Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | LG749 | — |
received the child hep B, the Engerix-B ped dose instead of the adult dose; received the child hep B, the Engerix-B ped dose instead of the adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b). On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose) and adult use of a child product (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose). 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: 27-MAR-2025 Medical assistant called to provide the information as a patient received her second dose of Hepatitis B, Engerix-B pediatric dose instead of the adult dose, which led to underdose and adult use of a child product. She had her first dose February first the regular dose that she was supposed to have. That was Heplisav which you guys did not have, so, she received that one and for her second one a kids dose. So, they were just wondering if like, she need a third dose of the kid's to be up to date with her two hepatitis B series. The reporter requested to not store her personally identifiable information (PII). For pharmacovigilance follow-up the reporter's information was stored at member of public/the reporter's details in upper section.
Heplisav b