Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK229AA | OT / LL |
powder was mixed with the wrong diluent and administered to a patient with no Adverse Event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from Nurse. This case linked to US-SA-2025SA314872 cluster case. This case involves a 1 years old female patient and Nurse reported powder was mixed with the wrong diluent and administered to a patient with no adverse event for HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2025, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK229AA; expiration Date :30-Jun-2026) via unknown route in the left thigh for Immunization, powder was mixed with the wrong diluent and administered to a patient with no adverse event (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 thinks that the powder was mixed with the wrong diluent and administered to a patient. 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: 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-2025SA314872: