Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 7NX57 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | GC3M4 | — |
Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a female patient who received HBV (Engerix B) (batch number 7NX57) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number GC3M4) for prophylaxis. On 02-APR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Engerix-B administration of pediatric doses to adult patient) and underdose (Verbatim: Engerix-B administration of pediatric doses to adult patient). On 02-APR-2025, the patient experienced adult use of a child product (Verbatim: Engerix-B administration of pediatric doses to adult patient) and underdose (Verbatim: Engerix-B administration of pediatric doses to adult patient). 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: 24-JUL-2025 The pharmacist reported regarding Engerix-B administration of pediatric doses to adult patients and stated that the patient received 3 pediatric doses, which led to adult use of a child product and underdose The reporter wanted to know if revaccination with adult doses was required to complete the series or restarting it again. The Vaccine Administration Facility is the same as Primary Reporter