Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Bone disorder, Joint swelling, Pain
Clinical narrative: Subsequent to receiving three doses of Lymerix, pt complained of possible arthritis in the hands with achiness and slight joint swelling, which began after the second dose of Lymerix. The physician's assessment was osteoarthritis. Treatment included Celebrex, Maxalt and Ultram. The pt reported that Ultram was not working so Darvocet was prescribed. The pt reported no pain relief from Darvocet as her hand continued to ache, she also noted that she needed too many and it caused increased sedation. The physician's assessment was arthritis. Pt was treated with Vioxx. Follow up information indicated that the events were ongoing. The follow up states the vaccine's medical history included severe recurrent anemia, peptic ulcer disease, helicobacter pylori infection, gastrointestinal bleed, heinz body positive hemolytic anemia, unspecified gammaglobulinemia, low-normal G6PD level, breast mass, mitral valve prolapse, hypercholesterolemia, allergic rhinitis, chronic sinusitis, menstrual migraines, and "fuzzy" vision. She had no known allergies. She had a tick bite on the left shoulder and on the right arm, but no history of Lyme disease. Concurrent medications included Advil, Amerge, Naxait, Excedrin, an allergy shot, Flonase, Pepcid, prevacid, Allegra, and an iron supplement. Concurrent herbal supplements included milk thistle and acidophillous. On 3/23/99, the vaccinee received her first injection of LYMErix 0.5cc in the left deltoid. She received her second injection on 4/20/99, also in the left deltoid, and her third injection on 3/23/00 in the right deltoid. In a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain, in particular in her hands, ankles and knees. She also suffers from fatigue and anemia. In addition, she suffers from headaches." The following info was obtained from medical records. The vaccinee presented to the vaccine provider on 1/11/00, eight months following the second injection of LYMErix, with a chiefl complaint of a headache. She reported htat she had a cold the previous week. She self-medicated with "Benadryl sinus." On examination, the physician noted swollen anterior lymph nodes, postnasal drip, and maxillary pressure. The physician made a diagnosis of sinusitis and prescribed Augmentin and Entex LA. The vaccinee returned to the vaccien provider on 6/12/00, with a chief complaint of "possible arthritis in hands and feet" with achiness and slight joint swelling, which began "a few weeks" after the third LYMErix injection. The physician noted "slight swelling of PIP joints." The physician's assessment was osteoarthritis. The physician prescribed Celebrex and ultram. The vaccinee reported that the Ultram was "not working." Darvocet N-100 was prescribed on 7/17/00. On 7/31/00, at a follow up visit, the vaccinee reported no pain relief from Darvocet as her hand continued to ache (she also noted she needed too many and it caused increased sedation). The physician's assessment was arthritis. Vioxx was prescribed. Relevant labs included: total Lyme disease antibodies were positive at 3.35; Lyme disease IgM antibody, rheumatoid factor, and antinuclear disease antibodies were all negative; C-reactive protein and erythrocyte sedimentation rate were normal. Lyme IgG by western blot was unreadable due to dark background. Lyme IgM by western blot was reported as negative because two of the three required bands were not present; however, the sampel was positive for bands 31 and 30. The physician recorded in the medical record that the pt was "OspA gene positive." The vaccinee was referred to a rheumatologist on 9/11/00. At that time, she reported that her symptoms began two to three weeks following receipt of her third injection of LYMErix. She reported "discomfort and some pain in the PIP joints of her fingers and subsequently pain and discomfort in the left knee. She has had some discomfort in her ankles and hips, but it is mostly the knee and PIP joints that have been giving her problem." The rheumatologist noted that her previously elevated Lyme titer "was probably due to the vaccine." On physical examination, "Her upper extremities were completely within normal limits with the exception of hte PIP joints of all her fingers. They seemed to be somewhat thickened and mildly tender. The lower extremities revealed good range of motion of her hips and knees wihtout any swelling. The left knee though does have pain on comporession of the patella and also tnederness over the lateral joint space on compression of that area. There was good range of motion. There did not appear ot be any crepitus. Her ankles and toes were within normal limits. Her lower back and cervical spine moved well." The rhuematologist stated that the pt "appears to be developing what i feel is some osteoarthritis in her hadns and probably some mechanical derangement in the left knee, either consistent with a torn meniscus or possibly chondromalacia of hte patella." MRI of the left knee was performed on 9/19/00. The radiologist's impression was "there is degenerative joint disease with narrowing of the medial and patellofemoral joint spaces. There is thinning of hte articular cartilage of the femur as well as a small focus of increased signal in the lateral facet/intermediate facet consistent with mild chondromalacia patella. There is a partial tear of the psoterior cruciate ligament. There is intrasubstance increased signal in the posterior horn of the medial meniscus consistent with degenerative change." The vaccinee was seen again by the rheumatologist on 9/28/00. At that time, "she continues to ahve a lot of discomfort in that knee." The rheumatologist stated, "There were significant degenerative changes present within the knee and the meniscus as a cause for her complaints." The rheumatologist prescribed Arthrotec 75mg twice daily. On 5/7/01, the vaccinee returned to the vaccine provider with a chief complaint of "headache with dizziness all weekend. pt thinks she's anemic." She also reported that she was under the care of a "Lyme specialist," who had made a diagnosis of chronic Lyme disease and prescribed (Biaxin) and Ceftin. On physical examination, the physician noted pallor. The physician's assessments were "dizziness, headache, pallor." lab analyses revealed decreased hemoglobin and hematocrit and increased "feeling better." Headache and allergy symptoms were "better." She reported one black stool. She reported that she had been taking more Advil. She was still pale. The physician's assessments were "anemia, status-post PUD." The physician prescribed Prevacid and Niferex. The physician referred the vaccinee to a gastroenterologist. The vaccinee was seen by the gastroenterologist on 5/10/01, due to fatigue and black tarry stool. At that time, the vaccinee reproted her general health as "good." She reported that she was being treated for Lyme disease with Biaxin and Ceftin. Rectal examination revealed "dark and stornly hemocuult positive" stool. The gastroenterologist's impressions wee "Macrocytic anemia with prior history of hemolytic anemia. Histroy of peptic ulcer disease now with heme positive stool. History of Lyme disease." The vaccinee was instructed to continued Prevacid therapy and increase the iron dosage. The vaccinee underwent panendoscopy on 5/29/01, which revealed antral gastritis. On 6/7/01, the red blood cell count was decreased and mean corpuscular hemoglobin was elevated. Pharmacy records indicated that the vaccinee was under the care of an "emerging diseases specialist" from at least 11/10/00 until at least 4/16/01. During this period, the specialist prescribed Lortab, Biaxin, Ceftin, Darvocet-N 100, Suprax, and amantadine. The most recent info, received on 5/14/02, did not provide the outcomes of the reported event.