Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: This A0370083A describes possible rheumatoid arthritis in a 29 year old male who received  Lyme disease vaccine recombinant OspA (Lymerix) This report was received from the vaccinee's spouse and has been partially verified by a physician. The subject's past medical history included seasonal allergies and "multiple" tick bites. He had no known drug allergies. There were no known concurrent medications. Surgical history included left orchiectomy (1989) and"upper jaw which was straightened". It was reported that he had not experienced adverse events following previous vaccinations. On 03/03/00, 04/03/00 and 03/02/01, the vaccinee received his first, second and third (lot LY 147B9) injections of Lymerix respectively. His spouse reported that in July, 2001, he began to experience joint and body ache, especially in his hands and feet. He also had a  15 pound weight lose. He "gained a little bit back by eating a lot of food." He was seen by his physician and tested for Lyme disease and rheumatoid arthritis. His "Lyme's (sic) disease test (NOS) came back positive" and he was treated with doxycycline. His spouse stated that he was then "retested and the levels were even higher." On 10/04/01, Lyme antibody screen was positive. Lyme IgG and IgM Western blots were negative. Other laboratory analysis were within the reference ranges. Please see Laboratory Data section. On 10/24/01, the subject presented to the vaccine provider "with the persistence of fatigue, joint aches and weight loss over the last four months. Arthralgias are primarily in the fingers and feet. Patient was out in the woods a lot this year and had multiple tic (sic) bites though he never noticed a specific rash." Physical examination revealed "Hands and feet within normal limits without swelling, redness or tenderness to palpation of the joints. Patient has good grip strength bilaterally through he feels that his strength is not as good as it used to because of stiffness. Skin without rashes."  The physician assessments were 1. Arthralgias with borderline Lyme titer value. 2. Fatigue." the physician stated that the "borderline nature of the results of testing is discussed with the patient but on discussion of options, he is desirous of trial of doxycyoline and will start this at 100 mg twice daily for three weeks. If symptoms are not significantly improved by that time, I would consider repeat of Western blot titers and possible rheumatologic referral as needed. On 11/22/01, Lyme IgG and IgM Western blots were negative. On 11/26/01, the patient returned to the vaccine provider " for persistence of arthralgias. He had an equivocal Lyme's (sic) titer back in October and was placed on three course of doxycycline which he finished one week ago. He feels there has essentially been no change in his symptoms. He primarily complains of stiffness and aching of the joints in the hands and the feet, primarily in the DIP (distal interphalangeals and PIPs (proximal interphalangeals). He denies any swelling or redness over the area. This process is bilateral palpation of the joints is within normal limits.' the physician's assessment was "Arthralgias" the physician prescribed naproxen 500 mg twice daily. The subject was then refereed to a rheumatologist.  The subject was evaluated by the rheumatologist "for relatively new onest of joint pain." In a letter dated 02/11/02, the rheumatologist wrote" At this point, (the subject's) physical exam is unrevealing but his symptoms may fit with mild rheumatoid arthritis. I did check serologies which were normal and his sed rate is only 2. We have briefly touched on a trial of Plaquenil (hydroxychlorolquine phosphate) as remitting therapy and he is going to think about this. Most of all though, I have tried to reassure him that this does not appear to be a more serious arthritity."  On 09/13/01, the suybject returned to the vaccine provider. His chief complaint was neck pain, which "started approxiamtely two months ago when woke up with pain on the right posterior neck. He had been at his hunting cabin and was having no symptoms prior going to bed but woke up with his symptomatology. Since that time, he has continued to have stiffness and decreased range of motion in the neck. It is worse when looking to the left. he notes significant discomfort when trying to look for oncoming traffic while merging. He denies any radiation of pain into his shoulder or arms. No numbness, tingling or weakness. He has not been using any anti-inflammation medications at this time. The patient also has a history of multiple arthralgias for which he has seen a rheumatoologist. His laboratory workup was apparently unremarkable The patient is questioning  whether the Lymerix vaccination has something to do with this. On  examination "ther is some discomfort with )neck) flexium and extension but more pronounced with lateral rotation to the left. He can look leftward to approximately 45 degrees before the pain became significant. Rightward rotation to 75 degrees without pain. The pain, again is located along the posterior neck at the ventral border of the trapezius strain." The physician prescribed Flexeril (cyclobenzaprine) 10 mg three times daily as neeeded and physical therapy. The subject was also given some samples of metaxalone (Skelaxin) and nabumetone (Relafen) 750 Mg twice daily. The most recent information received on 10/01/02, indicated that arthralgia, neck pain, and neck stiffness persisted as 09/13/02. The adverse event "possible rheumatoid arthritis" "joint pain" and "joint stiffness" do not meet ICH serious criteria,but are being submitted as an expedited report by special FDA request per 06/28/00 letter.