Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK025AA | OT |
administered act-hib to a 15-month-old patient and it was already expired on 31mar2025 with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient for whom HIB (PRP/T) vaccine [ACT-HIB], administered already expired on 31-Mar-2025 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 hepatitis a vaccine and pneumococcal vaccine both for Immunisation. On 17-Apr-2025, the patient received an unknown dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UK025AA with expiry date 31-MAR-2025) via intramuscular route in the thigh NOS (Not Otherwise Specified) for Immunization, administered already expired on 31-Mar-2025 with no reported adverse event (expired product administered). 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.
HEPATITIS A VACCINE; PNEUMOCOCCAL VACCINE