Reporte zur Charge UJ456AA

Symptomtext

received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 9 months old female patient who received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event, after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination. On 08-Feb-2022, the patient received dose 4 of suspect HIB (PRP/T) VACCINE (strength, dose, formulation: unknown) with lot UJ456AA via unknown route in the left thigh as immunization. It was reported that patient received their 4th dose of acthib 3 months early on 8-Feb-2022; patient received their 3rd dose on 22-Nov-2021 at 6 months of age and would not be due for their 4th and final dose until 12 months of age (inappropriate schedule of product administration) following the administration of HIB (PRP/T) VACCINE. No adverse event was reported. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was Unknown for the event This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.