Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK208AA | OT / LA |
ACTHIB that was reconstituted with a different diluent (0.9% Sodium Chloride) was administered to a patient, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 3 years old female patient for whom HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent (0.9% sodium chloride) was administered to a patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The list of concomitants as no other vaccines On 29-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once),Powder and solvent for solution for injection (Strength = standard) lot UK208AA expiry date-30-Apr-2026 via intramuscular route in the left deltoid for immunization that was reconstituted with a different diluent (0.9% sodium chloride) was administered to a patient, with no reported adverse event (product preparation error) (latency same day). Action taken: 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.