Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9237Y | — |
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; 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 29-year-old female patient who received HBV (Engerix B pediatric) (batch number 9237Y, expiry date 27-OCT-2025) for prophylaxis. On 22-MAY-2025, the patient received Engerix B pediatric. On 22-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult patient) and underdose (Verbatim: Pediatric dose administered to adult patient). The outcome of the adult use of a child product and 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: 27-JUN-2025 The Licensed Practical Nurse explained that a patient was about to start her adult series of Engerix B vaccine, but instead they gave pediatric dose which led to adult use of a child product and underdose.