Age: 60.0
Sex: F
Vaccine: LYME
Symptoms: Rash, Red blood cell sedimentation rate increased, Somnolence, Vertigo, Viral infection
Clinical narrative: The vaccinee received injections of Lymerix on 5/13/99, 6/10/99 and 7/8/99. The 3rd injection was administered 2 months after the 1st injection, rather than the recommended interval of 12 months. The pt was seen by a new PCP on 7/27/01. She reported that she "has been experiencing Lyme symptoms-arthritis-like pain in legs, back and shoulders". The pt reported that she had "2 years of illness" and had "read research regarding Lymerix". She reported that she did no have osteoarthritis and that a bone scan (NOS) had been negative. She stated that she had made an appt to see an infectious disease specialist. The pt told the physician that she had received an injection of hyalgan (Synvisc) and was currently taking Celebrex, Paxil 40mg daily, Soma X 3 daily and Ultram 50mg every 8 hours for pain relief. The physician made a dx of fibromyalgia. The pt returned on 8/3/01, with chief complaints of back pain and right knee pain. She attributed the knee pain to "a lot of walking". The physician made a dx of polyarthritis. He prescribed Valium 5mg X 3 daily, Zanaflex, Ultram and increased walking. She was seen again on 8/17/01 and stated that she had read an article regarding fibromyalgia and it mentioned an infectious disease specialist and chronic Lyme disease. She made an appt. She returned to her PCP on 8/30/01, stating that she was "very depressed and wants to discontinue Paxil". The physician discontinued Paxil and prescribed Celexa 40mg daily. The pt was seen again on 9/13/01 saying she had a "tingling feeling". She said she was seen in the ER 1 week prior, due to dizziness. She was seen again on 9/27/01 and stated that she "felt like dying" 2 days earlier. The physician made a dx of viral syndrome. He prescribed doxepin (Sinequan). The pt was seen by an infectious disease specialist on 9/29/01 "for further evaluation and management of a Lyme vaccine reaction". She had always been in excellent health and is not sure whether she had any tick bites or rashes. She did have an illness in 11/95 with headaches and blurred vision. There was some question as to whether that was Lyme disease. She had a 1st injection of Lymerix on 5/13/99 and on 5/23/99, she started having some blurry vision, vertigo, fatigue and achiness all over. After the 2nd injection, she continued to be ill with ear pain and swollen glands and was placed on amoxicillin. On 7/8/99, she received the 3rd injection and started to get diarrhea, pain in her lower abdomen and continued feeling ill. In 10/99, she was placed on Ciprofloxacin and had to stop working in 1/00. She was lethargic, achy, slept a lot of the time, had a rash on her chest of unknown cause and continued with pains and blurred vision. She received Cortisone shots and was told she had chronic fatigue, fibromyalgia and depression. Her symptoms continue to the current time, with sweats, ear pain, pain in her legs, thighs, calves and knees, some swelling in her ankles and knees, bruises, dizziness, hot flashes, SOB, numbness in her hands, urinary frequency, a sensation of tremors in her body, memory and concentration problems since 1999, unstable mood with some panic, muscle aches and itchiness all over. Post exam, my impression is that she fits the multi-symptom complex of chronic Lyme disease, which was likely reactivated by the Lyme disease. The most recent information received on 1/18/02, indicated that the vaccinee was feeling better as of 1/9/02. The symptoms are considered to be disabling. On 2/11/02, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee suffers from debilitating pain and swelling of her left knee and right shoulder, along with fatigue, short-term memory loss and dizziness which progressively developed after each of three vaccinations with LYMErix. The most recent information received 2/11/02 did not specify the outcomes of the reported events. The follow up states the pt's medical history included depression. The vaccinee was allergic to Bactrim and jewelry. Surgical history includes removal of benign breast lumps. The vaccinee experienced cellulitis of the left thigh. Concurrent medications included Bactrim, Ceftin, amoxicillin and Ciprol. The vaccinee was seen by a physician on 1/4/00 with a chief complaint of a rash on her chest and breast that had been present for one week. The vaccinee reported