Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
administered the TENIVAC vaccine via IV to a patient with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old male patient who received the diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] via IV (Intravenous) to a patient 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 23-Jul-2025, the patient received unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection (Unknown strength, lot and expiry date) via IV NOS (Intravenous Not otherwise specified) route in unknown administration site for Immunization 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, Nurse administered the vaccine. 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.