Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Pain, Thinking abnormal
Clinical narrative: This report describes osteoarthritis in a 56 y.o. female who received LYMErix vax. This report was received w/forwarding of medical records. The medical history included allergy to codeine, Lyme disease, nervous breakdown ('98), suicide attempt, fibromyalgia, HTN, hypothyroidism, iodine deficiency, foot cyst and lipoma, panic attacks, vein stripping ('70), deep vein thrombosis, volar wrist ganglion, degenerative arthritis and synovitis of both knees, chest pain, foot pain, left calcaneal cyst, hysterectomy, shingles, mitral valve prolapse, osteoarthritis, knee cyst, periodontal disease, and hypoglycemia. Concurrent medications included estradiol (Estrace), minocycline, hydrocortisone acetate (Proctosol), vitamin D, and iodine. On 3/15/99 and 4/15/99, the vaccinee received her 1st and 2nd injections of LYMErix, respectively. In a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from vaccine-induced arthritis to her knees." The following info. was obtained from medical records. The vaccinee stated that by June '99, she began to have joint "problems" and she saw her chiropractor for 8 treatments. On 8/18/99, she was "suffering w/joint pains in my knees, headaches, and difficulty concentrating along w/depression." She was seen by an MD who ordered "a Lyme test". On 9/1/99, "because the joint pain had gotten so severe and I was becoming irritable w/the swollen knees that were keeping me from my daily activities, I ordered clocosamine / chondoitin". On 8/18/99, the vaccinee's fibrinogen was elevated; the C-reactive protein screen was positive; the C-reactive protein titer was elevated; the Lyme disease antibody by Elisa immunoassay was negative. "seronegative. Absence of exposure to B. burgorferi or diminished antibody response due to therapy." On 12/1/99, the vaccinee stated that she was not feeling any better. "My knee pain persisted and I was becoming depressed." On 3/6/00, the vaccinee received her 3rd injection of LYMErix. The vaccinee stated that "after receiving this 3rd vax, I had a severe reaction. I lay down on the sofa and couldn't move my body, especially my legs. I felt paralyzed and called the MD. He said these Sx's should go away in about 8 hrs, which I finally did. I must say I was really scared. On 3/9/00, the vaccinee requested an appmt w/the MD. She still wasn't feeling well. She had joint pains and weakness that were keeping her from exercising. She was having nose bleeds. In a letter, the vaccinee wrote that she had not exercised all winter because she was having prob's w/foot prob's (she had a cyst and benign tumor in her foot). On 3/29/00, the vaccinee stated that she had the following lab studies performed: toxoplasma IgM antibodies positive; IgM antibody detected. Interpretation: "possible recent infection w/in the last 12 mts". On 3/29/00 the fibrinogen level was elevated, the C-reactive protein screen was negative, and the toxoplasma IgM antibody was positive. On 4/11/00 she had a stool analysis performed which showed that she had an imbalance in the bacterial flora resulting from a parasite or bacterial infection, "which could lead to rheumatologic and other systemic complaints." On 8/15/00, she complained about constant fatigue, weight gain, and depression. Her knees were still "giving [her] trouble." The MD suggested that a good sensitivity test be performed. On 8/22/00, because of arthritic Sx's, "the MD suggested I stay away from the nightshade foods." On 9/12/00 the PT was seen by the MD. The blood pressure was 180/100. Neurological and extremity exams were normal except for crepitus in both knees w/minor pain. Impression: 1) Mild degenerative joint disease- knees. 2) Hypertension uncontrolled. 3) Post menopausal syndrome. Plan: The PT was taking progesterone (Prometrium) 100 mg one daily, Tri Estrogen 2.5 mg daily. She was started on lisinopril (Zestril) 5 mg daily, a low sale diet, and given some exercises for her knees. On 9/19/00, the PT was concerned w/the severe pain in her knees and ankles. On 9/20/00, the vaccinee wrote that her joints hurt, especially her knees and ankles. "I have HTN and bouts of depression and fatigue. I'm just one big mess. My stress level is high; my blood pressure is 180/100, something I've never had." On 11/21/00, the PT had severe pain in her knees and legs. She could not kneel w/out discomfort. On 11/24/00 Lyme disease antibodies ELISA Immunoassay index was elevated. The Lyme disease Western Blot was negative. IgG bands present were 31, 23 kD. IgM was neg. Erythrocyte sedimentation rate was elevated; anti-nuclear antibodies screen was negative; anti-streptolysin O screen was positive; anti-streptolysin O titer was positive. On 12/7/00, an unspecified radiologic study of the right knee was performed. Impression: Small 3 mm extraosseous soft tissue clacification projecting into the anterior aspect of the right knee joint. This could represent a focal synovial clacification, or possibly represent a small calcific loose body in the anterior aspect of the right knee joint. The exam of the right knee was otherwise unremarkable. On 12/7/00, an unspecified radiologic study of the left knee was performed. Impression: negative study of the left knee. On 12/7/00, an unspecified radiographic study of the right foot was performed. Impression: tiny posterior right calcaneal spur. Mild first metatarsophalangeal joint hallux valgus deformity of the right foot. On 12/7/00, and unspecified radiographic study of the left foot was performed. "The lateral film demonstrates a small posterior left calcaneal spur at the site of insertion of the Achilles tendon. There is a cystic lesion seen in the left calcaneus visualized on the lateral projection. This measures about 1.5 cm. This radiographically appears benign, but I would suggest further assessment w/either an orthopedic or podiatric consultation." On 12/8/00, the anti-streptolysin O value was normal; the Lyme disease Western Blot was negative (IgG bands 31, 23 kD present; IgM band 41 kD present). The vaccinee wrote that she had continued pain in her knees. "I now have diminished eyesight and ask[ed] the MD if it could be from the Lyme vax." The MD said that the vax had fibromyalgia and prescribed unspecified medication. The PT was seen by the MD on 12/8/00 and c/o'd bilateral knee pain. On 12/9/00, the vaccinee wrote that she was now having difficulty sleeping and she needed to take sleeping pills. On 1/8/01, the Lyme antibody screen Elisa Immunoassay index value was elevated. The Lyme disease Western Blot was negative (IgG bands 31, 28, 23 kD present). On approx 2/6/01, a local government health group called the vaccinee to tell her that she had tested positive for Lyme disease and suggested that she see an infectious disease specialist. Magnetic resonance imaging of the left knee was performed on 2/6/01. The MD's impressions was "Degenerative arthritic changes medically with chondomalacia patella and degenerative changes of the patella. There is a joint effusion, Baker's cyst w/fluid posterior medially, and some edema related to the pes anserinus tendons." Magnetic resonance imaging of the right knee was performed on 2/6/01. The MD's impression was "There is evidence suggesting a small, older area of osteochondral injury involving the medical femoral condyle, possibly representing a small osteochondritis desiccans. Plain film radiographs demonstrate what may be a small loose body, possibly associated w/this older injury. Subcortical bone marrow edema is seen in the posterior lateral tibial plateau which may represent an area of stress injury. There is a small to moderate-sized effusion and a synovial cyst in the posterior medial aspect of the knee." On the MRI form, under provision diagnosis/ history, the MD wrote: "right knee and left knee pain surrounding patella when kneeling or moving. No injury. No [Sx's to knees]. PT varicose veins removed bilat calves in '70. Recent weight gain. PT believes Sx's occurred following third injection of Lyme vax." On 2/14/01, the vaccinee was seen by the MD. The vaccinee reported that the MD told her that she had "arthritis." On 2/27/01, the erythrocyte sedimentation rate was elevated and the C-reactive protein was normal. The medical record indicated that the vaccinee's reaction to the Lyme vax was "legs hurt lasted one day; severe pain in knees, difficult to get in and out bathtub; labs showed infection; confused, forgetful." The physical exam noted arthralgia, crying, and weeping. On 3/19/01 the vaccinee was seen by the MD and was placed on unspecified antibiotics. On 3/12/01, the PT was seen by the MD. There were no changes. The knee pain persisted. HLA-DR4 was negative. Magnetic resonance imaging showed degenerative joint disease. There was no clinical knee swelling or effusion. The Lyme disease Western Blot IgG was negative (bands 30 and 23 kD were present). On 4/3/01, the PT was seen by the MD. She felt depressed, and sometimes "flew off the handle". She was taking Amoxil, and salicylamide (Nytol) and tryptophan for sleep. She occasionally took