Report 1999012802-1 described osteoarthritis in a 53-year-old female who received LYMERIX. The vaccinee had no drug allergies. Her medical history included depression, anxiety, respiratory disease (NOS), breast disease (microcalcifications), chronic hand pain secondary to sewing which stopped when she stopped sewing, thoracic spine scoliosis, arthritis {NOS}, tubal ligation (1981), possible osteoporosis, left knee skiing injury, bone deformity (thenar eminences), unspecified distal interphalangeals deformity, metatarsalgia, bunion formation, and 36-pound weight change {NOS}. She has been a smoker (one pack per day for 42 years; sometimes she did not smoke and used nicotine gum, patch or inhaler instead). The vaccinee had run all her life; she reportedly ran only short distances. She had no history of Lyme disease. There was no family history of inflammatory arthritis. She received VIOXX, PREMARIN, CYCRIN, CLONAZEPAM, ASPIRIN, PREMPRO, PAMELOR. On 04 March 1999 and 07 April 1999, the vaccinee received her first and second doses of LYMERIX, respectively. After dose 2, the subject complained of weight loss, arthritis symptoms, headaches, tiredness, and upset stomach. She took ADVIL and stated that it "helped a little". Medical record of 27 April 1999 noted that the subject complained of pain in both breasts. The diagnosis was "Rule out breast mass". 03 April 2000 medical record noted "lumpy left breast". The vaccinee was diagnosed with "rule out breast mass" and PREMPRO was prescribed. 02 May 2000 physical therapy note: The vaccinee was diagnosed with osteoarthritis on 09 April 2000. The vaccinee complained of pain in both hands, lumbar spine, both hips, both feet, toes, callus muscles, and forearm muscles. She also had a "constant' headache and weak grip. The vaccine stated that these symptoms were caused by "medication". The vaccinee had positive myofascial restrictions, normal upper and lower extremity range of motion, and normal ankle strength. 30 May 2000 physical therapy report: the vaccinee received six sessions of physical therapy. Her treatment protocol consisted of soft tissue techniques, range of motion, stretching, moist heat, "E-stim", paraffin to bilateral hands, home exercise program, and a comprehensive and strengthening pool program. At discharge, the vaccinee reported good/bad days. Pain complaints fluctuated in intensity and region. Objectively, active range of motion was normal throughout all tested regions. Gross strength was within functional limits. Special testing revealed scoliosis. Myofascial restrictions were significant throughout T/S/L/S (thoracic and lumbar spine). At discharge, the vaccinee was encouraged to manage her condition with stretching and strengthening, including a pool program. It was recommended that she perform light impact activities, i.e. walking, swimming, for cardiovascular fitness. Recommendation: discharge with home exercise program. 29 June 2000 medical record noted "vaginal lump". The vaccinee was diagnosed with left Bartholin abscess and underwent marsupialization of the left Bartholin abscess on 01 July 2000. The subject tolerated the procedure well. The Bartholin biopsy abscess showed "fragments of fibroconnective tissue with acute and chronic inflammation; no epithelial lining seen." Please note that the events of "lumpy breast mass' noted 03 April 2000 and 'Bartholin abscess' were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. 12 December 2000 physician visit: The subject was seen by an orthopedic surgeon for complaints of pain in the low back, knees, hands, and possibly hips. According to the subject, the onset of her symptoms was "very shortly after a second Lyme disease vaccination." The surgeon stated, "One of her physicians feels that this may have been related because of triggering of an autoimmune phenomenon." The subject reported that pain in the low back was exacerbated by certain activities. She also had pain in the knees with long periods of standing or walking. She had"some complaints of her feet, and she has had known metarsalgia and bunion formation, prior to the onset of these symptoms." The subject reported that she did not notice any swelling in any of the joints she had complaints about following the onset of symptoms. She apparently had been evaluated by a rheumatologist, as well. On physical examination, her thoracic spine showed "moderately severe scoliosis. The lower lumbar region has some direct tenderness and there is some mild restriction with lateral bending and rotation, but she had relatively good forward flexion and extension of the lumbar region. The pelvis is unremarkable. The hips have excellent range of motion. Both knees have full range of motion. There is no evidence of effusion. There is some mild direct tenderness about the knee. It does not appear to be very focal and not related to meniscal pathology. The anle is unremarkable. The hindfoot is also unremarkable. The right foot had a moderate hallux valgus deformity, a mildly tender medial eminence and a hammertoe deformity of the second lesser toe. The left foot had a mild hallux valgus deformity. Both feet have some thinning of the fat pad in the metatarsal regions. There is some mild plantar tenderness over the forefoot." Palpable osteophytic changes at the CMC (carpometacarpal) joint at the base of each thumb were noted. "The rest of the hand exam shows no significant swelling of loss of range of motion of the small joints of the hand or function of the wrist." The subject supplied the surgeon with x-rays of her lower lumbar region, which were taken on a unspecified date. There x-rays "show fairly significant facet arthritis in the lower two segments. The hips have no significant arthritic changes. The knees also appear to be quite normal for her age. There are very minimal changes or loss of joint space." Both hands were x-rayed by the surgeon. The x-rays "demonstrate considerably carpometacarpal arthritis at the base of the thumb, consistent with her complaints." The surgeon stated, "My impression, at this time, is that she has Significant osteroarthritic changes of the carpometacarpal joints of both thumbs....certainly there is treatment available for this common arthritis of the hand. In terms of thoracic spine, she had significant pre-existing scoliosis and this may have lead to some compensatory changes of the lower lumbar region and definitely in showing some osteoarthritic changes of the lumbar