Reporte zur Charge U67093AA

Symptomtext

Max/low temperature reached: 20.7 F( -6.2C) for 71 hours 30 minutes with no reported AE; ADACEL was administered to one patient post excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old female patient who was administered Adacel post excursion with no reported adverse event and max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported adverse event, while receiving vaccine 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. Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation. On 08-Aug-2022, the patient received a dose number 1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE( lot U67093AA and expiration date: 18-Jun-20223) at a dose of 0.5ml via intramuscular route in the left deltoid for immunization. On an unknown date, the reporter stated that refrigerator malfunction and vaccine max/low temperature reached: 20.7 f( -6.2c) for 71 hours 30 minutes with no reported ae (product storage error). On 08-Aug-2022 (latency: same day),the patient developed a non-serious event of adacel was administered post excursion with no reported adverse event (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Action taken :not applicable. It was not reported if the patient received a corrective treatment for the events. Outcome: 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 has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 01228270: