Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK227AC | — |
they used an alternate sterile diluent instead of the provided diluent for ACT-HIB and administered to a patient with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 months old male patient to whom HIB (PRP/T) VACCINE [ACT-HIB] vaccine was administered with an alternate sterile diluent instead of the provided 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 (DAPTACEL); PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20); and HEPATITIS A VACCINE INACT (VAQTA) all for Prophylactic vaccination (Immunisation). On 26-Sep-2025, the patient received a dose 4, 0.5 ml, 1 X (once) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK227AC and expiry 30-Jun-2026) was administered with an alternate sterile diluent instead of the provided diluent with no reported adverse event (product preparation error) (latency same day) via unknown route in right leg for immunization (strength: standard). 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.
DAPTACEL; PREVNAR 20; VAQTA