Age: 51.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Paraesthesia, Red blood cell sedimentation rate increased, Urinary incontinence, Vision blurred
Clinical narrative: The pt received her 1st injection of Lymerix on 3/31/99. No adverse experiences were recorded in the pt's medical records. She received the 2nd injection of Lymerix on 5/3/99. On 5/8/99, 5 days post vax, she awoke in the morning with loss of vision in her left eye. She was seen by 3 ophthalmologists. One noted possible glaucoma and performed laser trabeculectomy. The ophthalmologists contacted the pt's PCP because he was "concerned by her progressive loss of vision". The ophthalmologist requested "a study of her sella turcica". The pt was referred to a neurologist. The neurologist recommended immunomodulation therapy with interferon beta-1a, but the pt refused. The pt was referred to an infectious disease specialist on 6/13/00 because "she continues to have concerns about Lyme disease...Over the years she has had frequent tick encounters and tick bites and probably had erythema migrans on at least 2 occasions in the past. She had been treated with oral antibiotics for presumed early stage Lyme disease both times. More recently, she developed visual disturbance and MRI abnormalities and abnormal CSF most consistent with a dx of MS. She had never been treated with IV antibiotics for Lyme disease. There has been no past history of Bell's palsy, inflammatory arthritis, carditis or peripheral neuropathy. She was given a course of oral Doxycycline 100mg BID X 30 days. I do not feel the IV therapy is necessary at this time. She was to start on Avondex for MS but didn't use it yet; she is going to yet another neurologist for another opinion. Positive emotional lability, obvious, cries easily. Walks very slowly with walker and she and her husband state that her eyesight improved within 2 weeks of starting doxycycline. Repeated 30 day course of doxycycline per pt's request. The latest neurologist noted ataxic gait with a component of spasticity. All records, labs and clinical history are consistent with a dx of MS and I have instructed her to start on Avonex. The pt consulted another neurologist on 4/4/01 and noted that there was a problem with walking dating back 4 years ago. This was attributed to osteoarthritis in the right hip and in 12/98 she had a hip replacement. The pt has noted recent nocturnal incontinence of urine but she says there are no problems with urinary control during the day. She returned to the 3rd neurologist on 4/25/01 and reported that she had forgotten to tell him that she has already been taking baclofen 10mg X 4 daily and Enodcet X 1 weekly. She stated that she was "willing to try med for MS now". He prescribed Copaxone 20mg SC injection daily. He increased the dose to 10mg X 5 daily. The pt returned on 6/20/01 and reported that she had begun Copaxone therapy on 6/4/01. She reported her meds as Detrol LA 4mg daily, baclofen 20mg X 3 or 4 daily and Endocet as needed for relief of foot pain. The neurologist's impression was "MS, neurogenic bladder". On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from loss of vision and blurred vision. In addition, (she) has experienced joint pain, swelling and numbness in her right foot, as well as fatigue." MS is consider "Medically Serious". The adverse event "joint pain" does not meet serious criteria. The follow up states the medical history included mumps, and chicken pox. Following the reported onset of multiple sclerosis, the vaccinee also experienced stage II decubitus ulcer ont he buttock. She was also found to have aortic valve thickening and stenosis, mitral valve calficication and regurgitation and left atrial enlargement. The vaccinee was seen by a neurolgoist on 5/7/99. He noted that the vaccinee had received Lyme vaccine on 3/31/99 and 5/4/99. In addition, he noted that the vaccinee had Lyme disease in 1995. The vaccinee was seen an orthopedist on 6/7/99 "for evaluation of pain involving the right hip and knee area. The condition has been bothering her for the past year and a half. The past 6 months the condition she claims has been most severe. She has difficulties going up and down the stairs, difficulties walking distances without holding onto a walker. She has pain and discomfort when she pus her shoes and socks on the right foot. Denies any history of any prior trauma to the right hip." He noted a past medical history of arthritis. "Review of the x-rays obtained of both hips showed significant osteoarthritis of the right side and early osteoarthritis on the left. Diagnosis: severe arthritis right hip." orthopedist recommended total hip replacement. The vaccinee was seen again by the orthopedist on 10/22/99 for "re-evaluation and discussion of hip replacement surgery. She was unable to proceed with the total hip replacement because of partial loss of eye sight in the right eye. The pt's husband advised me that they felt that the partial loss of eye sight may be "circulatory in nature." She is aware of the complications (hip replacement surgery) and is willing to undergo the procedure." The vaccinee completed a health questionnaire for the neurologist in which she noted that she had received vaccines for influenza and pneumonia in 1999. She also noted a history of chicken pox, mumps and arthritis/rheumatism. The vaccinee was seen by a neurologist on 11/8/99 "regarding a chief complaint of loss of vision. The pt is a 52 year old right handed white female, who noted acute loss of vision on 5/7/99. She had subsequent workup by ophthalmologists. A lazer trabeculectomy was performed for possible glaucoma with no apparent significant improvement in vision noted by the pt." The neurologist reviewed the previous diagnostic evaluations. He noted "left themporal artery biopsy on 9/13/99 reported medial calcification, but no evidence of active inflammation." The pt noted that she has a history of two separate episodes of Lyme disease; one in 1995 and one in 1998, both apparently treated with antibiotics, while still in the cutaneous phase of the disease, without any apparent systemic manifestations. She stated that she had Lyme disease vaccinations, performed on 3/31/99 and 5/4/99. On further questioning, the pt also ntoed that she had noticed deterioration in her balance, noticeable for a minimum of six months, and possibly significantly longer than that. She otherwise denied any other related neurological symptoms. Past medical history is also significant for longstanding hypertension, type II diabetes mellitus, and osteoarthritis. Current medications: Cardizem CD, Glucophage, Corec, and Arthrotec. On physical examination, her height was 5'4" and her weight was 295 lbs. Extremities significant fo rabsence of Tinel's or Phalen's signs. Mental status revealed her to be awake, alert and oriented. There was no evidence of aphasia or memory disturbance. Cranial nerve examination revealed visual acuity to be 20/400 (+1) on the left and 20/200 on the right with and without corrective lenses. Pupils were equal, round and reactive to light and accomodation. Extraocular muscle movements were full, but saccadio eye movements were noted during smooth pursuit. No facial asymmetry was noted. The palate and tongue were midline. No atrophy or fasciculations of the tongue were noted. Optic fundi showed flat disks. Motor revealed no focal weakenss, but there was marked slowing of distal rapid alternating movements, bilaterally. No abnormal involuntary movements were noted. Muscle tone was within normal limits. Sensory revealed only minimal stocking decrease in vibratory sense, but was otherwise unremarkable. Cerebellar revealed some finger-to-nose dysmetria, bilaterally. Gait revealed her unable to rise from a chair without assistance. She tended to immediately fall backwards and could not ambulate independently. She could ambulate with a walker. Gait was extremely slow. Reflexes were 3+ bilaterally, except for the ankles which were 1+. There was Rabinski sing on the right. There was a Hoffman's sign on the right. Impression: she demonstrates evidence, both on examination and MRI, of diffuse central nervous system pathology. The examination is significant for marked decreased visual acuity, bilaterally, marked slowing of distal rapid alternating movements in all extremities, ataxia and positive Rabinski and Hoffmann reflexes on the right, as well as bilateral finger-to-nose dysmetsia. The etiology of her condition, as confirmed on the MRI of the brain, is uncertain at this time. The white matter changes are nonspecific, although certainly suspicious for a variety of ? including multiple sclerosis as well as microvascular disease. The presence of areas of diminished T1 signal are suggetive of more chronic pathology and have in the case of multiple sclerosis, been implicated as possibly indicating the presence of associated axonal loss, in addition to the demyelinating process. Recommendation of lumbar puncture with fluid to be sent for appropriate studies including those for multiple sclerosis and Lyme disease as well as for other possible infectious inflammatory or neoplastic processes. The vaccinee underwent right total hip arthroplasty on 12/14/99. Surgical pathology report on acetabulum and bone fragments right hip 12/14/99. Final diagnosis-"A femoral head and multiple fragments of mature osteocartilaginous tissue with about 30%cellular bone marrow and focally attached skeletal muscle, periosteal fibrocollagenous tissue, meniscus and synovium showing focal severe destruction and reactive proliferation of articular cartilage and bone with focal fresh hemorrhages, florid granulation tissue formation, focal fragmentation of mature bone with many chips of bone within the soft tissue having foreign body type giant cell reaction and granulation tissue-formation and reactive proliferative synovitis, consistent with severe degenerative joint disease with recent fracture." The vaccinee was seen in follow uup by