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VAERS ID: 126718 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1999-06-14
Entered: 2000-04-05
   Days after submission:296
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction, Rash, Serum sickness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 1999013689

Write-up: p/vax pt exp a total of two episodes of arthus phenomenon;tics were on for a a short period of time (1-4 hours) producing the phenomenon;pt exp long lasting local rxn of up to more than 1month & also exp erythema migrans;pt outcome unk;


VAERS ID: 150619 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1999-03-07
Onset:1999-03-20
   Days after vaccination:13
Submitted: 2002-09-24
   Days after onset:1283
Entered: 2000-03-31
   Days after submission:906
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Albumin globulin ratio abnormal, Arthritis, Asthenia, Atelectasis, Bacterial infection, Blood calcium decreased, Blood potassium decreased, Bone disorder, Bundle branch block, CSF test abnormal, Cardiac arrest, Carpal tunnel syndrome, Cerebral infarction, Colitis, Diarrhoea, Difficulty in walking, Dyspnoea, Gastrointestinal disorder, Headache, Hypoxia, Infection, Influenza like illness, Myelitis transverse, Neurogenic bladder, Osteomyelitis, Paralysis, Pneumonia, Pulmonary oedema, Quadriplegia, Red blood cell sedimentation rate increased, Ventricular extrasystoles, Visual disturbance, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteonecrosis (broad), Chronic kidney disease (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 69 days
   Extended hospital stay? No
Previous Vaccinations: Flashing lights from the sides of her eyes; flu-like symptoms~Lyme (LYMErix)~1~0.00~In Patient
Other Medications: Lasix, clonodine and cortisone; Premarin; herbal preparation (unspecified) for treatment of arthritis; Librium; prednisone 5mg
Current Illness: UNK
Preexisting Conditions: Lyme disease (1989, 1992), Lyme related arthritis. Scarlet fever as a child with resulting sensorinaural deafness, swelling of the hands and face since at least 1970; use of hearing aids 1978; sinusitis; labyrinthitis; xerostomia treated with electrostimulation 1984; anxiety and depression treated with alprazolam (1985), chronic amoxicillin therapy for an unspecified indication (1996-1998); small infarction of the left internal capsule; PVC 1990; nonspecific intraventricular conduction defect 1990; recurring facial rash 1990; hypokalemia 1990; hypothyroidism 1990; elevated cholesterol 1990; triglycerides 1992; increased platelet ct 1995; low RBC 1996; hypertension 1997; Allergy to PCN, aspirin and received desensitization shots for allergies to house dust and mixed feathers (1984); tinnitis; total hysterectomy due to cancer in 1964; reconstructive surgery of both ears; osteoarthritis multiple joints; pain in both shoulders 1988 treated with paracetamol/caffeine/butalbital (Fioricet); pain in right shoulder 1992 that radiated down the arm and leg treated with Feldene and Anaprox; dx of diffuse osteoarthritis and DJD in 1992, treated with Darvocet-N 100, Anaprox, Relafen and Vicodin; cervical sprain 1998; leg numbness 1997; cervical subluxation; sick sinus syndrome; **Follow-up on 9/26/02: Allergy to dust, feathers, penicilllin; anxiety, aspirin sensitivity, bone spur, brain infarction, cancer, cat bite, cervical radiculopathy, cervical spine degeneration, cervical sprain, cervical subluxation, decreased red blood cells, degenerative joint disease, depression, desensitization, ear surgery, elevated cholesterol, facial rash, foot pain, H Pylori infection, hand swelling, hearing aid user, hypertension, hypokalemia, hypothyroidism, hysterectomy, increased platelet count, intraventricular conduction defect, labyrinthitis, leg numbness, lumbar, radiculopathy, lumbar scoliosis, lumbar spine degeneration, lyme disease, numbness in hands, osteoarterosis, polymyalgia ??sumatica, premature ventricular contraction, raised triclyceride, retrospondylolisthesis, Salivary gland resection, salpingo-oophorectomy, scarlet fever, sensorinevral deafness, sick sinus syndrome, swelling of face, tendon damage, tinnitus, tooth extraction, varicose vein, varicose veins stripping, xerostomia. The PT expresses the HLA-DR4 phenotype. She had a "strong" history of tick exposure. She received chronic amoxicillin therapy for an unspecified indication (86-98).
