Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9c295 | IM / LL |
a pediatric patient received an extra dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9c295, expiry date 02-FEB-2027) for prophylaxis. Previously administered products included Pentacel (1st dose received on an unknown date), Pentacel (2nd dose received on an unknown date), Pentacel (3rd dose received on an unknown date) and Infanrix (one dose received on an unknown date). On 15-OCT-2025, the patient received Pediarix (intramuscular, left thigh). On 15-OCT-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: a pediatric patient received an extra dose of Pediarix). 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: 15-OCT-2025 The reporter stated that a pediatric patient received an extra dose of Pediarix today (on the day of reporting) due to recordkeeping issues. She stated that she thought she was giving a catch-up dose today, dose 2. But then after administration the records came through showing that this patient had already had three doses of Pentacel and one dose of Infanrix.