Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK208AA | OT |
act-hib was mixed with sterile water with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 months old female patient who received HIB (PRP/T) Vaccine [Act-Hib], which was mixed with sterile water 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 04-Sep-2025, the patient received 0.5ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, frequency Once, lot UK208AA and expiry date 30-Apr-2026 via unknown route in right leg for immunisation, which was mixed with sterile water with no reported adverse event (product preparation error). 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