Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UJ992AA | OT |
patient took expired acthib with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 12 months and 18 days old female patient who received 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 pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), measles vaccine, mumps vaccine, rubella vaccine (MMR); aesculus hippocastanum [varivax] and hepatitis A vaccine (hepatitis A vaccine), all for Immunisation. On 03-Mar-2025, the patient received standard dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection once with lot UJ992AA and expiry date 28-Feb-2025 via intramuscular 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.
PREVNAR 20; MMR; VARIVAX [AESCULUS HIPPOCASTANUM]; HEPATITIS A VACCINE