Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK359AA | OT |
medical assistants most likely used the wrong diluent to administer ACT-HIB to a patient with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] 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 rotavirus vaccine; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); pneumococcal vaccine (pneumococcal vaccine); polio vaccine INACT (IPV); and hepatitis B vaccine, all for Immunisation. On 14-Oct-2025, the patient received a dose 1 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with frequency once with lot UK359AA and expiry date 31-AUG-2026 via intramuscular route in unknown administration site for Immunization with the wrong diluent with no reported adverse event (product preparation error) (Latency same day). 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.
ROTAVIRUS VACCINE; DTAP; PNEUMOCOCCAL VACCINE; IPV; HEPATITIS B VACCINE