Received Jan 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK360AB | OT / LL |
reported that a dose of ACTHIB was reconstituted with an incorrect diluent (sterile water) and administered to a patient with no reported adverse event; Initial information received on 20-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old male patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with an incorrect diluent (sterile water) 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); polio vaccine INACT (IPV); rotavirus vaccine and pneumococcal vaccine, all for Immunisation. On 30-Dec-2025, the patient received Dose 2 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK360AB and expiry date 30-NOV-2026 via intramuscular route in the left thigh for Immunization that was reconstituted with an incorrect diluent (sterile water) with no reported adverse event (product preparation error) (Latency same day). 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.
DTAP; IPV; ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE