Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | — |
administration of an expired ACTHIB dose, with no reported adverse event; Initial information received on 06-May-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a child patient of unknown age and unknown gender as there was administration of an expired haemophilus type b (HIB) vaccine (ACT-HIB dose, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 05-May-2026, the patient received expired haemophilus type b (HIB) vaccine powder and solvent for solution for injection (Strength = standard) as 0.5 mL, once (route: unknown) for immunization with no reported adverse event (expired vaccine used and expired product administered, and latency: same day) (batch: unknown, expiry: 30-Apr-2026). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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 medication 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