Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UJ614AB | OT |
administered of expired ACT-HIB with no reported Adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 3 years and 6 months old female patient who administered expired HIB (PRP/T) vaccine [ACT-HIB] 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 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine conj 13 V (CRM 197) (Prevnar 13) both for prophylactic vaccination (Immunisation). On 16-Mar-2023, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ614AB and expiry date 12-Mar-2023) (strength : standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Nurse reported that patients were administered expired two years ago. 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.
INFANRIX; PREVNAR 13