Received Apr 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9G523 | — |
Adult dose to an adolescent patient; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 9G523) for prophylaxis. On 07-JAN-2026, the patient received Engerix B adult. On 07-JAN-2026, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose to an adolescent patient) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK receipt date: 23-MAR-2026 During the conversation, the health care professional (HCP) reported that it was the 1 mL dose; however, the lot number 9G523 indicated the 0.5 mL. The reporter called back and asked about this; the HCP said that had no idea and that in their system it appeared as an adult dose. Because he/she had mentioned the 1 mL, we reported this as an adult dose administered to an adolescent patient. The case has been linked with case US2026039955 reported by same reporter.; Sender's Comments: US-GSK-US2026039955:SAME REPORTER