Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | H39Z4 | — |
she accidentally gave a pediatric dose of Engerix-B to an adult patient; she accidentally gave a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b adulto). On 11-APR-2025, the patient received the 2nd dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient). The outcome of the accidental underdose and adult use of a child product 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: 15-JUL-2025 The certified medical assistant explained she accidentally gave a pediatric dose of Engerix-B to an adult patient on 11th April 2025 which led to adult use of a child product and accidental underdose. The patient got a first dose of Engerix-B on 7th March 2025, it was the usual adult dose.
ENGERIX B ADULTO