Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypoaesthesia, Influenza like illness, Joint swelling
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain and swelling in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. 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 and swelling, headaches, flu-like symptoms, possible memory loss, fatigue, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated 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 07 January 2008 via medical records. Medical history included bunion surgery, pronatory gait, back pain, and verruca on the plantar aspect of the left foot. The subject's history also included two injuries with multiple traumas with multiple fractures that involved the right elbow and ankle, a tear at the gastroduodenal junction, and mastoiditis with bone grafting. The subject had atypical chest pain related to the musculoskeletal injury following the motorcycle accident. The 40 year old male subject was vaccinated with LYMErix on 04 June 1999. Approximately two months later, on 23 August 1999, the subject presented to a podiatrist for a chief complaint of right foot pain that had been ongoing for approximately two months. Impressions included chronic biomechanical imbalance, moderate pronatory gait, and acute tendonitis/capsulitis. He was under the care of the podiatrist from August 1999 through at least October 1999 for complaints including intermittent foot pain, and severe knee pain. On 18 October 1999, the subject reported that he had wore orthotics for several days and was doing well, then wore an unsupportive work showed and developed knee pain that was aggravated after doing "concrete work on his knees". Treatment included Relafen and/or Celebrex. Approximately 11 months after LYMErix vaccination, on 04 May 2000, testing for the HLA DR4 antigen was positive. On 12 May 2000, the subject presented to his family physician with complaints of fatigue and knee pain. He was diagnosed on that date with rheumatoid arthritis as well as premature ventricular contractions. This case was assessed upon follow up to be medically significant. The subject was followed by a rheumatologist from as early as 03 November 1999 through as recently as June 2006. On 03 November 1999, the subject presented with a three week history of inflammatory poly arthritis with right knee swelling and pain subsequently progressing to the left knee, accompanied by low grade fevers. He also experienced severe joint pain involving the shoulders and small joints of his hands. He reported a "known condition" of very mild degenerative arthritis of weight bearing joints, and a diagnosis of torn meniscus treated with Celebrex. Review of updated foot x-rays showed minimal osteoarthritis, and a knee x-rays showed no chondrocalcinosis. Overall impression was of inflammatory polyarthritis associated with fevers and positive rheumatoid factor. Fluid was aspirated from the left knee for analysis. Prednisone was added to Celebrex. On 18 November 1999, it was noted that the subject experienced a "dramatic response" to injection and aspiration of the knee. He was felt to have seropositive rheumatoid arthritis (versus "could also have inflammatory osteoarthritis"), but x-rays of the hands and wrists reportedly showed "erosions in the carpal bones to suggest disease of longer duration" than the 7 weeks reported duration of symptoms. Azulfidine therapy was added. On 29 November 1999, fevers had resolved, and the subject reported "dramatically" increasing the dose of prednisone due to intolerability of arthritis symptoms. Arava was added in order to stop azulfidine, followed by improvement of symptoms. By February 2000, he continued to experience low grade synovitis in the small joints of the hands and feet and prolonged morning stiffness. Methotrexate was added to Arava for the diagnosis of seropositive rheumatoid arthritis, and a taper from prednisone was initiated. Later in 2000, Enbrel therapy was initiated. The subject was seen for follow up of "seropositive mildly destructive rheumatoid arthritis" on 24 January 2001, and reported intermittent numbness in his hands and feet assessed as "suggestive more of an entrapment neuropathy rather than a peripheral neuropathy, either related to rheumatoid disease or Enbrel therapy". Dosage of prednisone continued to be alternately tapered and increased, and examinations showed joint tenderness and slight synovial thickening. On 19 June 2001: magnetic resonance imaging of left knee revealed degenerative changes, femoral chondromalacia and chondromalacia patella, a popliteal cyst, a meniscal tear, and complete anterior cruciate ligament tear. On 31 October 2001, the rheumatologist assessed the subject's "overall disease control has actually been very good", for diagnoses of seropositive minimally erosive rheumatoid arthritis and degenerative osteoarthritis of the left knee with a Baker's cyst. Treatment at that time included Arava, Enbrel, Celebrex, prednisone (reduced to 4.5 mg daily), as well as Zoloft. By April 2002 the subject was "almost asymptomatic", and prednisone had been discontinued and Zoloft reduced. Enbrel was stopped in September 2002 and he developed increasing achiness and stiffness, which improved following resumption of Enbrel. He continued to experience intermittent joint "flare-ups", although he exhibited a full range of motion on examination. Arava was discontinued "unless there is a documented flare of his disease" on 13 March 2003, as the subject was assessed to be in what appeared to be drug-related remission. He denied prolonged morning stiffness or pain, and examination showed no joint swelling. He remains on Enbrel, and was in apparent clinical remission as of 28 June 2004. In June 2004, he was also reportedly evaluated for possible depression. On follow up on 15 June 2005, he reported no symptoms to suggest recurrence of rheumatoid arthritis, and was receiving glucosamine and ibuprofen as needed for degenerative joint pain. On 23 May 2006, magnetic resonance imaging of the subject's bilateral knees was performed due to indications of pain, swelling, a history of rheumatoid arthritis, degenerative joint disease, meniscal tear, and anterior cruciate ligament trauma. Findings included an either complete or near complete chronically torn anterior cruciate ligament of the left knee and bilateral knee tri-compartmental osteoarthritis. On 01 June 2006, evaluation revealed recurrence of inflammatory osteoarthritis of both knees possibly representing a recurrence of rheumatoid arthritis after approximately 27 months of remission, with a degenerative component of bilateral knee osteoarthritis. Examination was negative for active synovitis, and both knees were injected with Kenalog following aspiration of inflammatory effusions of both knees. The rheumatologist noted that the subject "in the remote past had Lyme vaccines and there was this question about Lyme vaccine precipitating the disease. He may still well have Lyme antibodies, I am not going to draw on Lyme study for that reason." Enbrel therapy was re-initiated, and the dose of ibuprofen increased. According to the subject's rheumatologist in a letter dated 15 June 2006, the fluid aspirated from the bilateral knees was "definitely group II fluid and non-regenerative in nature, consistent with the rheumatoid disease". The knee inflammation was assessed to represent a return of rheumatoid arthritis. Two weeks post-fluid aspiration and steroid injection, on "full doses of ibuprofen", the subject reported that he was "doing fine". According to his primary care physician, the subject complained of neck pain and stiffness in November 2004, and reported that he had been treated by a chiropractor. On 11 November  2004 cervical spine x-rays revealed mild focal degenerative arthritic findings. Medications included Flexeril, which was stopped on 12 November 2004, as well as Percocet and Motrin. Diagnostic impression was torticollis. The subject was evaluated as recently as 09 January 2007 for follow up of rheumatoid arthritis and to obtain a prescription for Enbrel. In June 2004, the subject was diagnosed by audiogram with high frequency left sided sensori-neural hearing loss with a large, chiefly conductive, right sided hearing loss. On 31 July 2004, the subject tripped at a racquetball club and hurt his right hand; he presented to emergency rooms on 03 August 2004 (left prior to being examined) and 04 August 2004 with complaints of right hand pain, swelling, and bruising; no fracture was identified. These, as well as the events of moderate pronatory gait, and premature ventricular contractions were assessed to be incidental findings upon medical record review.