that the rash burned, itched, and was draining. The vaccinee returned to the physician on 1/11/00 with a chief complaint of dizziness. The vaccinee reported that the dizziness began on 1/10/00. The vaccinee also reported a slightly sore throat. Medications included Biaxin, and Paxil. The physician made a diagnosis of otitis media and prescribed amoxicillin. The vaccinee was seen again on 1/27/00 for a physical examination. She reported a slightly sore throat and feeling dizzy on 1/26/00. The vaccinee was seen by a physician on 3/27/00 with a six-day history of suprapubic pain that was moderate in intensity, constant, and dull with a feeling of constant pressure. The vaccinee also reported dark urine, dysuria, and diarrhea. The physician made a diagnosis of acute cystitis. The vacicnee returned to the physician on 3/31/00 with persistent diarrhea that began approximately 14 days prior to presentation, while taking Detrol. The vaccinee reported that her stools were "very dark colored, watery in appearance." She reported having four or more bowel movements per day. The vaccinee reported associated symptoms of malaise, weakness in her legs, and sweats. Abdominal examination revealed generalized tenderness to palpation. A stool sample was collected for analysis and the physician prescribed Lomotil. The vaccinee returned to the physician on 4/4/00. She reported that the diarrhea stopped on 4/3/00 and that she began to experience burning with urination on 4/4/00. The physician's impression was "abdominal cramping and diarrhea related to anxiety." Diagnoses were recorded as diarrhea and acute cystitis. The vaccinee was seen by a physician on 5/8/00 with a chief complaint of knee and shoulder pain, and to follow up in regrds to cystitis. The physician noted that the vaccinee had been evaluated by another physician who "wasnot convinced she has IC." The vaccinee also reported occasional nausea and blurred vision. The physician noted that the vaccinee had four eye examinations within the past year, all within normal limits. The vaccinee returned to the physician on 5/15/00 with a chief complaint of arthralgia involving her ankles, knees and wrists. She also reported fatigue, nausea, night sweats and frequent urination. On 5/16/00, the physician noted elevated liver function tests, and ordered serology for hepatitis . A previous chest x-ray had shown a possible inflitrate; the x-ray was repeated on 5/17/00. The vaccinee's left knee was also x-rayed at that time. The vaccinee returned to the physician on 5/18/00 with complaints of dizziness, nausea, fatigue, and aching joints. She was seen again on 5/30/00 with leg pain and fatigue. She reported that she had gone to the local emergency room twice during the past week for evaluation of fatigue and general malaise. She also reported that she had experienced an allergic reaction to Bactrim. On review of systems, the vaccinee reported pain and stiffness of an unspecified knee joint, anxiety, depression, "emotional problems," nervousness, fever, chills, increased sleep, decreased appetite, poor tolerance to exercise, and headache. She reported that she had no change in weight. She stated that she was "unable to conduct usual activities." On physical examination, the physician noted a rash on the lips and limited range of motion of an unspecified knee. The vaccinee returned to the physician on 6/1/00, reporting persistent left knee pain and fatigue. She was seen again on 6/2/00 with left knee pain and swelling. She reported that the pain had been present for five months and was "10 out of 10" in severity. She stated that the onset was gradual and progressing and began with light activity. The pain was aggravated by any position, leg extension, and leg flexion. She obtained relief with application of heat. Medications included paroxetine and diphenoxylate/atrophine. On examination, no erythema of the joint was observed. The physician aspirated clear fluid from the knee and had it analyzed. The physician prescribed Vioxx 25mg dialy. On 6/6/00, the physician prescribed Parcocet. The vaccinee returned to the physician on 6/8/00 with left knee pain, swelling and redness; increased fatigue; and cellulitis on the left suprapatellar area measuring approximately 8cm in diameter. No lymphangitis was observed. The physician prescribed Ceftin 250mg twice daily. Blood was obtained for lyme western blot analysis. on 6/9/00, the physician prescribed a tapering course of prednisone. The vaccinee was seen again on 6/12/00. She reported 'slight improvement" in left leg and knee pain. She reported 'severe' pain in her right shoulder. She also reported that she was still very fatigued and was "ready to sleep at 10am." She also reported short-term memory loss, described as being unable to find things or remember. The vaccinee again returned to the physician on 6/13/00 with right shoulder and left knee pain and swelling. She described the pain as a constant ache that was intermittently sharp. She rated the pain as "12 out of 10." Nothing aggravated or relieved the pain. She also reported a "noisy" cough that began on 6/9/00, runny nose, sore throat, otitis, sweats, and burning eyes. A diagnosis of bursitis of the right shoulder was made, and the right shoulder x-rayed. The vaccinee returned to the physician on 6/19/00 with chief complaint of depression and anxiety of one month's duration. Associated symptoms included dyspnea and insomnia. she also reported "urinary frequency and urinary problems" that were mild and had been present for two days. She also reported sudden onset of "severe" intermittent, sharp right elbow pain. The pain radiated to the shoulder, but the shoulder "feels fine." The left knee pain had improved, but the vaccinee was 'still limping.' On physical examination, the left knee had full range of motion. The right shoulder had limited range of motion; there was normal muscle strength and tone. Trage tenderness and synovial tissue swelling of the left knee were noted. Urinalysis revealed "blood, protein, trace white cells." The vaccinee was interviewed for a new story that was posted on the internet on 2/28/02. The vaccinee "said the vaccinee ruined her life. She has severe arthritis in her legs and shoulders and is constantly fatigued. She had to leave her job and now gets by on her social security disability check, "I know it was the vaccine, she said." The most recent info received 2/27/02, indicated that arthritis persisted. Outcomes of the other reported events were not provided. The follow up states pt's medical history also included elevated free thyroxine concentration (12/12/96), pneumonia, small pneumothorax (1999), microscopic hematuria, and a subaceous cyst at the base of the neck (January 1999). Surgical history also included replacemtn of an eye lens. Abnormal liver function tests, low back strain after turning, pneumonia and a foreign body in her left eye was stated. Antinuclear antibody titer was negative. On 5/10/00, serology and immunoblot for Lyme titer was negative. X-rays of the left? revealed "moderate degenerative type patellar spurring; no effusion was appreciated. Liver function tests ? to be abnormal. Serology for hep A, B and C performed 5/16/00, was negative. The vaccinee presented to the local ER on 5/26/00 with a chief complaint of "anxiety about recent ? of pneumonia." She also complained of cough, nausea, and dizziness. The ER physician ? pneumonia had been treated with Biaxin, which caused allergic rash. Biaxin was discontinued and the pneumonia was treated with levaquin. The vaccinee told ER physician that she had a history of a "spot on lung"; she also reported that she was told the ? day that she had a "collapsed lung." The vaccinee was reassured and instructed to continue her ? therapy. The vaccinee presented to the ER on 6/10/00 "with a history of a little bit of confusion, have been taking some Parocet for knee pain and Ceftin as an antibiotic for cellulitis. She has also been on ? for an allergic reaction. She had fallen and hit her shoulder which was unremarkable. Serology and immunology for Lyme disease were negative. Pt's impression was "osteoorthritic change of the AC joint resulting in mild ? of the implingement ? This may result in a non-calcific tendinopathy of the supraspinatus tendon. X-rays of the lumbosacral spine, performed 6/20/01, revealed sclerotic focux L4 may be related to bone island. One centimeter anterolisthesis of L4 on 5. Multi-level degnerative changes. ? density foci in left paraspinal region may be related to focal material versus rebal calculi. The vaccinee presented to the local ER on 9/26/00 with a chief coomplaint of bilateral ? swelling that had begun two to three days prior to admission. She indicated that the swelling was result, exacerbated by nothing, and relieved by nothing. She also reported a "slight" nonproductive cough and ? breathing when lying flat. The vaccinee