Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | K4JH7 | — |
pediatric dose administered to adult patient; pediatric dose administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 30-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 30-JUN-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. It was unknown if the reporter considered the adult use of a child product and underdose to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the adult use of a child product and underdose to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device. 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: 16-JUL-2025 The practice manager called in to request data about the administration of the pediatric presentation of Engerix-B to an adult patient which led to, adult use of a child product and underdose. The dose was the first in the series. The Vaccine Administration Facility was the same as Primary Reporter.