Age: 41.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Discomfort, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Report A0362529A describes sero-negative inflammatory arthritis in a 41 year old female who received Lyme disease vaccine recombinant OspA. This report was received as part of the litigation proceedings, with forwarding of medical records. The medical history included "long-standing" psoriasis involving the skin of the scalp, lactose intolerance, iron supplement-related constipation, herpes simplex infection, anemia, dysmenorrhea, rotator cuff tendonitis after an injury, hand pain from trauma and overuse, left small finger flexor tenosynovitis, left cubital syndrome, sinus bradycardia, and constipation. There were no known allergies. Family history was significant for psoriasis. Concurrent medications included calcium, vitamin C, ferrous sulfate, and psyllium. The vaccinee received her first injection of LYMErix on 5/20/99 (lot number not recorded). AFter she returned home, she telephoned the physician and reported that she was experiencing headache, dizziness, and aching. She was told that these events were"probably reaction to LYMErix." She was instructed to take Tylenol and to call again if the symptoms persisted. The vaccinee received her second injection of LYMErix (lot 104A2) on 6/22/99. She reported no complaints at that time. No adverse experiences were recorded after the second injection of LYMErix. The vaccinee returned to the vaccine provider on 3/15/00 for a complete physical examination. On review of symptoms, she admitted that she had "noticed occasional dizziness with change in position." The physician's assessment was "Positional dizziness-probably mild orthostatic changes with low normal BP." The vaccinee received her third injection of LYMErix (lot 146A9) in August 2000 (exact date not legible in the medical record). The vaccinee presented to the vaccine provider on 4/10/01, eight months following the third injection of LYMErix, with a chief complaint of diffuse body aches that had begun approximately one week earlier. She had no rashes, fever, cold symptoms, cough or upset stomach. She reported pain in her foot, knees and hands. She stated that she had been seen by her orthopedist for follow-up of an injury, and he had prescribed Celebrex. She reported no relief from Celebrex. On examination, there were "NO palpable effusions, warmth or tenderness. No redness. Full ROM." The physician's assessment was "Polyarthralgias-question cause. Explained that the cause may very well be viral, and it may improve completely on its own." He suggested that she try Tylenol for pain relief. Laboratory analyses revealed a positive antinuclear antibody titer and increased erythrocyte sedimentation rate. Lyme antibody screen was positive, but IgG and IgM was negative. Testing for babesiosis and ehrlichiosis was negative. The physician thought it possible that the vaccinee may have had Lyme disease, so she prescribed a 10 day course of doxycycline. the arthralgia persisted and the vaccinee was referred to a rheumatologist. The vaccinee was evaluated by the rheumatologist on 6/7/01. She complained of "diffuse joint pain dating back about 10 weeks. Her symptoms actually began back in April without any antecedent illness. At first she noticed some swelling and loss of motion of the left fifth finger. She also noticed some intermittent paresthesias in the left hand particularly when she would flex her elbow. She tried Celebrex and Naprosyn which really did not help. She says that lab tests were performed and apparently everything was negative but there was a question about a positive Lyme test. I should point out that she had the Lyme vaccine back in 1999 and again in 2000. When she returned for a follow up visit she was now having discomfort in her right hand as well as discomfort in her knees and both feet. For the first time she had also noted some swelling in her feet and rather significant morning stiffness lasting at least several hours. Because of the positive Lyme serologies she was given a 21 day course of Doxycycline, but this was not helpful. When I saw her she was simply taking Tylenol. Her history is interesting in that she does have a history of psoriasis involving the skin of the scalp. Her family history is also positive for psoriasis." On physical examination, "skin was normal. I could not detect any psoriasis. The hair was unremarkable. Nails were not pitted or clubbed. There was no lymphadenopathy. The shoulders and elbows were normal. Tinels and Phelan signs were negative at both wrists. The wrists were unremarkable. There was some tenderness of a few DIP joints in either hand with what looked liek some early Heberden's nodesThere was definite synovitis of a number of PIP joints of both hands and there was definite synovitis of selected MP joints of both hands. The hips, knees and ankles were unremarkable There was synovial thickening and tednerness of all the MTP joints of both feet. There was no dactylitis. X-ray of the right hand and feet were taken and these did not reveal any significant lesions." The rheumatologist's impression was "The vaccinee appears to have an inflammatory arthritis of her hands and feet. With the history of psoriasis it is certainly possible that she might have psoriatic arthritis and I am also concerned about the possibility of early rheumatoid disease. She does have young children at home but there is nothing else to suggest a recent parovirus infection." The rheumatologist prescribed prednisone. Lyme IgG Western blot was now positive and erythrocyte sedimentaiton rate was further elevated. Parovirus IgG was positive. The vaccinee remained under the care of this rheumatologist until at least 1/18/02. During this time, she reported that her morning stiffness "lasts all day." She also reported that walking was "harder." The physician noted an outbreak of psoriasis behind her ear; the vaccinee reported one other outbreak of psoriasis. The rheumatologist made a diagnosis of sero-negative inflammatory arthritis. During this time period, the physician prescribed Plaquenil. As of 1/18/02, the medication regimen included prednisone and Plaquenil. On 1/14/02, the vaccinee was evaluated by a hematologist regarding her pre-existing anemia. At that time, she reported "that she was vaccinated for Lyme in late 1999 and 2000 and after immunization had increased joint aches and pains. She still has symptoms in her wrists, knees, ankle and elbows." The adverse events " The adverse events "inflammatory arthritis," "headache," and "dizziness" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.