reported her medical history as interstitial cystitis, esophageal reflux disorder, asthritis, hypertension, fibromyalgia, and chronic fatigue. The ER physician also noted a history of alcoholism. Medications at that time included Vioxx, "meds for  Pexil, and "high blood pressure meds." The ER physician prescribed furosemiar ? mg daily and potassium 10 meQ daily. The vaccinee presented to the local ER on 10/13/00 with a chief complaint of left knee pain ? kept her awake the previous night. She rated the pain as 7 on a scale of 10. She reported that she had ? intra-articular injection of Synvisc on 10/12/00. She reported her medical ? rheumatoid arthritis, fibromyalgia, and chronic fatigue syndrome. Medications included Vioxx, Paxil, blood pressure med. The ER physician made a diagnosis of internal derangement of the left knee prrescribed Darvecet. ? performed on 6/18/01 was positive for DR? Serology and immunoslot for Lyme disease were ? 6/19/01. Bone densitometry performed on 6/22/01 revealed osteopenia. The vaccinee admitted to the local ER on 6/29/01 with a chief complaint of swelling and pain in her ankles. ? ER nurse that she "has autoimmune arthritis and is experiencing some swelling under ? ankles." She reported that the pain was constant and rated it as 6 on a scale of 10. Medications Celebrex, Paxil, Ativan, Soma, and Ultram. The ER physician made a diagnosis of arthritic exacerbation and increased the Ultra dossage. The vaccinee was seen by a new primary physician on 7/27/01. She reported that she "has been experiencing symptoms-arthritis like pain legs, back and shoulders." The vaccinee reported that she had "two years of ?" and had "read research regarding LYMErix." She reported that she did not have ?arthritis, and that a bone scan had been negative. She stated that she had made an appointment to see an infectious disease specialist. The vaccinee told the physician that she had received an injection of Synvisc and was currently taking Celebrex, Paxil 40mg daily, Soma three times daily, and Ultram 50mg every eight hours for pain relief. The physician made a diagnosis of fibromyalgia. The vaccinee returned to her primary physician on 8/2/01, with chief complaints of bac kpain and right ? She attributed the knee pain to "a lot of walking." The physician made a diagnosis of polyarthritis and prescirbed Valium 5mg three times daily, Zenaflex, Ultram and increased ? The vaccinee was seen by her primary physician on 8/17/01. She stated that she had read an article ? fibromyalgia. The article mentioned an infectious disease specialist and chronic Lyme disease. This ? infectious disease specialist with whom the vaccinee had made an appointment. The vaccinee returned to her primary physician on 8/30/01, stating that she was "very depressed. Wants to ? Paxil." The physician discontinued Paxil therapy and prescirbed Celexa 40mg daily. The vaccinee was seen by her primary physician on 9/13/01. She reported a "tingling feeling." She ? that hse had been seen in the local ER one week prior due to dizziness. The vaccinee was seen by her primary physician on 9/27/01. She stated that she "felt like dying" two ? earlier. The physician made a diagnosis of viral syndrome. He prescribed Sinequan. The vaccinee was seen by a infectious disease specialist on 9/29/01 "for further evaluation and ? of a Lyme disease reaction. She had always been in excellent health. She is not sure whether she had ? or rashes. She did have an illness in 11/95 with headaches and blurred vision. There are some ? as to whether that was Lyme disease. She received a course of Doxycycline for it. She received another course of Doxycycline in 1996 for a similar-type illness. She remained well until 1999, when she had her first injection of the Lyme vaccine on 5/13/99. on 5/23/99, she started to hve some blurry vision, vertigo, fatigue, ? all over. She received the second injection on 6/10/99 and continued to be ill with ear pain and swollen glands, and was placed on amoxicillin. On 7/8/99, she received the third injection, started to get diarrhea pain in her lower abdomen, and continued feeling ill. In 10/99, she was placed on Ciprofloxacin. She ? stoop working in 1/00. She was lethargic, achy, slept a lot of the time, had a rash on her chest of ? cause and continued with pains and blurred vision. She received Cortisone shots, and was told she had ? fatigue, fibromyalgia and depression. Her symptoms continue to the current time