Age: 76.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Laboratory test abnormal, Myalgia, Rash, Rheumatoid arthritis
Clinical narrative: Report A0359568A describes Lyme disease in a 76-year-old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. The medical history included bilateral angle closure glaucoma, bilateral cataracts, pseudophakic bullous keratopathy of the right eye 1995, right posterior vitreous detachment 1999, "probable small optic nerve drusen" in the right eye 1999, chronic cough, anxiety, past tobacco abuse, allergic conjunctivitis, allergic rhinitis, corneal erosion 1995, hyperkalemia, hen contusion 1988, hoarseness, benign calcifications of breast, 'probable tinea pedis" 1995, claudication, leg pain, laryngitis, gastroesophageal reflux disease, dizziness, depression, foot pain 1991, "probable bladder spasm," external hemorrhoids, fatigue, fractured ribs 1993, rib pain, glaucoma 1972, joint fluid retention, gastroenteritis, hematuria, left knee strain 1992, irritable bowel syndrome, external otitis, "probable neuritis" 1983, "probable costochondritis," temporary amnesia 1988, triceps tendonitis 1988, tendonitis right fifth toe 1991, "probable tinea corporis." 1997, hearing loss, hypertension, "headaches secondary to arthritis from the skull," 1998, trapezius strain chronic 1994, right hip pain 1994, lumbosacral strain 1994, low back pain 1994, bilateral feet paresthesias 1994, rashes on face, around eyes, on right leg, and knee diagnosed as contact dermatitis 1986, right painful red eye, scbaceous cyst, sinusitis, motor vehicle accident resulting in slurred speech and headaches 1996, subdural hematoma 1997, contusions of knees and elbow 1997, strains of knee and elbow 1997, "sleeping problems," "borderline early diabetes mellitus" 1999, xerosis of hand, allergy to hayfever, allergy to ragweed and "several other weeds," allergy to dust mite, and allergy to "several molds." The surgical history included right trabeculectomy 1972, right cataract removal 1972, left peripheral iridectomy 1972, right penetrating keratoplasty 1995, left frontal craniotomy 1997, appendectomy, and right corneal transplant 1995. She had no known drug allergies. Concurrent conditions included mild hypercholestermia, claudication, depression and "borderline early diabetes mellitus." Concurrent medications included Prozac, Trental, Zocor, HCTZ, Lotrisone, Prilosec, Flonase, Robitussin AC, Soma, Cipro, Elocon, and "blood pressure medications including diuretics "for unspecified indications." Concurrent medications also included Allegra and Rhinocort for the treatment of allergy symptoms. Following the reported onset of Lyme disease, the vaccinee experienced leg cramps, restless leg syndrome, bronchitis bronchospasm, sinus bradycardia, hearing loss, cataract extraction left eye, right iliac artery stenosis, cervial strain/sprain, sinusitis, acute respiratory influenza, laryngitis, and corneal transplant repeat. 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. The vaccinee received one injection of LYMErix on 5/27/99. In a Statement of Injuries, her attorney alleged that the vaccinee "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. 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 EM 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 (nonevent) 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 7/31/99, the vaccinee was seen by her physician for follow up to Lyme disease and complained of joint aches in her shoulder, back of neck, wrist, and legs. It was noted 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 250mg twice daily times three weeks. On 8/03/99, 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 with edema at the fourth and fifty metatarsal. Her blood work showed a "positive" Lyme titer "probably due to her history 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 travel 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 ID second shot." 9/16/99, the vaccinee returned to her physician for follow up for Lyme disease. She complained of vague arm pain, but indicated she was "doing well." The vaccinee stated she would like second shot of LYMErix and would talk to infectious disease ID as to when this can be done. Examination noted her elbows and wrist had no decreased range of motion and were nontender on movements. Her labs done the past week showed potassium  elevated at 5.5 non event, Lyme screening 2.3 with positive 4 bands. The physician's assessment revealed "Lyme disease with moderate control." The pt was to start Relafen. On 10/06/99, the vaccinee presented to her physician with complaint of tick bite for one day. The vaccinee had a history of Lyme disease in the past and was concerned about re-infection. She denied myalgia and arthralgia. She had no 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 on Ceftin 250 mg twice daily, as "this helped before." He indicated he was "not able to accurately diagnose at this time." It was noted that the vaccinee had Lyme arthritis before and he prescribed Vioxx 25 mg every day. On 10/2/99, 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 awhile and now has worsening with generalized pain in the arms, legs and hip joints." His assessment included Lyme arthritis and persistent sinusitis and she was to start Rocephin 1 g intravenously times four weeks. She was able to start prednisone 10mg taper to 10mg over two weeks. The physician indicated he "might consider referral to infectious disease ID 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 intravenous 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 EM 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 hyper cholesterolemia 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 she feels better for a couple of days then she "can't walk," she has "severe pain in the sacral area" and "can't walk for a couple days." The physician indicated she had just completed four weeks 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 LS spine had minimal tenderness to palpation and her range of motion appeared "normal." His assessment included "1.Lyme disease doing well on IV therapy 2. arthritis probably from Lyme disease and rheumatoid arthritis RA 3.hypercholesterolemia doing well, blood sugar borderline elevated 1116." 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, 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 consistent 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 Ceftina 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 urticaria 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 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 Ceftin 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 husband went to seek a second opinion regarding her treatment to make sure everything possible was being done for her, 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 (non event). His assessment included "1.status post Lyme disease with control. 5.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 noted 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 non event. She indicated her "knees and right shoulder are bothersome." It was noted that she was coughing non event somewhat and her energy was decent. The physician stated she was "more motivation and was playing golf a little more." His assessment included "5.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 Aleve occasionally and also Vicodin for pain. His assessment included "1.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 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 "1.headaches 2.status post subdural hematoma." On 4/17/01, the vaccinee presented to her physician for cough and congestion (non events). She had cough (non-event) times six months. She fell yesterday and had bruise of the arm and back. His assessment included "1.acute sinusitis and secondary mild pneumonia (non event) 2.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 Naproxyn and "between the two feels relief." Examination noted a rash slightly excoriated around her waistline. The physician's assessment included "1.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 physical examination for cateract non event. It was noted 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 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. This report of "joint pain," "joint swelling," and "headaches" is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.