Received May 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U5013AA | OT |
an inappropriate use due to patient mentioning she never wanted or approved to receive the TDAP/ADACEL vaccine with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who experienced an inappropriate use due administration of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] instead of Diphtheria-2/Tetanus-5 Adsorbed toxoids no preservative adult [Tenivac] that she never wanted or approved to receive it with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot U5013AA and expiry date, strength-unknown) via unknown route in unknown administration site for Immunization and she never wanted or approved to receive it with no reported adverse event (wrong product administered) (latency-same day). Reportedly-She wanted the tetanus vaccine but not a combination vaccine or one without the whooping cough component. 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.; Reporter's Comments: . Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who experienced an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5013AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. It was not reported if the patient received a corrective treatment for the event (an inappropriate use due to patient mentioning she never wanted or approved to receive the TDAP/ADACEL vaccine with no reported adverse event). At time of reporting, the outcome was Unknown for the event an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event. 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.