Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Skin discolouration
Clinical narrative: Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (1st dose received on 19th May 2022, from batch number X9HS4 and refer case US2022AMR171197) and Hiberix with an associated reaction of skin discolouration (1st dose received on 18th January 2022, from batch number 25N39 and refer case US2022AMR171264).   On 19th July 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration 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.   Linked case(s) involving the same patient:  US2022AMR171197, US2022AMR171264   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The reporter reported that the patient after received Pediarix vaccine experienced gray dot on the left thigh leg. The reporter did consent to follow up. Additional supportive information: This case had been linked with US2022AMR171197 and US2022AMR171264 by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: