Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 47XP4 | — |
Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. Previously administered products included Engerix B (received first dose of Engerix B on an unknown date) and Engerix B (received 2nd dose of Engerix B on an unknown date). On 29-SEP-2025, the patient received the 3rd dose of Engerix B pediatric. On 29-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered) and adult use of a child product (Verbatim: Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered). The outcome of the underdose and adult use of a child product 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: 29-SEP-2025 The registered pharmacist called to ask about vaccination schedule advise after the maladministration of a pediatric dose on an adult patient. This was intended to be the third dose on this patient vaccination schedule.