Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4D333 | — |
Pediatric dose to an adult patient; Pediatric dose to an 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 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 4D333) for prophylaxis. On 09-MAY-2025, the patient received Engerix B pediatric. On 09-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an 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: 09-MAY-2025 On 09-May-2025, a call was received and mentioned that one of their clients administered an Engerix-B pediatric dose to an adult patient which led to adult use of a child product and underdose. They had a new employee, adult employee, and they need the Hep B vaccine (Engerix-B), but the ped-adolescent one was given, so they are wondering what were the next steps that needs to be done, like if they can give another one will it equal out to the adult. The Vaccine Administration Facility is the same as Primary Reporter. The vaccine was administered on 09th May 2025.