Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK175AA | OT |
medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water with no reported adverse event; medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water and then administered to a patient with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old male patient who had medication error/an inappropriate use due to HIB (PRP/T) Vaccine [ACT-HIB] was reconstituted with sterile water and then 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. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 31-Jul-2025, the patient received a dose 4 with dosage 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK175AA, Expiry: 31-Oct-2025, Strength: Standard, Frequency: once) via intramuscular route in the Left Vastus Lateralis as Immunization which was reconstituted with sterile water instead of the diluent it came with no reported adverse event (product preparation error) (poor quality 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.
Dtap