Age: 60.0
Sex: F
Vaccine: LYME
Symptoms: Skin burning sensation, Skin disorder
Clinical narrative: Following dose 2 of Lymerix, she experienced burning sensation in forearms, hands, feet, ankles, and lower legs. Additionally, her knees were sensitive to the sun. She experienced anxiety and fluctuations in blood pressure. She was treated with Lopressor, Klonopin, and Doxycycline. The most recent information received on 9/7/99, reports the condition of the pt is unresolved. The follow up states that the subject's medical history included allergy to tree pollen, tobacco use, anxiety, depression, pneumonia, sinusitis, Lyme disease (1997), night sweats, hypertension, premature atrial contractions with compensatory pauses, irregular heart rate, adrenal tumor (1984), abdominal pain, palpitations (1994 and 1995), diverticulosis, right ovarian cyst, endometriosis, and uterine fibroids, inclusion cyst of the left index finger (1997), and hemangioma of the left index finger (1997).  The subject had no known drug allergies. Surgical history included removal of calculus from a submaxillary gland (1977), bilateral breast biopsies (1982), hysterectomy (1983), appendectomy 1984), removal large hemorrhagic corpeus luteum cyst (1984), and oophorectomy (1988), and excision of an inclusion cyst and hemangioma of the left index finger (1997).  Family history was significant for an unspecified form of dementia in the subject's mother and hypertension in the subject's mother, father and brother. Concurrent medications included Premarin, atenolol, metoprolol, hydrocholorthiazide, Cozaar, Prinivil, and Wellbutrin. The subject received injections of LYMErix on 4/1/99 and 5/3/99 (lot #'s not recorded).  She reported that following the second injection of LYMErix, she experienced a burning sensation in her forearms, hands, feet, ankles and lower legs. Additionally, her knees were sensitive to sun. She experinenced anxiety and fluctuations in blood pressure. On 4/27/00, she stated, "To date, I am still trying to recover from the damage." The subject submitted a report to VAERS on 10/12/99. Under "Description of adverse events," she wrote, "Unexplained burning on forearms, hands, feet, ankles. Pain in ankles. Twitching in legs and feet. Anxiety. Sweats and flushing. Pulse skips. Unexplained fluctuations in blood pressure to date. Treatment Lopressor, Klonopin, Doxycyline." She also stated, "I am currently being treated for chronic lyme disease." On 2/11/02, in a Statement of Injuries, the subject's attorney alleged that the subject "suffers from pain and burning sensation in both upper and lower extremities, with joint pain in her ankles. She also experiences muscle twitching, night sweats, anxiety and fluctuations of her blood pressure. An MRI of her brain has docemented mild hypoperfusion in the parietal lobes, occipital lobes (especially on the left side), and the temporal lobes." The subject was interviewed for a news article that was posted on the internet. The reporter stated that the subject "never had any full-blown symptoms of Lyme disease-until she got the vaccine. Her illness has been diagnosed as neuroborreliosis." The following info was obtained from medical records. The subject presented to the vaccine provider on 5/11/99 with complaints of "anxiety, hemorrhoids, worried about BP" and "worried about her pulse." The physiician noted, "She is having all types of problems. She's apparently very often anxious." On physical examination, the pulse was 60 beats/minute and the blood pressure was 142/88mmHg. The physician's impressions were "1. Hypertension, good response to Atenolol. I am trying to convince the pt that things are going the way they should. 2. Anxiety, obsessive-compulsive disorder, depression." The physician prescribed Paxil. The subject remained under the care of this physician until at least 2/19/02. On 5/17/99, she reported that she stopped taking paroxetine "because of night sweats, anxiety, burning feeling, calmed with Klonopin." The physician noted, "She is also very anxious and has obvious psychiatric problems that are not being resolved with Klonopin." The following signs and symptoms were reported during this time: palpitations; low back pain associated with numbness in both ankles; "numbness and tingling sensation in arms and legs; concerned about possibility of side effect from Paxil" (7/7/99); "paresthesias in her arms and legs which she associates with her Paxil" (7/12/99); "paresthesias as a possible side effect of Lyme vaccine" (8/17/99); "she's convinced that her paresthesias are from the Lyme vaccine, or perhaps now she thinks from Lyme disease" (9/13/99); burning of the arms, legs and hands; hip pain; and sweaty palms and feet. On 8/3/99, the physician told the