Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK230AA | OT |
act-hib was reconstituted with sterile water instead of the diluent with no reported adverse event; Initial information received on 14-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient as HIB (PRP/T) Vaccine [ACT-HIB] was reconstituted with sterile water instead of the 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); Polio vaccine (Polio vaccine); and pneumococcal vaccine for Immunisation. On 14-Aug-2025, the patient received a dose 3 of suspect HIB (PRP/T) Vaccine dose 0.5 ml 1x(once) Powder and solvent for solution for injection (strength unknown) lot UK230AA expiry date-30-Jun-2026 via intramuscular route in the thigh nos(not otherwise specified) for immunization, was reconstituted with sterile water instead of the diluent 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.
Dtap; Polio vaccine; PNEUMOCOCCAL VACCINE