Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9C295 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 7NX57 | — |
Extra dose administered; the patient was given pediarix that also has hep B in it and they gave also separately Hep B vaccine; 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 HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 9C295, expiry date 02-FEB-2027) for prophylaxis. Previously administered products included Pentacel (received 1st dose on an unknown date) and Pentacel (received 2nd dose on an unknown date). On 18-AUG-2025, the patient received the 4th dose of Engerix B pediatric and Pediarix. On 18-AUG-2025, an unknown time after receiving Engerix B pediatric and not applicable after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra dose administered) and overdose (Verbatim: the patient was given pediarix that also has hep B in it and they gave also separately Hep B vaccine). The outcome of the extra dose administered and overdose were 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: 18-AUG-2025 The reporter was calling to see if you have any information on if a patient were to get a Pediarix along with the Hepatitis B at the same time, if they have any information on any kind of adverse side effects that the reporter look at the patient. The reporter asked if the patient received both, the Pediarix and the Hepatitis B separately in the same visit was there any side effects that they needed to be watching for any in danger to the patient. The reporter asked it was the First dose of Pediarix, they had two pentacel. They did not Pentacel anymore, so they have switched for pediarix so then, the patient was given pediarix that also has hepatitis B in it and they gave also separately Hep B vaccine on the day of reporting as well. This would be the Third, actually, the Fourth Hepatitis B, because they had 2 doses on the day of reporting which led to extra dose administered and overdose.