Reporte zur Charge UJ650AAB

Symptomtext

a patient receiving an expired ACT-HIB with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 1-year-old male patient who was receiving an expired HIB (PRP/T) VACCINE [ACT-HIB] 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 HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. On 11-Apr-2023, the patient received dose 4 at 0.5ml total of suspect HIB (PRP/T) VACCINE (Strength: standard) (lot number: UJ650AAB, expiry date: 10-Apr-2023) via intramuscular route in the left thigh for Immunization and on the same day patient receiving an expired act-hib with no reported adverse event (expired product administered). It was reported, caller asked for information on how to proceed in this situation? 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 guidelines. 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.