Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | N733B | — |
A 19 years old female patient received a 20 mcg dose of Engerix-B.; Overdose; drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 28-AUG-2025, the patient received the 2nd dose of Engerix B adult. On 28-AUG-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: A 19 years old female patient received a 20 mcg dose of Engerix-B.), overdose (Verbatim: Overdose) and drug dose administration interval too long (Verbatim: drug dose administration interval too long). The outcome of the adult product administered to child, overdose and drug dose administration interval too long 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: 28-AUG-2025 The reporter reported on 28th August 2025 an assistant director of quality and nursing called to report that they administered on the day of reporting an adult dose of Engerix-B (20 mcg) to a patient who was 19 years old. The patient would be 20 years old in December. This was the 2nd dose of Engerix-B that the patient has received which led to overdose, Adult product administered to child and lengthening of vaccination schedule. First dose of Engerix-B was administered on 18th July 2025. The reporter asked how did they have to proceed with the third dose.
ENGERIX B