Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK151AA | OT / LL |
inappropriate use due to reconstituting the ACTHIB powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 2 years old female patient where reporter reported inappropriate use due to reconstituting the HIB (PRP/T) Vaccine [ACT-HIB] powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Jul-2025, the patient received 0.5 ml dose 4 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength- standard) (batch number- UK151AA and expiry date- 30-SEP-2025) via intramuscular route in the left thigh for immunization and inappropriate use due to reconstituting the acthib powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event (Single component of a two-component product administered) (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.