Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8654AA | OT |
some of it leaked out of the syringe, and some may have gone into the patient/administered 1/4 of the dose from a new Adacel prefilled syringe on the same day with no reported adverse event; some of it leaked out of the syringe, and some may have gone into the patient/administered 1/4 of the dose from a new Adacel prefilled syringe on the same day with no reported adverse event; 33 weeks pregnant received intramuscularly an underdose of the Adacel prefilled syringe, with no reported adverse event; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 32 years old female patient who was exposed to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in context of 33 weeks pregnant received intramuscularly an underdose of the adacel prefilled syringe, with no reported adverse event. some of it leaked out of the syringe, and some may have gone into the patient/administered 1/4 of the dose from a new adacel prefilled syringe on the same day with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported 33 weeks pregnant received intramuscularly an underdose of the Adacel prefilled syringe, with no reported adverse event. 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 an unknown date, the 33 weeks old pregnant patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: unknown) (lot: U8654AA, expiry date: 30-Sep-2027) via intramuscular route in unknown administration site for immunization, with noi reported adverse event (exposure during pregnancy) (latency: same day) and while administering some of it leaked out of the syringe, and some may have gone into the patient/administered 1/4 of the dose from a new adacel prefilled syringe on the same day with no reported adverse event (incorrect dose administered) and (underdose) (latency: same day). Action taken: not applicable. 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.