Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | lg749 | — |
adult given pediatric dose; adult given pediatric dose; 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 27-year-old male patient who received HBV (Engerix B pediatric) (batch number lg749, expiry date 13-SEP-2026) for prophylaxis. On 29-JUL-2025, the patient received Engerix B pediatric. On 29-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult given pediatric dose) and accidental underdose (Verbatim: adult given pediatric dose). The outcome of the adult use of a child product and accidental underdose were not applicable. Additional Information: GSK Receipt Date:29-JUL-2025 The reporter an adult need hepatitis b vaccine but they gave Engerix-B pediatric dose instead of adult dose, which led to accidental underdose and adult use of child product. Reached to quality and safety and to immuration org and someone asked the same question and recommendation was to go ahead and give the other half of the pediatric if patient was inside the clinic but if the mistake was found later then you would just count it as void and Start the series over, so quality and safety got to touch with manufacturing and see what the guidance would be if patient had already left the office but checking to see if he/she could call back the patient and saw if they get the 2nd half at the time of reporting, it was administered. The reporter consented to follow up.