the orthopedist on 2/10/00. "She is doing very well. She is approximately 2 months status post right total hip replacement. Her gait pattern is much improved fromt he last time she was here. She ambulates with a walker. X-rays taken at the office showed excellent position of the prosthesis." The vaccinee was seen by the orthopedist on 5/23/00. "The pt had x-rays taken which showed excellent position of the prosthesis. The pt is ambulatory but still has a rather abnormal gait pattern. She needs more PT." The vaccinee began physical therapy on 6/2/00. The therapist noted that she required significant effort in transfers, she ambulated with right Trendelenburg gait for approximately 50 feet and then became fatigued (use of walker with two wheels). Treatment was to consist of therapeutic exercise, pt education, stretching, strengthening and home exercise program. The vaccinee was seen by the orthopedist on 6/23/00. "The pt is very hesitant and actually filled with anxiety and ambulating without any assist. She walks with a shuffling gait in spite of the use of the walker. Her husband is rather concerned because of hte pt's unwillingness ot do away with the walker. Examination of the lower extremity showed no limitation of ROM of the hip. There is no shortening of the adductors." The vaccinee was discharged from physical therapy on 7/7/00 after completing a total of 13 visits. The therapist noted at discharge that the "pt was having little significant improvement when last seen. She still required the walker to ambulate secondary to her balance dysfunction. Pt reported at her last visit that hse had tested positive of Lyme disease." The vaccine was seen by a neurologist on 7/21/00. The pt "reported having had a successful total right hip replacement in Dec 99. Since then, the pain in the right hip has resolved. However, she still complains of extremely poor balance. Visionhappens to be about the same, subjectively. She recently saw an infectious disease specialist, who gave her an additional one month course of doxycycline bid, which is finishing today. She has noted some occasional pain and stiffness in the left leg, especially distally. Otherwise she has reported no changes in her status. Neurologic examination revealed her to awake, alert, and oriented x3. no aphasia was present. Cranial nerve examination revealed a visual acuity 20/70 on the right, 22/00 (-2) on the left, with a hand-held Snellen card, and  no corrective lenses. Puupils were equal, round, and reactive to light and accommodation. Extraocular muscle movements were full, but saccadic eyes movements were ntoed during smooth pursuit. There was no facial asymmetry. Palate and tongue were midline. No atroophy or fasciculations of the tongue were noted. Optic fundi demonstrated flat discs. Motor examination revealed no drift. Rapid alternating movements were decreased, bilaterally, worse on the right. Muscle tone was within normal limits. Sensory examination revealed a mild stocking decrease in vibratory sense. Cerebellar examination was normal. The gait revealed her unable to stand from the chair without using her hands. The gait was wide based and ataxic, with a tendency to fall backwards. She was uanble to adequately ambulate, without using a walker. The gait was slow even with the walker. Reflexes were 3+, bilaterally, except for the ankles, which were 2+. There was a positive Rabinski sing, on the right. Impression: multiple sclerosis and history of Lyme disease. Avonex 30mcg q weekly, Baclofen 10mg id, increasing to a maximum of 2 tablets qid prn for pain and muscle spasm, risks, benefits and alternative therapies of the above medications were discussed with the pt and her husband who was present throughout the history and examination. A follow up evaluation will be scheduled in 3 month's time." The follow up states on 10/4/99, the vaccinee received the following vaccines: influenza virus vaccine and pneumococcal polysaccharide vaccine. On 9/22/00, she received tetanus and diphtheria toxoids. On 9/27/00, she received influenza virus vaccine. On 12/19/01, she received influenza virus vaccine. On 6/28/00, Lyme antibody screen was positive. Lyme IgG western blot was positive; Lyme IgM western blot was negative. The vaccinee was seen by a new ophthalmologist who made a diagnosis of multiple scleorisis and optic neuritis. On 10/12/00 the vaccinee told this opthalmologist that she could "see better-began in June. Reading better." The most recent info received on 7/3/02, indicated that the multiple sclerosis persisted as of 10/25/00 and did not specify the outcomes of the other reported events. *Follow-up report on 10/10/02: Osteoarthritis was treated with cortizone injections... A rheumatologist noted that the vaccinee reportedly had significant lumbar spinal stenosis as well as moderate degenerative arthritis of the right hip and right ??? "due to her ???"... The most recent info, received 7/25/02, did not specify the outcomes of the other reported events.