Report A0367516A describes Lyme disease in a 53 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings, with forwarding of medical records. The medical history included Lyme disease, stress, visual floaters, decreased libido, decreased sexual response, lattice degeneration, myopia, presbyopia, gastroesophageal reflux disease, temporomandibular joint syndrome, fibrocystic breast disease, mild nasal septal deviation, chronic sinusitis, tonisllectomy, appendectomy, ovariectomy, hyperthyroidism, menopause, benign lump removed from left breast, difficulty focusing attention, diarrhea, head pressure, pharyngeal diverticulum, cricopharyngeal spasm, left shoulder/scapular pain, depression, low pain pain, fatigue, tingling in hands and feet, numbness, muscle aches, diverticulosis by colonoscopy, and asymptomatic recurrent urinary tract infections. The vaccinee was allergic to ragweed and ousters. Concomitant medications included doxycycline, levothyroxine sodium and valerian. She had no known drug allergies. The subject was physically abused as a child. On 8/28/98, the erythrocyte sedimentation rate was 9 mm/hr (0-20) and anti-nuclear antibodies were negative (<1:40). On that date, Lyme antibodies by ELISA immunoassay were less than 0.8 (negative <0.8). Magnetic resonance imaging of the brain with brainstem with and without contrast performed on 1/26/99 revealed borderline tonsillar ectopia, there is a slight asymmetry of the cerebrospinal fluid space at the region of the medulla and cervical-medullary junction. This is probably within normal limits for this particular patient. However, a small epidermoid cannot be altogether excluded. A follow up study in 6 to 9 months is, therefore, recommended. Tiny polypoid mucosal lesion of the nasopharynx in a right paramedian location for which direct visual inspection is recommended. On 4/8/99 and 5/8/99, the vaccinee received her first (lot LY120E9) and second injections of LYMErix, respectfully. In a statement of injuries, the attorney alleged that the subject suffers from joint pain, swelling, muscles twitch and tingles, numbness in face, the subject also suffers from deteriorating vision, depression, anxiety, and sleep disturbances. In addition, she has developed chest pain, fatigue, rashes, and recurring fevers. On 6/17/99, the subject called her physician's office complaining of extreme fatigue, moving joint pain, mental fog, sore throat, and headache. Lyme antibody measured on 6/17/99 showed an index value of <0.99. On a medical consultation form completed on 6/28/99, the patient stated that her chief complaint was being run down, stressed. She stated that she had possible Lyme disease for a couple of years and had a bad reaction to vaccine. She stated that she currently had muscle pain, muscle weakness, muscle cramps, muscle twitching, joint stiffness, and joint pain. An MRI of the brain, performed on 7/15/99 revealed stable mild tonsillar ectopia and stable very small probable polyp seen at the medical base of the left sphenoidal sinus since prior study of 1/26/99. No mass is seen at the corticomedullary junction. On a questionnaire completed on 10/25/99, the patient stated that she had been experiencing bong and back pain, chronic fatigue, general feeling of poor health, weakness, inability to concentrate, irritability, confusion, the sensation of cold (even when the room temperature is 98 degrees), dry hair, nasal congestion, severe joint pain, redness, and swelling, unusual bruising, numbness and tingling in hand and feet. The subject was evaluated by a psychologist on 11/30/99 at which time she complained of anxiety, decreased concentration, increased appetite due to exercise, and increased smoking and wine consumption. On a physician evaluation request dated 4/14/00, her diagnoses were listed as chronic Lymes, fatigue and insomnia. On that date, she was seen by the physician. He stated that for the past 10 years, she has a difficult stressful life with her father who is ill and her work schedule which disturbs her normal sleep pattern. She was being treated by a psychologist for depression, but seems to be doing much better. She has a history of onset of menopause in 1989, and was on natural supplements for that. She had a questionable history of Lyme disease. She had hypothyroidism, diagnosed in 1985, for which she took levothyroxine sodium. In 1999, she had a colonoscopy which revealed diverticulosis. Assessment: elevated triglycerides with the balance of her lipid panel being excellent, depression, controlled withouth medication, disturbed sleep pattern, no libido in spite of having a significant other. Plan: continue valerian at bedtime, limit nap to once a day for 20 minutes, walk vigorously daily or do equivalent exercises, TV off by 9 PM, no smoking, meditate 20 minutes daily. The physician taught the patient autogenic breathing and Jacobson's Progressive Relaxation She was to use that for her meditation and when she was in bed having difficulty staying asleep. Zolpidem hemitartrate 5mg at 11PM was prescribed. Dexascan in one year. On 5/12/00 the patient was seen by a physician. The medical record indicated that the patient looked well and relaxed. She was taking diphenhydramine hydrochloride 25mg, 2 at bedtime because of allergies and for sleep. She has given up naps as per physician's suggestion, given up smoking, and gone to a hypnotist for a 4 hour session. She was going to the pool, was on a treadmill 5 times per week, and was doing deep breathing relaxation daily. Assessment: sleep has improved, she was not smoking, her triglycerides done in June 1999 were 217, she had pollenosis. On 7/25/00, the vaccinee was seen by the physician. The assessment was myaglia, tremor, and arthralgia. She was experiencing crepitus, shortness of breath, and cough. The vaccinee stated that after her LYMErix injections she felt like I was going to have a heart. . .was in bed layed up for three weeks. . . Lyme symptoms were