Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
inappropriate use due to administration of a vaccine that was reconstituted with a wrong diluent with no reported adverse event; Initial information received on 21-Jul-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] that was reconstituted with a wrong diluent with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, 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, lot and expiry date) via unknown route in unknown administration site for Immunization that was reconstituted with a wrong diluent with no reported adverse event (product preparation error) (latency same day) Reportedly, Nurse stated they are not 100% sure but that they think ActHIB may have been reconstituted with sterile water and given to a patient. The nurse specifically asked if the vaccine was effective and whether it would be harmful to the patient. The nurse also inquired about the manufacturer of ACT-HIB and whether there is a different department the physician needs to speak to other than medical information. The nurse mentioned that they don't need the diluent but are gathering information since they don't have all the details or access to what occurred. The nurse asked if they were to revaccinate, should they administer the exact amount of 0.5 mL after reconstitution. Information on the batch number was requested corresponding to the one at time of event occurrence 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.