Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8366A | OT / LA |
adacel was administered to a patient above 65 years old; Myasthenia gravis localized in the right eye; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: no other vaccines On 06-Feb-2025, the patient received a dose of 0.5 ml once of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection with strength- standard, (lot U8366A, expiry date- 31-Jan-2027) via intramuscular route in the left arm for Immunization, above 65 years old (off label use) (latency- same day). On an unknown date in 2025 the patient developed myasthenia gravis localized in the right eye (Ocular myasthenia) (latency- few days approximately) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. Action taken was not applicable. The patient was given Prednisone and Ig (immunoglobulins) infusions and eye symptoms improved . At time of reporting, the outcome was Recovering / Resolving for the event Ocular myasthenia. Seriousness criteria: The event Ocular myasthenia was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 09-MAY-2025: This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old. Further information regarding allergic history, laboratory investigations, medical history 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.