Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | JP227 | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | TE499 | — |
patient has now 3 Dtaps; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 23-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TE499, expiry date 02-FEB-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number JP227, expiry date 22-AUG-2027) for prophylaxis. Previously administered products included DTap vaccine (received first dose on unknown date) and DTap vaccine (received second dose on unknown date). On 11-NOV-2025, the patient received the 3rd dose of Pediarix. On 10-NOV-2025, the patient received the 3rd dose of Infanrix. On 10-NOV-2025, an unknown time after receiving Pediarix and Infanrix, the patient experienced accidental overdose (Verbatim: patient has now 3 Dtaps). The outcome of the accidental overdose 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: 10-Nov-2025 and 11-Nov-2025 The reporter reported on 10th November 2025 that day she did an accidental two dose of DTap vaccine. According to reporter, she had given a dose of Pediarix and a dose of Infanrix to a patient. The patient had now 3 Dtaps taking into consideration these last shots of Pediarix and Infanrix in the same clinic day. No further details provided.