Age: 54.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Arthritis, Oedema
Clinical narrative: This is a spontaneous report from a physician and a RN referring to a 54 year old female and from the pt herself. On 7/1/99, the pt had her 1st dose of Lymerix and on July 3, 1999, she noted pain, swelling and stiffness of bilateral and distal interphalangeal joints and proximal interphalangeal joints without any other joint involvement. There were no systemic symptoms. The pt was evaluated by physician who noted objective joint swelling and initiated treatment with NSAIDS and Advil with little relief. She takes Celebrex, which provided only minimal relief. Pt reported that her dx was rheumatoid arthritis. She continues to experience the symptoms especially in the right hand and is in considerable pain that is causing her difficulty in performing her job. The most recent information, received on 9/13/99, reports the condition of the pt as ongoing. A 15-day follow up report received 5/30/2002 adds: The medical history included possible allergy to sulfa medications manifested by fever and "some scarring suggestive of old TB (tuberculosial)" on her right lung. Theh pt had unexplained fever and fatigue in 1997 that "lasted for a few weeks" and was treated with amoxicillin/clavulanate (Augmentin). On 06/30/1997, the pt telephoned the vaccine provider and reported that she had a fever of 104 degrees F and was very tired; she attributed these events to estrogen replacement therapy she had begun several days prior. The physician thought the events were "probably not related" to the estrogen; however, the pt discontinued it. The pt was seen by the vaccine provider on 07/01/1997 with a history of fever for 3 days, lack of appetite, weakness, body aches, chills and thirst. The physician's assessment was "Rule out Lyme". He prescribed Augmentin 500 mg 3 times daily. Laboratory analyses revealed decreased concentrations of blood urea nitrogen, phosphate and serum iron and decreaesd transferrin saturation. Concentrations of total bilirubin, direct bilirubin, gamma glutamyl transpestidase, espartate aminotransferase, alanine aminotransferase and lactic dehydrogenase were elevated. Lyme IgG and IgM Western blots were negative, with no bands demonstrated. White blood cell count was reduced and there was a left shift. Platelet count was also reduced. On 07/07/1999 the "pt feels great!" The physician noted the increased liver function tests; his assessment was "? viral". On 07/21/1997 all laboratory parameters had returned to the reference ranges. "In the winter of 1998-1999, she developed persistent stiffness in her legs for several weeks." There was no previous history of tick bites, erythema, migrans-like rashes, Lyme disease, or previous arthritic problems. There was no family history of arthritis or systemic rheumatic disease. There was no illness at the time of immunization. Testing for HLA-DR4 was negative. Concomitant medications included vitamin D, calcium and alendronate (Fosamax) 10 mg daily. On 07/01/1999 13:30 the pt received her first injection of Lymerix. Within 3 days post-immunization she noted pain, swelling and stiffness of bilateral distal interphalangeal (DIP) joints and proximal interphalangeal (PIP) joints without any other joint involvement. There were no systemic symptoms. The pt was evaluated by the physician who noted objective joint swelling and initiated treatment with NSAIDs and Advil (ibuprofen) with little relief. The swelling of the hands made it difficult for the pt to move them. Her condition became progressively worse, involving wrists, ankles, back, neck and shoulders. She was treated with celecosib (Celebrex), which provided only minimal relief. She was treated, in addition, with paracetamol (Tylenol), tramadol (Ultram), prednisone and hydroxychloroquine. The pt reported that a diagnosis of rheumatoid arthritis was made. She continued to experience the symptoms, especially in the right hand, and was reportedly in considerable pain that was causing her difficulty in performing her job. She was having "extensive therapy and testing" (NOS). The pt stated that her primary physician believed that the pt's condition was caused by Lymerix. The diagnosis had been confirmed by a specialist. Medical records indicated that the pt telephoned the vaccine provider on 08/03/1999 to report "reaction to Lyme vaccine - both hands are still swollen." The swelling persisted on 08/17/1999 and the pt was referred to a rheumatologist. A member of the vaccine provider's staff telephoned the pt on 09/02/1999 to see if she had scheduled an appointment with the rheumatologist; she had not. "She said she is feeling better - swelling still comes and goes, but it is improving. She said she really is not interested in seing the specialist". The pt returned to the vaccine provider on 