Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Chest discomfort, Depression, Dyspnoea, Influenza
Clinical narrative: Following the reported onset of arthritis, the vaccinee experienced shortness of breath and chest discomfort. These 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 pt received her 1st and 2nd injections of Lymerix on 3/2/99 and 4/6/99, respectively. The pt's attorney stated, "After receiving the vaccinations, (her) physical condition began to deteriorate. At first, the muscles in her arms and legs became painful. Her condition worsened and the pain increased and spread throughout her body." Onset of the muscle pain, as well as duration before worsening, was not provided. The vaccinee reportedly, underwent "extensive and intensive physical occupational, and rehabilitative therapies and modalities"; however, the "debilitating pain and arthritis throughout her entire body" allegedly persisted. The pt has also reportedly received "exercises/physical therapy regimens, antibiotic treatment and trigger point injections". The attorney stated that the pt continues to experience "incurable and at times debilitating pain", which "severely limited her employment options and opportunities". The attorney stated that the pt was told by her physician "that her physical problems were related to the Lymerix vaccinations." On 11/16/00, the vaccinee reported to her gynecologist that she had muscle, joint symptoms and PMS symptoms secondary to Lyme's. She stated that diagnosis of Lyme disease and granular/monocystic Ehrlichiosis were made on 9/1/00, after having symptoms for 3.5 years. At the time of the office visit with the gynecologist, the vaccinee was being treated with cefuroxime, doxycycline, pseudoephedrine/guaifenesin, and acidophilus. The most recent information received on 2/15/02, did not specify the outcomes of th reported events. The pt is considered disabled because of the "debilitating pain", which "severely limited her employment options and opportunities". The medical history included Lyme disease. On 03/26/1998, the vaccinee's gynecologist wrote, "Over the last year, she was treated for presumptive Lyme disease and couple of times with antibiotics; relief obtained each time." The medical history also included premenstrual syndrome treated with provera, Dyazide, and Zoloft; hot flashes, hair growh on upper lip, irregular menstual cycles, endometriosis treated with Lupron, abdominal adhesions, pelvic pain, ovarian cysts, and anemia. Surgical history included lapargscopy with lysis of right lower quadrant adhesions and fulgrationof endometriosis, cesarean section, and appendectomy at age 18. Following the reported onset of arthritis, the vaccinee experienced shortness of breath and chest discomfort. These 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. On 11/16/2000, the vaccinee reported to her gynecologist that she had "muscle, joint" symptoms and "PMS symptoms secondary to Lyme's." She stated that diagnoses of Lyme disease and "granular/monocystic Ehrlichiosis" were made on 09/01/2000, "after having symptoms for 3.5 years." At the time of the office visit with the gynecologist, the vaccinee was being treated with Ceftin, doxycycline, Duratuss, and acidophilus. The most recent info received on 02/15/2002, did not specify the outcomes of the reported events. Other medical histories include mitral valve prolase; mitral regurgitation, pelpitations, edema of hands and feet, atypical chest pain, shortness of breath, joint pain, joint swelling, limb pain, back pain, fibromyalgia, fatigue, nause, and headache. On 03/24/1999, the vaccinee informed her dentist that she received care at a hospital, either as an out-patient or as an in-patient, within the previous two years for "shortness of breath from complications thoght to be from Lyme disease. She also indicated that she was or had been within the previous two years, under the care of a physician for illness thought to be lyme disease. She indicated that she had taken amoxicillin, Zoloft, ibuprofen, and trianterane/hydrochlorethiaside within the preceding six months for unspecified indications. The most recent info, received on 04/11/2002 did not specify the outcomes of the reported events. **Follow-up report on 10/10/02: The vaccinee received her 2nd injeciton of LYMErix on 4/6/99. At the time of this visit, she was complaining of shortness of breath, palpitations, tiredness, fatigue and was feverish. On 8/1/00, the vaccinee was seen by the vax provider. She complained of aches and swelling of four days duration, right sided chest pains, tiredness, sleeping a "long time", bad moods, and arthritis. The MD prescribed ibuprofen 600 mg three times daily and noted that a Lyme titer was negative. On 8/2/00, the vaccine presented to the local ER with complaints of chest pain for 2 days, shortness of breath, left