Sex: F
Vaccine: TDAP
Symptoms: Movement disorder, Muscular weakness, Myositis, Paralysis
Clinical narrative: Being paralyzed for 3-months; not being able to move; myositis/ inflamed muscles; muscle weakness; Fatigue/too fatigued to eat; weakness; Initial information regarding an unsolicited valid serious case was received from a consumer/non-hcp (healthcare professional) via Agency (Reference number- 00609772) and transmitted to Sanofi on 20-May-2021.  This case involves a female patient who was paralyzed for 3-months (paralysis), not being able to move (hypokinesia), myositis/ inflamed muscles (myositis), muscle weakness (muscular weakness), fatigue/too fatigued to eat (fatigue) and weakness (asthenia), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past vaccination(s) included Flu vaccine with no adverse event. The patient's past medical history, medical treatments and family history were not provided.  On an unknown date in 2020 (also reported as 'last year'), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020 (also reported as 'last year'), after receiving the of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, the patient was diagnosed with serious events of being paralyzed for 3-months (paralysis) and not being able to move (hypokinesia), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events were assessed as medically significant.  On an unknown date  in 2020 (also reported as 'last year'), the patient developed a non-serious myositis/ inflamed muscles (myositis), muscle weakness (muscular weakness), fatigue/too fatigued to eat (fatigue), weakness (asthenia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  The reporter stated that she was told the vaccine was from Sanofi but does not know which vaccine name; that when the event took place she reported it to the CDC (Centers for Disease Control and Prevention) and supplied lot number then; that she was seen by a neurologist, rheumatologist, and her primary care practitioner; that she took many test; that she was placed on prednisone for 3-months; that she was told the myositis was a result from getting the vaccine with diphtheria, tetanus and pertussis; that still to this day she will have weakness and fatigue; that she has had vaccines with diphtheria, tetanus and pertussis and flu shots in the past without any reaction.  The patient would like to get the ingredients to the DTP (diphtheria tetanus and pertussis) vaccine to compare the ingredients with the Covid vaccine to make sure she doesn't get the same reaction when she takes the Covid vaccine. Caller would also like written ingredient information sent. Caller was unable to verify vaccine name. Caller stated she thought it was a Pfizer vaccine but they referred her to Sanofi.  Other laboratory data was not reported.  The patient was treated with prednisone for myositis.   It was not reported if the patient received a corrective treatment for rest of the events.  Outcome of the events fatigue and asthenia were reported as not recovered. Outcome of rest of the events were reported as recovering.; Sender's Comments: This case concerns a female patient who experienced paralysis, hypokinesia, myositis, muscular weakness, fatigue and asthenia, after vaccination with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The time to onset is unknown. Patient's medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.