Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1B511M | OT |
administered an ipol vaccine that was 3 days beyond the expiration date with no reported ae; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves an unknown age male patient to whom administered an IPV (Vero) [IPOL] that was 3 days beyond the expiration date with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) And Pneumococcal Vaccine Conj 21v (Crm197) for Immunisation. On 11-Sep-2025, the patient received a 0.5 ml 1x (once) dose of suspect IPV (VERO) Suspension for injection (strength: unknown, expiry date: 08-Sep-2025 and lot W1B511M) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) and that was 3 days beyond the expiration date with no reported ae (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.
VARICELLA VACCINE; PNEUMOCOCCAL VACCINE CONJ 21V (CRM197)