Age: 58.0
Sex: F
Vaccine: LYME
Symptoms: Sinusitis, Sleep disorder, Tinnitus, Urinary incontinence
Clinical narrative: The pt reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the pt "suffers from severe osteoarthritis in her left hand, resulting in severe, constant pain, especially in her left thumb. In addition, (she) suffers from fatigue, rashes and tinnitus, greatly impeding her ability to work (and enjoy) playing music". Time to onset following immunization, treatment and outcomes of the alleged events were not reported. The fatigue, rashes and tinnitus are considered disabling because they allegedly are "greatly impeding her ability to work". The follow up states the pt is a 58 year old female. Medical history included metastatic *differentiated, high-grade* adenocarcinoma *consistent w/ductal cancer, w/right axillary adenopathy but not detectable primary breast mass (i.e. stage T0N2, or stage IJIA; 1996) treated with doxoprubicin, cyclophosphamids, radiation therapy to the chest, and bone marrow transplantation (1998). Medical history also included multiple nevi including a melanocytic nevus (1998), deviated nasal septus, bronchitis, pneumonia, herpes simplex virus infection, acromiocclavicular joint degeneration (1998), right thumb pain treated by an surgeon with an injection or unspecified medication (1998), paresthesias, chest pain, irregular heartbeat, flatulence, gastroesophageal reflux disease, two uterine fibroids, nummular dermatitis, heel hyperkeratosis, and marijuana use. The vaccinee was allergic to sulfa and had lactose intolerance. Surgical history included removal of a lymph node in the right axilla (1996), two myonectomies, oophorectomy, and unspecified knee cartilage surgery. Following the administration of the third injection of LYMErix, the vaccinee experienced *'bladder prob's (frequency)' treated w/tolterodine (Datxol), ptosis of both eyes,* dyspnea on exertion, viral upper respiratory tract infection, multiple abrasions and contusions after a fall, concussion after a fall, *inability to turn her neck and arm after using a weight maching, numeness, occasional left sciatics and eczema*. These events 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 4/27/99, the vaccinee was seen by her oncologist, who noted that the vaccinee continued physical therapy "for right shoulder with some improvment, although she has been told chances for complete recovery are very poor." The vaccinee returned to the oncologist on 8/11/99. She reported that she had experienced nausea and diarrhea, "probably food related". She also "feels fatigued." The vaccinee exercised regulary. Medications included calcium 1200mg with vitamin D, vitamin E 800 . Valtrex twice daily, chondroitin sulfate, and glucosamine. Concurrent medications included Valtrex, waaspirrin, and cefuroxine. The vaccinee received her third injection of LYMErix (lot LY144B9) on 4/13/00. In a Statement of Injuries, her attorney alleged that the vaccinee "suffers from severe osteoarthritis in her left hand, resulting in severe, constant pain, especially in her left thumb. In addition, she suffers from fatigue, rashes, and tinnitus, greatly impacting her ability to work and enjoy playing music." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The following info was obtained from medical records. The vaccinee was evaluated by an otorhinalaryngologist on 5/1/00. She reported that, "two weeks ago, was using without paint stripper and noted the onset of tinnitus since that poitn. The tinnitus is not localized to one ear. It is episodic in nature." She denied hearing loss, vertigo, and otalgia. She stopped taking aspirin prior to the evaluation. "On physical examination, both post auricular areas, external auditory canals and tympanic membranes are grossly normal. Wober tuning fork exam with a 512 and 1024 tuning forks are midline. Rinne tuning fork exam with a 512 and 1024 tuning forks are normal bilaterally. Oral cavity and nasal cavity examination is negative. Neck examination reveals no masses nor carotid bruits. Cranial nerves II through III are grossly intact as are pupillary reflexes. There is no evidence of gaze nystagmus, ataxia, dysdiedochekinesia nor tremor." "Complete audiometric" examination revealed "normal and symmetrical hearing up to 8000 Hz, above which there is minimal symmetrical high frequency sensorineural hearing loss. The pt's speech reception threshold and speech discrimination scores are excellent. My impension is that she is a 58 yea rold woman with a two week onset of tinnitus that she temporally relates to exposure to paint stripper. The pt has  a normal examination and an essentially normal audiogram. I would not recommend any further evaluation at this point. There is no effective intervention that I could recommend for her tinnitus with the exception of minimizing caffeine and aspirin intake." On 5/8/00, the vaccinee asked the physician if he could refer her to "another physician that