Reporte zur Charge UJ646AA

Symptomtext

expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 13-month-old female, to whom an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event. 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); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. On 06-Mar-2023, the patient received a Booster dose at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, Strength: standard (lot number: UJ646AA, expiry date: 05-Mar-2023) via intramuscular route in Left Quad for Immunization and on the same day expired dose of acthib was administered to a patient with no reported adverse event (expired product administered). It was reported, requesting validity information. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown. 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.