Age: 76.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Laboratory test abnormal, Myalgia, Rash, Rheumatoid arthritis
Clinical narrative: The pt reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the pt  "has suffered from debilitating joint pain and swelling in her knees, shoulders and left hand. In addition, (she) has suffered from rashes, flu-like symptoms, fatigue and headaches". Time to onset following immunization, treatment and outcomes of the alleged events were not reported. This report of "joint pain", "joint swelling" and "headaches" is being submitted as an expedited report by special request per the 6/28/00 letter. The follow-up received states the medical history which included bilateral angle closure glaucoma, bilateral cataracts; pseudophakic bullous ketatopathy of the right eye (1995) right posterior vitreous detachment (1999), and "probable optic nerve drusen" in the right eye (1999). The surgical history included right trabeculectomy (1972), right cataract removal (1972), left peripheral iridectomy (1972), right penetrating keratoplasty (1995), and right corneal transplant (1995). The most recent info received on 4/3/02, did not provide the outcomes of the reported events. The follow up report states that the pt also has a medical history of chronic cough, allergy to ragweed and "several other", allergy to dust mite, and allergy to "several molds." Concurrent medications included Prozac, Trantal, Zocor, and "blood pressure medications including diuretios" for unspecified indications. Concurrent medications also included Allegra and budesonide nasal spray for the treatment of allergy symptoms. The follow up states the medical history also included anxiety, past tobacco abuse, allergic conjunctivitis, allergic rhinitis, corneal arosion (1995), head confusion (1988), hoarseness, benign calcifications of breast, "probable tings pedis" (1996), appendectomy, arthritis, bladder spasm, bronchitis, calcification of breast, chronic sinusitis, claudication, contact dermatitis, contusion of elbow, cranial contusion, craniotomy, depression, diabetes mellitus, dizziness, episodic hoarseness, external hemorrhoids. claudication, leg pain, laryngitis, gastroesophageal reflux. She had no known drug allergies. Concurrent medications included Trental, Zocor, Prozac, HCTZ, Lotrisone, Prilosec, Flonase, Robitussin AC, carisoprodol, Ciprol, Zlocoa. Following the reported onset of Lyme disease, the vaccinee experienced leg cramps, restless legs syndrome, bronchitis, brochospasm, sinus bradycardia, hearing loss, cataract extraction left eye, right artery stenosis, carvial strain/sprain, sinusitis, acute respiratory influenza, laryngitis, and corneal transplant repear. These events were not reported as adverse events due to the vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. On 6/10/99, the vaccinee reported to family physician with complaints of a "red mark on her left side for six days." It was noted that her left hip region had a circular erythematous rash with bulleye type appearance. The pt denied arthralgia, viral type illness, chills, or myalgia. A diagnosis of Lyme disease with erythema migrans was made and the vaccinee was to start on doxycycline for three weeks. On 7/8/99, the vaccinee presented to her physician with complaints of a stiff neck (non-event) for a few months. Reportedly, she developed Lyme disease two weeks after her first Lyme vaccine and since then she had not received her booster shot. She had completed a full three weeks of doxycycline. On 7/11/99, the vaccinee was seen by her physician for follow up to Lyme disease and complainted of joint aches in her shoulder, back of neck, wrist and legs. It was anoted that her "rash" had  gone away. Her joints did not show any obvious abnormality on examination. The physician's assessment revealed "Lyme disease" and the pt was to start Ceftin 250 mg twice daily times three weeks. On 8/3/99, the vaccinee returned to physician for follow up to Lyme disease. The physician's notes indicated that, "all of a sudden her wrist and hips started to become inflamed and swollen." His assessment included Lyme disease with "possible flare" and the vaccinee was to continue Ceftin and start hydrocodone as needed for pain. On 8/12/99, the vaccinee was seen by her physician for follow up to Lyme disease. She indicated that she "started feeling better now on Ceftin." She also stated she had "arthritis of the left hand." On examination it was noted that her left hand was iwth edema at the fourth and fifth metatarsal. Her blood work showed a "positive" Lyme titer "probably due to her histroy of having LYMErix and Lyme disease." The physician's assessment included Lyme arthritis "doing moderately well" and the pt was to continue Ceftin. On 9/9/99, the vaccinee presented