Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Reported on 03/03/2003: "Report A0327080A (formerly 2000015137-1) describes rheumatoid arthritis in a 49-year-old male who received Lyme disease vaccine recombinant OspA (LYMErix).  This report was received from the vaccinee's spouse.  Medical records were forwarded by the vaccinee's attorney.  This report corresponds to VAERS ID 157837.  The medical history included hyperlipidemia, tennis elbow for two years, sinus problem (NOS), allergic rhinitis, penicillin allergy, possible cefaclor (Ceclor) allergy, skin lesions, parvovirus titers "suggestive of an old exposure" (positive IgG, negative IgM), and possible injury of left shoulder and left thumb while hanging a basketball net.  The vaccinee had no history of gout, psoriasis, Crohn's disease, or Lyme disease.  He had no family history of lupus or rheumatoid arthritis.  Concurrent medications included ranitidine (Zantac) 150mg daily at bedtime and omeprazole (Prilosec) 20mg daily.  On 04/01/1999, the vaccinee received his first injectin of LUMErix (lot LY12089), with no untoward effects.  On 04/04/1999, he received his second injection of LYMErix (lot LY120p9).  Approximately eight months after receiving his second injection of LYMErix, in January 2000, he began to experience joint pain.  According to his wife, the pain started in his thumb and progressed to his hands, shoulder, knees, feet, and all joints.  Upon physical examination, his joints were warm and inflammed.  On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain and swelling, especially in his hand, as well as fatigue and stiffness.  He has been diagnosed with arthritis, post vaccine."  The following information was obtained from medical records.  A rheumatology consult on 02/14/2000 revealed the vaccinee had a six-week history of oplyarthritis, which began in his left thumb and shoulder.  "A physician assistant stated it was probably a muscle injury from haning basketball nets."  He contined to have pain with some swelling over the wrists and palms.  "It became erythematous".  he was given celecoxib (Celebrex) and naproxen (Naprosyn), without relief.  It became progressively worse.  He had morning stiffness.  The rheumatologist's impression was "Inflammatory polyarthritis of six weeks duration.  Still the most likely etiology is a prolonged viral arthritis, Parvovirus, adeno, etc.  are all possibilities.  he has had near complete ressolution on a Medrol Dosepak".  Radiology of the left hand on 02/02/2000 showed no findings suggestive of arthritis/arthropathy and/or calcific tendonitis/burstitis.  he had a "weakly positive' rheumatoid factor of 41 IU/mL.  Antinuclear antibody (ANA) titer was negative.  Western blot analyses for Lyme IgG and IgM were negative.  Erythrocyte sedimentation rats (ESR) was elevated at 26 mm/hr.  Phenotyping revealed a positive HLA-827 and HLA-DR4.  His complete blood count (CBC), streptozyme, chemistries, thyroid function tests, and creatine phosphokinase done in the past were normal.  On 02/29/2000, C0reactive protein was within the reference range.  Please see laboratory data section for details regarding diagnostic evaluations.  The vaccinee remained under the care of this rheumatologist until at least 02/05/2002.  On 03/16/2000, the rheumatologist thought the vaccinee had polyarthritis, polyarthalgies, myalgias, and possibly all fibromyalgia with a positive HLA-B27 and weekly positive rheumatoid factor but normal C-reactive protein.  In April 2000, the vaccinee was tapered off medrol and was given amitriptyline (Elavil) 50mg daily at bedtime and indomethacin sustained release (Indocin SR) 75mg twice daily.  On 04/10/2000, the vaccinee reported ringing in ears.  On 07/26/2000, the vaccinee reported to the rheumatologist that he had consulted a rheumatologist at a tertiary care center, who made a diagnosis of palindronic rheumatism.  During this time, the vaccinee reported "migratory arthritis associated with varied intensities with bouts lasting one to three days affecting the knees, hips, ankles, shoulders and neck.  There is some hand stiffness and during the attacks he has frequent urination, with a yellow-greenish color change....The attacks are associated with redness and a difference in color to the limb with some associated with swelling."  The vaccinee also reorted fatigue, nausea, "acute lumbago, night sweats, feeling hot, and "no dramatic response" to methotrexate.  he reported that he was working.  The vaccinee "contined to be concerned that this represents untreated Lyme disease."  The rheumatologist noted progressive synovitis in proximal interphalongeal joints, theumatoid factor 216 IU/mL, and "weakly" pisitive ANA.  By 02/06/2001, ESR and rheumatoid factor were within the reference renges.  The rheumatologist made additional diagnoses of "HLA-B27 positive; probable seronegative spondyloarthropathy acute" (04/13/2000); palindromic rheumatism (08/24/2001); and "Acute right back pain with urin change, question kidney stone or pyelonephritis" (02/05/2002).  On 02/19/2002, magnetic resonance imaging (MRI) revealed degenerative disc disease, disc herniation, and foraminal stenosis in the lumbosacral region.  The rheumatologist prescribed minocycline. pfecpxob (Vioxx), hydrocodone (Vicodin), clonarepam, zolpidem, and carisoprodol (Soma).  As of 02/05/2002, "He was doing well with his inflammatory arthiritis that had virtually resolved after over a year of treatment with minocycline and nightime Klonopin (clonazepam)."  he was taking no medication at that time.  The vaccinee was seen by a theumatologist at a tertiary care center on 04/27/2000.  The chief complaint was "polyarthralgias/polyarthritis".  The history of the present illness was recorded as follows.  "On 01/13/00, the paitnet developed swelling and pain of the left thumb.  After two three days, the patient had pain in the right shoulder.  The next day, which is about six days after it stared, he developed pain in both shoulders.  