Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid arthritis
Clinical narrative: On an unspecified date, the pt received a dose of Lymerix, it is not known if he had received previous doses of Lymerix. Subsequently, the pt reportedly, developed rheumatoid arthritis, which the reporter described as "severe". As of 5/16/01, the outcome of the adverse event was unknown. Report 2001012530 describes rheumatoid arthritis in a 36 y.o. male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, w/forwarding of medical records. *The subject's medical history included allergy to cats, kidney stones (85), fractured right knee and chipped patella due to a motor vehicle accident (86), rectal bleeding (96), diverticulitis (96), tick exposure, chronic bronchitis, and "rare" mariajuana use. There were no concurrent medications.* The vaccinnee received injections of LYMErix *on 5/3/99, 6/7/99, and 7/17/00.* "In early 2001", the vaccinee "began experiencing extreme pain and suffering in the joints and in his body." The vaccinee allegedly developed severe Rheumatoid Arthritis [sic] or a type of treatment-resistant Lyme Disease [sic]. It was further alleged that he has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities. his attorney stated, "(The vaccinee) has been advised that his condition is permanent." The most recent information was received on 09 November 2001. Since the vaccinee allegedly has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities, he is considered to be disabled. Therefore, this report has been reclassified as serious. *F/UP report on 3/3/03: The following info was obtained from medical records. The subject presented to the vax provider on 1/11/01 w/complaints of pain in the feet and neck stiffness. The MD noted decreased range of motion of the cervical spine. The MD's impression was "Fascitis of both feet. Cervical strain." The MD prescribed a rapidly-tapering course of mathylprednisolong (Medrol Dosepak) and celecoxib (Celebrex). On 1/23/01, x-rays of both feet were negative. The subject remained under the care of the vaccine provider until at least 5/9/02. On 3/13/01, he reported "All joints involved. Taking colchicine, but feet still hurt." On 3/13/01, the MD noted swelling of the right hand w/decreased grasp. On 5/9/02, the MD observed "trigger finger". Lab analyses performed on 3/13/01 revealed abnormalities. X-rays performed on 3/26/01 did not reveal abnormalities. Lyme IgG Western blot was Neg. on 6/18/01. Please Lab Data section. The MD made Dx's of osteoarthritis (3/13/01) and rheumatoid arthritis (4/12/01). Pharmacy records indicated that this MD prescribed dextropropoxyphene napsylate/ paracetamol and furosemide. As of 5/9/02, the rheumatoid arthritis persisted, and the vaccine provider referred the subject to a rheumatologist at a tertiary care center. The subject was evaluated by a rheumatologist on 4/5/01. At that time, he reported that he had been experiencing difficulty walking secondary to pain, swelling, and stiffness since Dec. 00. He stated that he then experienced left shoulder bursitis. He also reported that he developed intermittent swelling on his chest and progressively worse pain, swelling, and stiffness of his knees, hands, and wrists. These Sx's got "better as day goes". He reported "several hours" of morning stiffness. The rheumatologist's impression was "Rheumatoid Arthritis - seropositive." He prescribed hydroxychloroquine (Plaquenil) and naproxen (Naprelan); celecoxib therapy was discontinued. The subject remained under the care of this rheumatologist until 7/9/01. During this time, he reported neck pain, hand pain and swelling, and "stiffness all day". He also reported that his right knee, ankles, and toes were "difficult w/activity". The subject reported "good and bad days" and stated that physical therapy and occupational therapy were "Helpful with strength." During this time, the rheumatologist observed good range of motion of the cervical spine; full range of motion of the shoulders, elbows, hips, and anlkes; decreased range of motion "finger to palm"; warmth and a small effusion in the left knee; synovial swelling, thickening, and tenderness of the metacarpophalangeal, proximal interphalangeal, and metararsophalangeal joints; and flexor tendonitis of the right 5th finger. Naproxen therapy was discontinued. In addition to continuation of hydroxychloroquine therapy, the rheumatologist prescribed celecoxib, methotrexate, a soft neck collar, physical therapy and occupational therapy. The subject was evaluated by a physical therapist on 5/29/01. The subject reported that he experienced pain ranging from 0 to 7, on a scale of 0-10. He reported 5/10 pain at the time of evaluation. He reported that the pain increased w/activity, and decreased w/rest and showeing. He reported walking tolerance of two hrs. He stated his goal for physical therapy as "Back to being a normal person. To be medication free." The therapist noted swelling of the digits on both hands, decreased range of motion in the hands and feet, decreased strength - left greater than right, and decreased function. Using the General Pain Disability Index Questionnaire, the subject scored 78%, which the therapist recorded as "crippling disability". However, the therapist noted that the subject was still working, "doing modified duty." The therapist's