Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Malaise, Muscular weakness, Ocular discomfort, Pain
Clinical narrative: Initial information for this sponsored solicited case was received from a patient on 06-Oct-2017 in a patient support program. This case involves a 53 year old male patient who experienced low grade fever, fatigue, not feeling well, aches/often having pain, and needing to sit due to the pain, difficulty walking, particularly bad episode of hands feeling weak and clumsy from the elbows to the hands described as dropping a plastic cup of shake, Clumsiness, difficulty speaking described as the words were not coming out, left eye drooping described as feeling like the eyelid was closing but not happening seems really bad, increased tiredness, more fatigued, episodes of feeling cold from the leg knees down described as feeling like standing in ice water, the legs are not cold to the touch, increasing in occurrence and weakness after receiving influenza vaccine and AUGABIO. No past drugs, concurrent conditions or concomitant medications were reported. On 13-Sep-2017 patient started treatment with oral teriflunomide coated tablet 14mg daily for multiple sclerosis. On 29-Sep-2017 the patient reported having a flu shot. After a latency of few weeks, on an unknown date in 2017 the patient was experiencing not feeling well, a low grade fever, fatigue, difficulty walking, and aches. Treatment included trying to just get through it; yesterday he took ibuprofen in the morning and aspirin in the evening. The not feeling well, a low grade fever, fatigue, difficulty walking, and aches were ongoing. It was reported that the patient did not like to take any medication other than the teriflunomide. Since an unknown date in Sep-2017, the patient began experiencing having episodes of feeling cold from the leg knees down described as feeling like standing in ice water, lasting a few hours, occurring especially at night while in the bed, the legs are not cold to the touch, lasting for few hours then goes away, and increasing in occurrence. For the last three to four weeks in Oct-2017 (latency: few weeks), the patient began experiencing having a continual getting worse of being more tired, being more fatigued, and having weakness. On 19-Nov-2017 (latency: 9 weeks), the patient began experiencing having difficulty speaking described as the words were not coming out. On the morning of 20-Nov-2017 (latency: 9 weeks), the patient began experiencing having a particularly bad episode of hands feeling weak and clumsy from the elbows to the hands described as dropping a plastic cup of shake. For the last few days, the patient began experiencing constantly being in a lot of pain described as the pain. The patient reported that he took no pain medications; that before the teriflunomide the being more tired, being more fatigued, and having weakness would come and go; that the episodes usually would last for three to four days and he would bounce back; that the weather change had always badly affected being more tired, being more fatigued, and having weakness; that his hands have felt weak and clumsy in the past from time to time; that in the past the feeling weak and clumsy from the elbows to the hands usually was just an episode then moves on; that having episodes of feeling cold from the leg knees down happened once or twice in the first six weeks; and that in the last three weeks the having episodes of feeling cold from the leg knees down happen every second day. At the time of this report, teriflunomide was continuing. Action Taken: no action was taken with teriflunomide; not applicable for Influenza vaccine. Corrective treatment: ibuprofen and acetylsalicylic acid for low grade fever, fatigue, not feeling well, aches nos; not reported for difficulty walking; none for others. Outcome: not recovered for low grade fever, fatigue, not feeling well, aches nos, difficulty walking; recovered for others. Reporter causality: Not reported. Company causality: not associated. Follow-up information received from the patient on 20-Nov-2017: Verbatim and linking of ache nos updated; event added: hands weakness of, Clumsiness, difficulty speaking, ocular discomfort, increased tiredness, more fatigued, feeling cold and weakness; medical history added; teriflunomide start date updated; Influenza vaccine has been updated as primary suspect for the case. Text amended.