Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK166AB | OT / LL |
used sterile water as a diluent instead of the recommended saline with no reported adverse event; Initial information received on 05-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who received HIB (PRP/T) vaccine [ACT-HIB] and used sterile water as a diluent instead of the recommended saline 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 (Daptacel); and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) as both for Immunisation. On 05-Sep-2025, the patient received 0.5 ml of dose 4 of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 30-SEP-2025 and lot UK166AB) once via intramuscular route in the left thigh for Immunization and used sterile water as a diluent instead of the recommended saline with no reported adverse event (product preparation error) (latency- same day). Reportedly, reporter was asking if the dose was invalid and needs to be repeated. 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.
Daptacel; Prevnar