Report #2842693

Overview

Sex

Unknown

Age

Age unknown

State

HI

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

inappropriate use due to administration of vaccine post excursion as stored at -0 with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who had inappropriate use due to administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] post excursion as stored at -0 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 an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK114A and expiry date 30-Sep-2025) via unknown route in unknown administration site for immunization that had inappropriate use post excursion as stored at -0 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.