Allergies:
Diagnostic Lab Data: MRI; ESR-elevated; ECG-frequent PVC''s, incomplete right bundle branch block pattern and non-specific ST-T wave abn; CT of brain-small infarct of the left internal capsul; LP-elevated protein, 3 RBC; CXR-atelectasis in the right lung base and probable mild perhilar edema; WBC-elevated; potassium, calcium, albumin, total protein and albumin to globulin ratio were decreased; globulin-increased; Lyme EIA and Western Blot-all neg; sputnum culture-(+) staphylococcus aureua; NCV-right carpal tunnel syndrome. Cultures from sacral decubiti, obtained 08/13/99, were positive for "abundant Citrobactar species, moderate Klebsiells oxytoca, moderate Pseudomonas seruginosa, moderate methicillin resistant Staphylococcus aureus. Moderate Enterococcus. Triple-phase bone scan, performed on 08/17/99, revealed "evidence of probable sacral and possible pelvic osteomyelitis." August 1999, "for definitive cultures and institution of intravenous antibiotios." She was treated with intravenous vancomycin, tobramycin, and ceftazidime. CT of the pelvis performed on 08/25/99, revealed "findings within the lower sacrum and cocovx consistent with chronic osteomyelitis associated acute osteomyelitis is strongly suspected; acute osteomyelitis involving the posterior left ischium is also strongly suspected: early osteomyelitis of the posterior right ischium cannot be excluded." **Follow-up received on 9/26/02: Albumin, Serum 3/22/99, 2.6g/dL range 3.5 - 5.0; Albumin, Serum 3/23/99, 3.3g/dL range 3.5 - 5.5; Albumin, Serum 6/16/99, 2.3g/dL range 3.3 - 5.2; Albumin/globulin ratio 3/22/99, 0.8, range 1.5-2.5; Antinuclear antibody 3/22/99, negative range <1:40; Antinuclear antibody 3/23/99, 1:40; Antinuclear antibody 3/23/99, Specklad; Arsenic, blood 3/23/99, <1.0 mcg/dL range <3.0; Babesia microti, blood smear 10/26/00, not detected; blood culture 3/22/99, neg; blood culture, 6/16/99, neg; CSF culture 3/22/99, neg; CSF glocuse 3/22/99; 68mg/dL, range 45-80; CSF protein 3/22/99, 55mg/dL, range 15-45; CSF red cell count 3/22/99, 3; CSF white cell count 3/22/99, 0; Calcium, Serum 3/22/99, 7.7mg/dL range 8.5-10.5; Carbon dioxide 6/17/99, 32 mmom/L, range 24-32; Carbon dioxide 6/19/99, 38 mmom/L, range 24-32; Erythrocyte Sedimentation rate 3/21/99, 40mm/hr range 0-30; Globulin 3/22/99, 3.6g/dL, range 2.5-3.2; Globulin alpha-1 3/23/99, 0.3g/dL, range 0.1-0.3; Globulin alpha-2 3/23/99, 0.8g/dL, range 0.5-1.1; Globulin beta 3/23/99, 0.8g/dL, range 0.5-1.2; Globulin gamma 3/23/99, 0.6g/dL, range 0.1-1.55; HGE IgG 10/26/99 <54, range <54; HGE IgM 10/26/99 <20, range <20; Haematocrit (packed cell vol) 3/21/99, 34.5%, range 35.5-44.7; Haematocrit (packed cell vol) 6/17/99, 10.9%, range 36.0-46.0; Haematocrit (packed cell vol) 6/19/99, 10.1%, range 36.0-46.0; Haemoglobin 6/17/99, 10.5g/dL, range 12.5-15.0; Haemoglobin 6/19/99, 10.5g/dL, range 12.5-15.0; IgG 3/23/99, 659mg/dL, range 695-1618; IgM 6/23/99, 144mg/dL, range 48-271; Iron saturation 6/16/99, 14%, range 20-55; lead, blood 3/23/99, lmeg/dL, range <25; Lyme antibody screen 3/23/99, 0.31, range 0.00-0.80; Lymphocytes, blood 3/21/99, 7.9%, range 20.5-51.1; Lymphocytes, blood 3/22/99, 3.1%, range 20.5-51.1; Lymphocytes, blood 6/17/99, 8%, range 20-44; Lymphocytes, blood 6/23/99, 3%, range 20-44; Mercury, blood, 3/23/99, <0.5mcg/dL, range <5.0; Neutrophils, Blood 3/21/99, 89.2%, range 42.2-75.2; Neutrophils, Blood 3/22/99, 90.6%, range 42.2-75.2; Neutrophils, Blood 6/17/99, 88%, range 40-73; Neutrophils, Blood 6/23/99, 90%, range 40-73; Potassium 3/22/99, 3.1mEg/L, range 3.5-5.2; Potassium 6/16/99, 3.4mEg/L, range 3.5-5.0; Protein, serum, total 3/22/99, 6g/dL, range 6.4-8.2; Protein, serum, total 6/17/99, 5.4g/dL, range 6.0-8.2; Red blood cell count 3/23/99, 3.74x10^6, range 1.9-5.26; Red blood cell count 6/17/99, 3.25x10^6, range 1.7-5.2; Red blood cell count 6/19/99, 3.19x10^6, range 1.7-5.2; Ejogran''s SSA antibodies 3/23/99, neg, range <0.93; Ejogran''s SSB antibodies 3/23/99, neg, range <0.91; Sputum culture 3/23/99, S. sureus; Troponin I 3/21/99, neg; Urine culture 3/23/99, neg; Urine culture 6/27/99, neg; WBC count 3/21/99, 8700/cu mm, range 4100-11300; WBC count 3/22/99, 14600/cu mm, range 4100-11300; WBC count 6/17/99, 11800/cu mm, range 4100-11300; WBC count 6/20/99, 14900/cu mm, range 4100-11300; WBC count 6/23/99, 13800/cu mm, range 4100-11300; 3/21/99 ECG: "frequent premature voatricular contractures w/ventricular trigeminy. Incomplete right bundle branch block pattern. Non-specific ST-T wave abnormalities." 