Symptomtext
1st dose on 29/08/2022, 2nd dose on 19/09/2022 (Rotarix/ Hiberix/ Pediarix); Hiberix and Pediarix 1st dose given at 3.6 months age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HF4, expiry date 25th March 2024) 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 335N9, expiry date 25th May 2023) for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 2339G, expiry date 16th February 2024) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) for prophylaxis. Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX LYOPHILIZED FORMULATION). On 19th September 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 29th August 2022, not applicable after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix and ROTARIX LYOPHILIZED FORMULATION, the patient experienced inappropriate age at vaccine administration. On 19th September 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short were unknown. 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: 20-SEP-2022 Reporters comment: The medical assistant reported the patient received Pediarix, Hiberix, Rotarix on 29th Aug 2022 then received the same vaccines early on 19th Sep 2022 at patient's 4-month checkup. The medical assistant stated the patient was behind on vaccines and came in 29th Aug 2022 to catch up. The reporter did not consent to follow-up. Additional Supportive information: The patient received 1st dose of Hiberix and Pediarix at 3.6 months age, which led to inappropriate age at vaccine administration and received 2nd dose of Rotarix, Hiberix and Pediarix earlier than recommended time interval which led to shortening of vaccination schedule.