09/07/1999, "Now complaining of swelling and pain in hands. Also pain in knees, starting 2 weeks after vaccine date." On examination, the physician noted "definite rheumatoid changes fingers, wrist, knee, ankles. ? RA (rheumatoid arthritis) secondary to Lymerix. Refer to (rheumatologist)." The physician prescribed Celebrex 200 mg twice daily. The pt was seen by the rheumatologist on 09/23/1999. The pt reported that "in July, she had the Lymerix vaccine, one dose, and within several days developed swelling of both hands. She took Advil for 2-3 weeks which gave her some improvement but she then developed swelling of the ankles, knees and severe pain at the balls of her feet and in her hands. She has morning stiffness of about 1-2 hours. She was then changed to Daypro (oxaproxin) which caused stomach upset. One week later Celebrex was started 200 mg daily and she said although this helped the pain she still has problems particularly with the small joints of her hands. For example she has difficulty writing, cannot play the piano and is unable to open jars. The pt is concerned that this may have been an adverse reaction to the Lyme vaccine. The pt stopped Celebrex 2 days ago so that I could evaluate her swelling and pain. She denies any history of previous joint problems. She has had a lot of difficulty sleeping over the last few weeks and months secondary to the pain and in her sleep she describes almost razor-like pain. She has also noted neck and shoulder pain, has a lot of stiffness, some black and blue coloration of the knuckles and swelling almost all day...There is no family history of arthritis or thyroid problems...Review of systems revealed profound fatigue. She has had weight loss though she does not know how much, although she states that her clothes are falling off. She has had low grade fevers and generally feels unwell...Musculoskeletal exam was significant for severe bilateral active synovitis of the MCPs (metacarpophalangeals) and PIPs with decreased range of motion of the shoulders which appeared mostly periarticular. She also has active synovitis of both ankles and a positive MTP (metatarsophalangeal) squeeze. She had pain in the groin on range of motion of the hips. No focal neurologic deficit was noted. I concur completely with (the vaccine provider's) diagnosis that the pt does have rheumatoid arthritis which seems to be severe at this time as mentioned with involvement of both hands, wrists, right elbow, both shoulders, neck, possible ankles and feet. I...have given her samples of Celebrex and Ultran and have suggested that she take Tylenol for the pain. I also gave her a prescription for low dose Prednisone and Plaquenil (hydroxychloroquine)...I am also concerned that the pt may be osteoporotic. She is post menopausal and has not been on supplements. I have suggested that she take calcium 500 mg bid (twice daily) and a multi-vitamin with 400 IU of vitamin D. I share the pt's concern of this relation to the Lyme vaccine". The pt returned to the rheumatologist on 02/21/2000 "for follow-up of her inflammatory arthritis...she has been on 10 mg of Methotrexate once a week. Hydroxychloroquine 200 mg bid, Celebrex 200 mg bid, Fosamax 5 mg daily, folic acid 2 mg daily and calcium carbonate 1600 mg daily. (She) says that she is feeling fine but in fact she still has some stiffness and some swelling of the PIP joints bilaterally to the point where she is having a lot of difficulty being able to close both hands. There appears to be significant tendonitis. Otherwise the rest of her joints seem to be within normal limits...the last blood test I obtained from her was on 2/14/00 and she has new mild elevation of her liver function tests. Her AST (aspartate aminotransferase) was 39 (normal range less than 37), ALT (alanine aminotransferase) 41 (normal range less than 40) and alk phos of 124 (normal range 39 to 120)...I am also somewhat concerned that she has new symptoms of night sweats and as you know, she has some scarring suggestive of old TB on her CT (computed tomography) scan. I have suggested that she needs a PPD (tuberculin purified protein derivative)...I have also suggested that she increase her folic acid to 2 mg daily as she did mention she did have one episode of ulcers in her mouth. The pt was seen by an infectious disease specialist on 06/21/2000 "for further evaluation and management of a Lyme vaccine induced reaction." The pt reported that "in 1997, she had high fevers, a lot of fatigue and sleeping, had a rash of some sort, and multiple rashes, diagnosis of spider bite. She apparently had a Lyme Western Blot done then which was reported as negative. She was treated with some kind of antibiotics. On 07/01/1999 she received her first Lyme vaccine. In 3 days, she started to have swelling of her hands and ankles and she has not been the same since. It progressed and involved her knees, shoulders, swelling of the knees, fevers, sweats, exhaustion, decreased appetite, feeling like there were razors in her veins, and fatigue. She was tested and had a negative DR4 antigen, sedimentation rate in October of 1999 was 50, and rheumatoid factor was negative. She was placed on hydroxychloroquine in September of 1999, 200 mg bid and methotraxate in December of 1999, which she takes once a week along with folic acid. She uses Celebrex 200 mg bid for symptoms and she is also on Fosamax and vitamins...Her current symptoms are continued swelling of the ankles, knees and feet, some in her ankles, stiffness in her right shoulder, stiffness of her hands, nodules that she gets in her neck and foot. She has no headaches, no eye or ear symptomology, no palpitations, no irritable bowel, and no changes cognitively or mood wise." On physical examination, "Her Romberg is negative...Extremities without edema, good range of motion, good muscle strength. She does have some swelling of both knees medially without warmth. Neurologic is physiologic. Brief mental exam was normal except that she forgot 2 of the presidents. My impression is that she has a Lyme vaccine induced probable reactivation of Lyme disease...the reactions that she has as of April 2000 support a previous infection as well as possible ongoing reaction to the 31 KD protein. It seems unusual to have a single injection, continue to have antibodies by both IgM and IgG to the 31 KD protein without having not been there before. As far as any possible rheumatoid arthritis, I don't think that this is the case and would not recommend continuing methotraxate therapy. She is already on hydroxychloroquine and this is a very successful program for us in patients with chronic Lyme disease on that combination plus erythromycin antibiotic. Accordingly, we will add erythromycin 500 mg bid, discontinue the methotraxate and folic acid. She will also discontinue her vitamins at the EMS as we found this might retard treatment success. I will follow the pt by e-mail and repeat visit as necessary. I anticipate needing at least 3 months of treatment with this regimen and if she starts improving we will continue it for another several months and we might change her to tetracycline some time in the fall." In an undated electronic mail message, purportedly to the infectious disease specialist, the pt wrote, "In Dec. 99 and maybe Jan. 00 I remember my heart fluttering for about one minute, also in Feb. 00 I had an occasion of feeling as if I was going to faint that lasted about three minutes...By the second week in July I started a flare up, having more stiffness and feeling more fatigue...The next week I started to get the lumps back on my hands and wrists also I was running slight fevers, hot then chills. I wasn't feeling very well. The beginning of this week I started to feel less sick and a little stronger but Thurs morning 27th again I suddenly felt like I was going to pass out but it passed in about two min. Also from July 10th to the 21 I was having a lot of headaches. That seems to have stopped for now. I have been having a little trouble with loose bowels and stomach queasiness but not enough to be a problem. I have also noticed slight blotches of redness on the inside of my legs below the knees. They do not itch or bother me in any way neither are they raised or bumpy they are just there...I did have a few nights that I wasn't getting much sleep due to the pain so I took an "Ultran 50mg that (another physician) had given me." In another undated electronic mail message, purportedly to the infectious disease specialist, the pt wrote, "I am feeling very good. I only have slight stiffness in my ankles and right knee with just a little swelling, no pain. I still have the lumps on the tops of my hands (near wrists) all other swelling in my fingers appears to be gone although I still can't close my fists completely. My energy level seems to be back to normal and I have been very active...The beginning of September I had a very slight flare up for only 3 days...only 3 dizzy spells, no headache, and some fatigue...I have noticed that I easily break into a sweat with just slight activity...Also (the vaccine provider) took me off Celebrex and put me on Vioxx 25 mg I don't know if I need it because I don't feel any pain, but I keep taking it because of the slight swelling of my ankles." The pt presented to the vaccine provider on 11/30/2000 "for evaluation regarding Lyme arthritis." Medications included doxycycline 100 mg twice daily, Celebrex 200 mg, erythromycin 500 mg twice daily, Fosamax, and hydroxychloroquine 200 mg twice daily. The "pt feels better! Still boggy degenerative changes fingers (DIP, PIP), Dorsym band positive swelling and bogginess but definite improvement with decreased swelling from previous OV (office visit)." The pt returned to the vaccine provider on 02/13/2001 to "discuss Lyme arthritis for a lawyer." The physician noted "swollen, boggy HCP, PIP. Swelling, induration volar aspect bilateral left greater than right. Limited ROM (range of motion) (flex, adduction thumb). Right knee, both ankles - swollen, decreased ROM, positive crepitation. Definite deterioration from previous visit. In an electronic mail message dated 02/10/2001, purportedly to the infectious disease specialist, the pt wrote, "I still have swelling in my ankles and right knee, and the lumps on my upper hands near the wrists." In the beginning of Jan. I experienced several headaches and a stiff neck, but that passed after about a week. The stiff neck came back the beginning of Feb. but no headaches. I have had periodic pain in my knees and ankles but it comes and goers, I don't know if it is weather triggered or not. Energy wise I've been feeling normal and actively pursuing my job...Also I just remembered in Jan. I was having pain in my elbows and shoulders, now once in awhile have it in my elbows, there might be some lumps there (small)." The pt stated that she would soon by finishing doxycycline that the specialist had prescribed on an unspecified date. The pt was seen by a second rheumatologist on 05/04/2001 for evaluation of arthritis. At that time, she reported that within 3 days of receiving Lymerix, "she had developed swelling over the backs of her hands and in her knees and ankles. Pain and swelling progressed to involved her elbows, shoulders, fingers, and hips. The pains have become progressively more severe. She was evaluated by...a rheumatologist...Rheumatoid factor was negative. However, based upon her symmetrical large and small joint arthritis, she made the diagnosis of rheumatoid arthritis and started treatment with Pisquenil and Celebrex. She ordered methotraxate as well...She continued to have joint pain and swelling. Morning stiffness and fatigue were also severe at that time. She was evaluated by...an infectious disease specialist...He apparently made the diagnosis of Lyme disease and treated her with erythromycin 500 mg bid, which has been continued until the present time. He also treated her with doxycyline, 100 mg bid starting in October 2000 and continuing until last week. She has gradually improved over the past several months. She has continued to take Plaquenil but discontinued the methotraxate. She now describes persistent pain and swelling in her hands and wrists, shoulders, elbows, knees and ankles. Morning stiffness is mild, limited primarily to her legs and lasting only about 5 minutes. Her physical energy level is fairly normal now, without significant fatigue. She is still unable to close her fists, in spite of occupational therapy. She uses a Parrofin bath on a regular basis." Under past medical history, the rheumatologist noted that "in 1997, she had persistent unexplained fever and fatigue, which lasted for a few weeks. She was treated with Augmentin. In the winter of 1998-99, she developed persistent stiffness in her legs for several weeks." Medications at the time of the evaluation included erythromycin 500 mg twice daily, hydroxychloroquine 200 mg twice daily, celecoxib 200 mg twice daily, and alendronate (Fosamax) 10 mg daily. Under review of systems, the physician noted "persistent but mild fatigue. She describes weakness only in her hands and arms...She has had some dryness of her mouth. She describes occasional dizzy spells but no definite chest pain or dyspnea. She had had constipation for several months." He also noted that "Her DEXA study was positive." On physical examination, "She has crepitation in both shoulders, which is much more severe on the right. There is no inflammation in the elbows, but she is unable to fully extend the elbows beyond about 175 degrees. There is cystic synovial swelling over the dorsa of both wrists, with mild synovial thickening over the second, third and fifth MCP joints bilaterally and bony thickening over the PIPs. There is cystic swelling in the right popliteal space, consistent with a Baker's cyst. She has osteoarthritic changes in her first and fifth MTPs bilaterally."  The rheumatologist reviewed "multiple laboratory studies. He noted hemoglobin 13.4 g/dL on 07/21/1997, 11.0 g/dL on 12/27/1999 and 12.4 g/dL on 03/20/2000. Ertyrocyte sedimentation rate was 50 mm/hr on 10/22/1999 and 18 mm/hr on 03/20/2000. A test for HLA-DR4 was negative on 11/09/1999. On 04/11/2000 Lyme ELISA "showed an equivocal IgG level of 1:160 with non-reactive IgM." Western blot demonstrated 31, 50 and 60 kD IgG bands and 31, 41 and 66 kD IgM bands. The rheumatologist considered these results to be "equivocal". He concluded, "(The pt) has a symmetrical, large and small joint polyarticular arthritis. By history, this has been more severe in the past. By history, this arthritis developed within a few days of a single Lymerix vaccine. This suggests an immunologic reactivity to the vaccine. The findings are most consistent with a rheumatoid factor-negative reactive arthritis. She appears to have responded to the Plaquenil.  