with sweats, ear pain, ? her legs, thighs, calves, and knees, some swelling in her ankles and knees, bruises, dizziness, hot ? shortness of breath, numbness and tingling in her hands, urinary frequency, such that she goes every two ? and night, a sensation of tremors in her body, memory and concentration problems since 1999, unstable ? some panic, muscle aches, and itchiness all over. Her current medications include Sinequan for the ? and Celexa 40mg. She was on Celebrerx and vioxx, but discontinued those because of some ? side effects. Pharmacy records indicated that the vaccinee had also been treated with Claritin, promethazine, phenazophyridine, dextropropoxyphene/paracetamol and a rapidly-tapering ? methyl-prednisolone. Under lab data, the physician wrote, "Western blot reactions against the ? 35, 37, 61 and 83 kd proteins." On physican examination, he noted "extremities without edema. Good rnage of motion. Good muscle strength. Neurologic is physiologic. A brief mental exam was normal. My impression is that she fits the multi-symptom complex of chronic Lyme siease, which was likely reactivated by the Lyme vaccine. We discussed options and decided to hold on the brain SPECT scan and to give her a therapeutic trail using a combination of clarithromycin which is Biaxin 500mg and Hydroxycholoroquine which is Plaquenil 500mg bid over the next three to four months. Assuming that ? start to improve on this, we will extend that treatment for as long as it is beneficial to her. I will ? she will need that treatment and perhaps a cycle of Tetracycline treatment over the next 1.5 to 2 ? resolve most, if not all of her symptoms. I will be happy to follow her by E-mail, work with her primary physician, and see her in the future again, if desired. I think her overall  prognosis is resonably ? recovery from this reaction. The vaccinee reported to her primary physician that she was feeling better on 11/2/01, 11/29/01, 12/01 and 1/9/02. On 11/30/01, erythrocyte sedimentation rate was 28mm/hr. On 12/13/01, the physician noted that the ESR was 33mm/hr "secondary to fibromyalgia." On 2/11/02, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "suffers from dehibilitating pain and swelling fo her left and right shoulder, along with fatigue, short-term memory loss, dizziness which progressively developed after each of three vaccinations with LYMErix." The vaccinee was interviewed for a news story that was posted on th einternet on 2/28/02. The vaccinee ? vaccine ruined her life. She has severe arthritis in her legs and shoulders and is constantly ? She had to leave her job and now gets by on her social security disability check. "I know it was ?" she said. The most recent info receivedo n 4/11/02, did not provide the outcomes of the reported events. The follow up states vaccinee also experienced eye burning and sun sensitivity following the reported onset of activation of chronic Lyme disease. The vaccinee was seen by the vaccine provider on 7/12/99 for complaints of left ear pain. She was treated with Coly-Mycin otic drops. By 7/20/99, her ear still felt "funny" so she was started on Biaxin. The vaccinee was seen by the vaccine provider on 10/28/99 with complaints of fatigue for the previous several months and hot flashes. It was noted that the pt had been taking Paxil in the morning so it was switched to bedtime. The fatigue improved. The vaccinee was seen by the vaccine provider on 3/27/00 with a six-day history of suprepubic pain that was moderate in intensity, constant, and dull ith a feeling of constant pressure. She also reported swelling of the left knee. The vaccinee was seen by the vaccine provider on 6/19/00 with complaints of joint pain in the knee. Relief was noted with application of heat. The pain had been present for two weeks. The vaccinee returned to the vaccine provider on 6/27/00 for follow up for her knee pain. On 6/30/00, the vaccinee was referred to an orthopedist. The vaccinee was seen by the orthopedist on 7/13/00. The orthopedist wrote that the vaccinee had "a long history of rheumatoid arthritis." She complained of right shoulder pain since January 2000 and left knee pain since February 2000. On physical examination, she displayed "significant" right shoulder pain and weakness to resisted abduction and external rotation. Muscle strength was 4/5. Vascular, sensory, neck, neurologic and motor examinations of the neck and right shoulder were within normal limits. She had a positive