Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1B511M | OT / LA |
an inappropriate use due to administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 59 years old male patient who had an inappropriate use due to administration of an expired IPV (VERO) [IPOL] to a patient 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 Hepatitis b vaccine for Immunisation; Pneumococcal vaccine for Immunisation; Diphtheria vaccine toxoid, Pertussis vaccine, Tetanus vaccine toxoid (Diphtheria tetanus pertussis vaccine) for Immunisation; and Varicella zoster vaccine (Varicella vacc.) for Immunisation. On 11-Sep-2025, the patient received an expired 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot W1B511M, Expiry: 08-Sep-2025) (Strength: standard and Frequency: once ) via intramuscular route in the left arm as Immunization with no reported adverse event (expired product administered) (latency: same day). Action taken: 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.
Hepatitis b vaccine; Pneumococcal vaccine; Diphtheria tetanus pertussis vaccine; Varicella vacc.