Symptomtext
patient received a dose of ADACEL that was later found to have been expired with no adverse event; pregnant, at 28 weeks gestation with no reported adverse event; Initial information was received on 22-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 34years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] in context of patient received a dose of Adacel that was later found to have been expired with no adverse event and pregnant, at 28 weeks gestation with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received a dose of ADACEL that was later found to have been expired with no adverse event, pregnant and at 28 weeks gestation with no reported adverse event occurred at 28 weeks of pregnancy. The date of last menstrual period, estimated due date were not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. Concomitant medications included COVID-19 Vaccine (COVID-19 Vaccine) for Immunisation. On 21-Apr-2022, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (batch/lot number: U6539AA) via intramuscular route in the left deltoid (strength, formulation, expiration date: unknown) for immunization. On 21-Apr-2022, the patient received a dose of adacel that was later found to have been expired with no adverse event (expired product administered) and pregnant, at 28 weeks gestation with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Action taken: not applicable. At time of reporting, the outcome was Unknown for both the events (expired product administered and exposure during pregnancy). Additionally, at time of reporting, the outcome of the pregnancy is 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.