to her physician for follow up for LYme disease. She indicated for "the past week she felt good" and she was going to go to over-seas. Pt questioned if she could have "second LYMErix." It was noted that her swelling was down, her joints especially the wrist and elbow were nontender, and she had no rash at this time. The physician's assessment included "Lyme disease resolving." The physician also indicated that the vaccinee would "need to discuss with infectious disease second shot." 9/16/99, the vaccinee returned to her physician for follow up to Lyme disease. She complainte dof vague arm pain, but indicated she was "doing well." The vacicnee stated she would like second shot of LYMErix and would talk to infectious disease as to when this can be done. Examination noted her elbows and wrist had no decreased range of motion and were nontender on movements. He rlabs done the past week showed potassium elevated at 5.5 non-event. Lyme screening 2.3 with positive four bands. The physician's assessment revealed "Lyme disease with moderate control." The pt was to start Relafen. On 10/5/99, the vaccinee presented to her physician with complaint of tick bite for one day. The vaccinee had a histroy of Lyme disease in the past and was concerned about re-infection. She denied myalgia or arthralgia. She ha dno rash or fever. On examination, the back of her neck showed erythema and slight induration of puncture wound. The physician's assessment included "1. tick bite" and his plan was to start Ceftin 250 mg twice daily, as "this helped before." He indicated he was "not able to accurately diagnosis at this time." It was noted tha the vaccinee had Lyme arthritis before and he prescribed. On 10/28/99, the vaccinee returned to her physician for follow up to Lyme disease and sinusitis. The physician noted, the vaccinee had a "flare" and "possible second tick bite and was put on Ceftin." She had "improvement for a while and nwo has worsening with generalized pain in the arms, legs and hip joints." His assessment included Lyme arthritis and persistent sinusitus and she was to start Rocephin 1 gram IV times four weeks. She was also to start prednisone 10 mg to 10mg over two weeks. The physician indicated he "might consider referral to infectious disease if no improvement." The vaccinee was to continue Vicodin as needed for pain. On 11/18/99, the vaccinee reported to her physician for follow up to Lyme disease. She was on her third week of IV Rocephin. The physician indicated "this is an unusual corse of her progress. She was on two treatments of oral antibiotics with some benefit and had classical erythema migrans rash and then after her second course of oral antibiotics was bit again and had exacerbation of her pain." The vaccinee indicated she "feels great now." She offered no complaints. She is being monitored by an IV nurse. She denies arthralgia at this time. The physician's assessment included "1. Lyme disease doing well on IV therapy 2. History of hypercholesterolemia 3. Claudication 4. Anxiety/depression doing well." He indicated she was to continue IV Rocephin. On 11/23/99, the vaccinee presented to her physician for follow up to Lyme disease. She stated she was "still with back pain." She indicated shefeels better for a couple of days then she "can't walk," she has "severe pain in the several areas" and "cant't walk for a couple of days." The physician indicated she had just completed four weks of IV Rocephin. She had a "positive" Lyme titer. The vaccinee stated she "is feeling better, but still has discomfort." Examination noted that her lumbosacral spine had minimal tenderness to palpation and her range of motion appeared "normal." His assessment included "1. Lyme disease doing well on IV therpay 2. Arthritis probably from Lyme disease and rheumatoid arthritis 3. Hypercholesterolemia doing well.. blood sugar borderline elevated." His plan was to refer the vaccinee to infectious disease and she was to finish out IV Rocephin. Also she was to continue Vicodin, Naprosyn, Trental, hydrocholorotiaside, Prozac, and Zocor. 11/30/99, letter from family physician to infectious disease physician regarding consultation. "I saw her on 6/10/99. She had a typical very large rash consistant with Lyme disease. She had it for 5-6 days and denied any other symptoms at that time. First LYMErix vaccine 5/27/99. Since seen in June started on doxycycline, she had no problems. No blood work at that time. On 8/3/99 she developed wrist and hip pain, which was inflamed and swollen. She was started on Ceftin and a Lyme titer was drawn and she was given hydrocodone. The bloodwork on 8/3/99 showed her Lyme titer to be positive which met the criteria for Lyme disease. She had a recheck on 8/12 showing improvement, with no further arthritis or arthralgia. 