Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK166AB | IM / RL |
administration of an expired act-hib with no reported adverse event; Initial information received on 27-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of unknown age and unknown gender who was administered with an expired haemophilus type B (HIB) 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 medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular and tetanus vaccine toxoid. On 27-Mar-2026, the patient received a 0.5 mL once dose 4 of an expired haemophilus type B (HIB) vaccine powder and solvent for solution for injection (batch: UK166AB, expiry: 30-Sep-2025) (strength: standard) via intramuscular route in right thigh for immunization (Expired product administered) (latency- same day). Action taken: Not applicable. Reporter can be contacted by Sanofi: No. 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