Report A0360135A  describes systemic lupus erythematous in a female vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of limited medical records. Medical history included intravenous drug abuse, cocaine abuse, alchol abuse, hepatitis C infection (1980), mononucleosis (1983), cytomegalovirus infections (1985), positive tuberculin skin tests treated with a 2 month course of isoniazid (1985), uterine fibroids, menorrhagia, anemia requiring blood lipoma (1992), hot flashes (1997), allergic rhinitis, allergic conjuntivitis bronchial asthma, allergy to dust mites, allergy to dust, and insomnia (1997). The vaccinee recalls bouts of joint pain, fatigue and photosensitivity many years ago, before the alleged onset of the reported adverse events. Surgical history included exploratory laparotory, hysterectomy (1978), three unspecified sinus surgical procedure, and lipo excision (1992). Concurrent medications included chlorpherniramine maleate (chlor-Trimaton) as needed, salbutarol inhaler as needed,and allegy shots.  Following the reported onset of the adverse events, the vaccinee experienced fatty infilitration of the liver, elevated concentrations of asparate aminotransferase (AST) and alanine aminotransforase (ALT), biliary colic, right cortical lower pole renal cyst, cyst contiguous to the left ovary, left maxilary sinsu cyst, and fractures of the right forearm and wrist, hyperkeratosis, acanthosis, and prbably keratoacanthoma. 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 vaccinee reportedly received a "complete course" of Lymerix, the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccines "suffers from memory loss and confusion, as well as headaches", a feeling of 'pressure' in her head and joints, flu-like symptoms and depression. In addition,(she)suffers from pain, soreness and stiffness in her neck, and joint pain and stiffness in her fingers, feet, and knees. time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The vaccinee sought medical care on 7/10/00. She presented with fever and body aches that began 7/8/00. The vaccinee was taking Ambien at the time of presentation. She reported that, three weeks earlier, she had received a 10-day course of erythromycin and felt "better". She reported that she "had tick bites almost every week...Last bitten by ticks one week ago (x2)." she also reported that she "Received complete course of vaccine against Lyme six months ago." The vaccinee reported that she "has had fever/chills, body ache, arthritis, slight stiff neck for two days." She also reported decreased appetite. On physical examination, she was "tired-looking". Irritation of the posterior pharynx and tenderness over the right maxillary sinus were observed. They physician's assessment was "acute sinusitis versus lyme." He prescribed amoxicillin 500mg three times daily for three weeks. The vaccineereturned to the physician on 7/12/00, complaining of aching in her knees and calves that awakened her at night, temperature of 100.9 degrees F., the previous night, and a dry cough. she reported that "myalgia and arthralgia not much improved by Tylenol/Motrin. The physician's impression was "Ehrlichiosis, Lyme". Amoxicillin therapy was discontinued and the physician prescribed doxycycline 100mg twice daily for three weeks.  the vaccinee returned to the physician on 7/14/00. The vaccinee reported that she was feeling better since beginning doxycycline therapy. She had no more fever. However, she had been lying down watching television and reported that her neck "feels stiff and swollen". She also reported some radiation down her back. The physician's impression was "infectious process (most likely ehrilichiosis given thrombocytopenia and leukopenia and history) improved significantly. Neck stiffness most likely from inappropriate positioning." On 7/15/00, the vaccinee telephoned the physician to report that she was "getting better every day." However, she requested paracetamol with codeine (Tylenol #3) for pain relief. **Follow-up report on 8/5/02: On 9/16/00, Babesia IgG and IgM by immunofluorescent assay were negative. On 12/20/00, she represented to her primary medical MD for placement of a 12" peripheral IV catheter. She reported she was seen by a "Lyme Disease Specialist" and had received oral antibiotics since July 00. She reportedly disabled by posterior headaches, memory lapses, poor concentration, bilateral increased ankle stiffness and achiness, fatigue, parathesias of face, etc. Her exam was unremarkable. The assessment included "Lyme disease w/neuroborreliosis refractory to oral antibiotics."