he went to the walk-in clinic....and he was een by a physician assistant, who gave him Celebrex 100mg daily that was to be taken for one week.  After a week, the patient developed swelling of the right hand and, again, the returned to the walk-in clinic, and the right hand swelling was noted by the physician assistant, who then gave him Celebrex 200mg twice daily.  The right had swelling subsided after two days of taking Celebrex.  After a week, however, the patient developed again left hand swelling, which eventually got better after 2-3 days again off Celebrex.  At this time, laboratory examinations were done which included ESR of 13; APR (rapid plasma reagin) which was negative; a Lyme antibody screen which was negative, ANA was negative; rheumatoid factor was 1.41, interpretation of which was equivocal; and there was a normal serum calcium, as well as free TD (thyroxine).  After two days, however, the patient developed again left hand swelling, and this time he saw his primary care physician...(the physician)requested for some blood work.  Notably, he had a sedimentation rate of 26, a uric acid level of 4.7 and a streptozyme screen, which was negative.  This is because two weeks before all of this happened, sometime in early january, the patient had an episode of a sore throat.  Initially, the patient was given erythromycin plus a Medrol Dosepak.  However, when the test came back negative, erythromycin was stopped.  The patient, again, had improvement in his symptoms.  then after one week the patient again had recurrence of either the elft or the right hand swelling.  He was then sent to see (a rheumatologist)...and he did some blood work examinations, which are the following: CBC was normal, ANA was negative, Double stranded peroxidesc antibody were negative.  Theumatoid factor was 1.42.  L1 and C4 were normal.  Lyme essays were negative.  C-reactive protein wasnormal.  HLA-B27 was positive.  the Parvovirus IgG was positive, but the IgM was negative.  At the time of examination, however, according to (the rheumatologist's) notes, there was no active synovitis.  At the time, the consideration was still an inflammatory polyarthritis, probably of a viral etiology.  However, the patient contined to have 2-3 days of monoarticular arthritis involving either the shoulder, the hand, and the wrist, and now at this time had involvment of either knee and the feet.  All episodes, however, would only last for at most 2-3 days.  When he was seen next by (the rheumatologist) of March 2000, he was taking Medrol, and his physical examination contined to be negative.  The patient related however, that whenever he goes to see (the rheumatologist) the swelling of his joints would abate.  With all of this, the impression now of (the rheumatologist) was changed from polyarthritis/polyarthralgias to that of fibromyalgia, and he was started on 10-20mg of amitriptyline in the evening."  On review of systems, the reheumatologist noted "The patient sleeps well and has some days when he would have morning stiffness for about 30 minutes to 1 hour.  He denies any skin rash, dry eyes or dry mouth, inflammatory eye symptoms, diarrhea, urinary symptoms, and back pain."  At the time of the evaluation, the vaccinee was taking indomethacine sustained release 75mg twice daily, amintriptyline (Elavil)50mg daily at bedtime, and ranitidine (Zantac) 150mg daily at bedtime.  On physical examination, "Musculoskeletal examination only showed tenderness, as well as swelling of the CMC (carpam metacarpal)joint on the left.  All other joints had no active synovitis and has full ranges of motion.  Back examination showed no limitation of spinal movement.  No percussion tenderness."  The rheumatologist's assessment was "With the episodic swelling of one or two or three joints, involving mostly the hands, shoulders, knees and the feet, which would abate after 2-3 days, we are more inclined to think of a palindromic rheumatism.  With the added information that he has a weakly reactive rheumatoid factor, this could be the beginning of a rheumatoid arthritis".  the rheymatologist prescribed methotrxate 10mg once weekly, and a rapidly tapering course of methylprednisolone for every flare.  The vacinne was seen again by the rheumatologist at the tertiary care center on 06/01/2000.  The rheumatologist noted that ESR measured after the 04/27/2000 visit was 27mm/hr.  Rheumatoid factor measured after the 04/27/2000 visit was 1:320.  Since the last visit, the vaccinee "had two episodes of joint pains one on 04/30/2000 and the next one was about two weeks ago.  He also says he could not get out of bed, and he had to take Medrol...He also narrates that he notices that he has difficulty swallowing...He also compaines of some burning sensation in the anterior chest area....Teh general physical examination was benign.  the musculoskeletal examination showed no active synovitis.  The joints had full range of motion.  Indeed, (the vacinne ) is clinically manifesting a case of rheumatoid arthritis.  Today we recommended he continue his methotrexate, and in fact, we increased it to 15mg once weekly."  ESR measured after this visit was 14mm/hr.  A variety of aerologies for Lyme disease were performed on 10/31/2001.  the laboratory's overall nterpretation was "no evidence of seroreactivity beyond that expected from the Lyme vaccine."  Following the reported onset of rheumatoid arthritis, the vaccinee experienced tinnnitus; difficulty swallowing; burning sensation in the anterior chest; earache, congestion, and headache; lumbar degenerative disc disease; to vaccine administration, but were found during the course of review of the vaccinee's medical records.  Therefore, they are not listed as adverse events.  The most recent information was received on 04/23/2002.  As of 02/05/2002, the rheumatoid arthritis was "virtually resolved".  The adverse event "rheumatoid arthritis" does not meed ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.