Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Hypertension, Hypoaesthesia, Impaired work ability, Injection site reaction
Clinical narrative: Case number# PHEH2015US006431, is an initial report received from a physician on 01 Apr 2015 from a patient oriented program. This report refers to a 48-year-old female patient. The patient had left optic neuritis and an episode of transverse myelitis with residual sensory disturbances. The patient was diagnosed with multiple sclerosis in approximately 2010 after developing left optic neuritis. This manifested first as loss of color vision in her left eye followed by a central visual loss and scotoma. There was also some associated diplopia. The patient saw an ophthalmologist and eventually had MRI and lumbar puncture at which time the diagnosis was made and visual symptoms were resolved completely. The patient did well until 2012 when she had an exacerbation. The patient had underlying relapsing remitting multiple sclerosis and hypertension. The patient had sexual dysfunction since her last exacerbation. This occurred 2 weeks after a seasonal influenza vaccine (manufacturer and batch number: not reported) (route of admin: injection NOS). The patient was also having a skin infection at that time and under a lot of stressors. The patient initially developed numbness in her right leg on an unknown date. This spread to involve numbness from the waist down bilaterally. The patient was treated with SOLU-MEDROL and prednisone and did not do well with the therapy and then received ACTHAR gel. She still had residual numbness in her legs. Initially the patient was started on AVONEX but was having a lot of issues with the needle fatigue and injection site problems. This polymedicated patient received GILENYA capsule 0.5 mg for the treatment of multiple sclerosis from 08 Jan 2013 at a dose of 0.5 mg, (QD) oral. In Apr 2014, ALT (alanine aminotransferase) was 77, AST (Aspartate aminotransferase) was 47, alkaline phosphatase was 137, lymphocyte count was 0.5 and vitamin D was 39. Blood pressure on 25 Aug 2014 was 129/103 (left arm) and pulse was 67. Last week, she developed a new symptom of rainbow C of blurry vision and scotoma that lasted 20 minutes. She would not see her computer screen, which was resolved. This was also at the time of intense stress in the family with a death. She had not experienced similar prior episodes. She had some episodic migraines but had never been formally diagnosed with migraine headache. The patient was having trouble functioning at work, lot of cognitive and memory issues. The patient also had a lot of problems with fatigue, which she felt was in part related to twitching in her legs at night. The patient also had lot of cramping. The patient used cyclobenzaprine PRN, which caused to much sedation during the daytime for her to use routinely. Her feet were numb. She denied any residual visual issues. No visual loss or diplopia. She had speech issues with word finding problems. She had Lhermitte's phenomenon. There had been an aching numb pain in her left upper extremity recently with continuous numbness from her waist and feet. She had problems with her balance but had not fallen. She had bladder urgency with occasional incontinence, bowel urgency and fluctuating diarrhea and constipation. The patient was recommended to monitor her blood pressure in the outpatient setting with a goal blood pressure <130/80. The patient's medications may need to be adjusted. GILENYA was associated with hypertension. She also had elevation of liver transaminases which may be medication side effect as well. She had increased viral type infections during the winter months and also had evidence of lymphopenia. Both were associated with GILENYA and needed to be monitored closely. The patient asked for CBC differential currently. The patient was using cyclobenzaprine for muscle spasms for symptomatic management. The sleep issues and fatigue were complicated by the spasticity in her legs. Cyclobenzaprine would be switched with tizanidine 2 mg h.s for one week, then 4 mg h.s. On physical examination, the patient's attention and concentration were slightly impaired and tangential. Mild anisocoria was found in left slightly larger than right but both were reactive. The motor strength was found 5/5 throughout with increased tone in her legs. The patient had diminished pinprick in her legs compared to the arms. Vibratory sense was reduced in left great toe. DTRs were 1+ for biceps, triceps, brachioradialis, 3/4 knees and ankles. Plantar responses were down going. The patient had moderate to severe difficulty with tandem (gait). The patient had lot of cognitive problems, fatigue, muscle spasticity, neurogenic bowel and bladder issues and problems with her gait. The patient indicated having neuroimaging earlier this year. She would continue with GILENYA for disease modifying therapy. The physician advised her to be in compliance with her vitamins. Routine exercise and stretching program were advised. Neuropsychological and testing was recommended to screen for cognitive issues related to multiple sclerosis versus issues with sleep deformation and underlying anxiety and depression. On 01 Apr 2015, the patient expressed anxiety with getting lost on her way and arriving late. Blood pressure on same day was 157/109 (left arm) and pulse was 71. The patient had frustration with her employer and their request for every 6 month FMLA updates. She indicated at one point that FMLA had been completed which allowed her time off once every 3 months for provider office visits. The patient's employer penalized her for the missed work days and she was visibly upset. The patient reported that she no longer had a verbal filter and was quick to say inappropriate things. In fact she reported that the amantadine caused her to perform odd behaviors. She verbalized caregiver stress with her mother who resided in a nursing home. She verbalized lack of interest in life and felt she had no quality of life. She indicated the nocturnal leg cramps had not improved however she stopped the tizanidine provided at her last office visit due to side effects of making satisfied with the LEXAPRO 10 mg tablets. Current dose of LEXAPRO was 1.5 tablets. When enquired about the last monitoring lab parameters of GILENYA, the patient no one cared and nocturnal cramps. The physician recommended the patient for tolls to help with attention focus, psychotherapy formulation. The patient was tearful at times and her attention and concentration were moderately impaired and tangential. Her office visit primarily focused on review of her neurological test results and the recommendations for controlling anxiety, attention deficits thought to be fatigue related, and depression. The patient frequently went off topic to complain of her employer and inability to obtain current FMLA (Family and Medical Leave Act) forms, lack of caring from previous health care providers for her MS disease monitoring and when asked directly about her current request for an up to date FMLA form, she stated that she would not provide any further personal health related information to her employer. She verbalized an expectation that she may be terminated in her employment. The physician concerned that her anxiety/depression was inadequately controlled and requested to establish with a psychiatrist for medication management and link with a psychotherapist familiar with MS. The patient indicated willingness to link with the service. The physician also requested lab monitoring tests today to help differentiate variables adding to her fatigue, leg cramps and GILENYA management. The patient did not have abnormal findings on exam when she consulted with eye specialist recently. The patient's needs were not adequately addressed at this time mainly due to the effects of depression. The physician would establish her with a behavioral health specialist in the immediate future. The patient did not have any suicidal ideation and did not express any desire or plan to end her life. Therapy status with GILENYA was ongoing at the time of this report and not applicable for influenza vaccine. The patient fully recovered from vision blurred and visual field defect on an unknown date. The outcome of the other events was unknown. The seriousness of the events was not reported. Serious assessment of (relapsing remitting multiple sclerosis) was upgraded based on the NVS-IME list. The physician assessed viral infection, hypertension and lymphopenia as suspected to be related to treatment with GILENYA and not reported for Influenza vaccine. The causality of other events was not reported.