** On 01/05/01, the vaccines reported to her gynceologist that she had Lyme disease"including neuro and right knee with memory loss". She reported being under a physician's care for Lyme disease since July, 2000. On 01/05/01, she was receiving unspecified intravenous therapy. The vaccinee underwent cerebral SPECT (single photon emission computed tomography) on 1/31/01. The radiologist impression was "Diffusely inhomogenous cerebral activity indciating inhomogenous perfusion." The indication for the procedure was recorded as "lyme disease". The cerebrospinal fluid collected was 'Negative for malignant cells. Mixed white blood cells present." The vaccinee presented to the local ER on 5/22/02 with a one-day history of dull upper epigastric pain. She reported that she had "lyme disease - diagnosed July 2000" and arthritis. She reported that she was being treated with intravenous ceftriaxene (rocephia) for six weeks, oral doxycycline, Lithromax, Medrone, Ultram and Ambien. The vaccinee reprted that she was noted yesterday to have abnormal liver function tests. Her physician told patient he would dose Rocephin two times daily instead of once to alleviate problem. The ER physicians made a diagnosis of "acute abdominal pain. Gallbladder sludge probably secondary to ceftriaxone." The vaccinee was advised to discontinue ceftriaxone therapy until she could be evaluated by her physician.  On 01/30/02, the vaccinee reported to her gynecologist that she had been "recently" told that she had systemic lupus erythematous and had begun hydroxychlororoquine (Palquenil) therapy three month prior. She was "referred to alternative MD". The most recent information, recived 3/8/02, did not specify the outcomes of the reported events. Systemic lupus erythematous is considered  medically serious by the manufacturer. The follow up states the vaccinee recalls bouts of joint pain, fatigue and photosensitivity many years ago before the alleged onset of the reported adverse events. Elevated concentrations of aspartate aminotransferase and ALT, biliary colic, left maxillary sinus cyst. The vaccinee told her neurologist that she received LYMErix in February, March and April of 2000. In this situation, the third injection of LYMErix would have been administered two months after the first injection, rather tahn the recommended interval of 12 months. Medical reports from the vaccine provider have not been forwarded by the vaccinee's attorney; therefore, clarification of the immunization schedule is not possible. The vaccinee was seen by a neurologist on 2/22/01. At the time, she reported that she "received LYMErix vaccine in February, March and April of last year. She was very active outdoors and pulled a lot of ticks from her body in the course of May of last year. She had some reaction to the vaccine with achiness and fever but this was not extended. In July 2000 she got really sick with neck stiffness and high fever and was treated with Doxycycline which gave her some relief. She got functioning with the Doxycycline, which was continued for three months. Another physician switched her to tetracycline and she had significant deterioration in her cognitive functions and was back on Doxycycline followed by Biaxin and Cefrin with still difficulties with concentration and was eventually put on IV Rocephin for four weeks on December 21. She got somewhat better and is now working on a four hour a day basis. After the IV Rocephin she was started on Flaquenil and Biaxin, which she took for a month. On physical examination, she had very painful trigger points in both trapezius muscle siwth limitation of neck range of motion to about 25 degrees on the left and 30 degrees on the right. The neurologist's impression was that the vaccinee presents with what seems to be ongoing LYme encephalopathy. She had positive Lyme titers in the past and tick bites and her brain spect now is suggestive of encephalopathy which might be Lyme related. On the other hand there is a possibility that she is DM4 positive and developed an autoimmune disease plus lyme infections and oral vaccine (sic). The neurologist prescribed Provigil 100mg, morning and afternoon and physical therapy with emphasis on trigger point any myofascial release. It was also negative for oligoclonal banding, lyme antigen capture, lyme IgM and lyme OspA gene by polymeters chain rreaction. The CSF contained mildly elevated protein concentration and a 11kD band of lyme IgG. MRI of the brain performed on 3/15/01 revealed CSF signal intensity area lateral to the nodula on the right which the radiologist feel likely represents either an arachnoid cyst or epidermoid. It also revealed abnormal appearing paranasal sinuses. THe vaccinee was referred to an otolarynmologist. On 3/27/01, Babesia IgG and IgM titers were negative. Lyme IgG western blot demonstrated 31, 41, 30, 62 and 75 kD bands; this was reported by the lab as an "equivocal" result. Lyme IgM was non-reactive. PCR was negative for lyme OspA gene. The vaccinee was evaluated by the ptolarynaologis ton 3/28/02. "She is status post multiple sinus and nasal surgeries in the past and lately has been complaining of right-sided periorbital pain and