Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Antinuclear antibody positive, Arthritis, Arthropathy, Carpal tunnel syndrome, Fatigue
Clinical narrative: Following a Lymerix vaccine the pt subsequently experienced "inflamed joints". She was seed by a physician specializing in Lyme disease. He ran some studies on her and concluded that she did not have Lyme disease but was having an adverse reaction to the vaccine. As of 4/01 the outcome of the event is ongoing. Per F/U, on 5/10/99, the pt received her 2nd dose of Lymerix. She experienced no adverse event for approx. 4 months. In 9/99, the pt experienced fatigue, stiff neck, "inflammed joints" and right arm and right hand joint stiffness. She was seen by her physician in 1/00, who reportedly made a dx of "possible carpal tunnel syndrome and seasonal allergies". She returned to the physician's office in 5/00, because of increased neck stiffness. In 7/00, the consumer experienced numbness and tingling in her feet with pain. She also experienced "floaters" (NOS). She was treated with doxycycline. Her symptoms continued and she was seen by an infectious disease specialist in 10/00. Doxycycline treatment was continued. In 11/00, she saw a neurologist. He stated the pt "had possible Lyme". In late 1/01, symptoms started to return. She was seen by a rhematologist who dx'd "possible fibromyalgia". In 2/01, the pt's primary physician dx'd the pt with possible Lyme disease or autoimmune disease (NOS). The pt was subsequently seen by a physician who specialized in "Lyme and related disorders". Unspecified tests for Lyme disease were negative. DNA testing was positive which resulted in a dx of autoimmune arthritis. This physician considered the autoimmune arthritis to be "related to vaccine for Lyme". As of 4/30/01, the outcome of the events was unknown. The follow up states that the concurrent medications included nasal medication, methylprednisolone (Medrol dosepak), pseudo-ephedrine HCl (Sudafed), azithromycin (Z-pak), clarithromycin (Biaxin), gualfenasin/phanylephrine (Exgest LA0, erythromycin, sertraline (Zoloft), fexofenadine HCL (allegra D), allergy shots and loratadine (Claritin). She is allergic to penicillin, has seasonal allergies and multiple other allergies (NOS). Concurrent medical conditions included asthma. She has a history of temporomandibular joint disease (onset 4/1/99), recurrent sinusitis (onset 1997), mild infection of right hand due to cat bite (12/17/98), bronchitis, vertigo, nausea, stomach upset, ear pain, chest and ear congestion, depression, heart palpitations, onset pressure and possible irritable bowel syndrome. She was in a motor vehicle accident on 11/18/00. Family hisotry includes lupus (cousin on father's side) and the mother had Meniere's disease. The statement of injuries reported that the vaccinee suffers from joint pain, in particular she experiences burning in her feet, knees, hands and back. She also suffers from fatigue and flu-like symptoms. The following info was obtained from medical records via the litigation process: The vaccinee was seen by her family physician on 4/12/99 still complaining of left ear pain. The physician noted that the vaccinee requested to be given Lyme vaccine and the first LYMErix shot was given. In addiitona the vaccinee was prescribed Z-pak and was to continue with nasal medication (NOS) and pseudoephedrine HCL (Sudafed). The physician noted that if worses in one month then refer for allergy testing. The vaccinee's family physician wrote a note, dated 4/14/99, to the vaccinee's employer stating that the pt was experiencing fatigue secondary to sinusitis and should be excused from work until 4/19/99. The vaccinee was seen by her family physician on 5/10/99 and was given her second Lyme vaccination. Progress note of family physician on 7/23/99 noted that a MRI had been ordered by the allergist due to the vaccinee's sinusitis. The vaccinee was seen by her family physician on 1/22/00. She complained of a lump on her right hand, second finger, onset three days ago. The physician noted that it was a 3mmx2mm ganglion cyst, non tender. The avccinee was seen by a behavioral health center on 3/14/00. She was diagnosed with adjustment disorder with mixed emotional features and dysthymia. She was prescribed Zoloft 100mg daily. The vaccinee was seen by her family physician on 7/24/00. She complained of ongoing fatigue for the previous two to three months. The physician noted that the vaccinee had "been off periods regular... has had no aches or fevers, no thyroidmegaly" and that her impression was "fatigue of uncertain etiology." She scheduled the vaccinee for complete blood count, thyroid stimulating hormone, T4, chemical panel and sedimentation rate. The vaccinee was seen by her family physician on 8/7/00 complaining of flu-like signs and symptoms of tingling in the arms and legs and continued tiredness. The family physician noted that the vaccinee was scheduled the following month on 9/7/00 for "double strand DNA, C3, C4 and CHSO." Neurological exam was "intact" and it was ntoed that the pt was to get a MRI of the brain and x-ray of spine and" may need to see neurology." The vaccinee was seen for follow up by her family physician on 8/16/00. At this visit the vaccinee had been on doxycycline for one week and was "doing better about 40%. The tingling and numbness had decreased. Better when not at work." The vaccinee reported to the physician that she is "convinced she has lyme based on her feelings." The physician's impressions were "fatigue and malaise-pt referred to an infectious disease specialist and rheumatologist, MRI of brain revealed a questionable small lspot of no clinical concern, positive ANA." The vaccinee was seen by the infectious disease specialist on 8/18/00 (initial consultation). "vaccinee with history of reactive airway disease, allergies to dust, mites and molds. She has been sick for about two months but has had a worsening course over the last three months. She hikes with her dog in the state park, she has