Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 9K74F | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9K74F | — |
administered two pediatric doses of Engerix-B to an adult patient; administered two pediatric doses of Engerix-B to an adult patient; Administration dates were on February 4th 2025 and April 3rd 2025; administered two pediatric doses of Engerix-B to an adult patient; administered two pediatric doses of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis. On 03-APR-2025, the patient received the 2nd dose of Engerix B pediatric. On 04-FEB-2025, the patient received the 1st dose of Engerix B pediatric. On 04-FEB-2025, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administered two pediatric doses of Engerix-B to an adult patient) and underdose (Verbatim: administered two pediatric doses of Engerix-B to an adult patient). On 03-APR-2025, the patient experienced adult use of a child product (Verbatim: administered two pediatric doses of Engerix-B to an adult patient), underdose (Verbatim: administered two pediatric doses of Engerix-B to an adult patient) and drug dose administration interval too long (Verbatim: Administration dates were on February 4th 2025 and April 3rd 2025). The outcome of the adult use of a child product, underdose, adult use of a child product, underdose and drug dose administration interval too long 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: 13-AUG-2025 The nurse reported that they administered two pediatric doses of Engerix B to an adult patient (23 years old), which led to adult use of a child product and underdose. The reporter was ask should gave the patient an adult dose, when did had to did it. The health care professional mentioned that patient already had Hepatitis B but did not seroconvert with the first set in 2002 when the patient was a baby. Upon transfer to a second line it was confirmed that Hep B surface antigens were tested in January 2025. The nurse states that Hep B vaccine was received in 2002 and was unknown if it was Engerix-B. She had had the series, and did not seroconvert so this was her second set of shots, the doctor was aware of the error.