headache. Her ? There was no evidence of ? infection and everything appeared to have healed well. I obtained a CT scan of her sinuses to further delineate the abnormality. The CT scan demonstrated extensive sinus surgery with a single especified ethoids air cell on the left side. The cell had a slightly expanded appearance to it, which may suggest a mucocele, however no bony erosion or abnormalities were noted. Given the fact that the CT scan abnormality is opposite to the side of her symptoms and does not correlate with them I feel that this is unlikely the cause of her pain. It is more likely that she is suffering from some type of neuropathic pnenomenon status post her sinus surgery." lab evaluations revealed reduced platelet counts on 4/16/01 and 5/13/01. Erythrocyte sedimentation rate was within the reference range on 4/30/01, 5/7/01 and 5/13/01. AST and ALT concentrations were elevated on 5/13/01. The vaccinee returned to the neurolgoist on 5/23/01, "on her fifth week of treatment with IV Rocephin 2 gm per day. She is also taking oral doxycycline and dosage of 100mg twice a day. As far as her Lyme symptomatology goes, she is not going significantly different." The pt reported diminishing headaches since beginning physical therapy. She also reported that "she has difficulties wakine up in the morning, she's achy and has cognitive difficulties." The neurologist noted, "she has slight elevation of her liver enzymes and we're going to split her Rocephin dosage to 1 gm twice a day. If there won't be significant change in her condition, will stop her treatment." The vaccinee returned to the neurologist on 6/1/01. The neurolgoist noted that the vaccinee "did not have significant improvement" after six weeks of IV ceftriaxone therapy. Antiiotics were discontinued; "symptoms arre back, headace, neck aches, aches in leg increased. The physician's plan was to "reassess in a month after labs normalize. Consider alternative treatments." On 7/6/01, the neurologist prescribed Plaquenil and Zithromax. On 7/27/01, the neurologist certified that the vaccinee had "total disability from" work beginning 7/14/01 through 10/15/01, due to "chronic lyme disease with CNS involvement and physical limitation secondary to joint pain." The vaccinee was seen by the neurologist on 9/6/01. He noted that "she did not seem to do significantly different on the IV antibiotic, with low level of energy, difficulties waking up in the morning, achiness and cognitive difficulties. After her liver enzyme normalized we have started on tetracycline on which she reported continued cognitive decline. Two months ago, we started her Plfquenil and Zithromax, which helped to some extent with her muscles and joint pains, but she was taking as many as six tablets of Ultram per day. On her examination todya, she had very painful trigger points in both trapezius muscles with limitation of neck range of motion to about 30 degrees on the left and 35 degrees on the right." The neurologist's impression was that the vaccinee "continues to suffer from the same symptoms in spite of oral intravenous antibiotic treatment. It is possible that the Plaquenil helped somewhat with her joint pain." The neurolgoist recommended physical therapy, trigger point injections, and reuction of hte amoutn of tranadol she used. He prescribed Vioxx. On 9/6/01, anti-double stranded DNA antibody was positive. Rheumatoid arthritis screen, antinuclear antibody screen, testing for HLA B27 antigen, and testing for HLA DR4 antigen were negative. ESR was within the reference range. On 9/17/01, the neurolgoist injected 2.5cc of 1:1 mixture lidocaine 2% and Marcaine 0.5% into four trigger points. Two trigger points were then injected with Toradol 20mg each. "Pt had a transient mild vasovagal and then recovere with marked improvement in pain and ROM." On 9/18/01, Babesia microti IgG and IgM titers were negative. On 10/3/01, ANA screen, extractable nuclear natigen IgG, and anti-smooth muscle IgG were negative. Anti-double stranded DNA antibody was "borderline." **A variety of serologies for Lyme disease were performed on 10/11/01. The laboratory's overall interpretation was "...evidence of seroreactivity beyond that suspected from the Lyme vaccine."