Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
inappropriate use due to act-hib was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient received Hib (Prp/T) Vaccine [Act-Hib] which was reconstituted 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. On an unknown date, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, which was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. 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.