deals specifically with tinnitus." The physician made the referral. On 5/24/00, the vaccinee wrote a letter to each of her 18 physicians, regarding her disability status. The vaccinee stated, "Since my celll transplant two years ago, I've received social security disability insurance. My case is currently being reviewed to see if insurance will continue. You will be contacted. I want you to know the facts of my current medical situation as I've told social security. Happily, at present, my therapy has become difficult because I've developed tinnitus in the last five weeks, and I clearly find that even B1 mg aggravates this maddening condition. I have some damage to my lungs and arteries, perhapss from cancer or from treatment. I am prone to colds that become infections and last for a long time. In general, my energy level is reduced, and I take rests during the day." The vaccinee was seen by her cardiologist on 5/30/00. She reported that she had been seen by three specialists rergarding tinnitus. The third specialist reportedly attributed the tinnitus to aspirin. The vaccinee also reported tightness in her chest with fast walking. On 11/20/00, the cardiologist noted "symptoms resolved." The vaccinee saw an otoleryngologist specialist in neurotology at a terriary care center on 6/6/00. The neurotologist noted that the vaccinee presented for "a fifth opinion for tinnitus. She has tinnitus that has been present for more than two years." In a letter to the stat Division of Disability Determinations, the neurotologist wrote, "the tinnitus seems to have gotten worse after she was exposed to a paint thinner. She also has mild high frequency hearing loss that was present in the past. Physical examination of the ears, nose  and throat normal. She was also given a prescription for ? .5mg to use for anxiety control and sleep. She was instructed to follow up with me on yearly intervals. I am not planning any other surgical intervention and do not feel that she has an limitations to lifting, carrying, standing, sitting, pushing or pulling and I cannot provide a medical opinion regarding this individual's ability to do work-related activites as I am only seeing her for the tinnitus.  The vaccinee was seen by her primary physician on 6/13/00 with complaints of sore throat, congestion, laryngitis, and mild cough. The physician noted "history of tinnitus secondary to antibiotics." The physicians made a diagnosis of "probably viral upper respiratory infection." The vaccinee "Demands antibiotics for empiric bacterial infection." The vaccinee also stated that she needed an additional supply of antibiotics that she could take with her during her up-coming travel abroad. The physician prescribed Ceftin 250mg twice daily.  The vaccinee presented to her primary physician on 9/15/00 after falling onto concrete and hitting a metal door. She had hit her head, but had not lost consciousness. She had a bump on her head and headache. She reported "different rigns in both ears now." She had also hit her nose, upper lip, and left knee. The physician's impression was "multiple abrasions and contusions. CNS(central nervous system) Concussion." The vaccinee was seen by a rhinologist at a tertiary care center on 9/18/00, to insure that she had not injured her nose in the fall. At that time, she reported that clonazepem, prescribed in June, was not helping the tinnitus.  The most recent info, received 2/27/00, indicated that the tinnitus had resolved by 11/20/00. The outcomes of the other reported events were not provided. The fatigue, rashes, and tinnitus are considered disabling because they allegedly are "greatly impacting her ability to work." The follow up states that following the administration of the third injection of LYMErix, the vaccinee experienced "bladder problems (frequency)" treated with Detrol, and ptosis of the right eye. On 5/5/00, the vaccinee telephoned her ophthalomologist and complained of tinnitus. The follow up states the pt's medical history included cervical intraepithelial neoplasia (April 1998),koliocytotic  (4/25/98), loop electrosurgical excision procedure (4/25/98), colonoscopy (9/9/98), tonsillectomy and adenoidectomy. The vaccinee was seen by a neurosurgeon specializing in tinnitus on 5/15/00. The surgeon's finding were "1. Hearing within limits of normal language and speech. 2. Hearing loss-bilateral-sensorineural type-left greater than right-screening test. 3. Subjective idiopathic tinnitus-history. 4. Hyperacusis-history. 5. Chronic allergic rhinosinusitis. 6. Bilateral chronic caterihal otitis media -bilateral. 7. Fukoda stepping test-positive right. 