Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK372AB | OT / RL |
she grabbed the powder component of ACTHIB and reconstituted it with a sterile diluent instead of the diluent it came with,with no reported adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 months old male patient and at the time of vaccination when she grabbed the powder component of HIB (PRP/T) Vaccine [ACT-HIB] and reconstituted it with a sterile diluent instead of the diluent it came with,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 30-Sep-2025, the patient received 0.5mL (dose 1) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK372AB, expiry date 31-Dec-2026, frequency once, strength standard) via intramuscular route in the right vastus lateralis for Immunization and she grabbed the powder component of acthib and reconstituted it with a sterile diluent instead of the diluent it came with,with no reported adverse event (product preparation error). Reportedly, nurse was wondering if the vaccine needs to be regiven. 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.
Dtap