Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9359N | — |
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | X1D141M | — |
Extra dose of IPV component; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9359N, expiry date 10-OCT-2027) for prophylaxis. Co-suspect products included Polio vaccine inact (Ipv) (batch number X1D141M, expiry date 31-OCT-2026) for prophylaxis. On 05-MAY-2025, the patient received the 1st dose of Pediarix and the 1st dose of Ipv. On 05-MAY-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose of IPV component). The outcome of the overdose 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-MAY-2025 A registered nurse requested safety data about the administration of both Pediarix and a monovalent IPV vaccine on 05-MAY-2025. The monovalent IPV vaccine was confirmed to not be a GSK product. Patient received Pediarix and monovalent IPV vaccine on the same day, which led to overdose.