Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Irritability, Laboratory test abnormal, Mood altered, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Report A0362494A describes the occurrence of inflammatory arthritis in a 53 year old male who received Lyme disease vaccine recombinant OspA. This report was received as part of litigation proceedings, with forwarding of medical records. Medical history prior to diagnosis included an appendectomy, back pain, cough, pneumonia (1997), difficulty sleeping, nausea, headache, epicondylitis (diagnosed in April, 1997), generalized increase in joint stiffness, a laminectomy, leg numbness (diagnosed on 2/27/98), olecranon bursitis (March 1997), rotator cuff injury (2000), ruptured disc (L3), shingles, and tendonitis. In March 1997, he was found to have a positive rheumatoid factor. This claim does not include small cell lung cancer with pneumonectomy (removal of 1/2 lung) and chemotherapy (diagnosed in May 2000); this info was found in the course of reviewing medical records. Therefore, it is not listed as an adverse event. Following the reported onset of inflammatory arthritis, the vaccinee experienced anxiety (diagnosed 7/6/01), fatigue (diagnosed 9/26/01), heartburn (diagnosed 9/26/01), diverticulosis (diagnosed 9/13/00), hip pain diagnosed 3/31/00)), leg cramps (diagnosed in April, 2000), lumbar puncture (10/30/00), and a thoracotomy (June 2000). These events were not reported as adverse events due 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 vaccinee has no known allergies. Surgical history included knee surgery in 1973 for a torn cartilage and again on 3/28/00. Vaccinee commutes approximately 1 to 1 1/2 hours duration 2 times per day which requires increased sitting which vaccinee reports aggravates right knee and bilateral shoulder pain. Concurrent medications included Famvir. The vaccinee received injections of LYMErix on 3/23/99 (LY120B9), 4/20/99 (LY120B9) and 3/28/00 (LY144B9). Treatment medications included: Vioxx, vicodin, Zantac, Compazine, Biaxin, Plaquenil, Marcaine, Tylenol, Celebrex , Humibid, lorazepam, tetracycline, hydroxychloroquine, Tylenol no. 3, and Anaprox. The vaccinee was seen by the infectious disease physician on 7/8/00. The medical record noted: "Pt is a 52 year old married man and business executive who comes in for further evaluation and management of a vaccine related reaction. Pt has always been in good health, had an appendectomy at age 7 or 8 and some disc issues since 1990. He received his first Lyme vaccien on 3/23/99, his second one 4/20/99 and the third one 3/28/00. The same day as he received his third shot he started to have some hip pain that radiated down into the right knee. His knee continued to have some pain so he saw and an orthopedic surgeon, eventually had some arthroscopic surgery without any significant relief of his knee pain. He also had some shoulder aches that he said he had before that intensified after the third immunization, more on the right side than on the left. He also had some leg cramping and some fatigue since April of this year. He has no headaches, no fevers or sweats, no eye or ear symptomatology, some heart fluttering. He has had more difficulty with his sleep over the past year. He has some twitching on his shoulders that led to getting an MRI that apparently was negative. He also had some stiffness in his neck in the morning and some mood change, some irritability. About a year ago he developed swelling, which he called bursitis in both elbows, but primarily fluid collection bilaterally that did eventually go away. As part of the evaluation hehad a chest x-ray, was found to have a spot on his lung, work-up showed that it was a small cell carcinoma.  He has had a lobectomy five months ago and has been on chemotherapy ever since. Physical examination reveals a pleasant, alert man in no acute distress. His Romberg is negative. Pulse is 72 and regular. Head and neck exam is unremarkable including the fundi showing sharp discs. He had no adenoopathy. His chest is clear. He has a well healed scar in the left axillary area. His heart is without murmur. His abdomen is soft without organomegaly, masses or tenderness.  