Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | — |
punctured IPOL was administered to one patient after the previous excursion with no reported adverse event; Initial information received on 16-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a patient of unknown age and unknown gender who received punctured IPV (VERO) (IPOL) after the previous excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On an unknown date, the patient received an unknown dose of IPV (VERO) suspension for injection (batch: X1C891M, expiry: 31-Oct-2026) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation). Punctured IPOL was administered to one patient after the previous excursion with no reported adverse event (Poor quality product administered, onset: unknown, latency: same day). It was reported, "Reason: Power outage due to high winds Max/low temperature reached: 53.52°F Duration: 3 hours & 6 minutes Previous Excursion? Yes, for punctured IPOL: 34°F for 18 minutes Human error? No" 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
Comments: NONE