Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A191M | OT / LA |
patient received an expired dose of ipol with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68 years old female patient received an expired dose of IPV (Vero) [Ipol] with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation. On 07-Apr-2025, the patient received an expired, 0.5ml dose (once) of suspect IPV (Vero), Suspension for injection, Strength standard, lot W1A191M Expiry date 16-Feb-2025 via subcutaneous route in the left arm for prophylactic vaccination (immunisation) with no reported adverse events (expired product administered) (Latency same day). 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.
MENQUADFI