Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | TE499 | — |
Inadvertent administration after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number TE499, expiry date 02-FEB-2027) for prophylaxis. On 16-MAR-2026, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent administration after a temperature excursion). The outcome of the incorrect storage of drug 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: 17-MAR-2026 Reporter reported that Pediarix was given to a child after an above temperature excursion. This was the patient's first dose of Pediarix and the first excursion for this vaccine lot. No further details were provided.