Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 9k745 | — |
Pediarix and Engerix-B on the same clinic day; drug dose interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B) (batch number 9k745, expiry date 27-OCT-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 24-JUL-2025, the patient received the 2nd dose of Engerix B and the 1st dose of Pediarix. On 24-JUL-2025, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: Pediarix and Engerix-B on the same clinic day) and drug dose administration interval too long (Verbatim: drug dose interval too long). The outcome of the overdose and drug dose administration interval too long 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 Reporter stated that on a 2 months old baby received Pediarix and Engerix-B on the same clinic day, which led to overdose. Also stated that baby already had Hep B birth dose on 20-MAY-2025. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
ENGERIX B