Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | — |
received a dose of act-hib which was reconstituted using sterile water ," instead of the diluent that comes with the vaccine with no reported adverse event; Initial information received on 25-Mar-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a patient of unknown age and unknown gender who received a dose of HIB (PRP/T) vaccine [ACT-HIB] which was reconstituted using sterile water, instead of the diluent that comes with the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 24-Mar-2026, the patient received an unknown dose of HIB (PRP/T) vaccine powder and solvent for solution for injection (batch/expiry: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization which was reconstituted using sterile water, instead of the diluent that comes with the vaccine with no reported adverse event (Product preparation error) (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.
Comments: NONE