neer sign and a positive Hawkins sign. Examination of the left knee showed tenderness of the medial and lateral joint lines with increased pain on flexion and extension. Trace effusion of the left knee was noted. X-rays revealed "mild degenerative changes" of the right shoulder and left knee. MRI was attempted, but failed due to the vaccinee's claustrophobia. The vaccinee remained under the care of the orthopedist until at least 12/21/00. During this time, she reproted right knee pain, left knee weakness, and "polyarticular joint symptoms." The orthopedist noted negative "Monto" sign, "mild" patellofemoral crepitus and grinding in both knees, "mild" effusions in both knees, five varus deformity in both knees, and negative Lachman andMacMurray tests in both knees. He made diagnosis of right rotator cuff tendonitis (8/3/00), degenerative joint disease of both knees (9/28/00) and general polyarticular osteoarthritis (12/21/00). The vaccinee objected to intra-articular steroid injections and arthroscopic surgery. The vaccinee received five injections of Kaylgan into each knee. The injections worked "fairly well" in the left knee and "very well" in the right knee. The arthopedist also prescribed a rapidly-tapering course of Medrol Dosepak, Ultram, Vioxx and Celebrax. The vaccinee was seen by the vaccine provider on 4/5/01 also with decreased appetite. The most recent info received 9/13/02 did not provide the outcome sof hte reported events. Info received 2/27/02 indicated that arthritis persisted. Outcomes of the other reported events were not provided. Medical records received 1/18/02 indicated that the vaccinee was feeling better as of 1/9/02. The vaccinee returned to her physician on 6/16/00 for follow-up on her knee pain. The vaccinee returned to her physician on 6/16/00 for follow up on her knee pain. The pt complained of increased pain and decreased range of motion and stated she "can only crawl." she had not eaten for three days and drank very little fluid. Associated symptoms included shakiness. The vaccnee was seen by a physician on 6/19/00 with complaints of joint pain in the knee. Relief was noted with heat application. Physical assessment revealed full range of motion without limitation, normal full knee RGM, normal muscle strength, normal muscle tone, and no muscle rigidity. The vaccinee was soon on 6/23/02 for complaints of mild dyspnea. She also reported moderate right shoulder and bilateral leg pain described as steady and sharp. The onset of the pain was unclear in regards to timing and began in context with no detectable event. The problem was aggravated by light activity. Relief was noted with no particular event. The vaccinee returned to her physician on 6/27/00 for follow up for her knee pain. She reported no improvement and complained of severe sharp pain with weight bearing. The vaccinee was seen by her physician on 9/11/00 with complaints of eyes burning and sun sensitive during the previous week. The vaccinee was seen by her physician on 10/5/00 due to complaints of a persistent cough. Her lungs were clear to auscultation. She was started on Tusssonex one tsp. every 12 hrs. The vaccinee was seen by a physician on 12/8/00. She reported an ER diagnosis of pneumonia. At the time of the office visit, she was being treated with Lavaquin and Ultram and was feeling better. The physician discussed with her the need to exercise and lose weight. She had injections for her knee pain but she reported still having some hip and knee pain. An x-ray was planned at the finish of Levaquin. The vaccinee was seen on 12/21/01 for follow up for pneumonia and complaints of acid reflux. She was advised to stop Vioxx because it was causing nausea. Pt diatnosed with arthritis. Pt was started on medrol dose pack and Celebrex 200mg for one month. The vaccinee was seen by her physician on 2/15/01 with complaints of left eye infection "per emergency room paperwork." THe pt was concerned that she may have shingles in her left eye. The vaccinee returned on 2/20/01 for follow up for left eye complaints. She still feels like something was on her cornea and stil lhad blurry vision, although both symptoms had improved. The vaccinee was seen by a physician on 4/5/01 with complaints of dizziness, achiness all over, weakness, chills, sweats, bilateral ear discomfort, and severe fatigue during the previous two weeks. The most recent info received on 7/28/02 did not provide the outcomes of the reported events.