Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
a very serious injury; Initial information received on 09-May-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age female patient who experienced a very serious injury after receiving 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunisation . On an unknown date the patient developed a very serious injury (injury) (unknown latency) because they lost their arm and shoulder in amputation following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. This event was leading to disability. Action taken was not applicable. It was reported that the patient had undergone amputation as a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved With Sequelae on an unknown date for the event.; Sender's Comments: Sanofi company comment dated 16-MAY-2025: This case involves an unknown age female patient who experienced a very serious injury after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].. Further information regarding event details, onset latency, laboratory investigations, medical history, concomitant medication, administration technique and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.