Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
act-hib diluent was mixed with sterile water with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves HIB (PRP/T) vaccine [ACT-HIB] diluent was mixed with sterile water with no reported adverse event. On an unknown date, HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date-unknown) not reported via unknown route in unknown administration site for Immunization and 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.