Lyme disease is much less likely as a potential cause. Lupus arthritis must also be considered, although she does not have any other signs or symptoms of systemic lupus erythematosus...I have recommended she follow-up with (the first rheumatologist), for continued long-term therapy of presumed seronegative rheumatoid arthritis." On 05/10/2001, antinuclear antibody titer and rheumatoid factor were negative. Erythrocyte sedimentation rate was 19 mm/hr. On 05/12/2001, X-rays of the right hand revealed "small bony erosions are noted most pronounced at the 4th PIP and DIP joints and to a lesser extent at the 3rd DIP joint. Subchrondral cyst formation is noted in the distal radius and in the scaphoid and the base of the first metatarsal. Periarticular osteoporosis is suggested." The radiologist's impression was "Bony erosions and subchondral cyst formation as above. The distribution is not absolutely typical for rheumatoid arthritis but the appearance of the erosions and the osteopenia are consistent." X-rays of the left hand demonstrated "small erosions are noted at the 4th PIP and DIP joints and the 2nd DIP joint. Subchrondral cyst formation is noted in the distal radius and ulna and in the scaphoid. Periarticular osteopenia is suggested." The radiologist's impression was "Bony erosions as above. The appearance is consistent with rheumatoid arthritis although visualization is not typical." In an electronic mail message dated 05/24/2001, purportedly to the infectious disease specialist, the pt wrote, "Since I stopped the Doxycycline, within about 3 to 5 days I went immediately into a flare up, swelling and some pain in my feet top and bottom by my toes, ankles, and the back and front of my knees, some pain in my elbows and a lot of crunching in my neck (although the neck thing has been going on for a couple of months), now this week I think I'm starting to get some slight swelling in my hands. At first I thought this might be one of those monthly flare ups of the lyme that would pass quickly but it isn't going...Also I wanted to let you know that my lawyer sent me to see a (rheumatologist). This man kept trying to tell me I had RA (rheumatoid arthritis) of course he is an MA doctor...he did prescribe some tests...One was a anti nuclear test to see if my immune system had been triggered for RA or lupus...(negative) and then a comparative X-ray of my hands from the previous X-ray of 1999. (The vaccine provider) said that showed classic bone determination (sic) from RA." On 10/08/2001 the pt presented to the vaccine provider, stating that her "lawyer request new Lyme Western blot sent to (a particular) lab. Pt still has swelling wrist, decreased finger joints. Positive bogginess ankles. ?obtain synovial fluids ankle to check Lyme." On 10/30/2001, various Lyme serologies demonstrated "No evidence of seroactivity beyond that expected from the Lyme vaccine." The most recent info, received on 05/14/2002, indicated that the rheumatoid arthritis persisted as of 10/08/2001. On a VAERS report completed by the pt, she indicated that the event was disabling; thus this case has been upgraded to serious. The most recent information received on 5/22/00 reports the condition of the pt as ongoing. VAERS report indicates that the event was disabling, thus, this case has been upgraded to serious. A 15-day follow up report received 4/11/2002 adds no new info. The follow up received on 2/13/02 describes rheumatoid arthritis in a 54 yea rold female who received an injection of LYMErix vaccine. The medical history included possible allergy to sulfa medications manifested by fever. The vaccinee had unexplained fever and fatigue in 1997 that "lasted for a few weeks" and was treated with Augmentin. "In the winter of 1998-1999, she developed persistent stiffness in her legs for several weeks." There was no previous hisotyr of tick bites, erythema migraine-like rashes or previous arthritic problems. There was no family history of arthritis or systemic rheumatic disease.  Concomitant medications also included Fosamax 10mg daily. The vaccinee was seen by a rheuamtolgoist on 5/4/01 for evaluation or arthritis. At that time, she reported that within three days of receiving LYMErix, "she had developed swelling over the backs of her hands and in her knees and ankles. Pain and swelling progressed to involve her elbows, shoulders, fingers, and hips. The pains have become progressively more severe. She was evaluated by a rheumatologist. Rheumatoid fafcotr was negative. However, based upon her symmetrical large and small joint arthritis, she made the diagnosis of rheuamtoid arthritis and started treatment with Plaquenil and Celebrex. She ordered methotrexate as well. She continued to have joint pain and swelling. Morning stiffness and fatigue were also severe at that time. She was evaluated by an infectious disease specialist.  