Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | TE499 | LL |
Rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TE499, expiry date 02-FEB-2027) for prophylaxis. On 06-OCT-2025, the patient received the 1st dose of Pediarix (left thigh). On an unknown date, an unknown time after receiving Pediarix, the patient experienced rash (Verbatim: Rash). The outcome of the rash was resolved. The reporter considered the rash to be related to Pediarix. It was unknown if the reporter considered the rash to be related to Pediarix Pre-Filled Syringe Device. The company considered the rash to be related to Pediarix. It was unknown if the company considered the rash to be related to 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 23-DEC-2025 The reporter consented to follow up.