Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8115AA | OT / RA |
pregnant patient received two adacel doses with no reported adverse event; 2-weeks pregnant patient was given two tdap within a six-week period with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 26 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in context of 2-weeks pregnant patient was given two tdap (adacel) within a six-week period 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 20-Aug-2024. The estimated due date is 20-May-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Mar-2025, the 2 weeks pregnant patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot: U8115AA, Expiry date: 31-Mar-2026) via intramuscular route in the right deltoid for immunization, with no reported adverse event (exposure during pregnancy) (latency: same day) and on 24-Apr-2025 she also received another 0.5 ml dose of vaccine (lot: U8232AA, Expiry date: 01-May-2026) via intramuscular route in the left deltoid for immunization, with no reported adverse event (extra dose administered) (latency: same day). Action taken : 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.