Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 39KS9 | — |
Extra Dose Administered; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis. Previously administered products included Pediarix (received 1st dose on 27-FEB-2024) and Pediarix (received 2nd dose on 27-JUN-2024). On 31-JUL-2025, the patient received the 3rd dose of Pediarix. On 31-JUL-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). The outcome of the extra dose administered was 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: 12-AUG-2025 and 13-AUG-2025 The reporter had a patient in clinic that received the Pediarix product and when it was administered, after it was administered, the nurse figured out that neither of the patient that got that product, needed the Hep B and got actually a Fourth of the Hep B component, the Hepatitis B component. So, he/she was wondering if there was any follow-up recommended from the manufacturer on that. The patient completed the Hep B series and so they got a fourth dose of Hepatitis B what was not recommended, which led to extra dose administered. The reporter consented to follow up. The case had been linked to US2025104067, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025104067:for 1 st patient