9/9/99 her blood work was repeated for comparison. Her titers were still elevated and her bands for her IgG and IgM were still positive. Her titer was down. THe following appointment was 10/6/99 when she came in for a tick bite and we started her on Cetin since this was early in the course and we did not know if this would develop into Lyme disease or not. With her history of having Lyme disease and prior LYMErix injection we felt it best to prophylactically treat her. No blood work was done at that time. The next appointment was 10/28/99 when she developed significant arthralgia and pain of multiple joints with fatigue. She had no rash at that time. Start Rocephin for month. She has improvement with this therapy. Presently off the IV Rocephin and she and her husbnad went to seek a second opinion regarding her treatment to make sure everything possible was being doene forher, I concur with this. I felt during the course of her illness we would consider a referral, but she continued to improve up until the last episode when she requires IV therapy. Once you see this pt I would be interested in your opinion regarding the injection of LYMErix having any precipitating factor for her disease process and also do we continue with the series of LYMErix, restart the course, or hold off on any further LYMErix injections." On 12/16/99, the vaccinee presented to her physician for a check up. She was seen by an infectious disease physician for follow up to Lyme disease. Pt told she was "doing well." The physician indicated his main concern now is that she has scheduled corneal transplant of the right eye. He noted that her "vision is going." She had corneal transplant three years ago, but the past few months noted decreased vision. His assessment included "1. status post Lyme disease with control. 2. corneal detachment." On 5/23/00, the vaccinee reported to her physician for a check up. She stated she "feels good." She also stated that her energy and appetite were good. The physician indicated her mood was good. It was ntoed that she has "occasional pain of back and arms secondary to osteoarthritis." Also she had Lyme disease in the past treated with IV therapy. The physician indicated she had "no problems at this time." On 7/18/00, the vaccinee presented to her physician for a check up. She complained of leg jerks at night. She indicted her "knees and right shoulder are bothersome." It was ntoed that she was coughing somewhat and her energy was decent." The physician stated she was "more motivation and was playing golf a little more." His assessment included "history of Lyme disease in the past possibly secondary to shot." On 6/27/00, the vaccinee returned to her physician for a check up. She indicated she was "having thumb and shoulder pain and headaches and that she got this probably partly secondary to having Lyme disease." It was noted that her energy was decent. And that she occasionally has headaches and some pain in the thumb and shoulder since she started having Lyme disease. She takes Aleva  occasionally an also Vicodin for pain. His assessment included "arthritis and arthralgia secondary to Lyme disease." On 8/24/00, the vaccinee returned to her physician for follow up for headaches. It was noted that she had history of subdural hematoma with evacuation two years ago. The physician also mentioned that she had "inflammatory arthritis and Lyme disease 2-3 years ago which was significant." His assessment included "headaches, status post subdural heamtoma." On 4/17/01, the vaccinee presented to her physician for cough and congestion. She had chronic cough times six months. She fell yesterday and had bruise of the arm and back. His assessment included "acute sinusitis and secondary mild pneumonia, contusion secondary to trauma." On 6/25/01, the vaccinee returned to her physician for a check up. It was noted that she was "having joint pain still." She started on glucosamine, but still had discomfort. She also takes Naprosyn and "between the two feels relief." Examination noted a rash slightly excoriated around her waistline. The physician's assessment included "arthritis and positive rheumatoid factor and C reactive protein." On 11/15/01, the vaccinee presented to her physician for a pre-operative visit and physicial examination for cataract. It was ntoed that she had "no real complaints other than pain in the hand secondary to arthritis." Examination noted slight prominence of the hands with arthritis changes. The physician's assessment included arthritis. The most recent info received on 6/3/02, indicated the outcome erythema migrans as resolved: Lyme disease, arthritis, inflammed joints, and pain as unresolved and arthralgia, joint swelling, fatigue, headache, influenza like symptoms, rahs, and rheumatoid arthritis as unknown.