Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK166AA | OT / RA |
administration of expired acthib with no reported ae; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 67 years old male patient who administration of 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 Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 02-Oct-2025, the patient received expired dose (0.5ml) of suspect HIB (PRP/T) Vaccine; Powder and solvent for solution for injection (lot UK166AA with expiry date 30-SEP-2025) via intramuscular route in the right deltoid for Immunization with no reported ae (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.
Menquadfi