Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK151AA | OT / RL |
gave a dose of ACT-HIB that expired yesterday with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 15 month old female patient to who was given a dose of HIB (PRP/T) vaccine [ACT-HIB] that expired yesterday 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 20v (CRM197) (Prevnar 20) for Immunisation. On 01-Oct-2025, the patient was given a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (once) (Strength: unknown), lot UK151AA and expiry date 30-Sep-2025 via intramuscular route in the right thigh for immunization, that expired yesterday with no reported adverse event (expired product administered) (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 20