Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK113AB | OT |
an inappropriate use due to the reconstitution of ACTHIB with sterile water instead of the diluent with no reported adverse event; Initial information received on 20-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with sterile water instead of the diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength) with lot UK113AB and expiry date 30-Sep-2025 via unknown route in unknown administration site for Immunization reconstituted with sterile water instead of the diluent with no reported adverse event (product preparation error) (Latency same day) Reportedly, reporter noted that during inventory they found a dose of the ACTHIB diluent but not the powder. The nurse noted that this product may have been recently administered to a patient, but they were unable to confirm as the administering HCP was out of the office at the time of the call, and so they could not confirm whether the ACTHIB suspected to have been reconstituted with sterile water was administered to a patient Action taken was 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.