Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
they were supposed to administer Boostrix but administered TENIVAC instead with no reported AE; Initial information received on 07-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was supposed to get Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered instead with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patient was supposed to get Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (lot number, expiry date not reported) for immunisation was administered instead with no reported adverse event (wrong product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. Reportedly, the nurse was confirmed with the brand names of the vaccines afterwards and informed that Boostrix is not a Sanofi product and advised them to call the manufacturer of Boostrix directly regarding their inquiry. 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.