was given between 05-oct-2025 and 06-oct-2025. Reporter wanted to know what the protocol is and if they need to restart the series.