Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | x9eps | — |
Pediarix as a 4th dose in the Hep-B series and IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number x9eps, expiry date 09-FEB-2026) for prophylaxis. Previously administered products included Hepatitis B (received 3rd dose of Hepatitis B on 24-OCT-2024). On 28-JUL-2025, the patient received the 4th dose of Pediarix. On 28-JUL-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Pediarix as a 4th dose in the Hep-B series and IPV series). 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: 05-AUG-2025 The nurse reported that a 15-month-old baby received Pediarix as a 4th dose. The patient had now 4 IPVs and 4 Hep-B, which led to extra dose administered.