Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | D252F | — |
rash on injection site; got an allergic reaction from it; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site rash in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number D252F) for prophylaxis. On 27-FEB-2025, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced injection site rash (Verbatim: rash on injection site) and allergic reaction (Verbatim: got an allergic reaction from it). The outcome of the injection site rash was unknown and the outcome of the allergic reaction was not reported. It was unknown if the reporter considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix Pre-Filled Syringe Device. 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 : 19-MAR-2025 Registered nurse called and reported the followed they gave one of our patient, a baby, the Hepatitis B vaccine, and then the baby got an allergic reaction from it, they had sent the baby to an allergist and now the allergist asked like a sample for the vaccine so they could do a skin test.