Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Erythema, Facial palsy, Fatigue, Gait disturbance, Hypertension
Clinical narrative: The subject's medical history included allergies to amoxicillin clavulanate (Augmentin), sulfa, gold, dust, mites, pollen, perfumes, and unspecified foods; asthma, allergic rhinitis; chronic serous otitis media; multiple episodes of sinusitis; possible nasopharyngeal retention cyst; viral meningitis ('89); fibromyalgia ('98); elevated concentration of parvovirus B19 IgG ('98); hypertension, confirmed tick bites (95 and 97); Lyme disease treated w/intravenous ceftriaxone sodium (96); Bell's palsy w/incomplete recovery characterized by hyperkinesis, synkinesis, and some facial twitching ('97); sciatica ('98); numbness of the hands, feet, right leg, and right lower quadrant ('98); temporomandibular joint syndrome; arthritis; degenerative joint disease of the lumbar spine ('98); lumbar degenerative disc disease ('98); irritable bowel syndrome; cholecystitis; hearing loss; irregular menstrual bleeding ('98); stage III endometriosis ('88); and three spontaneous abortions. Family history was significant for hearing loss in the subject's parents. Surgical history included cholecystectomy ('88), tonsillectomy ('80), adenoidectomy, and endoscopic balloon dacryoplasty of the left eye (11/6/01). Concurrent medications included loratadine (Claritin), cetirizine (Zyrtec), olopatadine hydrochloride ophthalmic drops (Patanol), losartan potassium (Cozaar), amlodipine (Norvasc), losartan / hydrochlorothiazide (Hyzaar), nabumetone (Relafen), milk thistle, acidophilus, and vitamins (NOS). Medical records from the vaccine provider indicated that the subject received her first injection of LYMErix on 5/14/99. She later told another MD that she received a single injection of LYMErix in June 99; this was not substantiated in the vaccine provider's medical records. In a statement of injuries, the subject's attorney alleged that the subject "suffers from flu-like symptoms, fatigue, rashes, dizziness, numbness in her arms, facial paralysis, frequent sinusitis, swelling in her legs and severe joint pain in her ankles, knees and back." The following info. was obtained from medical records. On 2/1/99, the subject told her allergist that she had Lyme disease and was being treated with doxycycline and cefuroxime (Ceftin). The allergist noted, "Lymes [sic] is improving." On 4/15/99, the subject told her allergist that she had "nerve damage from Lymes [sic] disease" and was taking nabumetone (Relafen) for pain relief. The subject presented to a "specialist in Lyme" on 6/21/99. At that time, she reported that she had received LYMErix in June 99 and "2 days post vax went down hill - got very sick: 1. Very tired/aching. 2. Could barely walk. 3. 'I feel like I have Lyme disease from three years ago'." She also reported fevers. The MD prescribed cefuroxime. Lab analyses revealed abnormalities. Please see Lab data section. The subject remained under the care of this Lyme specialist until at least 9/14/00. During this time, the subject reported increased dizziness, "some" myalgia, "still having joint problems." "walking (a little) better", "still having aches and pains in joints", "problems with feet swelling", and "sleep problem off and on". The MD made diagnoses of babesiosis (7/10/00), human granulocytic ehrlichiosis (7/10/99), and Lyme disease (7/10/00). He prescribed fluconazole (Diflucan), doxycycline, atovaquone (Mepron), clarithromycin (Biaxin), and naproxen (Naprelan). The MD noted the following: "Having a Herxheimer reaction this month" on 9/10/99, "Back pain better" on 10/14/99, "first time in 2 yrs had normal cycle" on 12/17/99, and "last 3 weeks ok" on 2/24/00. On 8/24/00, the subject "will go off all antibiotics." On 11/23/99, the subject told her allergist that she had received "The Lymes antibody vaccine [sic] - just 2 days could not walk, Bell's palsy got worse, tired, achy, hurt all over." The subject presented to her allergist on an unspecified date, presumed to be late Jan. 00 from the order of medical records. The allergist's impressions were "1) AR [allergic rhinitis]. 2) Sinusitis. 3) Asthma. 4) Lyme disease." She administered nebulized levalbuterol and prescribed clarithromycin (Biaxin), fluticasone inhaler (Flovent), and salbutamol metered-dose inhaler (Proventil). On 2/3/00, the subject telephoned the allergist and reported that "she was feeling somewhat better. Sleeping during the night. PT thinks Biaxin is helping." The subject came under the care of a new primary MD on 8/11/00. At that time, she was taking doxycycline and cefuroxime for the treatment of Lyme disease and atovaquone for the treatment of babesiosis. "She reports that she received the Lyme vax in 99 and 2 days after the initial dose she had profound lower extremity pain and weakness that she is not totally recovered from. She uses a cane for ambulation. She reports that whenever she discontinues her medication she has exacerbations of her of her generalized aches, pains and fatigue... She has significant lower extremity edema and has had that for quite some time. She occasionally gets some redness in the calves." Medications at the time of initial presentation included loratadine, doxycycline, cefuroxime, atovaquone, amlodipine (Norvasc), and losartan. On physical exam, the MD noted left-sided facial droop with tearing of the left eye, and bilateral leg edema w/some redness of the left calf that was not warm to the touch. The MD's assessments were "1) Lyme disease w/residual effects from Bell's palsy... 