Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7NX57 | — |
accidental administration of a pediatric dose of Engerix-B to a 49 year old; accidental administration of a pediatric dose of Engerix-B to a 49 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 19-JUL-2025, the patient received the 1st dose of Engerix B pediatric. On 19-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old) and accidental underdose (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old). The outcome of the adult use of a child product and accidental 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: 23-JUL-2025 The nurse reported that the accidental administration of a pediatric dose of Engerix B to the adult patient, with the 10 mcg dose administered, which led to adult use of a child product and accidental underdose. The vaccine administration facility was the same as primary reporter.