spine. I think that a lot of the symptoms are related to the facet arthritis of the lower lumbar region....In terms of both hips and knees, although they are painful for her, I cannot find a mechanical problem. This appears to be not related to arthritis. In terms of the feet, she definitely has metatarsalgia and bunion deformities. Both are consistent with her complaints. I cannot offer her any specialized treatment for her complaints of her hips and knee pain, but I do not believe that it is mechanical. It may have been an autoimmune phenomenon and is best treated by her rheumatologist." As of 11 July 2001, the outcome of the events is unknown. The adverse events of 'headaches' 'hip pain, 'knee pain', and 'osteoarthritis' do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Statement of Injuries received on 12 April 2006. The statement noted that the subject also experienced arthralgias, leg pain, numbness, tingling, cognitive difficulty, swollen joints, hearing problems, dizziness, memory loss, rheumatological symptoms, neurological impairment, decreased activities of daily life and decreased activity level. The outcome was unknown. Follow up information was received on 06 October 2008 via medical records. According to a Vaccine Adverse Event Reporting System (VAERS) for completed by the subject on 24 May 2000, she was vaccinated with LYMERIX on 04 March 1999 and 07 April 1999. Following the first vaccine she did not experience and adverse events, but following the second vaccine experienced aches, pain all over, and flu-like symptoms, and in February 2000 experienced swelling of the knees and muscle aches. At the time of completing of the VAERS form, she continued to experience pain in the lower back, hips, knees, hands, feet and toes. According to a Lyme Serology Information sheet competed by the subject on an unspecified date, the subject reported that she did not receive the scheduled third dose of LYMERIX. She reported that following the second LYMERIX vaccine, she experienced body aches and felt sick. On 26 May 1999 she was reportedly diagnosed with osteoarthritis treated with VIOXX. She was also diagnosed with Lyme disease, treated with BIAXIN without relief. Additionally, she reported experiencing fever/flu like symptoms, fatigue, pain, joint swelling/fluid (February 2000), chronic pain, depression, anxiety, and tiredness. At the time of completion of the questionnaire, she reported that her symptoms were less intense at times but "never totally gone." Following Lyme vaccine administration, the subject received BIAXIN empirically for Lyme disease from April 1999 to January 2000. She received monthly antibiotic shots beginning in January 2000, and refused continued shots on 27 March 2000. at which time she presented for evaluation for ongoing joint pain. On 21 April 2000, the subject was seen for follow up and continued to experience pain particularly in her knees, and was receiving VIOXX. Assessment included generalized osteoarthritis. In May 2000, she participated in six physical therapy sessions. On 01 December 2000, she reported that CELEBREX and VIOXX did not work and that the "Only thing which works is aspirin". Assessment included osteoarthritis. Follow up information was received on 19 November 2008 via medical records. The subject had reportedly been disabled from working since 1999 due to myalgias and arthralgias following Lyme disease vaccination. In May 2000, treatment included a course of physical therapy. On 15 June 2004, evaluation revealed osteoarthritis and some features of fibromyalgia. There was no clinical or diagnostic evidence of Lyme disease. Between 2005 and 07 July 2008, the subject was evaluated for ulnar neuritis, lower left calf pain (possible sciatica), groin pain, numbness of toes and anterior thighs, defined as paresthesias of the lower limbs, dizziness, insomnia, chronic knee pain (degenerative disease and osteoarthritis), depression, panic disorder, jaw and ear pain, anxiety, and weight gain. In July 2006 she complained of memory problems and questioned whether this was due to "vaccine or depression". It was noted that she had been HLA-DR2 positive in the past. On 19 July 2006, the subject reported that she had "nerve damage from LYMERIX 1997", and stated that the second vaccination with LYMERIX "created joint pain, fever, leg pain, possible osteoarthritis". On 22 August 2006, the subject was evaluated by a neurologist, and at that time reported problems with memory, arthralgias, numbness, and pain. The subject reported that she had no reaction following the first LYMERIX vaccine, but on the night of the second vaccine developed fever, muscle aches, nausea, and flu like symptoms, followed later by joint pain in all joints. At the time of examination in August 2006, she continued to experience left and sometimes bilateral leg pain and patelloremoral joint problems. Assessment was "I suspect that this patient has had an abnormal reaction to Lyme disease vaccination incurred several years ago, causing arthralgias and now some cognitive dysfunction". The subject had a normal mental status examination despite some reported problems with short term memory, and she had evidence of mild polyneuropathy that "could also be related to her prior history of heavy alcohol intake". On 29 September 2006, a lumbar initial evaluation revealed increased thoracic kyphosis right side with flexion and she was diagnosed with lumbar radiculopathy. On 17 October 2006, nerve conduction study results ere suggestive but not diagnostic for a peripheral polyneuropathy in the left lower extremity. In November 2006, the subject consulted a neurologist due to chronic neuropathy. A consult on 03 July 2008 indicated that he subject had "multiple problems" including neuropathy, painful feet, difficulty sleeping due to pain. An x-ray showed severe progressive loss of the patellofermoral joint space, and she was "down to bone-on-bone with cystic change laterally in the knee and she is also developing advanced arthritic change in the lateral component". She was diagnosed with advanced left knee osteoarthritis, and was advised that "no surgery is available to her except knee replacement and she is not interested in that". During the course of her treatment, the subject's medications included hydrocortisone, Aleve, fish oil, methylsulfonylmethane, Naprosyn, glucosamine, Co-enzyme Q10, Ibuprofen, and a nine-month course of unspecified antibiotic therapy.