Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint stiffness, Laboratory test abnormal, Neck pain
Clinical narrative: Report A0370083A describes possible rheumatoid arthritis in a 29 year old male who received Lyme disease vaccine recombinant. This report was received from the vaccinee's spouse and has not 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 3/3/00, 4/3/00 and 3/2/01, the vaccinee received his first, second, and third injections of LYMErix respectively. His spouse reported that in July 2001, he began to experience joint and body aches, especially in his hands and feet. He also had a 15 pound weight loss. He "gained a little bit of weight back by eating a lot of food." He was seen by his physician and tested for Lyme disease and rheumatoid arthritis. His "Lyme's disease test came back positive" and he was treated with doxycycline. His spouse stated that he was then "retested and the levels were even higher." On 10/4/01, Lyme antibody scrren was postiive, Lyme IgG and IgM western blots were negative. Other lab analyses were within the reference ranges. 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. Pt was out in the woods a lot this year and had multiple tic 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. Pt has good grip strength bilaterally though he feels that hsi strength is not as good as it used to be because of stiffness. Skin without rashes." The physician's assessments were " Arthralgias with borderline Lyme titer values. Fatigue." The physician stated that the "borderline nature of the results of testing is discussed with the pt but on discussion of options, he is desirous of trial of doxycycline and will start this at 100mg 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 pt returned to the vaccine provider "for persistence of arthralgias. He had an equivocal Lyme's titer back in October and was placed on three week course of Doxycycline whih 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 and PIPs. He denies any swelling or redness over the area. This process is bilateral. Physical examination revealed "Hands with relatively normal coloration. There is no warmth to the area and palpation of the joints is within normal limits." The physician's assessment was "arthralgias." The physician presecribed naproxen 500mg twice daily. The subject was then referred to a rheumatologist. The subject was evaluated by the rheumatologist "for relatively new onset of joint pain." In a letter dated 2/11/02, 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 as remittive 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 9/13/02, the subject returned to the vaccine provider. His chief complaint was neck pain, which "started approximately two months ago when he 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 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-inflammatory medications at this time. The pt also has a history of multiple arthralgias for which he has seen a rheumatologist. His lab workup was apparently unremarkable. The pt is questioning whether the LYMErix vaccie has something to do with this." On examination, "there is some discomfort with neck flexion and extension but more pronounced with lateral rotation to the left. He can look leftward to approximately 45 degrees before the pain becomes significant. Rightward rotation to 75 degrees without pain. The pain, again, is located along the posterior neck at the ventral border of the trapezius. There is mild spasm present there." The physician's assessment was "neck pain secondary to probable trapezius strain." The physician prescribed Flexeril 10mg three times daily as needed and physical therapy. The subject was also given some samples of Skelexin and Relafen 750mg twice daily. The most recent info, received on 10/1/02, indicated that arthralgias, neck pain, and neck stiffness persisted as of 9/13/02. The adverse events "possible rheumatoid arthritis," "joint pain" and "joint stiffness" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.