3/22/00 CT of head: "A tiny area of low density in the left internal capsule ia again seen. No mass or hemorrhage is evident. No interval cahnge." 3/22/99 chest x-ray: "There is mild prominence of the perihilar markings suggesting perihilar edema... There is atelectasis in the right lump base... IMPRESSION: 1) Probable mild perihilar edema," 3/23/99 Chest x-ray: "Mild increased markings in the right lung base most likely atcloctasis. Other consideration would include early infiltrate." 3/23/99 CT of brain, with and w/out contract: "1. Subtle hypodensity in the left inbornal tapaula which may be due to a subtle infaret. 2. Sinus disease." 3/23/99 CT of cervical spine: "Extensive degenerative changes of the cervical spine. No cord lesion could be demonstrated." 3/24/99 MCV of right arm and both legs: "normal motor conduction velocities in arm and leg, right CTS, right ulnar slowing across the elbow." 3/24/99 HMG of right arm and both legs: "no denervation seen in EMG of leg muscles." 3/24/99 CT of head: "DIAGNOSIS: Age appropriate volume loss w/small vessal ischonic change. There is a vague lucency w/in the posterior limb of the left internal capsule which could be due to a lacunar infarct." 3/24/99: skull x-ray: "no radio-opaque implant in the auditory canals." 3/24/99: MRI cervical spine with and w/out contract, MRA spinal canal, "DIAGNOSIS: Abnormal signal seen w/in the spinal cord from the cervical medullary junction to C4-5 level. There is no abnormal enhancement post Gadolinium injection and finding likely represents inflammatory etiology such as acute transferanoe (sio) myelitis. Degenerative spine disease... Vertebral arteries and carotid arteries are patent." 6/16/99 Chest x-ray: "DIAGNOSIS: Moderate-sized bilateral pleural effusions with mild pulmonary edema." 6/18/99 Barium videofluoroscopic swallow study: "Delayed epiglottic inversion w/aspiration w/thick and thin consistencies." There was "trace aspiration on thick liquid and moderate aspiration on thin liquids w/out ability to clear w/cough." 8/13/99: culture of sacral docubiti: "1. Abundant Citrobacter species. 2. Nodorate Elebsialla oxytoca. 3. Moderate pseudomonae aeruginose. 4. Moderate methicillin resistant Staphylococcus aureus. 5. Moderate Enterococcus." 8/17/99 triple-phase bone scan: "IMPRESSION: 1. Increased uptake over the sacrum. Cateomyelitis 2ndary to the known dequbitus cannot be excluded. 2. Increased uptake in the left inchium of the bony pelvis - if there is a docubitus ulcer in this area, then osteomyelitis may be present. 3. Nonspecific increased uptake in 3 of the lumbar vertebral bodies". 8/23/99 CT of the pelvis: "IMPRESSION: There are extensive areas of soft tissue ulceration posterior to the lower sacrum and coccyx, posterior to the left ischium and to a lesser extent posterior and interior to the right ischium. There are findings w/in the lower sacrum and coccyx consistent w/chronic osteomyalitis - associated acute osteomyelitis is strongly suspected: acute osteomyelitis involving the posteroir left ischium is also strongly suspecte; early osteomyelitis of the posoriox rights ischium cannot be excluded." CT Brain, 3/21/99: "Small infarct of the left internal capsule". Total Lyme antibodies by EIA, 3/22/99; Seronegative (<0.8). Lyme IgM Western blot, 3/22/99; Neg. (23 kD bend present). Lyme IgGM Western blot, 3/22/99; Neg. (41 kD bend present). Immunofixation, 3/23/99: No monoclonal protein detected. Lyme IgM Western bot, 10/26/99: neg. Lyme IgG Western blot, 10/26/99: neg (41 kd bend present). Lyme DNA PCR, 10/26/99: neg. Lyme IgM Western blot, 3/15/00: neg. Lyme IgG West blot, 3/15/00: neg (41 kD band present). Lyme antibody EIA, 7/1/00, 1.77 (positive, $g1.20). Lyme IgM West blot, 7/1/01: neg (23 kD band present). Lyme IgG West blot, 7/1/01: neg (41 kD band present). Trachcal aspirate culture, 6/14/99: moderate growth staphylococcus aureus (MRSA). Duplex lower extremities, 6/16/99: probable small right knee effusion. Stool sample, 6/16/99: Heme positive. Stool sample, 6/19/99: No C. difficile toxin detected. Stool sample, 6/23/99: No C. difficile toxin detected. Stool sample, 2/9/01: Positive for C. difficile toxin, Blastocystis hominis.
