Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration, Vaccine positive rechallenge
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, 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, Hib (Hiberix) (batch number 5Y9N9, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (1st dose received on 08 June 2022, from batch number X9HS4 and refer case US2022AMR171034), Hiberix with an associated reaction of skin discolouration (1st dose received on 08 June 2022, from batch number EK5Y2 and refer case US2022AMR171034), Pediarix with an associated reaction of skin discolouration (2nd dose received on 11 Aug 2022  from batch number N7HL3 and refer case US2022AMR171039) and Hiberix with an associated reaction of skin discolouration (2nd dose received on 11 August 2022 from batch number BD27G and refer case US2022AMR171039).   On 13th October 2022, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 3rd dose of Hiberix. On an unknown date, the patient received PREVNAR. On an unknown date, less than 2 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:  US2022AMR171034, US2022AMR171039   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: This was 1 of 19 linked cases, reported by same reporter. It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter