Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | B532G | — |
extra dose/Inappropriate schedule; 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 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G, expiry date 11-APR-2027) for prophylaxis. Previously administered products included Pediarix (Patient received first dose on an unknown date), Pediarix (Patient received second dose on 09-OCT-2024) and Pediarix (patient received third dose on an unknown date). On 02-FEB-2025, the patient received the 4th dose of Pediarix. On 02-FEB-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: extra dose/Inappropriate schedule). 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: 05-MAR-2025 Medical Assistant reported that a 6 month old patient completed Diphtheria, Tetanus, Pertussis Vaccine 2 doses on October ninth twenty twenty-four, they went to after that and the patient got vaccinated again for Diphtheria, Tetanus, Pertussis Vaccine there, the pharmacy was not aware of that. So, on February second patient received the 3rd Diphtheria, Tetanus, Pertussis Vaccine dose as recommended by the profile. Medical Assistant wanted to know as for the parent´s concern on the child´s health. Patient received fourth dose of Pediarix, which led to extra dose administered.