Received Jun 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | AZ4TN | — |
unapproved age/pediatric Hep B instead of the adult Hep B; unapproved age/pediatric Hep B instead of the adult Hep B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 39-year-old female patient who received HBV (Engerix B pediatric) suspension for injection in pre-filled syringe (batch number AZ4TN with expiry date 25-JAN-2027) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 17-JUN-2026, the patient received the 2nd dose of Engerix B pediatric. On 17-JUN-2026, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: unapproved age/pediatric Hep B instead of the adult Hep B) and underdose (Verbatim: unapproved age/pediatric Hep B instead of the adult Hep B). The outcome of the 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: 18-JUN-2026 The reporter just wanted to know whether that patient needed to be revaccinated and how this should have managed moving forward.