Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A191M | OT |
patient administered expired IPOL with no reported adverse event; Initial information received on 20-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 4 years old male patient who administered expired IPV (VERO) [IPOL] 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) for prophylactic vaccination (Immunisation). On 05-Mar-2025, the patient received a dose of 0.5 ml of expired IPV (VERO), suspension for injection (lot W1A191M, expiry date: 16-Feb-2025, strength: standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day). Reportedly, They wanted to know the next steps that they needed to take with the patient's immunization. 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.
Daptacel; Proquad