Received Feb 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 1 | — | OT |
an administration error since it was an extra dose, with no reported adverse event; patient that received the extra dose is pregnant, with no reported adverse event; Initial information received on 03-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional, processed together with same live follow-up. This case involves a 18 years old female pregnant patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of an administration error since it was an extra dose, with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported errors occurred at 28 weeks of pregnancy. The date of last menstrual period was reported as 23-May-2025. The estimated due date is 16-Feb-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. There were no other immunizations. On 04-Dec-2025, the pregnant patient received a Dose 1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site with no adverse event (exposure during pregnancy) (Latency: same day). On 30-Jan-2026 patient again received a Dose 2 with 0.5 ml dose of same vaccine (Lot: 3CA22C1, Expiry: 28-Feb-2026, strength: Standard) via intramuscular route in the right arm for immunization with no reported adverse event (extra dose administered) (Latency: same day). It was reported, "Caller was not aware of any adverse reactions post administration." 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.