subject that he "doubted that her paresthesias are related to LYMErix, more likely from anxiety. We will have her stop HCTZ (hydrochlorothiazide), to see if there may be some relation to that." Because of the subject's continued concern that the paresthesias had been caused by LYMErix, the physician contacted two physicians at a tertiary care center "who said that paresthesias were not caused by Lyme vaccine, that the only thing that could be done was to reassure the pt." On 3/2/00, the subject reported recent anxiety. "She suspects this is somehow related to Lyme disease, perhaps the Lyme vaccine." On 11/7/99, she reported that she was "Told she has a myofascial problems." The physician made diagnoses of "Palpitations" (6/10/99), "Low back pain" (7/1/99), "Paresthesias, secondary to Paxil" (7/12/99), ""Paresthesais " (8/3/99), "Anxiety disorder" (12/12/99), "? Lyme disease" (3/20/00), "Chronic Lyme disease" (4/10/00), "Chronic fibromyalgia, possible chronic Lyme disease" (7/10/00), "Osteoarthritis/fibromyalgia" (11/7/00), "Chronic pain syndrome, probably fibromyalgia" (3/7/01), "Chronic fatigue/chronic Lyme" (6/14/01). The physician prescribed Klonopin, Lopressor, hydrochlorothiazide, Prinivil, and Cozaar. The physician referred the subject to a neurologist, an endocrinologist, a psychiatrist, a Lyme clinic at a tertiary care center, and a physical therapist. The subject was under the care of a chiropractor from 5/3/99 until at least 8/25/02. Signs and symptoms reported during this time included leg pain, legs burning and tingling, lower back and neck stiffness, foot pain, right knee pain, restricted knee extension, muscle pain in buttocks, resistant pain/discomfort in the legs and hips, and pelvic pain with activity. On 5/8/01, the subject reported, "struggling a lot, not feeling cognitively clear due to Lyme." During this time period, the chiropractor made diagnoses of "polyneuritis possible or radiculopathy" (7/7/99), "peripheral neuropathy" (7/12/99), "piriformis syndrome" (11/22/99), "polyradiculopathy" (12/3/99), "adhesive capsulitis" (1/5/01), and "mild flare up-probably Lyme related" (8/31/01). On June 28, 2000, he prescribed physical therapy twice weekly for four to six weeks. The diagnoses were recorded as "bilateral gluteus medias, piriformis MF (myofascial) dysfunction, sacral joint dysfunction". On 8/13/03, the patient's restricted knee extension was assessed as "meniscus versus Lyme arthritis". On 8/20/03, and x-ray was performed for clinical indication of possible meniscal tear in the right knee versus chronic Lyme arthritis. Finding revealed minimal degeneration arthritis and possible minimal effusion. The subject presented to the psychiatrist on 6/2/99 "for evaluation and treatment of panic and anxiety." The subject reported that her symptoms had begun in February 1999, just before a trip overseas. The subject "had difficulty with her blood pressure and began having a missed heart beat and became quite concerned. Finally ended up in the ER, was told it was anxiety and she should be treated for it. She went ahead on the trip." The psychiatrist wrote, "I want to point out that this trip was the first overseas trip for her and was accompanied with a great deal of anxiety prior to going." The subject reported that she had been hospitalized 10 years prior "and was treated with an antidepressant and something for anxiety because of the anxiety and depression she suffered at that time. She does not remember being on that medicaiton for very long or that she got any particular relief and thought that it was a waste of time being in the hospital." The subject was "quite anxious" throughout her initial visit to the psychiatrist. The subject "denied any depression at this time and focused in on anxiety over her blood pressure, her heart beat and any possible physical malady that has been undiagnosed." His impression was "Panic disorder without agoraphobia, 300.01." He recommended therapy with either paroxetine or sertraline (Zoloft). The subject remained under the care of this psychiatrist until at least 9/7/99. During that time, she had "Many medical concerns and very typical of panic disorder." The psychiatrist also noted, "She continues to obsess over BP although it is now basically low. Not surprising for a panic pt." The subject was evaluated by the neurologist on 9/14/99. At that time, the subject reported "burning paresthesias in her arms and legs that is intermittent. She also reports achiness in her ankles, no weakness, no back pain, and no neck pain." She reported that the paresthesias began after the second injeciton of LYMErix. "She also reports interestingly that sse was quite ill around that time with a pneumonia initially treated with Biaxin, which was