Received May 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C89 | — |
temperature excursion for IPOL PUNCTURED as Max/low temperature reached: 47.19F 1HR 15 MINS LOW 33.13F 25MINS with no reported adverse event; Initial information received on 28-Apr-2026 regarding an unsolicited invalid non-serious case received from a physician. Case was upgraded from Non-valid to valid upon receiving information on 13-MAY-2026 This case involves a male patient of unknown age who was administered IPV (VERO) [IPOL] that had temperature excursion as Max/low temperature reached: 47.19F 1HR 15 MINS LOW 33.13F 25MINS with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received an unknown dose of IPV (VERO) suspension for injection (batch: X1C89, expiry: Oct-2026) (strength: unknown) via unknown route in unknown administration site for prophylactic vaccination [Immunisation], that had temperature excursion as max/low temperature reached: 47.19F for 1 hour 15 minutes and low 33.13F for 25 minutes with no reported adverse event (Product storage error). It was reported, "The reason for the excursion was reported as due to inventory management. A human error was confirmed. Extended stability data did not cover the excursion. I did administer one dose of the above mentioned punctured IPOL Vaccine to one of my patients. It is to complete his recommended Polio Vaccine doses as per Immunet. I have just spoken to the patient's mother who informed me that my patient is physically well. He had not had any adverse reaction/events after the vaccine was given." 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. Additional information received on 13-MAY-2026 from Physician: Case was upgraded from Non-valid to valid. Patient information added. clinical course updated. Text amended.