His genitals are normal male. His extremities are without edema, good ROM. No joint swelling over the knee area. Neurologica is generally physiologic except for some tremors  of both hands. Brief mental exam was normal. My impression is that he has had a vaccine induced activation or reactivation of the Lyme Disease. We do not know of any specific prior tick bite or rash. The so-called bursitis of his elbows might well have been part of the Lyme disease picture. We will get a Lye WB to see if he has evidence of prior Lyme disese and we wil give him a therapeutic trial combining Clarithromycin 500mg and Hydroxychloroquine 200mg bid over the next three months. I will evaluate his progress by email and repeat visit in 2 1/2 to 3 months. My interpretation of the vaccine reactions are that they are related to underlying Lyme disease and we are exploring the possibility that they are antibiotic responsive." On 11/18/00, the pt was seen by the infectious disease physician. The medical record noted: Pt returns after  his initial visit in July for questions of Lyme vaccine related adverse affects. He had some symptoms that occurred after the third injection, with hip pain and subsequently has had leg and shoulder pains that he has never had before. We evaluated him and got a WB that showed IgM reaction to the 31kd protein, IgG reactions to the 20, 23 an 31kd protiens. An MRI that he had showed multiple smal lwhite matter lesions in the right frontal lobe but also on the left consistent with Lyme disease. We started him on a course of treatment initially with a combination of flaquenil and Biaxin. Overall he has improved some, but he is not sure whether that would not have happened anyhow. He has some fatigue. Cognitively he is doing fine, mood-wise he is doing fine. He continues to have some generalized aches, but feels overall fairly well. he is getting radiation to his brain, some chemotherapy for lung small cell carcinoma. We had changed him over three weeks ago to tetracycline and he has not noticed any changes in his symptomatology one way or another. My impression is that he did have some vaccine induced reactivation of Lyme disease. The Lyme WB, especially with the IgM reaction is indicative of ongoing active disease and he had evidence with specific reaction to the 23kd protein of having had exposure to Lyme bacteria. We will continue to tetracycline for a total of three months and then discontinue it at that time and observe him for any relapsing symptomatology." The vaccinee was seen by the infectious disease physician on 2/3/01. The medical record noted: Pt returns last being here on November 18thy. We had initially had him on Plaquenil and Biaxin after his visit in July with some improvement but not complete return to normalcy. We then changed him to tetracycline. He has now been on that for 2 1/2 months, had decided to discontinue it three weeks ago because of some nausea. He also had been completing 18 courses of radiation therapy. The CAT scan of his lungs is apparently clear. Since being off the tetracycline, he is basically about the same. He continues to have fatigue, stiff joints, some less nausea. He has some muscle pains in his thigh. Cognitively he feels fine, mood is fine, but his wife feels that he is somewhat depressed, lacks motivation. My impression is that he still has some residual symptoms of Lyme disease. We decided to go ahead and give him one more course of Plaquenil and Biaxin to see if we can improve any of his symptoms. He will take them over the next 3-4 months and we will evaluate his progress at that time." The vaccinee was also seen by physicians as follows: family physician on 3/1/00 with chief complaint of right knee pain; family physician on 3/4/00 with CC of knee pain; orthopedic physician on 3/23/00 with CC of right knee pain; orthopedic physician on 3/31/00 with CC of back and left hip pain; family physician on 4/11/00 with CC of knee swelling and difficulty bending knee; orthopedic physician on 4/12/00 with CC of bilateral knee pain; shoulder pain; and neck pain; family physician on 4/24/00 with CC of pain in both shoulders; orthopedic physician on 4/25/00 with CC of bilateral shoulder pain and bilateral hip pain; physical therapist on 5/3/00 with CC of significant right knee pain secondary to arthroscopic surgery on 3/28/00 (pt's complaint this date was an inability to lift objects without significant upper extremity pain, right greater than left; pt reports he is not able to perform functional activitie, awakes throughout the night secondary to right shoulder pain, is unable to obtain a comfortable position and one week after right-knee surgery on 3/28/00, bilateral shoulder pain became progressively increased to an intensity of 8 out of 10); orthopedic physician on 5/15/00 with CC of bilateral shoulder pain; family physician on 7/8/00 with CC of some heart fluttering, difficulty with sleeping and twitching on his shoulders; family physician on 9/26/01 with CC of fatigue; family physician on 11/18/00 with CC of fatigue and generalized aches. Family physician's notes of 6/27/00 questions a reaction to the Lyme vaccine; radiation oncologist physician notes of 10/13/00 states, "Possible etiologies of the subcortical white matter lesions may be such things as Lyme disease."