Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8232AA | OT |
patient were given ADACEL after the excursions with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who were given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] after the excursions with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received Unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength (Unknown expiry date) with lot U8232AA via unknown route in unknown administration site for Immunization after the excursions with no reported adverse event (poor quality product administered) (Latency same day) Reportedly, The previous report stated the vaccines were not administered after the excursions that deemed them no longer suitable for use, but after investigating further she found that 3 patients were given adacel after the excursions 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.