Report #2854016

Overview

Sex

Female

Age

21 yrs

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

vaccine fridge temperature out of range , vaccine administered with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 years old female patient (170 cm and 95 kg) as Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] fridge temperature out of range , vaccine administered 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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection lot 48563AA expiry date-30-Apr-2027 (strength unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) fridge temperature out of range , vaccine administered with no reported adverse event (poor quality product administered) (same day latency). 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.