2) Hypertension. The Norvasc may be contributing to her edema so will cut back on that to 5 mg daily... 3) Season allergies... 4) GYN... 5) Health maintenance... 6) Significant obesity. It is certainly contributing to her hypertension and edema." The MD recommended a supervised exercise program. The subject remained under the care of this primary MD 'til at least 4/28/02. On 9/28/00, the MD noted "Edema - improving w/decreased Norvasc. Likely effect of venous stasis secondary to obesity." He discontinued amlodipine and losartan therapy and prescribed losartan / hydrochlorothiazide (Hyzaar). On 10/5/00, the subject reported, Hyzaar making her tired". The MD discontinued Hyzaar therapy and reinstated losartan (Cozaar) therapy. During this time, the MD noted "some swelling of both feet, some improvement w/walking." On 1/15/01, the subject presented w/a stuffy nose, pressure around her eyes, and watery eyes. On physical exam, the MD noted frontal tenderness, congested nares, and "mild" oropharynx erythema. He made a diagnosis of sinusitis and prescribed clarithromycin. During this time, the MD also prescribed flunisolide (Nasarel). As of 4/28/02, the subject continued to experience "Edema - some fluid retention - mostly obesity" and joint pains that prevented her from sleeping well. The subject came under the care of another "Lyme specialist" on 1/25/01. The subject reported that she "had one LYMErix shot June 99. Unable to walk after shot." She reported that another MD had prescribed cefuroxime (Ceftin) in Dec. 00. Sx's reported at the 1/25/01 visit included fatigue, joint pain, bilateral leg redness, "both edema", night sweats, and right ear noise. At the time of evaluation, her height was 68 inches and her weight was 317 lbs. No abnormalities were noted on the MD exam. The MD made a diagnosis of Lyme disease. The subject remained under the care of this "Lyme specialist" until at least 11/12/01. During this time, she reported leg pain, back pain, asymmetric shoulder pain, asymmetric knee pain, feeling worse when decreasing medications, "neuropathic type pain" of the face, increased fatigue, "not sleeping", visual floaters, no relief from joint pain with rofecoxib (Vioxx) therapy, numbness of the hands and arms while driving, hip pain, memory prob's, stiff neck, and yeast infection. During this time, ,the MD noted left facial palsy and "significant" lymphedema in the legs. Lab analyses revealed abnormalities. Please see Lab data section. On 10/29/01, the subject was seen by the MD for a sinus infection. On physical exam, the MD noted a full left tympanic membrane that was pink, swollen and red nasal membranes, red pharynx, and sinus tenderness. He made a diagnosis of sinusitis and prescribed clarithromycin. On 11/2/01, the subject returned to the MD, who noted full tympanic membranes, post-nasal drip, tender sinuses, and lympadenopathy. His assessment was sinusitis, and he prescribed clarithromycin and fluticasone nasal spray (Flonase). The subject returned on 11/19/01, stating that she was feeling better, but still had a sensation of fluid in her ears. The MD noted that the left tympanic membrane was "a little full" and the sinuses were tender. His assessment was "Resolving otitis" and he prescribed ciprofloxacin (Cipro). During this time, the MD also prescribed doxycycline, "Schumaker protocol w/4 grams of Questran [cholestyramine] b.i.d. [twice daily]", 10 wkly injections of benzathine penicillin G (Bicillin L-A), tinidazole, and fluconazole (Diflucan). The MD noted the following: "feeling better" on 9/17/01; "had good week, positive energy" on 12/8/01; "less use cane", "regarding improved", "memory has improved", "Floaters have improved", and "Numbness in the arms resolved" on 10/23/01; and "not hurting as much this week" on 10/29/01. However, after experiencing sinusitis and otitis, on 11/12/01, she reported that she "hurt all over". Fatigue, insomnia, joint pain, and lymphedema persisted as of 10/23/01. Following the reported onset of Lyme disease, the subject experienced exposure keratoconjunctivitis, epiphora, visual hallucinations, right earache, tinnitus secondary to a venous hum, hypercholesterolemia, hypertriglyceridemia, increased concentration of lactic dehydrogenase, and a "lot of neck pain" after a fall at work. These events were not reported as adverse events due to vax 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 info, received on 9/26/02, did not provide the outcomes of the reported events. Info. received on 7/9/02 indicated that leg edema and joint pain persisted as of 4/28/02.