Received Feb 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK175AB | OT |
administering an expired ACT-HIB with no reported adverse event; Initial information received on 16-Jan-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 months old male patient (83.82 cm and 10.9 kg) to whom administered an expired HIB (PRP/T) VACCINE [ACT-HIB]with no reported adverse event. The Unspecified number of patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient received an expired suspect HIB (PRP/T) VACCINE with no reported adverse event (expired product administered) (latency: same day) (Powder and solvent for solution for injection) (lot UK175AB and expiry date: 31-OCT-2025) (dosage text: unknown 1X (once) via intramuscular in unknown administration site for immunization. It was reported "Doctor states that the ACT-HIB might have been given past the expiration date. Is there any extended stability data? The first lot of UK166AB it was administered 14 days ago or less. The second lot UK175AB was administered 10 weeks ago or 70 days ago. There were no studies on efficacy or safety of the products past its expiration date. Doctor said that it is unknown how many patients were administered with these expired ACT-HIB. She said at least 2 patients were administered, but they're still figuring out how many were administered. She does not have any patient information because she's not at the office." 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. Additional information was received on 03-Feb-2026 from healthcare professional: this case became valid on follow up dated 03-Feb-2026; added patient details including (age, weight and height) of the patient; added route of the patient; text amended accordingly.; Sender's Comments: US-SA-2026SA016224: