Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Ovarian cyst, Sarcoidosis, Sleep disorder, Urinary tract infection, Visual disturbance
Clinical narrative: This report describes the occurrence of sarcoidosis in a 49 year old female who was vaccinated with Lyme disesase vaccine LYMErix for prophylaxis. This report was received as part of litigation proceedings with forwarding of medical records. The vaccinee submitted a report directly to VAERS (ID 175566). The subject's past medical history included right cervical/trapezius muscle spasm (1987), carpal tunnel syndrome (1980), gastroenteritis with possible secondary reflux esophagitis (1992), chronic insomnia (1992), heartburn (1992), "severe" dysphagia (1994), esophageal reflux (1996), torticollis (19960, weight gain (1989), hypercholesterolemia, hypertriglyceridemia, hypertension (1994), migraines, seasonal allergies, upper respiratory infection, bronchihtis, pharyngitis (1994), otitis media (1996), urinary tract infection (1991), urine stress incontinence (1997), monilial vagnitis (1986), mastitis (1989), breast mass (1996), hemorrhoids (1986), constipation (1986), peptic ulcer disease (1995), seborrheic dermatitis (1992), facial rash (1993), rash (1996), peeling of skin on hands (1996), depression (1997), and tobacco use. There were no unknown allergies. Surgical history included hysterectomy (1982), radial keratotomy (1995), and cholecystectomy. Family history was significant for breast cancer in the subject's sister and brain cancer in the subject's mother. Concurrent medications included atorvastatin calcium, Imitrex, Premarin, Allegra, Zyrtec, Claritin-D, Nasonex, and Wellbutrin. Concurrent vaccines included tetanus toxoid (1998), pneumococcal pneumonia vaccine (November 1999), and influenza virus vaccine (November 1999). The subject received LYMErix on 4/12/99, 5/13/99 and 11/10/99 (lot numbers not recorded). The third injection was administered seven months after the first injection, rather than the recommended interval of 12 months. On 9/24/02, in a Statement of Injuries, the subject's attorney alleged that the subject "developed kidney stones due to her pain medication. She was diagnosed with Sarcoidosis. She developed a cyst on her ovary. She has difficulty swallowing. She was suffered from swelling of her entire body as well as hand, wrist, finger, neck and back pain. She was unable to walk due to swelling in her ankles, legs and feet. She suffers from her muscles binding and locking in place. She also experiences blurry vision, heart racing, fatigue and inability to sleep." The following info was obtained from medical records. The subject presented to the vaccine provider on 12/3/99, 23 days after receiving the third injection of LYMErix, with chief complaints of not sleeping well and depressed - lot of family stress. The physician's assessments were ERT, increased cholesterol, migraines, depression, insomnia. Bupropion therapy was discontinued and the physician prescribed trazodone. The subject remained under the care of the vaccine provider until 9/13/00. During that time, the subject reported possible carpal tunnel syndrome in the right wrist; a feeling of food being stuck in her esophagus; swelling of her feet and hands; pain on the right side of her head that radiated down her neck; generalized swelling that continued to worsen; decreased appetite; pain in her ankles, knees, elbows and hands; myalgias; muscle stiffness; weakness; and "visual problems" caused by prednisone. During this time, the physician noted weight gain, up to "2+" edema of the feet, and soft tissue swelling above the clavicular notches. On 3/28/00, the subject reported that another physician had made a diagnosis of arthritis. The vaccine provider made additional diagnoses of dysphagia (3/2/00), carpal tunnel syndrome (3/24/00), generalized edema (4/4/00), arthralgias (4/4/00), fatigue (4/4/00), myalgias (4/26/00), hemoptysis (4/26/00), weakness (6/21/00), and uncomplicated urinary tract infection (6/29/00). Based on the evaluations, the following diagnoses were made: diffuse esophageal spasm (3/20/00), cervical radiculopathy (3/28/00), chronic gastritis (5/10/00) and sarcoid myositis (7/21/00). The vaccine provider prescribed Prevacid, Ambien, Ativan, Celebrex, Vioxx, Bactrim DS, Sinequan, and triamcinolone 1% cream. The vaccine provider referred the subject to a gastroenterologist, an orthopedic surgeon, a rheumatolgist, and a physical therapist. On 3/13/00, the subject presented to an ER "complaining of acute onset of right back pain, radiating to her lower right abdomen since approximately 12 moon today. Th ept had undergone an esopohagram for upper GI reflux and shortly thereafter had a yogurt after which she had the sudden onset of right lower back pain." She stated that she was unable to walk due to the pain. In the ER, "an ultrasound showed a 5cm hemorrhagic mass with frec fluid in the abdomen." She underwent laparoscopic evaluation, which showed a hemorrhagic left ovarian cyst. A left salpingo-oophorectomy was performed. She was discharged from the hospital on the afternoon of 3/14/00. On 3/23/00, the subject was evaluated by