Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
inadvertently administered the vaccine via SC route instead of IM to a patient with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] via sc route instead of im to a patient 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 Suspension for injection (strength, lot number, expiry date-unknown) via subcutaneous route instead of intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (incorrect route of product administration) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly- He inadvertently administered the vaccine via SC route instead of IM to a patient. 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.