Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 2tp34 | — |
Pediarix extra dose accidentally given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 9-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2tp34, expiry date 19-SEP-2027) for prophylaxis. Previously administered products included Pediarix (received first dose on an unknown date), Pediarix (received second dose on an unknown date) and Pediarix (received third dose on an unknown date at 6 months of age). On 02-DEC-2025, the patient received the 4th dose of Pediarix. On 02-DEC-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Pediarix extra dose accidentally given). 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: 03-DEC-2025 The Vaccine Administration Facility was the same as primary reporter Practice manager called to report that a patient received inadvertently a fourth dose of Pediarix. The patient completed the schedule during their 6 months appointment and then during their 9 months appointment it was repeated by accident.