Age: 52.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Paraesthesia, Red blood cell sedimentation rate increased, Urinary incontinence, Vision blurred
Clinical narrative: Report describes multiple sclerosis in a 51 year old female who received LYMErix. This report was received as part of litigation proceedings with forwarding of medical records. The medical history included alopecia areata, hypertension since age 19, bilateral leg edema, type 2 diabetes mellitus since 1997, osteoarthritis of bilateral hips and knees, cervical spine degeneration, tendonitis, carpal tunnel syndrome, multiple tick bites, Lyme disease in 1996 and 1998, low tension glaucoma, dysfunctional uterine bleeding, and endometrial hyperplasia. The vaccine was intolerant of Zestril, which she reported to worsen her vision. Following the reported onset of multiple sclerosis, the vaccinee experienced a uterine fibroid, cataracts, hypercholesterolemia, constipation, and two urinary tract infections. One of tese infections resulted in urosepsis. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The vaccinee was seen by an ophthalmologist on 09/27/1999 for a disability examination. Ocular examination revealed "best corrected vision in the right eye was 20/400 and the left eye was count fingers. Her intraocular pressure was 15 in both eyes. Her pupils reacted equally but were sluggish bilaterally. On ocualr examination she had a bitemporal pallor. Visual fields showed marked loss in both eyes." It was noted that the vaccinee was being treated by her ophthalmologist for low tension glaucoma with Timoptic and Xalatan. The ophthalmologist's impression was,"the pt's vision puts her into the category of legally blind." The vaccinee was referred to a neurologist. Lumbar puncture was performed on 11/30/1999. The resulting cerebrospinal fluid was analyzed. The studies are not consistent with a diagnosis of multiple sclerosis. The neurologist recommended immunomodulating therapy with interferon beta-la, but the pt refused. The pt was referred to an infectious disease specialist on 06/13/2000 because "she continues to have concerns about Lyme disease. Over the years she has had frequent tick encountersna dn tick bites and probably had erythema migrans on at least two 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 diagnosis of multiple sclerosis. She had never been treated wtih intravenous antibiotics for Lyme disease. There has been no past history of Bell's palsy, iflammatory arthritis, carditis or peripheral neuropathy. Current review of systems is essentially negative with the exception of the visual disturbance, fatigue and arthralgias. She specifically denied headaches." The infectious disease specialist reviewed the results of the carotid doppler echo performed on 07/26/1999, the MRIs performed on 10/11/1999, the CSF analysis performed on 11/30/1999, and Lyme serology performed in 1998. He wrote," it is my opinion that her clinical evidence points strongly towards a diagnosis of MS. Indeed, a negative PCR on spinal fluid is strong evidence against Lyme disease of the central nervous system. Because serologic data suggesting late infection I feel it is prudent to offer her a course of oral Doxycycline for the next 30 days. I do not feel that intravenous therapy is necessary at this time." The vaccinee returned to the infectious disease specialist on 08/22/2000. In the office note, the physician wrote, "Was to start on Avonex for MS. Didn't use it yet but going to yet another neurologist for another opinion. No new complaints. Positive emotional lability, cries easily. Walks very slowly with walker. Pt and husband state tha ther eyesight improved within two weeks of starting doxycycline. Again explained intravenoous therapy not indicated and that oral probalby won't help neurological compaints due to MS. Advised start MS therapy as advised by others and myself last time. Repeat 30 day doxy course." The vaccinee was seen by anothe rneurologist on 08/23/2000. He noted, "Approximately one year ago, she started to develop symptoms of pain and numbness in the bottom of her feet. She has noted progressive deterioration in vision as well as gait. She has since seen an infectious disease specialist, was started on doxycycline, and has noted improvement in her vision." Ataxic gait was noted on physical examination. visual evoked response study was performed. The neurologist's impression was "this is an abnormal VER study indicating no evidence of central conduction through the left optic nerve pathways." The neurolotist saw the vaccinee again on 10/18/2000. "She has noted no significant change in her neurologic function. She denies change in gait or change in strength of the upper or lower extremities. Vision has remained stable." On physical examination, gait was "ataxic and there is alos a component of spasticity." The neurologist wrote, "After reviewing all her records, her clinical history and laboratory data are consistent with a diagnosis of relapsing and remitting multiple sclerosis. I have instructed her to start on Avonex." The vaccinee consulted another neurologist on 04/04/2001. This neurogist noted, "There was a problem with walking dating back four years ago. This was attibuted to osteoarthritis in the right hip and in December of 1998 she had a hip replacement. She has continued to need to use a walker since the operation and continues to have problems with her balance. The husband tells me Lyme disease was raised as a possibility for the problem and she has had the Lyme vaccine shots. She apparently had Lyme disease in 1995 and 1998, both