Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV
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 infant 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 and Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   Previously administered products included pediarix with an associated reaction of skin discolouration (received 1st dose on 20th June 2022, refer link case US2022AMR171169) and hiberix with an associated reaction of skin discolouration (received 1st dose on 20th June 2022, refer link case US2022AMR171169).   On 19th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 3 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. 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, Pediarix Pre-Filled Syringe Device and Hiberix.   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:  US2022AMR171169   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving Pediarix, Hiberix The reporter was consented to follow up. Additional supportive information: This was 1 of several linked cases, reported by same reporter.; 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-US2022AMR171169:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: