Age: 41.0
Sex: F
Vaccine: FLUX, LYME
Symptoms: Cough, Echocardiogram normal, Episcleritis, Fatigue, Gastrooesophageal reflux disease
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 (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced severe joint pain of the hands, feet, shins, knees, shoulders, elbows, wrists, and palms, eye redness, blisters in the corner of the eye, cough, pin in the foot, pain with walking, tinnitus, stiffness, fatigue, reflux symptoms (nos), chest pain, eye twitching, cold intolerance, and activities of daily living impaired. The statement further alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive sequella of an autoimmune, immune-mediated, or other biological mechanism, all caused by vaccination with LYMERIX, including but not limited to those symptoms set forth above". At the time of reporting the outcome of the events was unspecified. Follow up information was received on 05 January 2009 via medical records. The subject received her first LYMERIX vaccine on 26 April 1999. She received her second LYMERIX vaccine in approximately September 1999 or October 1999, along with an influenza vaccine (unknown manufacturer). In March 2000, she developed episcerlitis with eye redness. On 05 May 2000, she complained of arthralgias and ongoing episcleritis. On 23 May 2000, she was evaluated for complaints of hand pain. A progress note dated 25 May 2000 indicated that the subject was diagnosed with sarcoidosis secondary to Lyme vaccine. Treatment included VIOXX. On 02 October 2000, she was evaluated for a five-day history of dry cough, aches, and fatigue, in addition to the sarcoid affecting her eye. Impression included upper respiratory infection, most likely viral. On 31 January 2002, she was seen by an allergy specialist who diagnosed cough and allergic rhinitis. According to a physician's note dated 18 March 2002, the subject had a history of questionable sarcoid secondary to Lyme vaccine, but was seen subsequently by a pulmonary consultant who did not feel that she had a sarcoid. Treatment included steroids and antibiotics. On 02 July 2003 she complained of chest pain, with a chest x-ray showing no acute pathology. On 11 July 2003, the subject was seen after presenting to the emergency room due to sudden onset of substernal chest pain that worsened with deep breathing. Treatment included Toradol, and she was diagnosed with costochondritis and was discharged. At the time of examination on 11 July 2003, the subject noted fatigue associated with Lupron injections to regulate her menstrual period. Impressions included 1) costochondritis, resolved, 2) probable viral illness, and 3) fatigue possibly secondary to Lupron. On 12 March 2007, she was evaluated for "incapacitating" tinnitus treated with steroids including prednisone. Other conditions included chronic episcleritis, synovitis, and leukocytosis. Methotrexate was prescribed at that time for treatment of autoimmune disease. She also continued to experience arthralgias.