ineffective and then treated with Zithromax, which finally cleared up her infection. She has also been quite anxious with her symptoms. Tried to take some Klonopin for the anxiety and that seemed to be somewhat effective. She was placed on Paxil but subjectively reports that her symptoms worsened with that. She was switched to Zoloft and the symptoms persisted so she is not on any further antidepressant medications." No abnormalities werre noted on physical examination. Specifically, "Pinprick, vibration, turning position are intact." The physician's assessment was "A woman with subjective reports of a burning dysesthesia in her arms and legs, which is associated with the Lyme vaccine. It is unclear that it would be directly related to this or not. Certainly we will investigate this and see if she has any neuropathy that may be secondary to previous Lyme disease." The results of electromyelography (EMG) and nerve conduction studies were interpreted as "normal." Lyme serologies were negative. The subject was evaluated by a "Lyme specialist" on 10/5/99. At that time, the subject reported that the night sweats she experienced when she had Lyme disease in 1997 did not resolve after a three-week course of doxycycline. She also reported that the burning sensation in her arms, feet and toes began after the first injection of LYMErix. She stated that ankle soreness began after her second injection of LYMErix. She reported her current symptoms as "burning sensation below the knee, twitches and anxiety." No abnormalities were noted on physical examination. The physician prescribed doxycycline. The subject remained under the care of this "Lyme specialist" until at least 11/29/01. The following signs and symptoms were reported during this time: "ankles stiff, ache off and on," low back pain, bilateral buttock pain, foot pain, premature ventricular contractions, right arm pain, abdominal pain and gas, hip discomfort, "tingly" sensation in the feet and ankles, pain in all joints, "hard time walking," burning sensation of the lower abdomen, left lateral rib pain, neck pain, left shoulder pain, right elbow pain, difficulty concentrating, and "Cognitive problems." The subject reported on 10/23/99 that the "paresthesias improved" after starting doxycycline therapy. On 5/26/00, she reported that "anxiety has improved" and overall, she was "80% better." However, on 3/20/01, the physician noted, "we are at a major impasse." During this time period, the physician noted that the subejct had a sinus infections and a yeast infection. The subject reported that she also had two other episodes of sinusitis treated by other physicians with azithromycin and an approximately four-week course of cefuroxime. X-rays of the hips and left shoulder were "normal." MRI and single photon emission computed tomography of the brain revealed abnormalities. The physician prescribed amoxicillin, Flagyl, Z-pak, and Diflucan. This physician referred the subject to an infectious disease specialist.  The subject was seen by another physician on 01/16/01 "for evaluation of her left shoulder." At that time, the subject reported that she "has had approximately one month of left shoulder pain with decreased range of motion. There is no inciting injury. She only takes over the counter antiinfalmmatories for it and (the chiropractor) started her on some pendulum exercises as well. She is also complaining of some pain at the right epicondyle as well. Patient has a history of "Lyme disease" possibly stemming from a LYMErix vaccine going back approximately two years associated with paresthesia and anxiety....She was treated with antibiotics for which the parathesias resolved....She has never had any other joint involvements". On physical examination, "left should has limited range of motion and abduction 90 degrees. Internal rotation 0, external rotation 45. She has no tenderness posteriorly and no indication of swelling in the capsule. There is no significant tenderness in the subacrominal space indicative of bursitis. She has no radiation of pains down the arm other than locally in the upper brachium. She also has tenderness at the lateral epicondyle with full range of motion and no swelling. The physician's impression was "patient appears to have a frozen shoulder on the left with some early lateral epicondylitis on the right. She does not appear to have any intraarticular effusion involvement, and I cannot definitely say that this was associated with Lyme disease or LYMErix vaccine, nor can I fully rule that out....I would recommend an intensive course of physical therapy with over the counter antiinflammatories. The subject was evaluated by the infectious disease physician on 4/14/01. At that time, she reported the onset of