Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
administration of tenivac instead of adacel with no reported adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 83 years old male patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine [Flu] for Immunisation. On 02-Oct-2025, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (strength: standard) (lot number; expiry date not reported) via intramuscular route in the deltoid NOS (Not Otherwise Specified) for Immunisation instead of diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number; expiry date not reported) (wrong product administered) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. 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.
FLU [INFLUENZA VACCINE]