Reporte zur Charge HN7L7

Symptomtext

Extra dose of IPV given; Got Kinrix at two months of age; Got Kinrix, months later got complete series of Pediarix; 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 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number HN7L7, expiry date 31st August 2021) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX) and DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX). On 18th February 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 30th December 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 18th February 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 30th December 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and extra dose administered 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 details were provided as follows: Clinical Supervisor reported that, the patient received a dose of Kinrix at two months of age, which led to inappropriate age at vaccine administration. Several months later, the patient received a complete series of Pediarix. The 1st dose of Pediarix was given on 19th April 2021 (batch number 4977T, expiry date 5th September 2022) and 2nd dose on 21st June 2021 (Batch number 4977T, expiry date 28th November 2021) The patient received 3rd dose of Pediarix leaving him with an extra dose of IPV given which led to inappropriate schedule of vaccine administered and extra dose administered. Pediarix was given on the correct schedule, but started at the incorrect age. The reporter consented to follow up.