Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 5J7EF | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
inadvertently administered an extra dose of Pediarix vaccine instead of the scheduled Infanrix vaccine; the patient received the 2nd dose on 06-Aug-2025 and 3rd dose on 24-SEP-2025; the patient received the 1st dose of Pediarix on 22-May-2025 and the 2nd dose on 06-Aug-2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) suspension for injection in pre-filled syringe (batch number 5J7EF) for prophylaxis. Co-suspect products included DTPa (Infanrix) suspension for injection in pre-filled syringe for prophylaxis. Concomitant products included PEDIARIX. On 01-JUL-2026, the patient received the 4th dose of Pediarix. On an unknown date, the patient received Infanrix. On 06-AUG-2025, not applicable after receiving Pediarix and Infanrix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: the patient received the 1st dose of Pediarix on 22-May-2025 and the 2nd dose on 06-Aug-2025). On 24-SEP-2025, the patient experienced drug dose administration interval too short (Verbatim: the patient received the 2nd dose on 06-Aug-2025 and 3rd dose on 24-SEP-2025). On 01-JUL-2026, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered an extra dose of Pediarix vaccine instead of the scheduled Infanrix vaccine). The outcome of the wrong vaccine administered, drug dose administration interval too short 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: 02-JUL-2026 The batch number was not provided upon follow- up with the reporter.
PEDIARIX