8. RO-secondary endolymphatic hydrops-bilateral, right greater than left; CNS disease." The most recent info received on 3/13/02, did not specify the outcomes of the reported events. The most recent information received 5/14/02, did not specifiy the outcomes of the reported events. Information received on 2/27/00 indicated that the tinnitus had resolved by 11/20/00. The outcomes of the other reported events were not provided. The fatigue, rashes, and tinnitus are considered disabling because they allegedly are "greatly impeding her ability to work". Per follow up: The vaccinee told her orthopedist that she had "peripheral neuropathy from a stem cell transplant" and "lung ans heart damage from right mastectomy and radiation and stem cell transplant".Bilateral wrist pain and finger numbness after falling off a ladder (1997) right extansor carni ulnarie tenosvnovieie (1998) treated with injections of triamcinolone (Kepalog). Spontaneous split of the nail plate on the right thumb. Medications Intermittent chemotherapy.  The vaccinee returned to the orthropedist on 24 May 2000 with pain in the left first MC joint. The physician injected Kenaloc 4mg into joint. The vaccinee returned to the orthropedist on 14 June 2000. She reported "good response" to the Kenalog injected on 24 May 2000 "until scrubbed floor- noe left pain first MC again. The surgeon injected Kenalog 4mg into the joint. *Follow-up report on 09/09/2002: The vaccinee presented to her primary MD on 9/15/00 after falling onto concrete and hitting a metal door. She had hit her head, but had not lost consciousness. She had a bump on her head and headache. She reported "different rings in both ears now." She had also hit her nose, upper lip, and left knee. The MD's impression was "multiple abrasions and concusions, CNB (central nervous system) Concussion." The vaccinee was seen by a rhinologist at a tertiary care center on 9/18/00, to ensure that she had not injure her nose in the fall. At that time, she reported that clonarepam, prescribed in June, was not helping the tinnitus. The vaccinee was seen by her oncologist on 9/20/00. She reported that "if she sleeps well, the tinnitus is less." She also reported "reoccurrence of numbness in foot at end of day associated with vigorous exercise, but otherwise not present... The PT does exercise regularly... Was exercising at an altitude of 4,500 feet and toloerated well." She reported that she was in the mountains for ten weeks at an altitude of 4,500 ftt and was going to London for the next six weeks. Medications included Valtrex, vaginal estradiol (Estrace), multivitamin, and calcium. The oncologist noted that bone soon, perfoemd in June 00, revealed degenerative joint disease; affected joints were not specified. The vaccinee remained under the care of her oncologist until at least 5/9/02. During this time, the vaccinee reported that she still experienced tinnitus, however, she had less tinnitus if she slept well. She reported that she used olonasepum rarely. The MD also noted, "complained of fatigue have improved - but does not sleep well at night". The vaccinee reported on 5/9/02 that she would be spending the next 6.5 months traveling abroad. On physical examination on 5/9/02, the oncologist noted "DJD [degenerative joint disease] in hands". The vaccinee returned to the orthopedist on 11/29/00. "Today x-rays show minimal change. Today repeat 4 mg Kenalog left first MC." She returned to the orthopedist on 1/23/02. It was noted she had 18 mts. of pain relief but for the previous three weeks, she had experienced a recurrence of pain in the left first MC joint. The surgeon injected Kenalog 4 mg into the jiont. "Lidocaine gave full relief." On 5/15/02, the vaccinee received another injection of Kenalog 4 mg into the left first MC joint. The orthopedist noted that her splint provided only 20 degrees of matacarpolphalangaal flexion, and ordered a new one with 40 degrees of flexion. He noted "static left thumb hasal joint OK." The most recent info, received 8/28/02, did not specify the outcomes of the reported events. Info. received on 8/16/02 indicated that tinnitus and fatigue persisted as of 5/9/02. Info. received 6/20/02 indicated that the left thumb osteoarthritis persisted as of 5/15/02. The fatigue, rashes, and tinnitus are considered disabling because they allegedly are "greatly impeding her ability to work." *Follow-up report on 10/10/02: Addition to medical history: Spastic colon, spastic bladder syndrom sinos at least 1983, cystitis singe at least 82 treated with long-term use nitrofuratoin (Macrodantin). *The most recent info, received 8/16/02 indicated that tinnitus and fatigue persisted as of 5/9/02.