paresthesias as 7/12/99. The physician noted, "on 3/16/00 MRI of the brian showed high signal abnormaltiies of the left frontal and parietal lobes consistent with LYme disease." The subject reported "a sensation of increased heat in the morning, occasional sweats, ear and head pressure, increased gaseousness, left hip pain, left shoulder pain, paresthesias of her ankles and occasionally forearms and anxiety." No abnormalities were ntoed on physical examination. He prescribed clarithromycin and hydroxychloroquine. The subjet remained under the care of this infectious disease specialist until at least 4/29/02. The following signs and symptoms were reported during this time: "BP started to fluctuate, headed towards low blood pressure" pain in her hips, ankles and feet; numbness and burning in her hands, worse in the left hand; "memory and concentration issues", waking from sleep with  pain; "some skipped beats"; left-sided pain from ribs to feet; a burning sensation in her mouth and around her eyelids; lower back pain; "a feeling of sluggishness of her intestinal tract; frequent bowel movements; sinus congestion; left and right sciatic pain; numbness of the knees; insomnia; pelvic pain; and burning of the back and arms. On 07/21/01, she reported "more stamina, is more relaxed about her illness." She also reported, "no further shoulder pain". Her memory is fine. On 12/22/01, "she denies any further shoulder pain or fatigue. Hip pain and frequent bowel movements have decreased." On 04/13/02, she reported "more fatigue". She also reported "no sweats". She reported exacerbation of symptoms in mid-July 2000, three weeks after discontinuing therapy with clarithromycin and hydroxchloroquine. By 12/14/02, the fatigue and knee numbness had resolved, pelvin pain had decreased.  The specialist made diagnoses of "Lyme disease reactivated by the vaccine" (07/21/02), "dysautonomia" (07/21/01), and "chronic Lyme disease" (09/29/01). He prescribed tetracycline, gabapentin (Neurontin), cefuroxine (Ceftin), tramadol (Ultram), and minocycline. As of 04/19/03, "overall most of what would appear to be Lyme symptoms have improved. She has overwhelming pain however. Her energy appears to be enough, she has some numbness and tingling in her feet, some burning pain in her hip. Her upper extremities and neck are fine. Cognitively she feels that her concentration is improved....Brain SPECT Scan done 01/14 showed no real changes in the SPECT Scan, still some frontal, parietal, and temporal hypoperfused areas. So she might still have areas of Lyme disease affecting her central nervous system." He prescribed clonazepam and topical fentanyl (Duragesic). On 8/22/01, the subject told her endocrinologist that she had left sciatic pain, pain in her ankle and feet, and fatigue, which she attributed to chronic Lyme disaese. Another healthcare provider prescribed physical therapy for the treatment of "chronic Lyme disease? on 01/24/02. The therapy was to be performed twice weekly for 12 weeks. The patient presented for the first session on 02/12/02. At that time, she reported "pain 5/10/10, constant left hip/knee, bilateral legs/feet". She also reported, "Lyme affecting sensory nerves and intestinal tract (secondary to meds), sacral plexuses. Paresthesias left lateral leg, right leg, bilateral fee, bilateral proximal H/S (hamstrings)." On 04/15/02, "patient discontinued, has had 18 visits with little change in symptoms".  The subject was seen by another neurologist on 06/09/03 for evaluation of "the various pains that she is having. The left tibula, left lower rib cage and left sciatic notch pain radiating down the left leg with some numbness in the left leg in an L4-5 distribution is felt by the patient to be related to her Lyme disease....A year ago she had an MRI scan, which showed a disc bulge at L4-5 and as far back as 1999 she had some complaints similar to this, but not involving the ribs....she is getting some relief from Neurontin 100-100-1500 mg a day with Elavil 25 mg. at night." On physical examination, "palpation of the left lower rib cage and upper iliac creast area revealed some tenderness but no masses noted. No sensory level along the dorsum of the spine and no tenderness to percussion along the entire dorsum of the spine. Forward flexion of the spine was normal....heel walking she could perform but it seemed to cause her some pain in a sciatic nerve distribution in the left leg....Palpation of the left sciatic notch however was positive and she complained of some hypesthesia in an 4-5 distribution, but pinprick, vibration, light touch, and joint position sense were all normal in both lower extremities in multiple dermatomes." The neurologist's impression was "this patient has some increasing pain over this past year, but the pain dates back four or five years before this." MRI of the lumbar spine, EMG, and nerve condution studies revealed abnormalities. X-rays of the left hips and left ribs did not reveal abnormalities. The neurologist stated that the history, physical, examination, and electrodiagnostic studies were "very suggestive of a left SI root irritation."  