Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK210AA | OT |
staff member may have given the ACTHIB with sterile water instead of the diluent, with no reported adverse event; Initial information received on 27-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] 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 UK210AA and expiry date 28-FEB-2026 via unknown route in unknown administration site for Immunization With sterile water instead of the diluent, with no reported adverse event (product preparation error) (Latency same day) Reportedly, Reporter stated that 1 of the 4 people that they administered ACTHIB to, was given that vaccine. reported that at the time of this call they are not sure if the ACTHIB was prepared and given; that they are looking into the charts to see if a possible medication error took place; that something may have happened to the ACTHIB powder vial and not used or another reason that the diluent was left alone. 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.