Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 2ME34 | — |
44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 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 44-year-old female patient who received HBV (Engerix B) (batch number 2ME34, expiry date 15-JUL-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 2ME34, expiry date 15-JUL-2026) for prophylaxis. On 05-AUG-2025, the patient received the 3rd dose of Engerix B. On 04-AUG-2025, the patient received the 2nd dose of Engerix B. On 04-AUG-2025, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: 44 year old received a pediatric dose of Engerix-B) and underdose (Verbatim: 44 year old received a pediatric dose of Engerix-B). On 05-AUG-2025, the patient experienced adult use of a child product (Verbatim: 44 year old received a pediatric dose of Engerix-B) and underdose (Verbatim: 44 year old received a pediatric dose of Engerix-B). The outcome of the adult use of a child product, underdose, adult use of a child product and underdose 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: 05-AUG-2025 A nurse reported that 44 year old patient received a pediatric dose of Engerix-B and then came back on August 5th 2025 and received a second dose of the pediatric presentation of Engerix-B to complete the series at the instruction of a physician. The realization of the second dose was uncovered during the phone call. They stated that the those that were had been given on 4th August 2025 was the patient's second dose in the hepatitis B series and that the one that was given on 5th August 2025 was the 3rd dose., which led to adult use of a child product and underdose.