Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 7NX57 | — |
pediatric dose administered to an adult patient; pediatric dose administered to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 68-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Previously administered products included Engerix-B (1st dose received on an unknown date) and Engerix-B (2nd dose received on an unknown date). On 09-JUN-2025, the patient received the 3rd dose of Engerix B pediatric. On 09-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose administered to an adult patient) and adult use of a child product (Verbatim: pediatric dose administered to an adult patient). 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: 05-NOV-2025 The patient was 69 years old at the time of reporting. An office manager called to report the administration of pediatric 3rd dose of Engerix-B to an adult patient. The 1st dose was in compliance, as well as the second dose. The reporter wanted to know how to move forward. This was 1 of 2 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025143805:Same reporter, different patient