treatment plan included paraffin, active range of motion, isotonics, aquatic exercises, and a home exercise program. The rehab potential was recorded as "good". The subject attended 14 sessions of physical therapy from 5/30/01 'til 7/20/01. Because hand and digit pain did not initially respond, the therapist added ultrasound therapy. By 6/15/01, the subject had experienced "Good improvements in strength. Pain seems much improved w/change in medication." The subject's score on the General Pain Disability Index was 35%, which the therapist recorded as "moderate disability". On 7/20/01, the therapist wrote, "Pt relays pain is much improved. Able to stand for 4 to 5 hrs at one time." The subject's score on the General Pain Disability Index was 25%, which the therapist recorded as "moderate disability". The therapist wrote, "All goals met. PT instructed in home exercise program and water exercises if able to find pool. Recommend discharge to home exercise program." The subject was evaluated by an occupational therapist on 6/3/01. The therapist "Observed difficulty w/pinching, cutting, opening containers. Difficulty w/tool utilization/ wringing. Decreased knowledge of joint protection/ joint conservation." Upon examining the right hand, the therapist observed "Mild enlargement of first MP [metacarpophalangeal]/ second MP, mild laxity to ulnar deviation." The therapist wrote, "symptomatic bilateral right greater than left hand/ joint stiffness, decreased ability to complete dexterous/ prehensile tasks, decreased knowledge of joint protection. Education completed on joint conservation / protection w/application to self care, work, leisure tasks. Also educated on tendon gliding and hand ROM tasks... No further need for O.T. [occupational therapy]. Has written handouts / HEP (home exercise program)." The subject was evaluated by a 2nd theumatologist on 7/11/01. At that time, the subject reported hi chief complaints as "RA [rheumatoid arthritis] is affecting my ability to have a normal life - hands, feet, knees - pain and stiffness. He reported a 6-month history of pain. Medications at the time of the evaluation included celecoxib and hydroxychloroquine. On physical exam, the rheumatologist noted synovitis of metacarpophalangeal joints, proximal interphalangeal joints, and the wrists. Tenderness of metatarsophalangeal joints was also observed. The rheumatologist made Dx's of "RA. ? Lyme vax reaction." He prescribed methotrexate and methylprednisolone (Medrol). The subject remained under the care of this rheumatologist until at least 7/1/02. The subject reported diffuse arthralgias and myalgias, aching type pain that improved w/rest, fatigue, and poor sleep. The rheumatologist noted that the subject also reported "cognitive deficit?" on 12/11/01, the subject reported that after discontinuing methylprednisolone therapy, he experienced "immediate return of diffuse arthralgias in neck, wrists left greater than right, knees, anlkes. Positive response to restart of Medrol." During this time the rheumatologist noted persistent stiffness and decreased range of motion of the digits on both hands, antalgic gait, and ulnar deviation of the right 2nd and 3rd metacarpophalangeal joints. Lab analyses performed on 2/5/02 revealed abnormalities. Please see Lab Data section. The rheumatologist recorded the subject's prognosis as "fair". He prescribed applications of heat, stretching, and aerobic exercise. On 7/1/02, he recommended that the subject add etanercept (Enbrel) or infliximab (Remicade) to the therapeutic regimen. The subject underwent a rehab hand evaluation on 8/6/02. At that time, the subject reported the onset of foot pain as 10/1/00. He reported difficulty gripping and pulling objects. The subject stated his goal for treatment as "Fix right hand." Medications at the time of evaluation included hydroxychloroquine, methotrexate, methylprednisolone, and celecoxib. The therapist observed decreased function, decreased range of motion, decreased strength, pain, and ulnar deviation. The therapist recorded "minimal" restriction in activities of daily living, "moderate" work restriction, and "severe" sport restriction. The therapist recommended range of motion exercises, pain control, "MH [moist heat]/ paraffin/ ice", possible splinting to great ulnar deviation, and a home program. The rehab potential was recorded as "Good". Following the reported onset of rheumatoid arthritis, the subject experienced a kidney stone w/hydronephrosis, possible cholelithiasis, and a ganglion cyst on the right wrist. These events were not reported as adverse events due to vax admin, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. Info. received on 11/9/01 indicated that since the vaccinee allegedly "has been unable to perform his usual duties and occupations, and has been unable to go about his usual activities", he is considered to be disabled. Therefore, this report has been reclassified as serious. Info received on 11/15/02 indicated that the rheumatoid arthritis persisted as of 8/6/02. The most recent info, received on 1/8/03, did not provide the outcomes of the reported events.* Follow up on 02/26/04: "The most recent information, received on 05/12/03, indicated that the rheumatoid arthritis persisted as of March 2003.  The outcome of the possible Lyme disease was not reported."