Report #2858663

Overview

Sex

Female

Age

5 yrs

State

GA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who was administered to IPV (Vero) [IPOL], which had Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes 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 0.5mL of suspect IPV (Vero), Suspension for injection (lot W1C831M, expiry date 21-Nov-2025, frequency once and strength standard) via intramuscular route in the left arm for Immunisation and Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes with no reported adverse event (poor quality product administered) (latency same day). Reportedly, there was fridge malfunction. No, Previous excursion and no Human erro was involved. It was administered post-excursion. The extended stability data did not cover the excursion. 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.; Sender's Comments: US-SA-2025SA270817:IPOL