Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK151AA | OT / LL |
expired ACT-HIB was administered today, with no reported adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA313599 (Cluster case). This case involves a 5 months old male patient who had expired HIB (PRP/T) VACCINE [ACT-HIB] was administered today, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine for Immunisation; and Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) for Immunisation. On 20-Oct-2025, the patient received an expired 0.5 ml 1x (once) dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK151AA, Expiry: 30-Sep-2025, Strength: standard) via intramuscular route in the left thigh as immunization with no reported adverse event (expired product administered) (Latency: same day). It was reported "Office manager stated that they placed the order in August and it came in 12-Aug-2025 but the vaccines expired right away. They were mailed almost expired vaccines." 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.; Sender's Comments: US-SA-2025SA313599:
Rotavirus vaccine; Vaxneuvance