Symptomtext
Patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02Jun2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix on24Jun2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received Hib (Hiberix) (batch number UJ437AB, expiry date 3rd May 2022) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Concomitant products included Hib (Hiberix), DTPa-HBV-IPV (Pediarix) and Rota (Rotarix lyophilized formulation). On 24th June 2021, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 24th June 2021, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and an unknown time after receiving Hiberix, Pediarix and Rotarix lyophilized formulation, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: A medical assistant had reported that a patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02 June 2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix earlier than the recomended interval, which led to drug administration interval too short. No symptoms were reported. Reporter consented to follow-up.