Received Feb 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8730AA | OT / LA |
administering ADACEL, which they were advised not to use due to a shipping excursion with no reported adverse event; Initial information received on 06-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 56 years old female patient who were administered with the suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] post excursion, which they were advised not to use due to a shipping excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Feb-2026, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot U8730AA, expiry date;31-Dec-2027, Strength: standard, frequency: once, via intramuscular route in the left deltoid for Immunization, post excursion which they were advised not to use due to a shipping excursion with no reported adverse event (poor quality product 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.