Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Tenderness, White blood cell count normal
Clinical narrative: Report 2001003926-1 describes rheumatoid arthritis in a 68-year-old male who received LYMERIX. This report was received from the patient, with medical records provided on follow-up. Medical history included tuberculosis as a child, positive result following application of tuberculosis purified protein derivative (PPD, 1980 and 1995), recurrent hemoptysis (1981), bronchiectasis, left upper lobe lung resection (1986), occasional shortness of breath (1995), severed right bicep as a result of a crush injury (1975), back injury (1979) after which the patient was told he had "disc disease" (NOS), arthritis first documented in 1983 and treated with NALFON, bilateral carpal tunnel syndrome, hyperlipidemia, elevated triglycerides, chest pain while shoveling snow (1994), near syncope (1997), colonic polyps (1995), penicillin allergy (rash), multiple acrochordons (1996), seborrheic keratoses (1996), and nevus (1996). The patient had foot pain first documented on 10 October 1973. On that date, the patient reported to his primary physician that he had seen a podiatrist, who told the patient he had gout. The primary physician noted that the patient had "normal UA." The patient is an avid hunter and fisher. On 13 January 1999, the patient saw his primary physician. The patient reported right hand weakness and pain after chopping wood. The physician noted, "Pt had eval by Neurosurg eval [sic] demon neuropathy." On physical examination, right hand weakness and decreased range of motion were noted. Paresthesias were also noted. The physician's impression was "Neuropathy right hand. Rule out CTS." The patient was referred to a hand surgeon. Concurrent medications included LIPITOR 20 mg daily, aspirin 81 mg daily, FIBERCON two tablets daily at bedtime, and one multiple vitamin (NOS) daily. The patient reported that he received his first injection of LYMERIX on 14 April 1999; no adverse experience was reported following the receipt of this injection. He received his second injection of LYMERIX on 19 May 1999. By August 1999, approximately three months following the second injection, the patient stated that the joints in his fingers and wrists became "extremely" swollen. In October 1999, the patient was seen by a neurologist, who performed unspecified tests and x-rays to rule out carpal tunnel syndrome; the results of these procedures were not provided. The neurologist reportedly referred the patient to an orthopedic physician. The patient stated that he was seen by the orthopedist in November 1999, at which time lidocaine was injected into the patient's hand. This provided no relief. The orthopedist referred the patient to a physiatrist, who conducted motor nerve conduction tests and unspecified muscle tests. The physiatrist made a cast and brace for the patient's right hand and prescribed physical therapy. The patient received physical therapy twice weekly from December 1999 through 08 April 2000. The patient stated, "My hands were still swollen so much I could not tie my shoestrings or brush my teeth and were extremely painful." The patient reported that he received his third injection of LYMERIX in July 2000 (exact date not provided). The patient stated that his hands and wrists became "worse than ever." He was seen by his internist. Antinuclear antibody titer measured on 30 August 2000 was negative. Rheumatoid factor measure on 30 August 2000 was 95 IU/mL. A diagnosis of rheumatoid arthritis was reportedly made and the patient was referred to a rheumatologist, who prescribed MEDROL. As of 01 February 2001, the patient's "hands are almost normal, but still pain [him] at times." The patient stated, "I never had RA before. However, due to the Lyme vaccine, my bloodwork showed a RA factor of 95, which should have been 20." Review of medical records provided the following information. The patient saw his primary physician on 24 September 1999. Office medical record documents that the patient had received two injections of LYMERIX prior to the office visit. No patient complaints or joint signs/symptoms were noted. The patient saw his primary physician on 22 March 2000. During this visit, the patient reported that he had experienced decreased range of motion of his right hand. He had seen another physician for this, who prescribed physical therapy. No problems were noted on physical examination. The physician's plan was recorded as "1. LYMERIX. 