CDC Split Type: A0323439A

Write-up: The pt was diagnosed with Lyme disease in 1989 and 1992. Since then she has had several additional tick bites. she has been treated with cortisone for Lyme-related arthritis. Prior to the adverse event, the pt was reportedly a very active woman, involved in aerobics, four-mile walks daily and a part-time job. On 2/7/99, post vax, pt experienced flashing lights from the sides of her eyes and thought she was having a stroke. the lights disappeared, but she then experienced flu-like symptoms for several days. She advised her MD of these symptoms. On 3/7/99, the pt received a 2nd dose. She experienced flu-like symptoms again. On 3/20/99, she started to feel weakness on her right side and had excruciating pain at the base of her skull, This was also brought to the attention of her MD. She was rushed to the hospital. It was determined that the symptoms she was having were the result of Lymerix. She was given an injection and then released. She had to literally be carried to her car and into her house. The attending MD at the hospital said the injection would wear off in several hours. Twelve hours later she was still not awake. An ER MD called and asked about her condition. The MD was told that the pt was sleeping and then awakened and still complained about a terrible headache and weakness all over her body. The MD thought something may have been overlooked in their initial exam and had her brought to the hospital via ambulance. Then was admitted for the night. Around 10:00 on 3/31/99, the headache again became severe and she was then experiencing paralysis. She was put on a stretcher and while on the way to ICU she reportedly coded in the elevator. Within 25 minutes she was mechanically ventilated. She was transferred to a second hospital for an MRI. Two days later she was dx with acute transverse myelitis. She spend about six weeks in ICU on a ventilator and then a tracheostomy and a feeding tube were inserted, which she still has today. She went back and forth from the hospital to a rehab center for the next eight months until she was discharged home on 10/20/99. She is confined to a wheelchair and requires 24 hour home health care. A 15-Day follow-up states the pt experienced paralysis throughout her body, her oxygen levels were determined to be low, while hospitalized the pt developed bed sores as well as pneumonia. She was readmitted with suspected pneumonia and bone infection resulting from the bed sores. The pt was discharged to home "under 24 hours home healthcare with a Trach tube, feeding tube, foley catheter and confined to a wheelchair. As of 2/1/01, the pt still required the use of the feeding tube. The most recent info received on 8/10/01, did not provide the outcome of the transverse myelitis. F/U the pt pad slow neurologic improvement. On 3/26/99, the neurologist noted that the pt had improved, she could move her left arm and leg and shrug her shoulders. By 4/3/99, she could wiggle her toes and on 4/4/99, she could wiggle the fingers of her R hand.On 4/10/99,she was noted to have fllaccid quadripaesis. On 4/17/99, rehabilitation medicine documented neurogenic bowel and bladder and quadriplegia. The pt continued to make slow improvement. Because her oral intake remained inadequate a percutaneous endoscopic astrostomy (PEG) tube was placed on 4/20/99. On 4/28/99 she was exhibited slight movement right arm, little more on left. On 5/12/99 she was able to lift her L arm off the bed. On 5/18/99, she was successfully weaned from the respirator ad was able to sit ia a chair. On 5/24/99, she was able to move her procimal upper arm and lift her L leg. On 5/26/99, the neurologist stated everyday has slow improvement. More shoulder shrug. Moving L arm horizontally. On 5/28/99 the pt was transferred from the tertiary care ctr to a rehab facility.On 6/15/99 medical records indicated that she was readmitted to the tertiary care ctr on that date due to episodic dyspnea and hypoxia with increased mucus plugging. The pt''s attorney reported that in 8/99 she was admitted to the hospital with bone infection resulting form the bed sores. As of 2/1/01 the pt still required the use of the feeding tube. The most recent information rec''d 8/10/01 did not provide the outcome of the transverse myelitis. The pt was seen in the local emergency room on 06/02/2001 to have her foley catheter changed. Her family reported that the "Foley tube is green. States it''s been green for one week." Bed sores were also noted by the ER nurse. A urine specimen contained a "small" amount of leukocyte ester, at least 300 mg/dL protein, "too numerous to count" white blood cells per high-powered fields, WBC''s in clumps, 25 to 50 red blood cells per high-powered field. "2+" bacteria, "occasional" squamous epithelial cells, and Gram negative rods and Gram positive cocci. A diagnosis of urinary tract infection was made, and the pt was treated with Bactrim DS one tablet twice daily. Please note that the urinary tract infection was not reported as an adverse event due to vaccine administration, but was found during the course of review of the pt''s medical records. Therefore, it is not listed as an adverse event." The most recent info received on 12/17/2001. As of 07/01/2001, the pt required the use of a Foley catheter. As of 10/24/2001, the pt required the use of a feeding tube, trach tube and wheelchair. Following the onset of transverse myelitis, the pt experienced urinary tract infections, acute paranoid schirophrenia, dehydration, insomnia, congestive heart failure, anemia, Clostridium difficilo related diarrhea/colitis, cough, and alergic rhinitis. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt''s medical records. Therefore, they are not listed as adverse events. Medicla records from the rehabilitation facility indicated thatt he pt was transferred from that facility to an acute care hospital for treatment of osteomyalitis. She was treated with intravenous antibiotics. She recovered and was transferred back to the rehabilitation facility. Despite persistently negative Lyme serology, the arithromycin therapy was continued. On 6/20/00, Suprax was added to arithromycin therapy. The pt returned to physical therapy on 7/03/00, for gait training. She was discharged from physical therapy on 10/05/2000. The therapist wrote,"pt continues to have limited function secondary to her condition. However, pt has made significant progress and is independent with some functions." The pt was evaluated by a speech therapist on 07/07/2000. The "pt presents with sponic speech due to tracheostomy." The therapist wrote,"pt received home care from October 1999 until January 200 which ended due to severe anxiety attacks and cnfabulation. Pt behavior has returned to normal and is now able to tolerate therapy. Family has obtained electrolarynx for pt to be trained on." Further "therapy not recommended. Pt pleased with speech using electrolarynx." On 08/02/2000, the pt reported that she was "doing well." She continued "doing well" no complaints on 02/07/2001. She was still taking arithromycin and cefixime for treatment of Lyme disease on 02/07/2001. The pt resumed physical therapy on 01/04/2001. She was discharged from therapy on 03/02/2001. The therapist wrote, "No significant progress with pt''s functional status secondary to poor endurance. Unable to successfully stretch hip and bilateral heel cords secondary to inability to carry over stretching at home and pt''s inability to assume supine position. Pt may benefit from pressure relieving ankle foot orthosis." The pt was seen by a gastroenterologist on 03/15/2001 because of "diarrhea for about a month." A stool sample collected on 02/09/2001 was positive for Clestridium diffiolle toxin. The gastroenterologist wrote, "my impression is clostridium difficile related diarrhea/colitis. The pt is to discontinue to Zithromax and the flagyl. She will begin Vancomycin 250 mg orally fours times a day for a minimu of two weeks. The lomotil use is to be reduced to be used only as needed every four hours for severe diarrhea." The most recent info received on 03/09/2002. As of 01/17/2002, the pt required the use of a foley catheter. As of 10/24/2001, the pt required the use of feeding tube, trach tube, and wheelchair. The follow-up states that x-rays performed on 08/18/1999 revealed anterior subluxations of C3 and C4 and C4 on C5 with disc space narrowing at C5-6 and C6-7. On 09/01/99, the pt told one of her physicians that the subluxations were "old." The pt also experienced fungal infection. Medical records form the rehabilitation facility indicated that cultures from sacral decubiti, obtained 08/13/99, were positive for "abundant