Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
administration error for acthib, it was diluted with sterile water and was administered with no reported adverse event; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case (along with live follow-up processed together with csd dated: 07-Nov-2025) received from a nurse. This case involves an unknown age and unknown gender patient who was administered with Hib (Prp/T) Vaccine [ACT-HIB] which was diluted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2025, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) frequency: once, via unknown route in unknown administration site for Immunization which was diluted with sterile water with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.