Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK328AA | OT |
administered ACTHIB with the wrong diluent to a patient, with no reported adverse event; Initial information received on 07-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent, 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunization. On 30-Jun-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 31-May-2026 and lot UK328AA) once via unknown route in unknown administration site for Immunization, with the wrong diluent with no reported adverse event (product preparation error) (latency- same day). Reportedly, they said that they did not observe any adverse reactions afterwards. They wanted to know what the possible effects would be on the 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.
DTAP