Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UJ995AA | OT / RL |
1-year-old patient received an expired act-hib vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Immunisation. On 05-Mar-2025, the patient received a dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UJ995AA with unknown strength and expiry date) via intramuscular route in the right vastus lateralis for Immunization. On 05-Mar-2025 the patient received an expired act-hib vaccine with no reported adverse event (expired product administered). Action taken 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.
Dtap; PNEUMOCOCCAL CONJUGATE VACCINE