arm numbness, left leg numbness, and lightheadedness for 5 days. She stated that she had been seen by her primary MD on 8/1/00. The ER MD confirmed this. The vaccinee's primary MD stated that complete blood count, erythocyte cadimentation rate, and uric acid concentration were w/in the reference ranges, rheumatoid factor and Lyme titer were negative (please see Lab data section for details re. diagnostic evaluations). At the ER, Lyme antibody screen was "presumatively positive". Lyme IgG and IgM Western blots were negative. The ER MD's impression was "Recurrent Lyme Disease" and he prescribed doxycycline. On 8/14/00, the vaccinee presented to another family MD for the first time. The MD noted that the vaccinee stated that she had possible Lyme infection in '96 with Lyme vaccine on 3/2/99 and again on 4/6/99. This was subsequently followed by the chief complaints listed at this visit as unexplained sweats and weight changes, fatigue, chronic sinus infections, pelvic pain, unexplained menstrual irregularities, irritable bladder, bladder dysfunction, decreased libido, stomach problems (NOS), chest pain, shortness of breath, heart palpitations, joint pain in multiple major joints, muscle pain, cramps, twitching of her facial muscles, headaches, neck stiffness, stiffness in the joints of her back, tingling numbness in her extremities, double vision, floaters, photosensitivity, buzzing, ringing in her ears, sensitivity to sound, dizziness, lightheadedness, difficulty with concentrating, reading or following plots, decreased short term memory, ,mood swings, irritability, depression, crying for no reason, sleep disturbances (NOS), and early awakening. Medications at the time of this visit included doxycycling 100 mg twice daily. Physical exam revealed a 6th cranial nerve palsy (greater on left than on right). Extensive diagnostic evaluation was negative, except for Lyme IgG and IgM Western blots, human monocytic ehrlichoisis (HME) IgG and IgM, and human granulocytic ehrlichiosis (HGE) IgM (please see Lab data section for details regarding diagnostic evaluations). The MD indicated that the Lyme serology(?) indicated "Lyme disease in the past more than 2 yrs" and "current infection of Lyme disease". On 9/5/00, the vaccinee was seen in follow-up by the family MD. The MD noted his impressions as myalgia, arthralgia, HME, and HGE. The vaccinee was given penicillin G benzathine (Bicillin LA) 2.4 million units IM and was prescribed cefuroxine exetil (Coftin) 500 mg twice daily. On 9/18/00, the vaccinee was again seen by the family MD. At that time, she reported some improvement in her symptoms. Her temp was 100.1 deg F. The MD noted that she had a "positive Herxheimer reaction". The MD continued treatment with Ceftin and added ciprofloxacin (Ciloxan) four drops 3 times daily." On 10/20/00, the vaccinee was seen by the fmaily MD. She reported, "I really feel improved", "I really don't have a headache now". She also reported that she had not perceived any changes to her "ocular sensations", "sounds seemed to be louder than normal" and her "heart fluttered". The MD noted his impression as hyperacusis, HME, HGE, Lyme disease, He continued Ceftin therapy and added doxycycline (Doryx) 100 mg daily. He encouraged the vax to begin walking on a daily basis to "boost her immune system". On 11/9/00, the vaccinee was seen by the family MD. She reported "having been doing everything which the MD noted made her sick. He advised the vaccinee "that when she starts to feel good, to take it easy, if she worked hard one day, to rest the next because it could bring on an exacerbation of her symptoms." The vaccinee also reported that she had been compliant w/walking, up to one mile daily, but had noticed an increased stiffness over the past month. The MD continued Doryx and Ceftin therapy and administered Bilcillin LA 2.4 million units. On 11/16/00, the vaccinee reported to her gynocologist that she had "muscle, joint" symptoms and "PMS symptoms secondary to Lyme's [sic]". She stated that diagnoses of Lyme disease and "granular/monocystic Ehrlichiosis" were made on 9/1/00, "after having Sx's for 3.5 yrs". At the time of the office visit w/the gynocologist, the vaccinee was being treated w/cefuroxine (Ceftin), doxycycline, psuedoephodrine/ guoifenasin (Duratuss), and acidophilus. On 12/5/00, the vaccinee was seen by the family MD. She reported improvement in her symptoms (NOS), but also complained of chest wall pain off and on in the sternal area as well as hearing prob's (NOS). She also stated that "maybe she had a virus this past month that was contributing to these maladies." The MD noted that the "chest wall tightness from what we have noted as a Herxheimer reaction where symptoms are exacerbated during the treatment and die off of the organisms of Lyme disease Borxelia." He continued treatment with Doryx