Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Pain
Clinical narrative: Within 4 days of 2nd dose, pt experienced pains and stiffness in joints of all fingers, both hands, pains in upper arms and stiff neck. Vaccine given 6/99. To date, pt still experiences these pains, although, less severe. The letter from a rheumatologist received on 10/3/00 states, "thank you for referring pt for rheumatologic consultation. I saw pt in my office on 8/12/99. The pt is a 55 year old female who complains of generalized muscle and joint pain. The pt ws well until December 1998 when she was diagnosed ulcerative colitis after presenting with bloody diarrhea. 20 years ago she had a brief episode of ulcerative proctitis but ahs been generally well until this past December. She received Prednisone 40mg daily which was tapered, and her diarrheal symptoms have not returned. She is maintained on Pentasa. She is also maintained on Synthroid for hyperthyroidism. She was generally well with no muscle or joint pain until 6/8/99 when she had her second dose of Lyme vaccine. Four days later she developed sever pain and swelling in the hands and wrists along with an aching in the bending her hands. She states her neck is slightly stiff. She also had some aching in the lower back. She denies rash, dry eyes, dry mouth, fevers of fatigue. She states her appetite is good. She has a long history of Raynaud's pphenomenon but this is mild. She denies eye symptoms. She has never had Lyme disease. The pt's physical exam was significant for a supple neck with full range of motion. Heart, lung, and abdominal exams were normal. Extremities were without edema. Nailbed capillaries were normal. There was full range of motion at all joints without synovitis. There was no specific muscle tenderness. The neurologic exam was normal. No skin rashes were seen. I believe this pt's myalgias and arthralgias are related to the LYme vaccine. I have seen a number of patients who devleoped similar symptoms after receiving a Lyme vaccine, and symptoms persisted for a number of months before resolving. This is differnt than the reports of reactive arthritis which have occurred after Lyme vaccine. These typically occur in genetically susceptible patients who developed frank synovitis after the vaccine, which require more aggressive therapy. I do not believe her symptoms are related to the ulcerative colitis. Despite this pt's low-positive ANA, I do not believe she has lupus or Sjogren's syndrome. The pt was placed on Vioxx 12.5mg daily. She recently had an extensive lab evaluation done by Dr. and I will be reviewing the final results. I will follow her clinically and further treatment will be based on her clinical course. I expect her to improve rapidly and that no other treatment will be necessary. Thank you for placing your confidence in me by referring your pt for consultation. Please call me if there are any questions or I can be of any further assistance."  The follow up received on 7/9/02 states medical history included allergy to sulfa, ulcerative colitis, hemorrhoids, inflammatory bowel disease, hyperlipidemia, hemorrhoids, hypothyroidism, fibroids, ulcerative proctitis, Raynaud's phenomenon, sinusitis, upper respiratory infection, postnasal drip, viral pharyngitis, viral illness, bronchitis, scoliosis with lumbago, spastic diverticulosis, skin lesions, endocervical polyp, and osteopenia of left hip and left femoral neck. Surgical history included multiple clonoscopies with biopsies, sutures below left eye, total abdominal hysterectomy, laparoscopy, and dilatation and curattage. Concomitant medications included Evista, Pentasa, Synthroid, and Premarin. On 5/5/99, hte pt received her first injection with Lymerix at an unspecified dose for prophylaxis. She immediately experienced a sore arm at the injection site, which resolved in 3-4 days. On 6/8/99, the pt received the second dose. On 6/10/99, the pt had pain in all her joints of her hands and had upper arm achiness. Blood work was done including lupus antibody test, all of which were negative. No treatment was given. After the reported onset of arthralgia, the vacicnee was diagnosed with focal active colitis, hyperparathyroidism, pharyngitis, sinusitis, and "chostrochondronodrlaris helices." These events were not reported as adverse events due to vaccine administration, but were found during the review of the vacicnee's medical records. The following info was obtained from medical records. On 6/7/99, the vaccinee was seen by her gynecologist. The vaccinee was prescribed Evista. On 7/27/99, Lyme IgM Western blot was "negative" and Lyme IgG Western blot was "indeterminate, 41, 45, 66 kD bands were present." On 8/27/99, the vaccinee's rheumatologist wrote a letter to her internist. THe rheuamtologist noted he had a consultation with the vaccinee on 8/12/99. He wrote, "The pt is a 55 year old white female who complains of generalized muscle and joint pain. The pt was well until December 1998 when she was diagnosed with ulcerative colitis after presenting with bloody diarrhea. 20 years ago she had a brief episode of ulcerative proctitis but has been generally well until this past December. She received Prednisone 40mg daily which was tapered and her diarrheal symptoms have not returned. She is maintained on Pentase. She is also maintained on Synthroid for hypothyroidism. She was generally well with  no muscle or joint pain until 6/8/99 when she had her second dose of Lyme vaccine. Four days later she developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thigh. The pt feels very stiff in the morning and describes difficulty bending her hands. She states her neck is slightly stiff. She also has some aching in the lower back. She denies rash, dry eyes, dry mouth, fevers, or fatigue. She states her  appetite is good. She has a long history of Raynaud's phenomenon but this is mild. She denies eye symptoms. She has never has Lyme disease. The pt's physical exam was significant for supple neck with full range of motion. Heart, lung and abdominal exams were normal. Extremities were without edema. Nailbed capillaries were normal. There was full range of motion at all joints without synovitis. There was no specific muscle tenderness. THe neurologic exam was normal. No skin rashes were seen. I believe this pt's myalgias and arthralgias are related to the Lyme vaccine. I do not believe her symptoms are related to the ulcerative colitis. Despite this pt's low-positive ANA, I do not believe she has lupus or Sjogren's syndrome." The pt was prescribed Vioxx 12.5mg daily. On 10/9/99, bone densitometry revealed the following impression, "At the left hip and left femoral neck, there is diminished bone mineral density with severe osteopenia at the femoral neck and generalized milder degree of osteopenia at the rest of the hip. Compared with the previous examinations, there has being a statistically significant decrease in the bone mineral density is borderline on the osteopenic range and is lower limits of normal for pt's age. There has being an overall slight decrease in the bone mineral density at the lumbar spine compared with the previous examinations and this is statistically significant." On 12/8/99, the vaccinee telephoned her gynecologist's office. She stated she has felt "achiness in neck and arms since she started Evista." The vaccinee was instructed to stop Evista for two weeks to see if she felt better, if not she was on telephone the office. Various types of Lyme IgG Western blot analyses were performed on 10/24/01. The laboratory's overall interpretation was "no evidence of seroreactivity beyond that expected from the Lyme vaccine." In a Statement of Injuries, her attorney alleged that the vaccine "suffers from myalgias and arthralgia secondary to vaccinatio with LYMErix, which manifests itself in pain and swelling in multiple joints. In particular, she experiences pain and swelling in the joints in her hands, and wrists, as well as pain and aching in her back, arms and thighs. She also expereinces pain and stiffness in her neck." Information received on 8/23/99 reports the symptoms have lessened significantly. The most recent info received 7/9/02, did not provide the outcomes of the reported events. The adverse events "arthralgias," "myalgias," and "joint swelling" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.