Report #2896479

Overview

Sex

Male

Age

75 yrs

State

FL

Recovered

Unknown

Vaccinated

Mar 21, 2026

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Received IPOL post excursion, max/low temperature reached: 46.8°F, duration out of labelled range: 1 hour and 10 minutes with no reported adverse event; Initial information received on 14-May-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75-year-old male patient who received poliomyelitis vaccine (INACTIVATED) [IPOL] post excursion where max/low temperature reached: 46.8°F for the duration out of labelled range: 1 hour and 10 minutes with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 21-Mar-2026, the patient received a 0.5 mL once (booster dose) of poliomyelitis vaccine (INACTIVATED) suspension for injection (batch number: Y1D03P1, expiry date: 31-Aug-2027) (strength: standard) via intramuscular route in the right arm for immunization post excursion where max/low temperature reached: 46.8°F for the duration out of labelled range: 1 hour and 10 minutes with no reported adverse event (product storage error). It was reported that, the first excursion happened on FEB2026 involving a punctured and unopened IPOL, while the second excursion occurred on 08MAY2026 involving unopened IPOL only. Reason: Door was left slightly opened. Human Error: Yes. Does extended stability data cover the excursion: No. Previous excursion: No. List concomitant or no other immunizations: No other immunizations 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.