Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK193AA | IM / RL |
patient has been given an expired Act-Hib, with no reported adverse event; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional. This case involves a patient of unknown age and gender who has been given an expired HIB (PRP/T) Vaccine (ACT-HIB), with no reported adverse event after receiving . The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 01-Apr-2026, the patient received a 0.5 mL once dose of HIB (PRP/T) VACCINE powder and solvent for solution for injection (batch: UK193AA, expiry: 31-Mar-2026) (strength: standard) via intramuscular route in right thigh for immunization. On 01-Apr-2026, a medical assistant reported that a patient has been given an expired ACT-HIB with no reported adverse event (Expired product administered, latency: same day). Action taken: Not applicable. 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.
Comments: NONE