Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Alanine aminotransferase increased, Alopecia, Antinuclear antibody positive, Arthralgia, Blood lactate dehydrogenase increased
Clinical narrative: On 4/19/99, the pt received her 1st Lymerix vaccination with no untoward effects. On 5/19/99, she received her 2nd dose. After 2-3 weeks, she experienced a rash which worsened. The rash was hive-like, ecchymotic, purpuric, burned and was eventually biopsied on 8/24/99. She was dx'd with leucocytoblastic vasculitis and was treated with a shot of cortisone and a 6 day supply of prednisone. After the corticosteroid therapy ended, her condition worsened. She was given prednisone. "In general, she felt more fatigued and had malaise more than usual". She did not improve much but developed joint pain on 9/15/99. She was dx'd with rheumatoid arthritis in 9/99. Prednisone was increased to 60mg/day and hydroxychloroquine 400mg was started. Prednisone was tapered to 20mg/day, hydroxychloroquine was stopped and methotrexate 7.5mg/week was begun on 10/29/99. Her rash returned while on 30mg of prednisone and she still had sever joint pain. The methotrexate was increased to 15mg/week. She still had pain in her knees, ankles, knuckles, wrists, elbows and fingers. A rheumatology consult on 5/12/00, revealed the pt's joint symptoms were improving, but she still had a return of small spots of vasculitis on her arms and legs. The pt reported to the rheumatologist that she was told by a Lyme disease specialist, "she had a vaccine induced vasculitis but the Western Blot suggested Lyme disease as well". The pt was placed on Biaxin 500mg 2X/day. The information received reported the symptoms were ongoing. The adverse event of leucocytoblastic vasculitis is considered "Medically Serious". F/U report revealed degenerative changes most marked C4-5 and C5-6 with disc space narrowing, 3/10/97 MRI revealed herniation of the nucleus pulposus and reversal of the normal lordotic curvature of the spine at C4-5. The chircopracter's diagnosis were cervical subluxation, degeneration of  cervical intervertebral disc, cervical sprain/strain, radicultitis. The pt was treated with hot/cold packs, electric muscle stimulation and chiropractic adjusting.F/U over the past year the pt had complained of fatigue, headaches and lightheadedness. F/U On that date epstein-Barr virus (EBV)-VCA Igm titer vas 0.01, EVB+V-VCA IgG titer was 3.14 and EBV nuclear antigen IgG titer was 6.24. The lab reported that these titers were consistent with past infection. That day, a Lyme Elira was 0.09 and a Lyme Igm was 0.07. Medical records from an endocrinologist were rec'd on 4/4/01. On 6/8/99, the pt was seen by an endocrinologist for complaints of fatigue and light headedness associated with nausea, a weight gain of 10 pounds over the past year despite good effort with diet and exercising. preponderance of abdoninal obesity, headaches, mild depression and inability to concetrate. No mention of rash was made by the pt. On exam, the endocrinologist noted that the pt had some mild facial fullness as well as some supraclavicular fullness. There was some slight increase in downy facial hair.. The skin appeared to be of normal texture and temperature. The doctor stated it is my sense that the pt's complaints probably do not have an endocrine basis. However, the pt has enough soft signs and symptoms of cortisol excess to be screened fpr Cushing's syndrome. I have also requested a glucose tolerance test because of the family history of diabetes and  ? suggestion that some of these symptoms may be related to hypoglycemia. A dexaathasone suppression test performed 6/11/99 was interpreted as normal. A five hr glucose tolerance test performed 6/22/99 was negative. Medical records were rec'd from the pt's gyn dr on4/4/01. at a 11/7/00 office visit the pt reported tha she had been diagnosed with Lyme disease. At that time, she reported that she was beigh treated with cefuroxima (Ceftin) 1000mg daily. F/U on 12/6/99 the pt reported to her rheumatologist that she had increased hair loss, thinning skin. In addition an old psoriatic lesion was active. Her skin lesions were improving. Her prednisone dosage was decreased from 25mg daily to 22.5 mg daily. The methotrexate dosage was maintained at 15 mg weeksy. The folate dosage was increased from 1mg daily to 2mg daily. 