Reporte zur Charge U6923JAA

Symptomtext

adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from health care professional. This case involves a 51-year-old female patient to whom adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Related case 2022SA098672 On 20-Mar-2022, the patient received a dose of 0.5 ml, Frequency: once, Strength = standard, of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot number: U6923JAA, expiry date:21-Jan-2023) via intramuscular route in the right deltoid for immunization. On 20-Mar-2022, Adacel was administered and lowest temperature was 29.2 degrees F with no reported adverse event (product storage error) (Latency: same day). Action taken was not applicable. Outcome was unknown. 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.