Received Mar 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK193AA | IM / LA |
product was administered with the wrong diluent with no reported adverse event; Initial information received on 03-Mar-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 72 years old male patient to whom product HIB (PRP/T) VACCINE (ACT-HIB) was administered with the wrong diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 09-Feb-2026, the patient received a 0.5 mL once dose of HIB (PRP/T) VACCINE powder and solvent for solution for injection (batch: UK193AA, expiry: 31-Mar-2026) (strength: unknown) via intramuscular route in left deltoid site for immunization, which was administered with the wrong diluent with no reported adverse event (Product preparation error) (Latency: same day). It was reported, "The reporter, a clinical pharmacist in primary care office, stated that the product was administered with the wrong diluent. It was not the 0.4% Normal Saline, but they used the sterile water. The caller was asking if this was an invalid dose." 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.