He apparently made the diagnosis of Lyme disease and treated her with erythromycin 500mg bid, which has been continued until the present time. He also treated with doxycycline, 100mg bid starting in October 2000 and continuing until last week. She has gradually improved over the past several months. She has continued to take Plaquenil but discontinued the methotrexate. She now describes persistent pain and swelling in her hands and wrists, shoulders, elbows, knees and ankles. Morning stiffness is mild, limited primarily to her legs and lasting only about five mintues. Her physical energy level is fairly normal now without significant fatigue. She is still unable to close her fists, in spite of occupational therapy. She uses a Farrafin bath on a regular basis. Under past medical history, the rheumatologist noted htat "in 1997, she had persistent unexplained fever and fatigue, which lasted for a few weeks. She was treated with Augmentin. In the winter of 1998-1999, she developed persistent stiffness in her legs for several weeks. Medications at the time of the evaluation included erythromycin 500mg twice daily, hydroxychloroquine 200mg twice daily, Celebrex 200mg twice dialy, and Fosamax 10mg daily. Under review of systems, the physician noted "persistnet but mild fatigue. Seh describes weakness only in her hands and arms. She has had some dryness of her mouth. She describes occasional dizzy spells but no definite chest pain or dyspnea. Seh had constipation for several motnhs." He also noted that "her DRXA study was positive." On physical examination, "she has crepitation in both shoulders, which is much more severe on the right. There is no inflammation in the elbows, but she is unable to fully extend the elbows beyond about 175 degrees. There is cystic synovial swelling over the dorsa of both wrists, with mild synovial thickening over the second, third, and fifth MCP joints bilaterally and bony thickening over the PIPs. There is cystic swelling in the right popliteal space, consistent with a Baker's cyst. She has osteoarthritic changes in her first and fifth MPT's bilaterally. The rheumatologist reviewed "multiple" lab studies. He noted hemoglobin 13.4g/dL on 7/21/97, 11.0g/dL on 12/27/99, and 12.4 g/dL on 3/20/00. Erythrocyte sed rate was 50mm/hr on 10/22/99 and 18mm/hr on 3/20/00. A test for HLA-DR4 was negative on 11/9/99. On 4/13/00, Lyme ELISA "showed an equivocal IgG level of 1:160 with non-reactive IgM." Western blot demonstrated 31, 50 and 60KD IgG bands and 31, 41 and 66 kD IgM bands with non-rreactive IgM. The rheumatologist considered these results to be "equivocal." He concluded, "The vaccinee has a symmetrical, large and small joint polyarticular arthritis. By histoy, this has been more severe in the past. By history, this arthritis developed within a few days of a single LYMErix vaccine. This suggests as immunologic reactivity to the vaccine. The findings are most consistent with a rheumatoid factor-negative reactive arthritis. She appears to have responded to the Plaquenil. Lyme disease is much less likely as a potential cause. Lupus arthritis must also be considered, although she does not have any other signs or symtpoms of systemic lupus erythematousus. I have recommended she follow-up ith the first rheumatologist, for continued long-term therapy of presumed seronegative rheumatoid arthiritis." On 5/10/01, antinuclear antibody titer and rheumatoid factor were negative. Erythrocyte sed rate was 19mm/hr. On 5/12/01, x-rays of the right hand revealed "small bony erosions are noted most pronounced at the fourth PIP and DIP joints and to a lesser extent at the third DIP joint. Subchondral cyst formation is noted in the distal radius and int he scaphoid and the base of the first metatersal. Periarticular osteoporosis is suggested. The radiologist's impression was "Bony erosions and subchondral cyst formation as above. The distributions is not absolutely typical for rheumatoid arthritis but the appearance of the erosions and the osteopenia are consistent." X-rays of the left hand cyst formation is noted in the distal radius and ulna and in th escaphoid. Particularly osteopenia is suggested." The radiologist's impression was "bony erosions as above. The apparance is consistent with rheumatoid arthritis although visualization is not typical." The most recent info, received on 2/13/02, indicated that the rheumatoid arthritis persisted as of 11/4/01. On a VAERS report completed by the pt, she indicated that the event was disabling; thus this case has been upgraded to serious.