Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | EJ577 | — |
a Pediarix dose, which had expired, was accidentally given to a 6 month old male patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number EJ577, expiry date 13-AUG-2025) for prophylaxis. Previously administered products included Pediarix (received 1st dose of vaccine on an unknown date). On 18-AUG-2025, the patient received the 2nd dose of Pediarix. On 18-AUG-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: a Pediarix dose, which had expired, was accidentally given to a 6 month old male patient). The outcome of the expired vaccine used 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: 20-AUG-2025 A physician contacted GlaxoSmithKline to report that a Pediarix dose, which had expired, was accidentally given to a 6-month-old patient, which led to expired vaccine used. The reporter wanted to know if GlaxoSmithKline had any data to share. They did request to remain anonymous but did consent to receive follow up to the following phone number, on Monday, Wednesday and Friday.