Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | LG749 | — |
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 accidental underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. On 13-OCT-2025, the patient received Engerix B pediatric. On 13-OCT-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Pediatric dose administered to adult patient) and adult use of a child product (Verbatim: Pediatric dose administered to adult patient). The outcome of the accidental 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:14-OCT-2025 Nurse Practitioner mentioned she accidentally gave a pediatric dose to an adult patient. Second line agent asked caller and turns out that it was the second dose of a Hepatitis B vaccine for the patient, but brand name, lot number and expiration date for the first dose were not asked. The reporter consented to follow up.