Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK093AB | OT / LL |
one of the medical assistants used sterile diluent to dilute ACTHIB instead of the diluent that comes with the vaccine with no reported adverse event; Initial information received on 29-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9-month-old male patient and is reported one of the medical assistants used sterile diluent to dilute HIB (PRP/T) Vaccine [ACT-HIB] instead of the diluent that comes with the vaccine 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 b vaccine (Hep b vax) for Immunisation. On 29-Jul-2025 at 08:55 hour, the patient received a 0.5 ml (dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UK093AB and expiry date: 30-Sep-2025 via intramuscular route in the left thigh Frequency: once, Strength: standard for Immunization and one of the medical assistants used sterile diluent to dilute acthib instead of the diluent that comes with the vaccine with no reported adverse event (product preparation error) (latency: on 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.
Hep b vax