the orthopedic surgeon with "symptoms quite suggestive of carpal tunnel syndrome bilaterally. She has pain and numbness in the typical medial nerve distribution. She has symptoms while driving and with overhead activity. She has been wearing splints with incomplete relief." The results of EMG and nerve conduction studies performed on 3/28/00 were abnormal. On 4/5/00, the physician noted that the subject "has a positive Tinel's bilaterally, positive Phalen's test. We have scheduled her for carpal tunnel release, the right to be followed by the left." The subject underwent right carpal tunnel release with neurolysis of median nerve on 5/9/00 and left carpal tunnel release with neurolysis of median nerve on 6/27/00. On 4/3/00, the subject was evaluated by the gastroenterologist "for approximately a ten year history of reflux symptoms. The pt notes that often the first swallow of a meal is associated with spasm which seems to occur above the bolus of the food. The pt then states that she can 'blackout' or at least have some limited amnesic recollection for the episode. She states that these episodes are quite frequent." Medications at the time of the evaluation included lansoprazole, atorvastatin, conjugated estrogens, fexofenadine, and trazodone. An esophagram performed on 3/13/00 revealed "a lot of spasm. " An endoscoopy revealed "erosive gastritis" and a "large hiatal hernia." Esophagogastroduodenoscopy with biopsy was performed on 4/6/00. The gastroenterologist's diagnoses were "diffuse erosive gastritis" and "large hiatal hernia." Biopsy of the gastric antrum revealed "chronic gastritis." The subject received physical therapy from 4/7/00 until 5/24/00. The diagnosis provided by the vaccine provider was "cervical radiculopathy." The subject reported "chronic" pain in her cervical spine and left paraspinal muscles. On 5/26/00, the subject was evaluated by the rheumatologist. At that time, the subject reported "a history of having diffuse arthralgias and myalgias with a sense of feeling 'beaten' since 3/1/00. The pt complains of arm and leg weakness and she states that her hands are always stiff. The pt is concerned of possibly having Lyme disease. She denies any hip, knee, or metatarsal symptoms. There is no history of psoriasis or inflammatory bowel disease. The pt denies any lupus-like symptoms nor any SICCA symptoms. The pt states that she had a GI workup which was normal." Physical examination was remarkable for ankle tenderness and "4/5" motor strength of the hip girdles "with pain." "Extensive" laboratory analyses were negative. The rheumatologist requested that the orthopedic surgeon perform a deltoid muscle biopsy. Muscle biopsy revealed "non-caseating granulomas witha probable vasculitis component." Angiotensin converting-enzyme concentration was elevated. The rheumatologist made a diagnosis of sarcoid myositis and prescribed prednisone. He referred the subject to a neurologist. The subject remained under the care of this rheumatologist until at least 11/10/00. On 6/9/00, the subject was evaluated by the neurologist. On that day, an EMG and nerve conduction studies revealed "Left peripheral neuropathy, lower extremity, mild." Note: there is evidence of mild peripheral neuropathy with delayed conduction and occasional polyphasics potential. No evidence of myopathy, no fibrillation noticed. Peripheral neuropathy may be secondary and mild." As noted above, the subject presented to the vaccine provider on 6/29/00 with complaints of urinary frequency and urgency, abdominal pressure, and nausea. A diagnosis of uncomplicated urinary tract infection was made, and the physician prescribed trimethoprim/sulfamethoxazole. At 19:00 that evening, she "felt severe, stabbing back pain radiating to groin on left." The pain was accompanied by nausea and vomiting. She went to the local ER. An IVP demonstrated "a left distal ureteral stone." The subject was hospitalized for pain control and hydration, under the care of a urologist. The next morning, an x-ray of the kidneys, ureters, and bladder revealed that "the stone had been passed, and there is some question of 1 to 2 mm stones on the right." The subject was asymptomatic and was discharged. The subject remained under the care of this urologist until at least 9/19/00. On 8/22/00, the subject underwent a cystoscopy, left retrograde pyelogram, left ureteroscopy with stone extraction, and left stent placement after she presented with recurring calculus. The urologist prescribed Percocet, ciprofloxacin and Ditropan. The stent was removed on 8/24/00. Four days later, on 8/28/00, she presented to the ER with complaints of "severe" left flank pain, nausea, and vomiting. An IVP revealed an obstruction of the distal left ureter. The subject was hospitalized for pain relief and hydration. On 8/29/00, the subject underwent cystoscopy, ureteroscopy, and insertion of a double-J stent. She was discharged from the hospital on 8/30/00. On 9/19/00, the subject' underwent a cystoscopy and subsequent removal of the left double-J stent. The urologist noted, "stenosis resolved." On 11/7/00, the subject came under the care of a new primary physician. Upon the