Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4); This serious case was reported by a consumer via interactive digital media and described the occurrence of neutropenia in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received the 3rd dose of Pediarix. On an unknown date, 66 days after receiving Pediarix, the patient experienced neutropenia (Verbatim: my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4)) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the neutropenia was unknown. The reporter considered the neutropenia to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The company considered the neutropenia to be unrelated 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: 04-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her child was diagnosed with neutropenia 66 days after Pediarix. The reporter mentioned that the burden of proof was to show product did not cause , had neutropenia.; Sender's Comments: Neutropenia is an unlisted event which is considered unrelated to GSK vaccine Pediarix and Pediarix PRE-FILLED SYRINGE DEVICE.