Symptomtext
administered an expired ACT-HIB vaccine to a patient, with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 7-month-old male patient to whom administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine, 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 DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for Immunisation. On 13-Feb-2023, the patient received dose 3 at 0.5ml total of suspect HIB (PRP/T) VACCINE, Strength: standard (formulation: unknown) (Lot Number: UJ472AC, UJ472ACA; Expiration Date :2022-06-23, 2022-07-08) via intramuscular route in the left thigh for Immunization and on the same day administered an expired act-hib vaccine to a patient, with no reported adverse event (expired product administered). It was reported that a nurse at the facility misread the expiration date on a vial of ACT-HIB of 23JUN2022 and believed that it didn't expire until 2023 so it was kept in the refrigerator. Caller asked for guidance on how to proceed in this situation. Caller asked if there was a waiting period for re-vaccination or if it could be done right away? 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.