initial history and examination of the subject, this physician noted that "she was diagnosed with sarcoid in July 2000 after many missed diagnoses such as osophagitis, carpal tunnel syndrome. She had bilateral carpal tunnel release with no results. She was finally diagnosed with a sarcoid and treated with Prednisone. She started to get renal lithiasis as a result of one of the medications she was on to treat the many diagnoses preceding s the sarcoid." The subject reported that she "has had significant side effects from the Prednisone such as facial swelling, significant weight gain." The physician's assessments were "Sarcoidosis under moderate control at this point, hyperlipidemia, insomnia." The subject remained under the care of this physician until at least 12/26/01. During this time, the subject reported ankle swelling, pain, and bruising after a fall; flank pain; dysuria; ankle swelling unrelated to injury; and itching, pain, and redness of the eyelids. On 12/4/00, the subject reported that another physician had made a diagnosis of fibromyalgia. On 9/27/00, the subject reported that the second rheumatologist had made a diagnosis of psoriasis. The primary physician made additional diagnoses of ankle sprain (2/21/01), seasonal rhinitis (4/13/01), anxiety (4/13/01), nephrolithiasis (4/26/01), and left eye contusion (12/26/01). The physician prescribed Ultram, Percocet, Cipro, Zyrtec, and Nasonex. This physician referred the subject to a second rheumatologist. On 12/18/00, the subject was evaluated by a second rheumatologist. He wrote," she had a muscle biopsy performed that did indeed show Sarcoidosis. At that time she was then started on 60mg Prednisone and within 48 hours lost 45 pounds of weight. She then tapered down on the Prednisone but when she got to 12.5, the pain and the swelling started to come back and she then went back up to 50mg about two to three weeks ago and has been on that since. She has gotten progressively cushingoid." On physical examination, she was "cushingoid appearing. Upper extremities revealed some pain on movement of the shoulders, but no objective findings of swelling. She had good range of motion for hips, knees, and feet." The physician prescribed Plaquenil, and tapering doses of prednisone. Lab analyses performed on 7/5/01 demonstrated abnormal results. The subject remained under the care of this rheumatologist until at least 4/15/02. During this time, the subject reported that she felt weak and fatigued, had "prickly" feeling to her skin, and a rash on her feet. The physician noted that she was "getting progressively cushingoid." He also noted that "each time we try her on NSAID she develops edema and did the same this time with" rofecoxib. He also noted, " the Plaquenil was started 12/00 and has enabled us to reduce her dose of prednisone with no change in her complaints except she has been unable to get below 5mg without hurting more." The physician made an additional diagnosis pr psoriasis (8/13/01). He prescribed calcium, tramadol and Vioxx. As of 4/15/02, the medical regimen included hydroxychloroquine, prednisone, zolpidem, atorvasttin, and calcium. The rheumatologist wrote, "She is now down to 3mcg of Prednisone. Overall doing well and she is going to gym and exercising regularly." Following the administration of LYMErix, the subject experienced anxiety, seasonal rhinitis, bronchitis, diverticulosis, chronic diffuse erosive gastritis, "large" hiatal hernia, melanosis coli, urinary tract infection, ankle sprain, left eye contusion, fibromyalgia, and psoriasis. These events were not reported as adverse events due to vaccine administration, but were found during the course of the review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 9/24/02, indicated thatt he ovarian cyst resolved on 3/14/00 and the kidney stone resolved on 9/19/00. The sarcoidosis persisted as of 4/15/02, but the subject was "overall doing well."  Progress notes received on 20May04 and dated 15Jul03 indicated that the pt was walking with a normal gait without the use of aids. She could cross one leg over the other and arise from a chair without the use of hands albeit with difficulty. She could raise her arms over her head, walk on toes and heels but she was unable to do a squat due to weakness and a sense of muscle stiffness. She was unable to rise from a supine position without the use of her hands. She had a mild degree of weakness of neck flexors and proximal musculature of upper and lower extremitites. A trial of intravenous immunoglobulin (IV IG) was recommended. No information was provided on whether the pt received IV IG. Information received on 24Sept2002 indicated that the ovarian cyst resolved on 14March2000 and the kidney stone resolved on 19Sept2000. The sarcoidosis persisted as of 15April2002, but the subject was "overall doing well". Information received on 01July2004 indicated that, as of 28April2003, the pt still complained of fatigue, weakness, and prickly feeling the skin. The most recent information, received on 27July2004, did not provide outcome of the reported events. The sarcoidosis in this report is considered medically serious. (OMIC)