Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 1 | — | OT |
patient received a dose of Adacel single-dose prefilled syringe on 02 Sep 2025 but then was accidentally administered a second dose of Adacel today, 29 Sep 2025 with no reported adverse event,; Patient is 32 weeks pregnant with no reported adverse event; Initial information received on 29-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 39 years old female patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] on 02-Sep-2025 but then was accidentally administered a second dose on 29-Sep-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 not reported. The estimated due date is Oct-2025. The actual date of delivery 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 02-Sep-2025, the pregnant female patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) in unknown administration site for Immunization with no reported AE (Exposure during pregnancy) (Latency Same day). On 29-Sep-2025 she also accidentally received a 0.5ml (dose 2) of vaccine Suspension for injection (lot-U8670BA and expiry date-31-Aug-2027) via intramuscular route in the left deltoid for Immunization with no reported adverse event (extra dose administered)(Latency Same day). Action taken was not applicable. 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.