Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
HCP states that one of their medical assistants administered ACT-HIB using a sterile water instead of the one provided with it with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves an unknown age and unknown gender patient for whom hcp (Healthcare Professional) stated that one of their medical assistants administered HIB (PRP/T) Vaccine [ACT-HIB] using a sterile water instead of the one provided with it with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, hcp stated that one of their medical assistants administered HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization using a sterile water instead of the one provided with it with no reported adverse event (product preparation error) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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.