Reporte zur Charge U75611AA

Symptomtext

adacel being administered to a pregnant female twice in one month with no adverse event reported; adacel being administered to a pregnant female twice in one month with no adverse event reported; Initial information was receivedon 25-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 39 years old female patient who was exposed to vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] in context of adacel being administered to a pregnant female twice in one month with no adverse event reported. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported adacel being administered to a pregnant female twice in one month with no adverse event reported and adacel being administered to a pregnant female twice in one month with no adverse event reported occurred at unknown gestation periodthe gestation period at onset and gestation period at exposure data needs to be populated, if available The date of last menstrual period was not reported. The estimated due date was 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. On 03-Jan-2023, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot U75611AA) (with unknown strength, expiry date) via intramuscular route in the deltoid for immunization. On an unknown date she also received a dose of the same vaccine lot U7627AA. On 03-Jan-2023 the patient developed a non-serious event of adacel being administered to a pregnant female twice in one month with no adverse event reported (exposure during pregnancy) (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine. On 24-Jan-2023 the patient developed a non-serious event of adacel being administered to a pregnant female twice in one month with no adverse event reported (Extra dose administered) (latency: 21 days) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine. Relevant prenatal testing after exposure included Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable. At time of reporting, the outcome was Unknown for the event adacel being administered to a pregnant female twice in one month with no adverse event reported. 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.