Report #2871164

Overview

Sex

Male

Age

13 yrs

State

MI

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

fridge too warm product not viable;Opened IPOL have been administered after the excursion occurred, with no reported adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old male patient (168 cm and 48.5 kg) who was administered to IPV (Vero) [Ipol]: after the excursion occurred, fridge too warm product not viable; opened ipol have been, 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 Y1A201, expiry date 31-Jan-2027 and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and fridge too warm product not viable;opened ipol have been administered after the excursion occurred, with no reported adverse event (poor quality 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.; Sender's Comments: US-SA-2025SA313446: