Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Menstruation irregular, Neuropathy, Ovarian cyst, Paraesthesia, Rash
Clinical narrative: The pt reportedly received 2 injections of Lymerix. Medical records provided by the pt's attorney, documented 1 injection of Lymerix (lot LY123B9 on 5/5/99. Medical records indicated that the pt saw a new PCP on 7/7/99. "She presents convinced that she has Lyme disease. She reports a several month history of non-specific symptoms, primarily profound malaise, fatigue and posterior scalp and neck paresthesias that are intermittent. Sometimes there is an associated dull ache. As a result of these symptoms, she has had to withdraw from work for the past 3 to 4 weeks. She denies actual fever. No rash was noted. No severe headache, vision change, neck stiffness, palpitations or joint swelling has been reported. She did have intermittent abdominal discomfort which has since resolved. She has been treated with a course of antibiotics. This pt initially pursued evaluation with her previous PCP, who ordered comprehensive blood work, including CBC, chemistry panel, TSH and Lyme Western blot testing. She has a (+) Lyme screen secondary to having received 2 of 3 shots in the series. Her Western blot was entirely negative. The doctor, as part of empiric therapy, started her on doxycycline. She was concerned enough to want to pursue further evaluation with a specialist and went to (a tertiary care center) where she was informed that she did not have Lyme disease based on blood work testing. In contacting her PCP again, he continued her on 2 additional weeks of doxycycline and she is now completing her 4th week. Not satisfied with the medical opinion to date, she made an appt with (infectious disease) specialists. That appt is later in July and feeling uncomfortable enough to pursue further workup and treatment prior to that, she presented here for evaluation. She denies symptoms of depression and otherwise has a benign past medical history. Doxycycline is the only current medication." On exam, the pt is anxious and highly talkative and very focused on the problem at hand. Her husband is also present and he fills in a good part of the story. The family wishes to proceed and an order for IV Rocephin was given for 2gm IV for 30 doses to be given Monday through Friday for 6 weeks. Rocephin therapy began on 7/20/99. On 8/23/99, the pt reported that she was "much better". She also reported that the neurologist recommended an additional 4 weeks (20 doses) of Rocephin; the additional doses were ordered. On 9/28/99, she stated that the neurologist recommended that the Rocephin be followed by a 6 week course of doxycycline. On 11/2/99, the pt telephoned the physician and stated that the neurologist said she should stay on doxycycline therapy for 9 months "per schedule". The pt telephoned the physician on 12/21/99, "requesting that I order a urine antigen test for Lyme. (She) thought she should get it now because she felt as if she was in one of her "flares" wherein she gets diffuse aches. She attributes this to the 4 week cycling of release of the Lyme spirochete effect supported by her neurologist friend". On 12/22/99, the pt "popped in unexpectedly and stated that she was having one of her flares and according to the literature, suggested that she resume IV Rocephin therapy. I informed her that I would not be comfortable with this given the lack of confirmation that she has Lyme or, for that matter, neurological manifestations of Lyme." The physician spoke to the neurologist and "told him of my concern that (the pt) and her husband are locked in as this being the only absolute dx and a result, turning a blind eye to other possibilities that may warrant investigation, for example; multiple sclerosis". The pt reported that she had an appt in 1/00 to be evaluated by a "Lyme specialist". The physician wrote, "In the meanwhile, I agreed not to pursue IV Rocephin, but use the oral alternative in the form of Ceftin 500mg tid". On 12/29/99, the pt reported that she had developed a rash. She discontinued Ceftin, and the rash resolved. The physician "Agreed, given 'flare' to pursue IV Rocephin on condition she saw 'Lyme specialist'. On 2/2/00, the Lyme specialist telephoned the pt's PCP and stated "she thought (the pt) could be treated with PO second course of IV Rocephin 2 q a day. She is just about to complete the course of this medication and it is felt that her symptoms have improved with the exception of cranial symptomatology. Specifically, the degree of her cranial symptoms, i.e., sensation of a "fist in her head" with some pressure has decreased some. Her extremity symptoms which include shooting pains has minimized. She states that her menses have become regular and the burning sensation in her eyes has dissipated. Her appetite has recurred again and her fatigue and malaise has abated so that she is not falling asleep as much during the day. She is very fearful of coming off the Rocephin for concern regarding relapse. She requests an additional 30-day cycle of treatment. Rocephin 30-day therapy, 2g a day IV was ordered." The pt returned to her PCP on 2/9/00 "primarily to get blood work and to present paperwork to me regarding a summary of her symptoms and treatment for her Lyme to date and also, in particular, a symptoms checklist which she got from (the Lyme specialist) in order to demonstrate the extent of symptoms she had and also how she has responded in terms of symptom abatement with IV Rocephin therapy. She currently continues on IV Rocephin. Again, she stresses that a wide variety of her symptoms have all improved dramatically on IV Rocephin. The physician's assessment was "Clinical Lyme neuroborreliosis". The physician wrote, "She has a good relationship with an out of state neurologist who I will recommend that she continue care with in that she has a well established relationship that is long standing and it will be important that she receive continuity of care through him as an advocate for her. Given this, I will recommend to the pt that she not visit with a psychiatrist who is reported to be a Lyme specialist." In a letter dated 2/7/02, the neurologist referred to above wrote, "In approx. 6/99, she called my wife at home and described several symptoms she was experiencing and on that day, I talked with the pt on the phone and she told me about her symptoms. I explained to her that I could not be her doctor. She has never been my pt for the purpose of treatment, assessment, billing or diagnosis. I never ordered any tests or reviewed her medical records/lab tests. I have not seen or had the occasion to talk with her in over 1 year". On 2/21/00, Western blots were negative for IgM and IgG. On 2/23/00, the PCP was notified that the pt's transaminase concentrations were elevated, he recommended discontinuation of Rocephin. The transaminase concentrations slowly returned to the reference range. On 3/1/00, the pt telephone her PCP to report that she was "happy with visit with rheumatologist who is doing more blood work." On 3/15/00, the rheumatologist prescribed defotaxime (Claforan) 2g IV every 8 hours for 30 days; therapy began approx. 3/30/00. The pt's transaminase concentrations increased again and Claforan was discontinued on 3/30/00. It was restarted at a dosage of 2g IV every 12 hours on 4/3/00. The pt returned to her PCP on 4/10/00. "She is presently being treated for Lyme disease with neurological manifestations on IV Claforan 2g every 12 hours." On 4/26/00, the pt telephoned her PCP to report that the psychiatrist had changed her antibiotic therapy to imipenem/cilastatin (Primaxin) 500mg IV, 3X daily. The scintigraphic findings are nonspecific but have been described in vasculitis, including neuroborreliosis as well as chronic fatigue syndrome. On 7/13/00, the psychiatrist changed the Primaxin dosage to 1000mg IV twice daily. On 9/24/00, the pt telephoned her PCP and reported that she "just completed long course of IV antibiotics for Lyme disease". On 9/27/00, the pt telephoned her PCP to report that "she's stressed; wondering about Xanax to help her through this". The physician prescribed Xanax 0.25mg 1 or 2 tablets 3 X daily, as needed. The pt was referred for physical therapy for "Post-Lyme Syndrome" on 11/10/00. The pt reported to her PCP on 12/22/00 that the psychiatrist had prescribed doxycycline 200mg X 2 daily "due to recurrence of headache-she states it has helped her substantially. ENT visit because of fullness in left ear resulted with a dx of Eustachian tube dysfunction. He prescribed Touro La to take 1 b1d and Flonase 2 sprays into the left nostril. The PCP wrote, "in light of negative serology, headache looks more and more like fibromyalgia syndrome and informed pt that she would not longer receive any antibiotics for presumed Lyme disease from this office. I would be glad to treat for fibromyalgia. On 5/7/01, the pt called her PCP to report that she had "stabbing head pain and back pain and tingling down spine". She said the psychiatrist "suggests possible co-infection". The pt wishes a Babesia test. Put on doxycycline. The follow up states one the the vaccinee's physicians submitted a report directly to VAERS. The vaccinee reported that she received two injections of LYMErix on 5/5/99 and 6/2/99 respectively. Medical records indicated that a Lyme antibody screen performed on 4/14/99 was 3,180, Lyme IgM and IgG western blots were negative. On 7/7/99 Lyme IgM and IgG western blots were again negative; however, both demonstrated a 31 kD band. No Babesia organisms were seen on blood smear. Human granulocytie ehrlichiosis (HGE) IgG titer by immunofigurescence assay was 1:32. Results of a computed tomogram of the head, performed with and without contrast on 7/12/99, were interpreted as "normal." Lyme urine anigen that test performed on 12/22/99 was negative. The Lyme speciaalist wrote to the primary physician on 2/3/00. The specialist's letterhead indicated that her practice was cardiology and internal medicine. The specialist wrote, "This past year, the pt was had two LYMErix vaccines. The first being 5/5/99 and the second 6/2/99. She complained of dizziness after the first shot and was told this was normal. After the second vaccine, the pt felt worse feeling "jerking" movements, decrerased memory, shooting pains down her body, voice changes, burning sensations of the scalp and rib pain. Apparently, her symptoms have gotten significantly better. Currently, her symptoms started to recur and her treatment of Rocephin was restarted. The pt improved to the point where she was able to return to work. We had a very long and extensive discussion with the pt as well as her husband regarding the diagnosis fo seronegative Lyme disease which indeed could be a possibility though it is only the minority of the patients who they have this particular entity. If indeed the pt has received by now two courses of IV Rocephin with significant improvement. Unfortunately, I am not in the position to evaluate or judge her improvement from the beginning when she apparently felt sicker and nwo seems to have given her an opportunity to be treated for this. I do not think I can recommend any further IV therapy in this particular case because of the risk of any further evidence of an ongoing problem of Lyme disease. The vaccinee was seen by the psychiatrist on 4/25/00. He administered an IV injection of "Thymus." The vaccinee returned to the psychiatrist on 5/25/00. She reported "less burning... now can hardly feel it." The psychiatrist noted that the vaccinee was "feeling best she ever felt." The vaccinee reported "some intense burning in ear," still fell some pressure. No neck stiffness... memory clearer now.... some burning down back minimal. Slight muscle twitches. Sleeping through-out night-not tired. Continue for 30 days Primaxin. The psychiatrist submitted a report to VAERS on 6/22/00. On 7/17/00, in a letter to the vaccinee's insurance company, the psychiatrist stated that the vaccinee "is in teatment for chronic persistent Lyme disease with encephalopathy." On 7/20/00, the psychiatrist noted that the vaccinee was "still feeling a lot of ear pressure. Burning down back has ceased." The psychiatrist began to administer IV hydrogen peroxide and high-dose IV vitamin C on 8/22/00. On 9/5/00, the psychiatrist noted "olive leaf extract is helping-in addition to IV antibiotics. Was able to run one mile. Burning less significant. Able to work some." On 9/27/00, the peripherally-inserted central catbeter was removed and the vaccinee began taking oral Flagyl. On 10/12/00, the vaccinee reported to the psychiatrist "decreased depression. Flagyl did not agree-stopped it." The vaccinee was seen by an infectious disease specialist on 1/4/01. At that time, the vaccinee reported that she "apparently became ill after receiving Lyme vaccine in April an dMay of 1999. She began experiencing shsooting pains all over her body with poor sensory, dizziness, headaches, rib pain, and lymphadenopathy." The vaccinee also reported that "her headache is gone although she still has some irritating numbness in the occipital part of her head. She also has pain in her left ear which is better on the Doxycycline but she still feels that "something is still there." She remains tired but  not as achy." On physical examination, "neuro exam shows hyperreflexic deep tendon reflexes, normal cranial nerves, normal gait, speech and strength." The infectious disease specialist's imprression was "the vaccinee presents with unusual neurologic symptoms at present which are in my opinion probably not due to lyme disease. Although she has responded to antibiotics with a negative lyme serology I don't feel that she has active lyme disease which would account for her current symptoms or necessitate further antibiotics. If her symptoms continue she should be re-evaluated by a neurologist and consider neuropathy, multiple sclerosis, or another neurologic procerss. I am somewhat concerned about ehr proteinuria and wonder whether she could have an autoimmune disease which may be having kidney involvement and causing the positive ANA. Her symptoms may also be due to a lyme vaccine immune reaction. In my opinion it would be okay to discontinue doxycycline however she is not inclined to do this at this time. If she requires any further treatment for her lyme disease, would refer her back to the psychiatrist who is willing to treat seronegative pts for prolonged periods of time with IV antibiotics. On 6/14/01, the psychiatrist noted that the vaccinee experienced "eruption-like feeling with Malarone. Had a hard time on doxycycline. Then went to amoxicillin. Felt better." The psychiatrist wrote an open letter on 7/13/01, stating, "the vaccinee has been under my care for the treatment of lyme disease since 4/4/00. History of present illness: Pt first presented with the following symptoms: severe fatigue, severe memory difficulties, muscular spasms and pain, head and spinal burning, anxiety and depression. She has been treated with both oral and IV antibiotics neither of which have had a lasting effect on her condition. I have recommended that she undergo hyperbaric oxygen therapy as a new avenue of treatment. Several of my lyme encephalopathy pts have had success with this treatment as a means by which to increase oxygen flow to areas of hypoperfusion." "Acute left groin and leg pain, left ovarian cyst" (non-events) were made. The vaccinee returned to the psychiatrist on 1/15/02 and reported that she was "doing so well. Wroking in hospital again. 'Brick' in head much lighter. Ozone two times per week continues (30th treatment)." On 1/15/02, Babesia IgM and IgG titers, Babesia DNA by polymarase chain reraction (PCR) in whole blood, human monocytic ehrlichiosis (HME) IgM and IgG titers, HGE IgM and IgG titers were negative. The most recent info, received 2/25/02, indicated that the vaccineew as doing well and had returned to work. She was still resolving ozone therapy. Depression and anxiety are considered incapacitating because the vaccinee reported that she was unable to work for at least three to four weeks in 1999, and during hyperbatic oxygen therapy. The follow up states the vaccinee began physical therapy on 11/20/00. The therapist wrote, "Pt presents with fitigue and pain in head extending down through the spine." The vaccinee graded the pain as 3 on a scale of 10 "on a good day" and 10 on a scale of 10 "with menstruation." The vaccinee reported that the date of onset was 1997. At the time oft he evaluation, the vaccinee "walks one mile three times per week. Was running two miles prior to Lyme vaccine." The vaccinee reported "sic weeks aog she couldnt' walk down street." The therapist instituted an aquatic exercise program, myofascial release, and "evaniosedral work." The vaccinee was to attend physical therapy two or three times per week for four weeks. The most recent info, received 4/3/02, did not specify the outcomes of the reported events. The follow up states the vaccinee was seen by a physician on 6/14/99 with a chief complaint of gastrointestinal upset. She also reported "fatigue times a few months. Recent concerns due to Lyme disease (daughter) and pt received two doses of LYMErix." The physician noted that the vaccinee had "no true indigestion symptoms." His assessment was "fatigue/GI upset." malicobacter pylari IgG was negative. Lyme antibody screen was positive, but no bands were demonstrated on IgG or IgM western blots. On 6/17/99, the physician recorded, "LYme positive antibody, western blot negative. Will do further testing, but in interim will treat for two weeks Doryx 100mg twice daily."  The most recent information received on 6/13/02 did not specify the outcomes of the reported events. Information received on 2/25/02 indicated that the vaccinee was doing well and had returned to work. She was still receiving ozone therapy. Toxic encephalopathy, Lyme encephalopathy, fibromyalgia, depression, and anxiety are considered incapacitating becasue the vaccinee reported that she was unable to work for at least three to four weeks in 1999, and during hyperbaric oxygen therapy. A 15-day follow up report received 9/9/2002 adds: Report A0360407A describes toxic encephalopathy and Lyme encephalopathy in a 38-year-old female who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of medical reports. One