Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 7nx57 | — |
Administration of pediatric dose; Administration of pediatric dose; This non-serious case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B 10 mcg) (batch number 7nx57, expiry date 12-DEC-2026) for prophylaxis. Previously administered products included Engerix b (received 1st dose on 04-MAY-2005), Engerix b (received 2nd dose on 06-JUL-2005) and Engerix b (received 3rd dose on 21-SEP-2005). On 16-JUL-2025, the patient received the 4th dose of Engerix B 10 mcg. On 16-JUL-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: Administration of pediatric dose) and underdose (Verbatim: Administration of pediatric dose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The patient's age was 20 years and 4 months The pediatrician reported that an adult accidentally received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose. The Vaccine Administration Facility is the same as Primary Reporter.