treated with antibiotics. The pt had nted recent nocturnal incontinence of urine but she says there are no problems with urinary control during the day. Occasionally she notes that her legs "jump," on the left more than the right. She denies numbness or tingling. She denies all cranial nerve symptoms and the left vision has improved." On physical examination, "she had a mild cynarthria, She used a walker, She had a wide-based gait. She could stand on heels and toes for a short time. No afferent pupillary defect. There was some mild spasticity in both arms and moderate spasticity in the legs. Both arms pronated when outstretched, and the fine nose testing was done slowly but without tremor. Rapid alternating movements were done with a mild dysmetria. Heel to shin testing was done slowly but without tremor. Nevative L'Hermitte's sign." The neurologist wrote, "In summary, this 53 year old female has a history and physical examination compatible with a diagnosis of MS. She and her husband will have to make a decision as to whether they want to try one of the immunomodulating medications, but she does not appear interested in such and is not interested in taking any needles. She might benefit by using Detrol and Baclofan may help the leg spaticity." The vaccinee returned to the third neurologist on 04/25/2001. At that time she reported that she had forgotten to tel the neurologist that she had already been taking baclofen 10 mg four times daily and oxycodone/paracetamol one tablet weekly. She stated that she was "willing to try med for MS now." The neurologist prescribed glatiramer acetate 20 mg subcutaneous injection daily. He increased the baclofen dosage to 10 mg five times daily. The vaccinee returned to the neurologist on 06/20/2001. She reported that she had begun Copaxone therapy on 06/04/2001. She reported her medications s Detrol 4mg daily, baclofen 20 mg three to four times daily, and Endocet as needed for relief of foot pain. She stated "right foot curves in -causes pain in right heel." The neurologist's impression was "MS, neurogenic bladder." The vaccinee returned to the infectious disease specialist on 09/25/2001. Medication sincluded Copaxone, baclofen, fosinopril, carvedilok, and simvastatin. The physician's impressions were MS. Fear of Lyme disease, wants antibiotics, no harm to give Doxy 100mg for 30 days. No indications for intravenous based on old CSF analysis. The vaccinee was seen by the third neurologist on 09/26/2001. Her husband reported that he had noticed deterioration in walking and thought the vaccinee was getting weaker. MRI of the brain was performed on 09/27/2001 which showed slight interval worsening in atrophy. Stable white matter lesions. The vaccinee returned to the neurologist on 01/04/2002. She reported no changes. Her examination was unchanged. On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee 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. Multiple sclerosis is considered disabling because of vaccinee was reported to be legally blind five months after initial vision loss. The adverse event "joint pain" does not meet serious criteria. This report of a serious expected event and a nonserious expected event is being submitted as an expedited report by special FDA request per the 06/28/2000 letter. The follow-up states that the records from one of the ophthalmologists indicated that the vaccinee presented on 5/13/99, stating that her left eye (OS) had been "sore" for one week, and that her vision had "decreased," that morning. The physician noted "lids puffy fundus background OS lighter. Pallor emp (oral) OS disc?" The impression was "retinal and optic nerve ischemia. Blepharo chemosis." Treatmentw as begun with "W.C." and Rotamax four times daily. The vaccines was referred to another opthalmologist within the same practice. This second ophthalmologis examined the vaccinee on 5/14/99. He noted "covered right eye couldn't see out of OS. Puplis sluggish." His impression wasa "probable glaucoma." He prescirbe Xalatan instiled into each eye at bedtime. He ordered visual field assessment and instructed the vaccinee to return to the office in two weeks. She returned on 5/28/99. The ophthalmologist noted that visual field assessment revealed "increased vision loss characteristic of glaucoma." He prescribed Timoptic XE instilled into each eye at bedtime. Xalatan was continued but was used daily in the morning rather than at bedtime. The vaccinee underwent laser trabeculeotomy on 6/21/99. She returned to the opthalolomogist on 6/29/99; he noted "decreased visual acuity." The ophthalmologist's impression was "will need to rule out chiamal lesion. Spoke to the primary physician-they will arrange for CT of cells. The most recent info, received on 6/25/02, did not specify the outcomes of the reported events. Info received on 6/11/02 indicated that the multiple sclerosis persisted as of 7/21/00. The follow up states the vaccinee remained under the care of this neurologist until at least 8/2/02. During this time the physician noted bilateral arm uronation, right greater than left and bilateral hemiparesis which was worse on the right side. He also noted that she could not walk without help. The most recent info received on 9/3/02, indicated that the multipld sclerosis persisted as of 8/2/02. Outcomes of the other reported events were not specified. Multiple sclerosis is considered disabling because the vaccinee was reported to be legally blind five months after initial vision loss. The adverse event joint pain does not meet serious criteria. This report of a request per the June 29,2000 letter.