Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | X9EP5 | — |
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 7D2Y4 | — |
localized reaction of redness; localized reaction of pain; gave a patient a Kinrix and a Pediarix at the same time; were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. On 06-NOV-2024, the patient received the 4th dose of Pediarix and the 3rd dose of Kinrix. On 06-NOV-2024, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: gave a patient a Kinrix and a Pediarix at the same time) and inappropriate schedule of drug administration (Verbatim: were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series). On an unknown date, the patient experienced localized erythema (Verbatim: localized reaction of redness) and pain localized (Verbatim: localized reaction of pain). The outcome of the localized erythema and pain localized were resolved and the outcome of the overdose and inappropriate schedule of drug administration were unknown. It was unknown if the reporter considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. It was unknown if the company considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix 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: 06-NOV-2024 and 23-DEC-2024 The medical assistant reported that they gave a patient a Kinrix and a Pediarix at the same time and according to reporter, the doses were the 3rd and 4th doses of the patient in the DTap series, which led to overdose and inappropriate schedule of drug administration. The patient may had more localized reaction of redness or pain but that patient would be fine and no follow-up was needed. The Vaccine Administration Facility was the same as Primary Reporter