Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | UA115AA | OT |
intramuscular formulation admistered by other route; administration of ADACEL to a pregnant patient by subcutaneous route with no reported adverse event; Initial information received on 01-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old pregnant female patient who was inappropriately administered to Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] of intramuscular formulation by subcutaneous route with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal exporsure during pregnancy occurred at 30 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date is 10-Jun-2025. 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 31-Mar-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, Suspension for injection (lot UA115AA, expiry date 01-Mar-2026,strength standard and frequency once) via subcutaneous route in unknown administration site for Immunisation and inappropriate use due to the administration of adacel to a pregnant patient by subcutaneous route with no reported adverse event (incorrect route of product administration), (exposure during pregnancy). Reportedly, there was no other vaccines as concomitants involved. 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.