Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
there was a vaccine that was administered on 04oct2025 and then the staff didn't realize the expiration date is 30sep2025 with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a Nurse Practitioner. This case involves a 4 months old male patient and there was a vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was administered on 04oct2025 and then the staff didn't realize the expiration date is 30sep2025 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, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix) for Immunisation. On 04-Oct-2025, the patient received a expired 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Expiry date: 30-Sep-2025, strength: standard, indication: immunization, batch number, route, was unknown) in anterior thigh (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.
Pediarix