Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UJ995AA | OT / LL |
administration of an expired product with no reported adverse event; Initial information received on 07-Mar-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 14 months old male patient who had administration of an expired Hib (PRP/T) Vaccine [ACT-HIB] with no reported adverse event. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3) On 06-Mar-2025, the patient received an expired dose 3 of 0.5 ml dose of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection,(Frequency: once, strength=standard, expiry date: 28-feb-2025, lot UJ995AA) via intramuscular route in the left thigh for Immunization, with no reported adverse event. (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; MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE