Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology positive, Cognitive disorder, Condition aggravated, Decreased activity, Diarrhoea
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain throughout her body, fatigue, decreased activities of daily life, headaches, flu-like symptoms, possible memory loss, tingling in extremities, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-related or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information was received on 15 January 2009 via a claimant interview. The subject is a 52 year old female. Medical history was indicated as hypothyroidism (for which the subject received SYNTHROID), dislocated shoulder (which had required surgery), back pain, anxiety and depression. It was documented that the subject received LYMERIX vaccine in April 1999 and again in May 1999. Two weeks after the first vaccination, the subject developed severe muscle pain and aches. The muscles in her thighs were the first muscle to be in pain. A rheumatologist prescribed Cortisone. The Cortisone was helpful for the pain and she continued to take it for several weeks. All of her symptoms returned once she finished the Cortisone so antibiotics were prescribed. Antibiotics did not help. She began Cortisone treatments again. X-rays and MRIs were performed (details not specified), but no treatment was recommended. Different physicians then prescribed antibiotics, which were not effective. Additional, unspecified tests were performed and her knees were drained. This relieved the knee pain. They eventually swelled up again, but were not as painful. One of the subject's physician's started her on a special diet which was supposed to be an anti-inflammatory diet. She continues on the diet and supplements. After two months, she felt better and six months later she was feeling like she was back to being able to do what she needed to do in her life. Her symptoms are now much reduced. She does still have fatigue and difficulty with organization. The pain is generally much better. Events specifically identified as beginning two weeks after the first vaccination with LYMERIX included muscle pain and aches; joint pain and swelling; hip, shoulder, elbows, hands and finger pain; fatigue; fogginess; inability to carry out tasks and fevers and inflammation. All were continuing at the time of reporting. It was reported that the subject felt very ill following LYMERIX vaccinations and there were times she could not walk across the room. Concurrent medications were identified as SYNTHROID, EFFEXOR, ABSPAR and progesterone. Follow up information was received on 30 March 2009 via medical records. Medical history included Ehrlichiosis in 1997, right shoulder impingement, and back pain requiring physical therapy. In April 1999, the subject received the first dose of LYMERIX and "soon after the first injection" developed right hip pain. She received the second LYMERIX vaccination in May 1999; following the second LYMERIX injection, the pain worsened and she developed thigh pain, knee pain, headache, and neck pain. On 15 June 1999 and 23 June 1999 she was evaluated for hip, thigh, knee, and shoulder pain that was unalleviated by physical therapy, and possible diagnosis included polymyalgia rheumatica. It was noted that the "timing of the Lyme vaccine is unclear as to what role it may have played". Magnetic resonance imaging of the hips on 03 June 1999 showed "marked swelling" and Lyme disease IgM antibody was positive (IgG negative). She was treated with ARTHROTEC without improvement, then with prednisone which reportedly helped her hip pain. However, symptoms recurred following dose reduction of prednisone. In July 1999, she received antibiotic therapy for presumed Lyme disease, including two courses of doxycycline, as well as FLAGYL, dirythromycin, and BICILLIN. Other symptoms included nausea, vomiting and diarrhea. In January 2000 she utilized homeopathic treatment, in addition to various nonsteroidal anti-inflammatory medications including CELEBREX, VIOXX, and ibuprofen. In January 2000 joint pain spread to the shoulders, metacarpophalangeal joint, and ankle, and she developed radiating numbness and tingling from the right shoulder down the arm. She also experienced morning stiffness, a "gelling phenomenon" when sitting, and awakening at night with pain. She was evaluate by a rheumatologist between 24 January 2000 and 05 April 2000 for complaints including joint pain and synovitis, as well as pain with hip and shoulder motion. The symptoms were most consistent with rheumatoid arthritis although she remained seronegative. On 08 February 2000, physician's evaluation indicated a presumed differential diagnosis of rheumatoid arthritis versus new Lyme disease versus reaction to Lyme vaccine. The subject was evaluated on 01 March 2000 by a second rheumatologist for joint symptomology following Lyme disease vaccination. Assessment included inflammatory arthritis possibly representing early rheumatoid arthritis. Other treatment included an "extremely strict diet" and intravenous vitamins, and on 02 August 2000 the subject reported decreased pain and increased energy. On 09 April 2000, the subject was feeling better, "especially the right knee" following knee injection. She continued to experience symmetrical inflammatory synovitis of one year duration, and diagnosis was seronegative rheumatoid arthritis. Methotrexate therapy was recommended. This report was assessed to be medically significant based upon follow up information.