vitamin B12 and took daily vitamin supplements and acidophilus. She had anxiety and was perfectionistic. She was Dx'd with major depressive disorder, recurrent; rule-out generalized anxiety disorder, rule-out anxiety disorder (NOS). The PT reported feeling fatigued, which the MD felt was related to Lyme disease. She was "more irritable, less tolerant of others." On 5/7/01, the vaccinee was seen by the MD. She c/o'd of pain in both knees and had difficulty walking. There was "some" swelling. There was no popping, locking, snapping, or giving way. After aspiration of her knees, she received an injection of betamethasone (Celestone) 1 cc and bupivicane (Marcaine) 1 cc in her knees. She obtained relief which lasted for a week. Dx: mild to moderate degenerative arthritis and synovitis of both knees. She was to use heat three times daily; naproxen (Naprosyn) 500 mg twice daily was prescribed. On 9/11/01, the vaccinee was seen by the rheumatologist for a follow-up to her initial evaluation on 8/21/01. The vaccinee c/o'd of increasing bilateral knee pain which worsened w/activity and radiated into her anterior tibias and sometimes into both feet. The vaccinee reported that her problem started w/a Lyme vax in March 99. She obtained the vaccine in March 99 and April 99. Around June 99, she c/o'd some joint pain and saw a chiropractor. In Aug. 99, the joint pain was worse especially affecting her knees. She also c/o'd of headaches, trouble w/concentration, and depression. In Sept. 99, she reported that her knees were swollen and she started glucosamine / chondroitin. In March 00, she had a 3rd vax (LYMErix) and soon after c/o'd of total body pain, but then was fine about 8 hrs later. HTN was diagnosed and her knees continued to bother her along w/fatigue, depression, and ankle pain. Through Nov. 00, her labs were positive for Lyme. In Dec. 00, knee x-rays were done. The possibility of fibromyalgia was raised. In Feb. 01, she was seen by an infectious disease specialist and then in March 01, the referring MD saw her, and she was started on unspecified antibiotics. In May 02, she was seen by an orthopedist and both knees were injected w/steroids which helped "a lot", but provided relief only lasted one week. She also had an endocrine evaluation in June 01. Currently, she c/o'd of ongoing bilateral knee pain. Her other prob's seemed to be better, but the knees were a little worse. She tried a pool exercise program a few wks ago and she "really felt good" in the water. However, recently after a bout of laughing, she developed severe left anterior chest wall pain. She was seen in the ER. Her blood pressure was high and her x-rays were negative. She c/o'd of a chronic headache and a 40-pound weight gain, chronic depression, crying spells, fatigue, bilateral feet and ankle pain, and bilateral knee pain. She had possible tinea versicolor. The blood pressure in the right arm on 9/11/01 was initially 200/110. A few mins later it was down to 180/90. The left arm at first 180/100 and then in repeat 160/90. About 10 mins later both arms had blood pressure 160/90. The upper extremity joints were w/out synovitis or nodules. Lower extremities from hips, ankles and feet were not tender to palpation. There was full extension, but flexion about 90 degrees w/complaints of discomfort, although she could flex them both much more on her own. An MRI of the left knee showed possible chondromalacia patella in Feb. 01 medical joint space w/osteoarthritis changes. The right knee w/possible osteochondral area of injury medial femoral condyle. Impression: 1) Bilateral knee pain. The pain may be on the basis of underlying osteoarthritis / chondromalacia. 2) Hypertension. Very labile. 3) A team conference (T/C) physical therapy program w/attention to instructing her in knee exercises. The MD was also concerned about the possibility of underlying osteoporosis. He advised a DEXA (dual-energy x-ray absorptiometry). On 9/24/01 her Lyme Disease Antibody screen by Elisa Immunoassay index was elevated "indicating prior exposure to B. burgdorferi." The Western Blot was negative. C-reactive protein was negative. On 10/23/01, the Lyme Elisa titer IgG was 80 (normal <80). The Lyme Western Blot IgG and IgM antibodies were negative. "One commercial Western Blot yielded a positive result by CDC criteria. Prior studies suggest that this reflects a false positive and can be caused by vax alone." On 2/20/02, the erythrocyte sedimentation rate was elevated. The most recent info, received on 6/11/02, did not provide the outcomes of the reported events.