Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK306AA | OT / LL |
inappropriate use due to act-hib being reconstituted with the incorrect diluent and administered to a patient with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional (Live follow up processed together on the same day). This case involves a 15 months old female patient who had inappropriate use due to HIB (PRP/T) Vaccine [ACT-HIB] being reconstituted with the incorrect diluent and 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 Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation. On 29-Aug-2025, the patient received a 0.5 ml (dose 1) dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: Standard, frequency: once, expiry date: 31-Aug-2026 and lot UK306AA) via unknown route in the left thigh as Immunization and inappropriate use due to act-hib being reconstituted with the incorrect diluent and administered to a patient with no reported 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.
Prevnar; Infanrix