Received Jan 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 4 | W1C741M | OT / RL |
reported that an expired dose of IPOL was administered to a patient with no adverse event; Initial information received on 20-Jan-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who was administered an expired dose of IPV (Vero) [IPOL], with no 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 (Dtap) for Immunisation. On 20-Jan-2026, the patient received an expired 0.5mL (dose 4) of suspect IPV (Vero), Suspension for injection (lot W1C741M, expiry date 17-Nov-2025, frequency once and strength standard) via intramuscular route in the right thigh for Immunisation. with no adverse event (expired product administered) (latency same day). It was reported "caller would like to know whether the dose was valid and how to proceed." 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.
Dtap