Following the reported onset of Lyme disease, the subject experienced burning sensation in the mouth, multiple episodes of sinusitis, tonsillitis, bronchitis, upper respiratory infection, gastroenteritis, yeast infection, colonic polyp, adhesive capsulitis of the left shoulder and "mild" chronic obstructive pulmonary disease. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. Information received on 08/29/03 indicated that left leg pain and numbness persisted as of 06/09/03. Information received on 08/15/04, revealed that in 02/04, the patient was treated with intravenous rocephin for one month to treat symptoms of Lyme Disease.. In May 2004, the patient received intravenous vancomycin for one month to treat symptoms of Lyme Disease. She continued to have burning pain in her ankles and aches around her knees. At a follow-up visit with her primary care physician 07/20/04, her symptoms were less intense and she was able to walk better. An amended legal complaint was received on 09/15/04 in which the attorney alledged that the patient, now 65 years of age, experienced "joint pain, numbness, severe burning and paresthesias with demyelination on MRI and hypofusion on SPECT Scan. Time to onset, treatment, and outcome were not reported. Information received on 01/05/04, reported that the patient continued to receive vancomycin (every two weeks) through October of 2004. No adverse events were reported. The patient's condition was stable.  Medical records received on 04/03/05 indicated that a complete brain spect was performed on the patient on 09/08/04. Conclusion: Although in general, there is interval improved activity in the brain as a whole, there are more prominent defects seen particularly in the frontal lobes when compared to previous exam. This could be consistent with progressive Lyme disease. Information received on 04/27/05 indicated that the patient required additional treatment for chronic Lyme disease in late September 2003. She began a course of Tetracycline, 500mg twice daily 20 min before meals for one week, then 750mg twice daily 20 min before meals. No improvement in the patient's condition was noted as of an office visit date 01/17/04. She was then started on a course of intravenous Ceftriaxone 2gm daily for an initial period of six weeks. Some improvement of the patient's condition was noted on 04/10/04, in her seventh week of Ceftriaxone. Liver tests became elevated and Ceftriaxone was discontinued on 04/13/04. Treatment with Vancomycin was then initiated with oral penicillin beginning on 05/14/04. Some improvement of her symptoms was noted in 08/04. Vancomycin and penicillin were discontinued on 11/15/04. One week later symptoms began gradually returning including burning sensations previously mentioned and right sided knee pain. A new symptom of burning pain along the bilateral scapulae was noted. Additional treatment for chronic Lyme disease was indicated on 12/04/04 in the medical record. Medical records were received on 01/23/06. Please see laboratory results section for results of an abdominal ultrasound that was performed on 05/27/04. For a follow-up visit with a nurse practitioner on 12/04/04, paresthesias on the bottoms of her feet had lessened. The patient had a follow-up visit with a physician on 04/30/05. It was reported that one week after discontinuing intravenous vancomycin and oral penicillin in mid-November 2004, her symptoms returned and she had disabling symptoms since. The physician prescribed tetracycline. She had some increased symptoms, especially bowel symptoms, diarrhea. Tetracycline was discontinued, especially since she was going on 4 cruises. She restared tetracycline at a lower dose, one gram daily over the past month. She had burning pain in her legs and her hip with some spasms, more on the left side than the right side, rib pain, burning of her eyes, and numbness and burning on the left side of her tongue. Her energy was "generally pretty good overall". She continued to take gabapentin (Neurontin), occasional Tylenol (acetaminophen) with codeine, hydrochlorothiazide, and sodium levothyroxine (Synthroid). On examination, she had no tremors and reflexes appeared to be normal in her upper and lower extremities. She also had some non-specific rashes on her arms and feet. Results of EMGs which showed abnormalities in both the right and left legs consistent with a demyelinating polyneuropathy, were reviewed. Impression/Plan: The physician's impression was that she had longstanding chronic Lyme disease exacerbated by the Lyme vaccine. She had some improvements, but she had continuing deficits. She was prescribed hydroxychloroquine (Plaquenil) and clarithromycin (Biaxin). She was going to consider getting a skin biopsy. Nerve biopsy was unlikely unnecessary since she already had documented neuropathy by the EMGs. In the future, she my receive intravenous immunoglobulin to see if that would help with any autoimmune type component to her illness. She may receive another course of Vancomycin and penicillin in the future.  