12/29/99 the pt reported that she was experiencing pain in the  buttock, which radiated down her leg. She also experienced increased pain in her elbows and knees. She reported that she had consulted chiropractor, she was instructed to take tylenol, apply ice to the affected areas and increase her prednisone dosage if she did not feel better after one day. On 12/30/99 the pt called regarding her prednisone dosage, which was 20 mg daily. She was doing better the dr instructed her to continue to take prednisone 20 mg daly. On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "has been diagnosed with arthritis, and leukocytoclastic vasculitis. She has suffered from moderate to severe joint pain and inflammation in her knuckles, knees, and hip. In addition, she has suffere from rashes, severe fatigue, cognitive difficulties and vision loss, as well as reflux caused by the medications for the above symptoms. The most recent info received on 02/1/2002 did not provide the outcome of the pt. The pt initially reported that she was a non-smoker, medical records indicated that as of 11/30/87, she smoked one pack of cigarettes per day. The medical history included otervcium of the left eye (10/14/98), "severe" dishydrotic eczema. Surgical history included hysterectomy (1983), cholecystectomy (1987), and bilateral carpal tunnel surgery (1991). Follwing the reported onset of vasculitis, the pt experienced seborrheic keratosis with features of solar keratosis on her forehead, granulomatous dermatitis secondary to a ruptured follicular cyst on her right forearm and basal cell carcinoma on her lower back. These events were not reported as adverse events due to vaccine administrations, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. Concurrent medications included Menalog 80mg IM, cephalaxin 1000 mg daily, Lac-Mydrin lotion, Ultravatel cream, Tenovate, Cordran Topal, Diprolene, Salmaterol and Flvent. The pt was scheduled to be seen by her dermatologist on 06/24/1999; the pt cancelled the appointment. The pt was seen by her dermatologist on 07/13/99 for follow-up of "severe" dishydrotic eczema. At that time, the pt reported that "she has noted increased fragility of her skin on arms and legs which I believe is secondary to systemic steroid treatment." No mention of the hive-like rash, ecchymosis, or purpura was noted in the dermatologist's records. On 08/23/99, the pt's rheumatologist contacted the pt's dermatologist to request that a skin biopsy be performed. The rheumatologist staes he believes the pt was sustaining a cutaneous vasculitis of arms and legs. The pt presented to the dermatologist on 08/24/99. She reported that the vaccine provider had given her an IM injection of Cortisone and a Medrol dosePak on 07/28/99. The dermatolotist performed a 3mm Keyes punch biopsy of the dorsal right forearm. The pathologist's diagnosis was "Subtle small vessel vasculitis with nuclear dust, from right dorsal arm. Note: although these changes are exceptionally subtle, as there is nuclear dust, a tad of fibrin, purpura and a mixed cell infiltrate, this is probably a very early expression of leukocytoclastic vesculitis." On 08/30/99, the pt told the dermatologist that her rheumatologist "placed her on Prednisone 60mg BID and her legs have improved but arms have not. She states the medication is making it impossible for her to sleep an she is having significant joint pains." The pt returned to the dermatologist on 11/30/99. At that time, her prednisone dosage was 25mg daily "She was given Plaquenilf or about one month which was not helpful and on 10/15/99 she was started on MTX which has now been increased to 15mg a week. She is still having problems with sleeping but her joint ain in her ankles are better and she seems t have more energy. She is also on Prilosec. The pt sought a second opinion and was told that everything that we being done for her was correct. All of her blood tests come back completely negative. The only thing she can attribute sher vasculitis to is a Lyme vaccination performed April and May 1999." The pt was examined by her ophthalmologist on 12/10/99 who noted "early cateracts-steroid induced." The pt returned to her dermatologist on 07/25/00 for treatment of dishydrotic eczema, eeborheic karatosis and "body check." The pt stated that "her rheumatoid arthritis got so bad that she had to be in a wheelchair. She states now that after she got the Lyme vaccine she got Lyme disease in September. Her present meds include Methotraxate 2.5mg/week, Ceftin 1000mg QD daily and Bizxin 500mg QD." No mention of leucocytoclastic vasculitis was made at that time. The pt returned to her dermatologist for skin checks on 09/11/00, 09/19/00, 10/02/00, 10/16/00, 11/07/00, 11/14/00 and 11/20/00. No mention of leucocytoclastic vasculitis was made in the dermatologist's office notes on any of those dates. On 09/11/00, the pt told her dermatologist that "overall her health has improved a great deal recently." The most recent info received on 04/29/02 indicated that the rheumatoid arthritis persisted as of 07/25/00 and caused the pt to require the use of a wheelchair. The outcome of the leucocytoclastic vasculitis, Lyme disease, and cataracts were not provided. This report of rheumatoid arthritis is considered disabling because the pt required the use of a wheelchair. The pt saw her gastroenterologist on 09/06/00. He recorded, "Now off Prednisone/methotrexate. Since May and Biaxin/Ceftin for Lyme disease."