joint pain, muscle pain, tingling in her hands and feet, pain in her neck and pains in her hands and knees. She has decreased concentration. She has had some dry eyes and dry mouth and has had some abdominal pain over three weeks. She has been treated with doxycycline for one week and is not sure that it is helping. She is taking Xanax for sleep. She has a family history of allergy but no other diseases. She does not recall a specific tick bite but did have perhaps an atypical rash. Head and neck exam is normal. There are no real joint changes. Neurological exam is grossly intact. Lab exam includes MRI of the brain which is normal except for possible small abnormality next to the mastoid tip. An anti-DNA is negative. ANA is positive in a titer of 1:160 in an homogenous and speckled pattern. Thyroid testing is normal, x-ray shows mild narrowing in the lumbosacral joint. Lyme Western blot index is positive. Lyme EIA is negative. White count is 6.0 hemoglobin is 12 and platelets 207,000. Chemistries are normal. The pt has a history worrisome for Lyme disease but also worrisome for autoimmune disease with a positive ANA and dry eyes. Her hisotyr is a bit confusing. I will give her a month of doxycycline and recheck her labs, including the ruine antigen, Western blot, and the ANN. I am going to get a Schirmer's test, ES-A and SG-B looking for Sjogren's. I think she should be evaluated by neurology because of her specific symptoms and concerns. I will give her Clinpril for pain control and Flexeril to help her with sleep. The vaccinee was seen by a ear, throat and nose specialist on 9/16/00 for left ear pain. He noted that she "has Lyme disease." The vaccinee was seen for follow up by the infectious disease specialist on 10/5/00. The vaccinee was seen by her family physician on 11/21/00 following a motor vehicle accident on 11/18/00. At this visit the vaccinee was complaining of neck and low back pain. Family physician medical records noted that the vaccinee was given "tetanus" in Dec-00. Physical therapy consultation dated 1/16/01. The vaccinee was seen for follow up by the infectious disease specialist on 1/18/01. At this visit the vaccinee had been on oral doxycycline for about six months. She reported to the physician that she felt "well' and tha ther symptoms are entirely resolved and her only problem was a little bit of pain in her neck which had been present for some time. The vaccinee was seen for follow up by the infectious disease specialist on 2/8/01. The physician noted that the pt had been off doxycycline for about three weeks and that subsequently her symptoms recurred. The vaccinee reported to him that she had "increased pain in her hands and fingers, has been getting allergy shots and wonders if they may be associated. She has a bit of increased fatigue as well." The physician noted on physical examination that her "looks a bit down, head and neck exam normal, extremities revealed tender joints but no real swelling was noted." The vaccinee was discharged from physical therapy on 2/15/01. The physcial therapist noted that the "pt noted slight improvement in pain levels; however, fatigue noted in low back/Capne at end of day. Vacinee given a HEP of C/L flexability and strengthening. She noted slight improvement in functional activities with therapy; however, she did not follow through with therapy visits." The therapist also noted that physical therapy goals were not attained and that the pt made no progress. The vaccinee was again seen for follow-up with the infectious disease specialist on 3/8/01. Since she has discontinued the doxycycline, she has had episodes of significant fatigue, weakness, and worsening pain in her joints. On 3/9/01 HLA-DR and HLA-DQ phenotyping Lyme disease serology were performed a tthe order of a second rheumatologist. The results reported the detection of DR15, DR13, and DQ5 antigens. Western blots and serum were reported as equivocal. IgG bands 31 and 34 and IgM band 31 wre detected. PCR assayed serum revealed no "OspA gene." The vaccinee was seen by her family physician on 3/20/01. Vaccinee was seeking another referral for a rheumatologist for her Lyme disease. The rheumatologist faxed on 4/2/01 to the family physician handwritten notes; however, no date ws documented on these notes which appear to be the initial consultation. The vaccinee was seen by rheumatologist on 4/3/01 for a flare up with her joints. She reported that she had "burning lasting 1-2 days." The rheumatologist noted "bad arthritis.. long discussion about vaccine/autoimmune disease/long term consequences (unk)... assessment autoimmune disease from vaccine." The vaccinee was seen by the rheumatologist on 3/6/02. She reported that she was "feeling good, stopped taking medication x 2 weeks, said went ok until end of 7 day, getting all symptoms, burning, back on meds just two 1/2 weeks to build up to feel better." The adverse events of autoimmune arthritis and possible carpal tunnel syndrome do not meet serius criteria, but are being submitted as an expedited report by the special request per the 6/28/00 letter.  Follow up 10/10/2002: "On 11/17/2000, the vaccinee returned to the neurologist for follow-up.  He noted "no change" in review of systems and 'no deformities or edema' of extremities.  Subjectively he noted; "Laboratory Date: Normal MRI, CBC, SMAI8.  Positive Lyme titer.  Western Blot negative.  ANA 1-160, thyroid functions normal.  Sedrate, RPR, serum protein electrophoresis normal.'  His assessment was, 'Chronic fatigue syndrome.'  His plan was: "1) At this point I have no further neurological recommendations.  2)  The patient denies any muscle aching or pain or muscle weakness.  I have asked her to continue following with...(infectious disease physician) for chronic Lyme. 3) If her weakness or fatigue increase, she will return to se eme.  4) The patient has recently started Zoloft and then she was feeling like she was becoming more depressed.  I also advised her to return to...(other physician) if her depression increases."