Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK169AC | OT / GM |
ACT-HIB that was administered to a patient after being reconstituted with just a sterile diluent instead of the saline diluent that comes in the box with no reported adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered to HIB (PRP/T) Vaccine [ACT-HIB] after being reconstituted with just a sterile diluent instead of the saline diluent that comes in the box 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 Pneumococcal vaccine conj (Pneumococcal conjugate vaccine) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 24-Nov-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK169AC, expiry date 28-Feb-2026, frequency once and strength standard) via intramuscular route in the left gluteus medius for Immunisation and administered after being reconstituted with just a sterile diluent instead of the saline diluent that comes in the box with no reported adverse event (product preparation error) (latency same day). It was reported "they have a dose of ACT-HIB that was administered to a patient after being reconstituted with just a sterile diluent instead of the saline diluent that comes in the box. She was asking if that was ok or if they need to readminister the dose". 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.
Pneumococcal conjugate vaccine; Dtap