Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Early second dose of Engerix-B; given one adult dose of Engerix-B plus one pediatric dose of Engerix-B on the same clinic day; given one adult dose of Engerix-B plus one pediatric dose of Engerix-B on the same clinic day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a adult patient who received HBV (Engerix B adult) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 06-OCT-2025, the patient received the 2nd dose of Engerix B adult and Engerix B pediatric. On 06-OCT-2025, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B pediatric, the patient experienced drug dose administration interval too short (Verbatim: Early second dose of Engerix-B), adult use of a child product (Verbatim: given one adult dose of Engerix-B plus one pediatric dose of Engerix-B on the same clinic day) and overdose (Verbatim: given one adult dose of Engerix-B plus one pediatric dose of Engerix-B on the same clinic day). The outcome of the drug dose administration interval too short, adult use of a child product and overdose were not applicable. Additional Information: GSK Receipt Date: 07-OCT-2025 A healthcare professional reported an adult patient received one adult dose and one pediatric dose of Engerix-B on the same clinic day on 06th October 2025. The first adult dose of Engerix-B had previously been administered on 10th September 2025 (27 days earlier). The intention was to administer the first dose of Havrix; however, due to an error. The healthcare professional plans to administer the first Havrix dose soon. The batch number was not provided and a request for this information has been made.