Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK227AC | OT |
a dose of ACTHIB was reconstituted with a sterile diluent and administered to a patient with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] was reconstituted with a sterile 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) with lot UK227AC and expiry date 30-Jun-2026 via unknown route in unknown administration site for Immunization that was reconstituted with a sterile diluent and administered to a patient with no reported adverse event (product preparation error) (latency same day) 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.