Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
patient received IPOL after the excursion (with no reported adverse event); Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] after the excursion (with no reported adverse event). The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry Date) via unknown route in unknown administration site for Immunization after the excursion (with no reported adverse event) (poor quality product administered) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, reporter stated that, Power Outage. Max/low temperature reached: 59.9F for 5 hours product was Opened. Human error not involved. extended stability data did not cover the excursion. Nurse manager also clarified based on the stability calculator that if unpunctured, it's still stable and MIS confirmed. Nurse manager also asked if the vaccine should be repeated since the opened IPOL was given to patient 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.