of the pt's physicians submitted a report directly to VAERS. Medical history included deep vein thrombosis (1992) and tick bite reportedly at the time of immunization. In approx Dec 1998, the pt experienced "extreme" tiredness and fatigue; her daughter was diagnosed at that time with Lyme disease. The pt believed that she also contracted Lyme disease at that time. She had no known drug allergies. Surgical history included tonsillectomy and adenoidectomy. Concurrent conditions and concurrent medications were not provided. The pt reported that she received 2 injections of Lymerix, on 05/05/1999 and 06/02/1999 respectively. Medical records provided by the pt's attorney documented one injection of Lymerix (lot LY123B9) on 05/05/1999. The pt was seen by a physician on 06/14/1999 with a chief complaint of gastrointestinal upset. She also reported "fatigue times a few months. Recent concerns due to Lyme disease (daughter) and pt received 2 doses of Lymerix." The physician noted that the pt had "no true indigestion symptoms". His assessment was "Fatigue/GI (gastrointestinal upset." Helicobacter pylori IgG was negative. Lyme antibody screen was positive, but no bands were demonstrated on IgG or IgM Western blots. On 06/17/1999, the physician recorded, "Lyme positive antibody, Western blot negative. Will do further testing, but in interim will treat for 2 weeks Doryx (doxycycline) 100 mg twice daily." The pt was evaluated by a rheumatologist at a tertiary care center on 06/29/1999. She was "referred here from her private medical doctor regarding suspected Lyme disease. Pt claims that 6 months ago she experienced extreme tiredness and fatigue, and her daughter was diagnosed at that time with Lyme disease and was treated for it. She believes that she also contracted the disease at that time. She claims that she did not seek medical attention at that time because she was too busy taking care of her daughter. Later on, the pt experienced headaches, dizziness, difficulty concentrating, tingling sensation in the arms and back of head. She denies any joint pain, any fever, chills or night sweats. She had gone to her primary care physician for a routine physical exam and explained to him the symptoms she was having. She also had taken the Lymerix vaccine, the first dose in May, the second dose on 06/02/1999. Her private medical doctor ordered some labs, the ELISA and Western blot. The ELISA was positive. The Western blot was negative. No bands were shown. The pt was started on doxycycline 100 mg b.i.d. (twice daily) for 2 weeks, pending the results of the ELISA and Western blot by the PMD (primary medical doctor). The pt denies any arthralgias or skin rashes." On review of systems, "The pt complaining of anorexia, more pronounced after she experienced the tiredness 6 months ago. The pt denies loss of weight or gain of weight." Medication at the time of the evaluation was doxycycline 100 mg twice daily. Nothing abnormal was noted on physical examination. Specifically, musculoskeletal examination revealed "Full range of motion, normal power in all extremities, no joint tenderness, no joint effusions, no instability, no problems with gait. Skin: no signs of rashes, bruises. Neurologic: Cranial nerves II to XII intact. No sensory deficits. Reflexes +2 in all areas." The rheumatologist reviewed the laboratory studies ordered by the primary physician, including the Lyme ELISA and Western blot. The assessment was "Nonspecific symptom complex. Laboratory workup consistent with Lymerix vaccine. Serology negative for exposure to LD (Lyme disease) agent. No evidence of connective tissue disease. No evidence of active Lyme disease." On 06/20/1999, the pt presented to her physician. The physician noted the "pt continues IV (intravenous) Primaxin (imipenemcilastatin sodium), appears stabilized, but not improved: approx 60% improvement...continue 4 weeks Primaxin increase by 25 x (times) 3, 750 mg x (times) 3 daily." In a Statement of Injuries, her attorney alleged that the pt "suffers from flu-like symptoms, fatigue, headaches, ear pressure and a burning sensation going from the head down the spine." The most recent info, received 08/23/2002, did not specify the outcomes of the reported events. Info received on 02/25/2002 indicated that the pt was doing well and had returned to work. She was still receiving ozone therapy. Toxic encephalopathy, Lyme encephalopathy, fibromyalgia, depression and anxiety are considered incapacitating because the pt reported that she was unable to work for at least 3 to 4 weeks in 1999, and during hyperbaric oxygen therapy.