Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4L454 | LL |
Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of legs in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454) for prophylaxis. Concomitant products included Mmr ii and Varicella zoster vaccine live (Oka/Merck) (Varivax). On 12-JUN-2025, the patient received Kinrix (left thigh). On 12-JUN-2025, less than a week after receiving Kinrix, the patient experienced limping (Verbatim: Limping) and vaccine administered at inappropriate site (Verbatim: administered a dose of Kinrix into the left thigh). In JUN-2025, the patient experienced swelling of legs (Verbatim: Swollen Thigh). The outcome of the swelling of legs was not resolved and the outcome of the limping was unknown and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the vaccine administered at inappropriate site to be unrelated to Kinrix. It was unknown if the company considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the vaccine administered at inappropriate site to be unrelated to Kinrix. 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: 13-JUN-2025 Physician stated that on 12th June 2025, she administered a dose of Kinrix into the left thigh of a pediatric patient, and mom noticed the patient was limping and complaining last night on 12th June 2025. The reporter stated that the patient did not let mom see the left thigh until today, 13th June 2025, and mom stated the left thigh was very, very big or swollen. Reporter stated that's all that was provided about these adverse events.
Mmr ii; Varivax