2. Office visit 3 months." The next recorded office visit was 07 September 2000. At that time, the patient "has acute swollen left wrist. Rule out reaction to Lyme Vax." On 30 August 2000, rheumatoid factor was 95 IU/mL. The physician prescribed MEDROL 8 mg daily and referred the patient to a rheumatologist. The patient was seen by the rheumatologist on 15 September 2000. The rheumatologist stated that, "for many years, he has been noted to have pain in the feet." The rheumatologist noted that the patient had experienced pain and swelling in the right hand in October 1999. He received "some shots" and physical therapy and the "symptoms appeared to subside and resolved". In July or August 2000, the patient experienced sudden onset of pain and swelling of the left wrist. The rheumatologist noted that the patient had been treated wit VIOXX and CELEBREX without improvement. An erythrocyte sedimentation rate (ESR), performed on an unspecified date, was reportedly 21 mm/hr. On 15 September 2000, "The patient at this time, also admitted to some morning stiffness. He admits to fatigue." On examination of the left wrist, the patient had "2+ soft tissue swelling with stress tenderness on dorsiflexion and palmar flexion. On the hands, the patient had soft tissue swelling with stress tenderness on the MCP [metacarpophalangeal] joint subluxation with 2+ stress tenderness." The rheumatologist's impression was "Seropositive rheumatoid arthritis, mild to moderate disease activity by global assessment." The rheumatologist noted that, "The patient has responded very nicely to the current treatment protocol." The rheumatologist recommended adding sulfasalazine therapy with slow weaning of methylprednisolone. The rheumatologist saw the patient again on 29 September 2000. At that time, the patient had a several-day history of headaches, neck stiffness, and fever as high as 101 degrees Fahrenheit. On physical examination, there was "1 to 2+ soft tissue swelling on the MCP and the PIP joints and also on the wrists." The rheumatologist's impression was "1. Rheumatoid arthritis, mild to moderate disease activity by global assessment. 2. Possible viral syndrome." Because of the possibility that the headaches, stiff neck, and fever could be caused by sulfasalazine, it was discontinued. On 29 September 2000, the white blood cell count (WBC) was 10,500 cells/cu mm with 86.9% neutrophils (absolute neutrophil count, 9125 cells/cc mm) and 4.9% lymphocytes (absolute lymphocyte count, 515 cells/cu mm). ESR by Westergren method was 12 mm/hr. Antinuclear antibody titer, Anti-Smith antibody titer, anti-ribonucleoprotein antibody titer, anti-double-stranded DNA antibody titer, Sjorgren's SSA antibody titer, and Sjorgren's SSB antibody titer were negative. Rheumatoid factor was 100 IU/mL. C-reactive protein (CRP) was 69.4 mg/L. The patient was seen by the rheumatologist on 17 October 2000; the patient "feels much better". The rheumatologist's assessment was "RA mild doing better." The methylprednisolone dosage was reduced. The rheumatologist saw the patient on 22 February 2001. At that time, the ESR was 1 mm/hr and the CRP was <5.0 mg/L. The adverse event of rheumatoid arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. In a Statement of Injuries, the subject's attorney alleged that the subject "suffers and has suffered from arthralgias, fatigue, limited use of hands, stiffness, swollen joints and pain in wrists and fingers. He suffers from inter alia, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX." In addition, "he has decreased activities of daily life and decreased ability to participate in recreational activities." Follow up information was received on 26 November 2008 via an interview between lawyers and the subject. The subject reported that he received LYMERIX on 14 April 1999, 19 May 1999, and 22 July 2000. Approximately five months after the second dose of LYMERIX, he experienced hand swelling and stiffness. Immediately after the third dose of LYMERIX he developed foot swelling and stiffness, and knee stiffness. In 2002 or 2003, he developed back pain. Treatment included MEDROL, VIOXX, CELEBREX, MOBIC, and prednisone. The events were unresolved at the time of reporting. The case was assessed by GSK to be medically significant at the time of receipt of follow-up information.