* Follow up received on 4/22/03 states the vaccinee saw an otolaryngologist specializing in neurotology at a tertiary care center on 6/6/00. The neurotologist noted that the vaccinee rpesented for "a fifth opinion for tinnitus. She has tinnitus that has been present for more than two years." In a letter to the state division of disability determinations, the neurotologist wrote, "The tinitus seems to have gotten worse after she was exposed to the paint thinner. She also has mild high frequency hearing hearing loss that was present in the past. Physical examination of the ears, nose and throat is normal. Cranial nerves exam and Romberg testing was also noormal. An audiogram revealed a mild, high-frequency-only sensorindural hearing loss. The speech discirmination scores were 100% bilateral. She had normal hearing through the 4000Hz level with only a mild 30dB hearing loss at the 8000Hz level. I advised the vaccinee concerning tinnitus therapy and possible intervention. She was also given a prescription for Klonopin, 0.5mg, to use for anxiety control and sleep. She was instructed to follow up with me on yearly intervals. I am not planning any other surgical intervention and do not feel that she has any limitations to lifting, carrying, standing, sitting, pushing or pulling and I cannot provide a medical opinion regarding this individual's ability to do work-related activities as I am only seeing her for the tinnitus." the vaccinee was seen by her primary physician on 6/13/00 with complaints of sore throat, congestion, laryngitis, and mild cough. The physician noted "history of tinnitus secondary to antibiotics." The physician made a diagnosis of "probable viral upper respiratory infection." The vaccinee "demands antibiotics for empiric bacterial infection." The vaccinee also stated that she needed an additional supply of antibiotics that she could take with her during her up-coming travel abroad. The physician prescribed Ceftin 250mg twice daily. The vaccinee returned to the orthopedist on 6/14/00. She reported "good response" to the Kenalog injection on 5/24/00 "until scrabbed floor-now left pain first MC again." The surgeon injected Kenalog 4mg into the joint. The vaccinee presented to her primary physician on 9/15/00 after falling onto concrete and hitting a metal door. She had hit her head, but had not lost consciousness. She had a bumpon her head and headache. She reported "different rings in both ears now." She had also hit her nose, upper lip, and left knee. The physician's impression was "multiple abrasions and contusions. CNS concussion." The vaccinee was seen by a rhinologist at a tertiary care center on 9/18/00, to insure that she had not injured her nose in the fall. At that time, she reported that clonazepam, prescribed in Jyne, was not helping the tinnitus. The vaccinee was seen by her oncologist on 9/20/00. She reported that "if she sleeps well, the tinnitus is less." She also reported "reoccurrence of numbness in feet at end of day associated with vigorous exercise, but otherwise not present. The pt does exercises regularly. Was exercising at an altitude of 4,500 feet and tolerated well." She reported that she was in the mountains for ten weeks at an altitude of 4,500 feet and was going for the next six weeks. Medications included Valtrex, vaginal estradiol, multivitamin, and calcium. The oncologist noted that a bone san, performed in June 2000, revealed degenerative joint disease; affected joints were not specified. The vaccinee remained under the care of her oncologist until at least 5/8/00. During this time, the vaccinee reported that she still experienced tinnitus; however, she had less tinnitus if she slept well. She reported that she used clonazepam rarely. The physician also noted," Complaints of fatigue have improved-but does not sleep well at night." The vaccinee reported on 5/9/02 that she would be speinding the next six and a half months traveling abroad. On physical examination on 5/9/02, the oncologist noted "DJD in hands." The vaccinee returned to the orthopedist on 11/29/00. "Today x-rays show minimal change. Today repeat 4mg Kenalog left first MC." She returned tot he orthopedist on 1/23/02. It was noted she had 18 months of pain relief but for the previous three weeks, she had experienced a recurrence of pain in the left first MC joint. The surgeon injected Kenalog 4mg into the joint. "Lidocaine gave full relief." On 5/15/02, the vaccinee received another injection of Kenalog 4mg into the left first MC joint. The orthopedist noted that her splint provided only 20 degrees of metacarpophalangeal flexion and ordered a new one with 40 degrees of flexion. He noted "static left thumb basal joint OA." The vaccinee returned to the orthopedist on 10/23/02. She reported, "Left first MC has flared-up with doing heavy work." The physician injected Kenalog 4mg into the joint. On 12/11/02, the vaccinee returned to the orthopedist and reported "two to five weeks full relief of left first MC pain" following the previous Kenalog injection. She reported that she used her splint "as circumstances persit." The orthopedist referred the vaccinee to an internist for systemic anti-inflammatory medication. The most recent info, received on 4/22/03, indicated that the osteoarthritis of the left first MC persisted as of 12/11/02. The outcomes of the other reported events were not provided. Information received on 8/16/02 indicated that tinnitus and fatigue persisted as of 5/9/02. The fatigue, rashes, and tinnitus are considered disabling because they allegedly are "greatly impeding her ability to work."