Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Adult dose to 18 year-old patient; Adult dose to 18 year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old patient who received HBV (Engerix B adult) for prophylaxis. On 18-JUN-2025, the patient received Engerix B adult. On 18-JUN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose to 18 year-old patient) and overdose (Verbatim: Adult dose to 18 year-old patient). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The reporter reported that an 18-year-old received an adult dose and came to them 4 weeks later for a 2nd dose, and they did not knew if they have anything supporting do you just count that as a first dose or you just skip a dose. They were going to administer the pediatric dose but then read they may be prone to increase side effects because we look at the volume for than the antigen content but then they did not know how to professionally guide this patient since he was new to them and wondered if GSK had any studies regarding overdosing on the first dose vs underdosing. The pharmacist, he came to their location Saturday to get a 2nd dose and that's when the pharmacist noticed that he was given adult dose 4 weeks ago which should have given pediatrics, which led to adult product administered to child and overdose. They were going to give but deicide to call GSK for guidance because they did not want him to have any side effects.