and Ceftin. At the time of the visit he administered Bicillion 2.6 million units IM and prescribed dextromethorphan/ phemylpropanolamine/ brompheniramine (poly-Histine DM) to be taken one to 2 teaspoonfuls 4 times daily. On 1/2/01, the vaccinee was seen by the family MD. She reported that for the 1st time in about 4 yrs, the edema in her left fingers had resolved. She also stated that the chest pain had improved and overall she was doing much better. The MD noted hemangiomas increasing on her skin "which is seen w/Babesiosis". Ceftin and doxycycline were continued. On 1/8/01, the PT was evaluated by a cardiologist for mitral valve prolapse and chest pain. Her physical exam and echocardiography were normal. The MD noted that it had "become apparent that some of the chest pain may well be related to Lymes (sic) disease". On 2/26/01, the vaccinee was seen by the family MD. She reported that she had discontinued her antibiotics "a few days ago". She stated that "she was stable". The MD noted that her skin had cleared. The vaccinee telephoned the MD on 3/13/01 and reported that she "feels like she is going downhill. She is more tired, hands and face painful, legs feel heavy again, can't think and difficulty w/word finding". She also reported in increase in the following symptoms: fatigue, swelling, lower back pain, joint pain, stiff neck, and bad moods. Serologies for Lyme disease, babesiosis, and HME, performed as part of management on 3/12/01 were positive. On 4/3/01, the vaccinee was seen by the family MD. The vaccinee reported that around 3/15/01, she felt "like she is going downhill, ,more tired, hand and face painful, legs feel heavy again, can't think, difficulty with word finding". The MD noted that at this time the vaccinee had been off antibiotics about 3 wks. At the current visit, the vaccinee was complaining of ongoing muscle cramps and pain. The MD noted that acne had returned and prescribed "X Gel" 27 grams topically twice daily. On 5/7/01, the vaccinee was seen by the family MD. She reported "her bad days are fever and farther between", increased energy, decreased finger swelling, but still c/o'd daily pain, occasional headaches and increased neck pain. The MD discontinued Doryx and prescribed atovaquone (Mopron) 750 mg in the morning and 1500 mg in the evening for treatment of babesiosis. Coftin therapy was continued. On 6/7/01, the vaccinee was seen by the family MD. She reported that after treatment w/Mopron, "I have had the best week in 4 yrs". However, she stated that she had a "flare-up" while in the waiting room and that she still has sweats, chills, stiff neck, and quadricop weakness (treated with megnasium). Mopron was discontinued and treatment for Babesiosis was changed to atovaquone/ proquanil (Malarone) one tablet for 21 days then 4 tablets for 3 days. On July 12 01, the vaccinee was seen by the family MD. She reported that she had a "rough month" as she was experiencing depression because her daughter had been bitten by a series of deer ticks. She also reported that when she was on Malarone therapy, she suffered from increased depression. The MD gave her samples of bupropion hydrochloride (Wellbutrin ER), titrating from 75 mg daily to 150 mg daily, and referred her to a psychiatrist who works w/PTs with tick-borne diseases and depression. On 7/30/01, the family MD wrote a letter to the vaccinee's attorney summarizing his course of treatment, which has been described above. W/in the letter he noted: "Impression: 1) Lyme disease for more than 2 yrs, secondarily exacerbated by Lymerax [six] vaccine which I have seen in dozens of cases in the past. 2) Human Monocytic Ehrlichiosis. 3) Human Granulocyte Ehrliochiosis. 4) Babesiosis. 5) Depression secondary to all the above. Prognosis: At this point the prognosis is fair to good. The PT has responded well to the antibiotic and antiparasitic treatment. However, I want to reserve the fact that we do not know what the future will hold for this PT. The PT is problematic because we had taken her off her antibiotic regimen and basically has relapsed which makes her case quite perplexing." On 8/13/01 the vaccinee was "doing ok". However, the family MD prescribed naproxon (Napralan) 500 mg twice daily. On 9/10/01, the vaccinee was "better this month". The vaccinee returned to the family MD on 10/2/01, stating that she was "sick yesterday. Numbness arm elbow to ulnar off/on". The vaccinee was referred to a neurologist. On 10/29/01, she reported "increased neurological prob's: balance off". The MD noted "HLA-DKA-gene detected may be the reason for PT having increased prob's from Lyme vax". The most recent info, received on 9/24/02, did not specify the outcome of the reported events. The vaccinee is considered disabled because of the "debilitating pain", which "severely limited her employment options and opportunities".