Sex: F
Vaccine: LYME
Symptoms: Rheumatoid arthritis
Clinical narrative: Post vax, the pt experienced rheumatoid arthritis. According to the reporter, the pt and her treating physician believe the rheumatoid arthritis was caused aby her vaccination with Lymerix. No other details were provided. The event of rheumatoid arthritis does not meet ICH serious criteria, but is being submitted expeditiously per FDA request.  Follow up on 02/02/2001: "Initial unconfirmed spontaneous report from a lawyer referring to a 53 year old female who claims to have experienced rheumatoid arthritis following vaccination with Lyme vaccine (Lymerix).  According to the reporter, the patient and her treating physician believe the rheumatoid arthritis was caused by her vaccination with LYMErix.  Follow up information received from the patient's physician documents that the patient's past medical history included hypertension, cervial cancer in situ and an episode of "neurocardiac" syncope (worked up two years ago with an electrocardiogram (EKG) and tilt table).  She has a history of allergy to prochlorperatine (Compasine).  It also "caused a seizure" (date, dosage and route of administration were not specified).  According to the physician's note of 08/29/2000, the patient, in the summer of 1998 (prior to receiving the Lyme vaccines) was doing more gardening and noticed "bumps" on her distal interphalangeal joints (DIPs)(hands).  She reportedly attributed this to "arthritis of getting older".  On 04/13/1999, the patient received her first LYMErix injection (LOt # LY120D9) 0.5cc intramuscular (IM), site not specified.  On 05/12/1999, the patient received her second LYMErix injection (Lot # LY120F9) 0.5cc IM (site not specified).  In July 1999, she was once again doing more work in her garden and noticed that the "bumps" had worsened.  She was reported to have more pain along her proximal interphalangeal joints (PIPS)(hands) as well.  She waited until November 1999 to see a physician who diagnosed osteoarthritis by x-ray.  The patient was to take glucosamine and chonroitin sulfate as well as wear a copper bracelet.  The patient noticed that her hands worsened at thist ime.  This would wake her up at night.  On 04/25/2000 she received her third injection of LYMErix (Lot #  LY144B9) 0.5cc IM, site not specified.  The patient eventually was evalutated by a rheumatologist in June 2000.  She was told that she had rheumatoid arthritis.  She was placed on Celecoxib (Celebrex) 200mg daily and hydroxychloroquine sulfate(Plaquenil) 200mg two times per day.  As of 08/29/2000 the patient had minimal morning stiffness.  She did have somepain and swelling of her hands but now only on her right.  Her most active joint was her third PIP.  The patient had reported that overall her hand swelling and pain has slowly diminished on Plaquenil.  She was seen at the NIH for a Lyme study.  As of 04/29/2000 the patient was also taking the following medications: metoprolol succinate (Toprol), conjugated estrogens (Premarin), glucosamine and chondroitin sulfate double strength (Cosamine DS) two per day, vitamin E, fish oil, aspirin and calcium.  Laboratory data received documents the following: 11/24/1999 antinuclear antibody (ANA) was 1:80 homogenous pattern, sedimentation rate was 7mm/hr., Rheumatoid factor was negative, bone morphogenic proteins (BMP) was normal, CBC without platelets was normal, 06/08/2000 urinalysis was negative, ANA positive 1:60 speckled and homogenous pattern, human leukocyte antigen (HLA) B27 was negative, Rheumatoid (NOS) - negative, CMP (NOS) was normal, uric acid 4mg/dl, CBC and platelet count was normal, sedimentaion rate was 4mm/hr, lymphocyte count was normal, thyroid stimulating hormone (TSH) was 2.3uU/ml, 07/14/2000 sedimentation rate was 7mm/hr, ANA was once again 1:60 homogenous patter, anticardiolipin antibodies negative, rheumatoid factor-negative, rapid plasma regain (RPR)-non reactive; hepatitis panel-negative, human immunodeficiency virus (HIV)-negative, HLAD4-positive, chemistries, TSH(NOS) and CBC were normal.  There was a question whether Lyme antibody test was positive.  It was reported that a follow up Western Blot was negative. On physical examination the patient had normal range of motion of her cervial spine, shoulders, elbows, wrists, and hands without rynovitis or deformities.  Hands: the left hand showed some tenderness over the PIP's without synovitis, second DIP bony enlargment bilaterally, most notable is the right third PIP which shows 1+ synovitis.  The patient had mildly diminished grip strength.  According to the physician's assessment of 008/29/2000, the patient was a generally healthy woman who developed signs and symptoms of osteoarthritis followed by an inflammatory arthritis of her hands, particularly of the right third PIP.  She has been seronegative with normal inflammatory markers.  She has had a low positive ANA without other symptoms of a connective tissure disorder.  There was soon initial question as to whether or not she had been exposed to lyme disease, however, follow up labs were negative for active Lyme disease.  Because of the patient's bilateral symptoms in the small joints of her hands, HLAD 4 positivity, and her response to Plaquenil, it did appear most likely that her diagnosis was seronegative rheumatoid arthritis.  The physician still wonders about the positive ANA in association with other specific autoantibodies.  The patient does not have sicca symptoms.  She has no other suggestion of psoriatic arthritis or pseudogout.  She has been screened for typical infectious or metabolic causes of the hand joint symptoms.  The plan was to further characterize the ANA with specific autoantibodies, discuss the diagnosis and management of rheumatoid arthritis, eye exam (already done), continue Plaquenil therapy for the next few months and if the right third PIP continues to be swollen, consideration would be given to a corticosteroid injection and/or a change in the disease modifying antirheumatic drug therapy.  The patient was to see the physician for follow up in three months.  The most recent information received on 10/20/2000 reports the outcome of the adverse events as not resolved.  The events of 'rheumatoid arthritis and osteoarthritis' do not meet ICH serious criteria, but are being submitted as an expedited report by special request  per the 06/28/2000 letter.  The initial section of this report was submitted on 09/21/2000."