Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK010AA | OT |
expired ACT-HIB given to a patient with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 1 years old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] given to a patient 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 INACT (VAQTA), hepatitis A vaccine (hepatitis A), measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (proquad) and pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), all for Immunisation. On 03-Mar-2025, the patient received standard dose 4 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection with lot UK010AA and expiry date 28-Feb-2025 via unknown route in unknown administration site for Immunization (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.
VAQTA; HEPATITIS A; PROQUAD; PREVNAR 20