Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | CT3Z7 | — |
Adult dose given to pediatric patient; Potential interchangeability; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 15-year-old female patient who received HBV (Engerix B adult) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis. Previously administered products included Engerix B (received first dose of Hepatitis B vaccine on unknown date). On 07-MAR-2025, the patient received the 2nd dose of Engerix B adult. On 07-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose given to pediatric patient) and overdose (Verbatim: Potential interchangeability). The outcome of the adult product administered to child and overdose 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: 09-DEC-2025 The reporter reported that a pediatric patient received first dose of Hepatitis B vaccine (date of administration, lot number or brand name unknown), and then they received second dose as Engerix-B on 07-Mar-2025, but it was an adult dose. Third dose has not been given yet. Potential interchangeability reported as a preventive measure, since it was unknown if first dose was also Engerix-B. The batch number was not provided and a request for this information has been made.