Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Continued with myalgia and arthralgia. Treated with NSAID. The follow up received on 7/10/03 states, received a spontaneous report from a lawyer referring to a 38 year old male who "felt terrible" after receiving Lyme disease vaccine recombinant OspA (LYMErix). The lawyer forwarded medical records. The pt had no history of Lyme disease or arthritis. Past medical history included indigestion, sinusitis (1996), left sided chest pain (1996), atypical chest discomfort (1996), feeling "drained" (1996), gastroesophageal reflux disease (1996), knee pain (1998), and "problems" with left ankle (1998). The surgical history included left medial meniscectomy and lateral release (1983) and right knee surgery (NOS, 1982). The pt has an allergy to penicillin, which gives him hives and shortness of breath. At the time of the event, it was not specified if the pt was taking concomitant medications. On 3/25/99 and 5/3/99, the pt received his first and second injections of LYMErix respectively. In July 1999, the pt reported that he felt terrible. In his words, his "belly was bad." He had aches and pains "arthritic-like" in his knees, hands, shoulders and sometimes, elbows. In a Statement of Injuries, his attorney alleged that the vaccinee "has suffered from fatigue and weakness, as well as joint pain in his knees, shoulders, and hands." The pt presented to his family physician on 7/19/99 with complaints of "sudden weakness in arms-soreness of muscles in arms and legs-ache and  hurt-worse at night." The physician also noted "swelling hands...tired." The physician's impression was "arthritis." The physician prescribed Daypro and doxycycline. On 7/21/99, Lyme antibody screen was positive. Lyme IgG and IgM Western blots were negative. The physician made a diagnosis of Lyme disease on 7/27/99 and continued doxycycline therapy. The physician referred the pt to an infectious disease specialist. The pt remained under the care of this family physician until at least 9/9/99. The pt was evaluated by an infectious disease physician on 8/13/99 for Lyme disease. At that time, the pt reported "numerous articular complaints and excessive fatigue." He reviewed the results of the 7/21/99 Lyme ELISA and Western blots. The physician noted that "Although he had a positive ELISA, his pattern on his Western blot is most consistent with his partial vaccination status and I believe the Lyme ELISA is a false positive." The physician noted, "I believe his fatigue is most likely secondary to his current stress level secondary to his work and recent move...Otherwise I think he is healthy." It was reported that after several course of medication, which included doxycycline 100mg twice daily (completed a mouth course as 8/23/99), Biaxin, and Zithromax, the fatigue and weakness lessened, but the joint pain remained. The pt remained on extensive antibiotic therapy for his symptoms. As of 8/13/99, the pt continued to have fatigue and required excess sleepy, persistent numbness of his one hand, and chronic aches in his left knee, which had been an ongoing problem. He was also concerned that he had pain in his right knee. According to a copy of a newspaper article received on 6/13/00, the author reported that the pt had reported that his condition had improved but he still had pain in his hands and knees that was sometimes so severe he could not work. On 3/26/01, the pt was seen by a new primary care physician. Since receiving LYMErix, the pt "has had joint pain, pain about the hands, knees, elbows, and shoulders along with significant cognitive dysfunction with word searching, some dyslexic type sentences, and some short term memory lapses. His sleep patterns were normal. His energy level waxed and waned. He was a bit more short-tempered and a bit more irritable which he attributed to just not feeling well." The pt remained under the care of this physician until at least 1/25/02. During this time period, the physician noted the pt to have pharyngitis and otitis. Cipro, Prevacid, and Hycotuss were prescribed. On 4/11/01, the pt underwent MRI of the brian with and without contrast. The clinical indication was possible myelitis, reaction to Lyme vaccine per pt, and numbness in hands. Impression: normal contrast enhanced MRI of the brain. On 4/13/01, Lyme disease antibody screen (total) EIA with Western blot showed an EIA value of <1.00. IgG Western bot was negative (41 and 30 kD bands present) and IgM Western blot was negative. HLA-DR4 antigen was detected. On 4/17/01, the physician removed an embedded tick on the pt's right shoulder. Doxycycline 100mg twice daily for 30 days was prescribed. The most recent info received on 7/10/03, did not provide the outcomes of the reported events. This case is serious as the pt has stated he has been unable to work for an unspecified period of time and thus, is considered persistently incapacitated.