Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 39KS9 | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
Extra dose administered; received 3rd dose late; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received 1st dose on 02-DEC-2020) and Pediarix (received 2nd dose on 07-FEB-2021). On 31-JUL-2025, the patient received the 4th dose of Pediarix. On 29-OCT-2021, the patient received the 3rd dose of Pediarix. On 29-OCT-2021, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: received 3rd dose late). On 31-JUL-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered 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: 12-AUG-2025 The reporter had two pediatric patients in my clinic that received the Pediarix product on 31st July 2025 and when it was administered, after it was administered, the nurse figure out that neither of the patients that got that product, needed the Hep B and got actually a Fourth of the Hep B component, the Hepatitis B component which led to extra dose administered. So, the reporter wondering if there was any follow-up recommended from the manufacturer on that. They both completed the Hep B series and so they got a fourth dose of Hepatitis B what was not recommended. The patient received 3rd dose longer than recommended schedule which led to lengthening of vaccination schedule.; Sender's Comments: US-GSK-US2025104399:for 1 st patient