Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A101M | OT |
administration of expired IPOL to a child with no adverse event; Initial information received on 14-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old male patient who was administered with an expired poliomyelitis vaccine (INACTIVATED) [IPOL] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Feb-2025, the patient received 0.5 ml of expired IPV (VERO) Suspension for injection with standard strength (expiry date- 10-Feb-2025 and lot W1A101M) once via intramuscular route in the arm NOS (not otherwise specified) as Immunization with no adverse event (expired product administered) (latency- same day). Reportedly, Practice manager wanted to know if they should be expecting any adverse events and if the IPOL was still good to use three days after the expiration date. 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.