Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK359AA | OT / RL |
administered ACTHIB using a pre-made 0.4% saline solution containing 0.7mL instead of the accompanying saline diluent, with no reproted adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves a 16 months old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] using a pre-made 0.4% saline solution containing 0.7ml instead of the accompanying saline diluent, with no reproted 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 12-Aug-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml 1x(once) (strength standard) lot UK359AA expiry date-31-Aug-2026 via intramuscular route in the right thigh for Immunisation, using a pre-made 0.4% saline solution containing 0.7ml instead of the accompanying saline diluent, with no reproted 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.
Hepatitis A