Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK042AA | OT / LL |
administration of an expired dose of act-hib with no reported ae; Initial information received on 30-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 15 months old male patient who administered expired dose of 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 20V (CRM197) (Prevnar 20) for immunisation. On 30-Apr-2025, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK042AA and expiry date 31-Mar-2025) (frequency: once and strength: standard) via intramuscular route in the left 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.
INFANRIX; PREVNAR 20