worse. Cefuroxime axetil was prescribed. On 7/26/00, Babesia by polymerase chain reaction (PCR) was negative. Ehrlichia (human granulocytic ehrlichiosis (HGE) and human monocytic ehrlichiosis (HME) by PCR was negative, Lyme disease by PCR was positive, Lyme disease spirochete load by PCR was postiive, and Lyme RNA was negative. The erythrocyte sedimentation rate was 5mm/hr (0-30). On 7/28/00, the Lyme IgM Western blot was negative (bands 23-25, 31, 34, 41 were present). The Lyme IgG Western Blot was negative (bands 23-25, 31, 34, 29, 41, 93 were present). The B. microti IgM titer was 1:80; the IgG titer was 1:40 (reference range unspecified); the human granulocytic IgG titer was 1:40 (reference range unspecified). The multiplex B. burgdorferi serum and whole blood genomic tests were negative. On 8/2/00, in a Lyme Disease Case Report Form filed with the county health department, the vaccinee wrote that since 4/25/00 she had experienced fatigue, chest pain, heart palpitations, joint symptoms and swelling, and muscle cramping. She was taking cefuroxime axetil and her laboratory results were PCR positive. On 8/8/00, the vaccinee was seen by the physician. His assessment was Babesia, Human granulocytic ehrlichiosis, myalgia/arthralgia, Lyme disease-polymerase chain reaction x 2. Had heart problem after receiving the vaccine. On 8/11/00, the vaccinee tested positive for the HLA-DR4 allele. On 11/8/00, the vaccinee was seen by the cardiologist. The physician wrote that the patient has a long history of Lyme's and had reactivation of symptoms after receiving a vaccine about a year ago. She had a lot of chest pain at that time, but this has resolved to a considerable degree and now she only gets some minor chest pressure from time to time which is not clearly exertional. She still gets palpitations and perhaps mild exterional dyspnea. . . I think a lot of her symptoms are probably Lyme's related arthritis and the like. Nevertheless, there are at least two soft risk factors (questionable cholesterol and history involving uncles) and one hard risk factor in terms of her smoking. I suggested she get a follow up stress test and I also suggested that this be done as a stress/echo to re-evaluate her mitral valve.  On 2/3/01, the vaccinee was seen by the physician. His assessment was Babesia, Human granulocytic ehrlichiosis, Myalgia, Lyme disease - still having some intermittent left facial numbness, but generally better. Amfebutamone hydrochloride was prescribed. On 2/26/01, the vaccinee was seen by the physician. The medical record noted that the patient was sleeping eight hours per night and feeling better. Her left facial numbness had improved. She discontinued Ceftin and was taking proguanil/atovaquone. The physician's assessment remained Babesia, Human granulocytic ehrlichiosis, myalgia and Lyme. On 3/9/01, the vaccinee was seen by the gynecologist. They discussed her decreased libido as well as her decrease in sexual response. This has been longstanding now for several years and we talked about possible etiologies. She had been started on testosterone by a different physician several years ago but did not notice much of an impact. The patient was willing to try sildenafil citrate. The physician thought that 100mg daily may make quite a bit of difference. During visit with her psychologist on 4/17/01, the subject reported having side effects from the LYMErix vaccine and that she was treated by a physician for six months rotating massive doses of antibiotics but she now feels ok. On 6/21/01, the Lyme IgM Western Blot was positive (bands 23-25, 31, 34, 39, 41 kDa present; the Lyme IgG Western Blot was positive (bands 23-25, 31, 34, 39, 41, 93 kDa present), Lyme disease by PCR was negative, Babesia by PCR was negative, Ehrlichia (HGE and HME) (by PCR) was negative, and Babesia Western Blot was negative (no IdM or IgG bands were present). On 6/29/01, the Lyme dot-blot assay panel (urine) was negative. On 7/5/01, the patient had a positive Lyme. . . antigen for Lyme disease. On 7/13/01, the patient underwent x-rays of the left knee. The clinical indication was pain. The physician's impression was mild degenerative changes. No fractures. Additionally x-rays of the left hip were obtained. The clinical indication was pain. The physician's impression was normal radiographic appearance of the hip. In a disease case report form filed with the county health agency, the vaccinee stated that she had experienced fatigue, numbness, floaters, memory loss, and ringing in ears since 6/29/01. Under the heading of laboratory results, urine antigen was marked positive. On 7/18/01, the Reverse Lyme Western Blot was positive (antigens detected 83/93 KD). On 7/27/01, the physician wrote that the patient went off and increased symptoms returned. He stated that the Babesia and human granulocytic ehrlichiosis had possibly resolved. Ceftin and amoxicillin trihydrate/clavulanic acid were prescribed. On 9/25/01, she was seen by the physician. She complained of joint pain. The physician's assessment was Lyme disease by history and doxycycline was prescribed. On 9/26/01, the Lyme Western Blot was negative (IgG band 41 KD was reactive). On 12/4/01 the Western Blot was negative. On 12/18/01, the multiplex B. borgdorferi genomic test was negative; the plasmid test was positive. The B. microiti IgM antibody titer was <1:20 (negative; the IgG antibody was <1:20 (negative). The human monocytic IgM antibody was <1:40 (negative); the IgG antibody was < 1:40 (negative). The Lyme IgG Western Blot was positive (bands 23-25, 31, 34, 39, 41, 93 present). The Lyme IgM Western Blot was equivocal (bands 23-25, 31, 34, 39, 41, present). As of 6/21/02, the chest pain had improved. The outcomes of the other events were unknown. The adverse events arthritis, joint pain, joint swelling, tremor, memory loss, inability to concentrate, numbness, and tingling do not meet ICH serious criteria but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.