Received Feb 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK166AB | OT |
administering an expired ACT-HIB with no reported adverse event; Initial information received on 16-Jan-2026 regarding an unsolicited non-valid non-serious case received from a physician. The case is linked to US-SA-2026SA016032 (Cluster case). This case involves an 12 months old male patient (80.01 cm and 10.07 kg) to whom administered 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. On 03-NOV-2025, the patient(s) received an expired dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK166AB, Expiry: 30-Sep-2025, with unknown strength) via intramuscular route in unknown administration site as immunization with no reported adverse event (expired product administered) (Latency: same day). It was reported "Doctor states that the ACT-HIB might have been given past the expiration date. 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 a physician: Patient age weight and height was added, Therapy start date updated, narrative amended accordingly.; Sender's Comments: US-SA-2026SA016032: