Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK208AA | OT |
they might have reconstituted ACTHIB with sterile water and it was administered to a patient, with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 years old male patient to whom they might have reconstituted HIB (PRP/T) Vaccine [ACT-HIB] with sterile water and it was administered to a patient, 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 Hepatitis a vaccine (Hepatitis A) for Immunisation. On 17-Jun-2025, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK208AA, expiry date 28-Feb-2026, strength standard and frequency once) via intramuscular route in Right central lateral for Immunisation and it was reconstituted with sterile water and was administered to a patient, with no reported adverse event (product preparation error). 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.
Hepatitis A