Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8115AA | OT / LA |
ADACEL was first given during her 28th week of pregnancy (28Jan2025) and the second shot was given on her 30th week (13Feb2025) (with no reported adverse event); received ADACEL two weeks apart in her third trimester of pregnancy (with no reported adverse event); Initial information received on 13-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 19 years old female patient who was exposed to diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] two weeks apart in her third trimester of pregnancy (first given during her 28th week of pregnancy (28-Jan-2025) and the second shot was given on her 30th week) (13-Feb-2025) (with no reported adverse event). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 16-Jul-2024. The estimated due date is 22-Apr-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy. On 28-Jan-2025, the pregnant patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (exposure during pregnancy) and on 13-Feb-2025, the patient received another dose of 0.5 ml of same vaccine, both with suspension for injection (lot number U8115AA) (strength and expiry date not reported) via unknown route in the left arm for immunization with no reported adverse event (extra dose administered) (Latency: same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. 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.