Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK229AA | OT / RL |
powder was mixed with the wrong diluent and administered to a patient, with no reported adverse; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old male patient who was administered with Hib (Prp/T) Vaccine [ACT-HIB] in which powder was mixed with the wrong diluent 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 Hepatitis a vaccine (Hepatitis A) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 23-Sep-2025, the patient received 0.5 ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Frequency :once, Strength: standard, lot UK229AA, expiry date:30-Jun-2026 via unknown route in the right thigh for Immunization in which powder was mixed with the wrong diluent with no reported adverse (product preparation error) (latency: same day). Caller stated that she noticed that the diluent for the ACTHIB was still there, but the powder was gone. Caller is asking if the dose is invalid. Caller stated that they don't know which patient it was administered to because two kids came in a day apart for the ACTHIB vaccine about a month ago The nurse reported that the ACTHIB was more than likely mixed with the sterile water from a frozen vaccine for children the ACTHIB. 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.; Sender's Comments: US-SA-2025SA313634:
Hepatitis A; Dtap