The patient had a follow-up visit with a nurse practitioner on 09/10/05. Sincer her last visit, the patient had undergone a skin biopsy of the left arm and left leg which showed small fiber neuropathy which was consistent with the EMGs which showed abnormalities of both the right and left legs consistent with demyelinating polyneuropathy. She reported that she had not noticed any changes in symtomatology since restarting clarithromycin and hydroxychoroquine. She tried stopping the medication for polyneuropathy one week but there was no change in symptoms. Pain was very bad in her rectum and muscle spasms in her right buttock which has lessened slightly. She treated the symptoms with Tylenol 3 (acetaminophen with codeine). Other ongoing symptoms included rib pain and a burning senstion from the left leg and ankle. She occasionally experienced burning around her eyes, face, forearms, hands, left side of her tongue, and left hip. The patient reported that secondary to the results of her skin biopsy of the left arm and left leg, her neurologist recommended gamma globulin infusions, in consultation with a physician, a treatment plan was discussed. Clarithromycin and hydroxychloroquine were to be discontinued at that time. She was to be scheduled for a repeat brain SPECT scan and physician consult about possibly receiving intravenous gamm globulin. She was to contact the physician if she had durther exacerbation of her symptoms, and she was given a prescription for azithromycin (Zithromax) and amantadine which could be started if needed. She was given a prescription for gabapentin (Neurontin) to be taken at bedtime. In addition, she continued to require gabapentin (Neurontin) twice daily. At the next scheduled follow-up visit the option of returning to treatment with intravenous vancomycin and oral penicillin would again be considered. The patient had an office visit on 06/14/01. The physician noted that "she doesn't feel much better, in fact, she gets an itchiness in her arms. Follow-up visit 07/02/01 patient seemed to have white coat syndrome. On 11/10/01 the patient had a stool culture which showed no Salmonella, Shigella, Aeromonas, Campylobacter, or E. coli 0157 isolated. The rapid screen for Clostridium difficile antigen was negative. Follow-up information was received on 04/10/06. The patient was evaluated by a neurologist on 03/10/05 with complaints of post-Lyme vaccination symptoms including weakness, burning sensations in the forearms and legs, jitterness, numbness of the left side of the tongue and eyes, pain in the left ribs, left hip, oscrum and buttocks, tenerderness of the knees, ankle pain, pressure headaches and burning pain across the back. Neurologist examination showed some stocking vibratory, cold temperature, and proprioceptive sensory loss, atrophy of the calves, difficulty in hopping on the left leg more the the right, fasciculation, hypoactive leg reflexes, romberg sign, tandem imbalance, and otherwise normal cognition, cranial nerves and confroncational limb strength. Skin biopsies performed in May 2005 showed significantly reduced epidermal nerve fiber density.  The most recent info, received on 9/5/02, indicated that the subject was "still having problems with Lyme" as of 2/18/02. Information received on 4/1/02 indicated that the pain and burning in the extremities persisted as of 3/31/02. The outcome of the panic disorder was not provided. The most recent info, received on 9/25/00, reported the outcome of the pt as not recovered. Following the reported onset of Lyme disease, the subject experienced burning sensation in the mouth, multiple episodes of sinusitis, tonsillitis, bronchitis, upper respiratory infection, gastroenteritis, yeast infection, colonic polyp, adhesive capsulitis of the left shoulder, and "mild" chronic obstructive pulmonary disease. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent, received on 15 October 2003, did not provided the outcome of the reported events. Information received on 29 August 2003 indicated that left leg pain and numbness persisted as of 09 June 2003.