Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK009AB | OT / RL |
15 months old patient was given expired Act HIB with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves 15 months old male patient who received 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 Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) for prophylactic vaccination (Immunisation). On 04-Mar-2025, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number UK009AB and expiry date 28-Feb-2025) (frequency: once, strength: standard) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (Latency: 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.
Prevnar; Adacel