** On 10/16/01, the neurologist certified that the vaccinee would be totally disabled indefinitely, beginning 10/16/01. The "reason for restrictions" was recorded as "lyme disease, recently diagnosed with lupus." The vaccinee was seen by the neurologist on 10/22/01. He noted that "we sent her four restudy of her collagen vascular disease panel, which came back positive for anti-double standard DNA antibodies (twice). her antinuclear antibodies were negative and she's not HLA DR4. She is going to follow with a rheumatologist this new diagnosis of possible systemic lupus erythematous. In retrospect the vaccinee recalls bouts of joint pain, fatigue and photosensitivity many years ago, before started suffering from lyme disease. In the time elapsed, another physician started her on Zithromax and Mapron which resulted in suppression of her episodic fever. In the past, she did respond Flaquenil, with significant reduction of her joint pain. She continues to suffer from significant joint pain of diffuse nature, fatigue, congitive difficulties and insomnia. The trigger point injections were given her helped her significantly, and the pain reduction benefits lasted for almost a month." The neurologist's impression was "in retrospect she has signs and symptoms compatible with SLE. her joint pain response to Flaquenil supports a diagnosis of collagen vascular disease of one kind or another. Due to her god response to trigger point injections, weight should consider repeating this procedure. On 11/13/01, anti-double stranded DNA antibody was positive, anti-single stranded DNA antibody was negative. On 2/22/02, ANA screen and rheumatoid factor were negative. Anti-double stranded DNA antibody was positive. THe most recent info, was received 7/17/02. The vaccinee was totally disabled beginning on 10/16/02 and continuing indefinitely, due to lyme disease and systemic lupus erythematosus. **Follow-up report on 8/5/02: The vaccinee underwent a neuropsychological evaluation on 6/28/01. The psychologist stated, "she received the vax for Lyme disease in early 00. As she thought that she was then protected from the illness, she initially did not seek medical attention for multiple tick bites in the spring and early summer of last yr, despite developing a bull's eye rash. Eventually, she developed a high fever accompanied by diffuse arthralgia, myalgia, and likely meningitis while vacationing. Diagnosed w/Erlichiosis, she was prescribed tetracycline w/limited success. Since that time, Tx w/various oral antibiotics has continued. The PT also reports receiving 2 course of TV antibiotic, the most recent of which was discontinued when she developed liver complications. Despite this treatment, (the vaccinee) continues to experience diffuse arthralgia, a chronic pressure in the back of the head, night sweats, fatigue, myalgia in the lower extremities, occasional fevers, and the aforementioned cognitive dysfunction... Neuropsychological testing revealed that [the vaccinee] demonstrates anterograde memory processes that are generally normative, but weaker than anticipated. Retrieval of noval info, be it verbal or figural appears to the most affected. For the most part, findings are mildly reduced below mid-to-higher normative premorbid expectation, rather than frankly impaired... [her] most notable deficit, however, is observed on a task demanding fluid and novel problem solving under ambiguous circumstances... Impression: "Overall, her neurocognitive profile is typical of those observed w/low-grade encephalopathic processes associated w/certain disease that have potential CNS manifestations, such as Lupus and tick-borne disease. Given her reported history, the laatter is likely responsible for this PT's current cognitive inefficiencies. It should be noted that contributions from the reported polysubstance abuse / dependence are likely minimal, given her years of sobriety. Additionally, findings do not reflect patterns consistent w/a primary degenerative dementia, subcortical disease, or congenital/ developmental disorder."** A follow up report received 7/22/2002 adds: (additional medical history) chest pain (1997), chronic sinusitis, nasal polyps, left ethmoid mucocele, chronic cough, degenerative disc disease L3-5 with low back pain treated with epidural steroid injections and radiofrequency ablation (1997), depression (1996), dyspareunia, gastroenteritis, hypoglycemia, stress headache (1998) and thrombocytopenia (1998). (Surgical history included) spinal surgery (1998), Caldwell-Luc procedures (1978 and 1988) and liposuction (January 1999). (Concurrent medications included) hepatitis B vaccine (brand name unknown), isotretinoin (Accutane), multivitamin, calcium, aspirin, bupropion hydrochloride (Zyban), vitamin C and zolpiden tartrate (Ambien). (Following onset of adverse events, the pt experienced) penicillin allergy, weight loss, anger, anxiety, swollen submandibular lymph nodes that were "benign appearing", acute drug-induced hepatitis secondary to caftriaxone sodium (Rocephin), viral syndrome, viral nasopharyncitis, osteopenia of lumbar spine and left wrist, and pain on swallowing while supine. Medical records from the vaccine provider indicated that pt received Lymerix on 02/10/1999, 03/10/1999 and 04/08/1999. ...On 07/19/2000 the pt presented to her physician. She reported "fever decreased, headache and neck pain gradually decreased."  ...On 10/05/2001, the pt returned to her family physician and she stated she was "told had positive lupus test - further tests pending."