Citrobactar species, moderate Klebsiells oxytoca, moderate Pseudomonas seruginosa, moderate methicillin resistant Staphylococcus aureus. Moderate Enterococcus. Triple-phase bone scan, performed on 08/17/99, revealed "evidence of probable sacral and possible pelvic osteomyelitis." August 1999, "for definitive cultures and institution of intravenous antibiotios." She was treated with intravenous vancomycin, tobramycin, and ceftazidime. CT of the pelvis performed on 08/25/99, revealed "findings within the lower sacrum and cocovx consistent with chronic osteomyelitis associated acute osteomyelitis is strongly suspected; acute osteomyelitis involving the posterior left ischium is also strongly suspected: early osteomyelitis of the posterior right ischium cannot be excluded." The pt was transferred back to the rehibilitation facility on 09/01/99. The osteomyelitis resolved and the intravenous antibiotics were discontinued on 10/05/99. The most recent info was received on 07/09/02. The most recent information received on 8/16/02, indicated that the patient required a trach tube as of 3/29/02. ** Follow-up report on 9/26/02: Report A0323439A (formerly 2000008570-1) is a spontaneous case from an MD referring to a 74 y.o. female who received lyme disease vaccine (Lymerix) and experienced acute transverse myelitis. Add''l info. and medical records were received thru the litigation process. Prior to the adverse event, the PT was reportedly a very active women involved in aerobics, daily 4-mile walks, and a PT job. The PT expresses the NLA-DR2 phenotype. Medical history included acarlet fever as a child w/resulting sensorineural deafness, swelling of the hands and face since at least 1970, use of hearing aids (1978), tinnitus, labyrinthitis, varicose veins, xerostomia treated with electrostimulation (1984), anxiety and depression treated with alprasclam (1985), chronic amoxicillin therapy for an unspecified indication (1986-1998), small infraction of the left internal capsule, foot pain (1990), premature ventricular contractions (1990), hypokalamia (90), hypothyroidism (90), elevated cholesterol (90), elevated triglyceriden (92), polymyalgia rheumatics (92), increased platelet count (95), decreased red blood cell count (96), hypertension (97), and Helicobacter pylori infection. The PT received desensitization shots for allergies to house dust and mixed feathers (84). She had an allergy to penicillin manifested by rash and shortness of breath, and an intolerance to aspirin manifested by tinnitus. Surgical history included total hysterectomy and bilateral selpingo-oophorectomy due to cancer in 1964, unspecified reconstructive surgery of both ears, varicose vein stripping, and salivary gland removal. The PT''s family indicated that the PT had bilateral auditory canal implants to treat sensorineural deafness. However, no radio-spague implants were observed on x-ray, and her hearing specialist only documented hearing aid use. In March 99, she had teeth extracted and had planned to have others extracted. Orthopedic history included a cat bite to the right thumb with damage to the flemor pollicus longus tendon, decreased thumb mobility, and intermittent hand numbness (1987), ostearthritis of the right thumb (1987), left thumb (1997), left second and fourth fingers (97), and left wrist (97); and spinal disease. "She experienced pain in both shoulders (88) treated with paraostamol/caffeine/butalbital (Fiofioet). She experienced pain in the right shoulder (92); the pain radiated down the right arm and right leg and was treated with pironicam (Feldone) and nop?? sodium (Anapron). A diagnosis of "diffuse ????? and DJD (degenerative joint disease) was made in 92, the PT was treated with dexecopyopoxyphane/paraostamoll (Darvocat-N 100), napxoxen sodium (Anaprox), nabumatone (Rolafen), and hydrocodone/paracetamol (Vicodin). In 1992, electromyelography and nerve conduction studies revealed C5-6 cervical radiculopathy and L5 lumber radiculopathy. X-ray of the cervican spine in 95 revealed "widespread demeneralization seen. There is significant degenerative changes with disc space narrowing at 5-6 and 6-7 and retroliathesic of C5 and C6 seen probably narrowing considerable the spinal canal at this level." X-rays performed on 8/18/99 revealed anterior subluxations of C3 on C4 and C4 on C5 with disc space narrowing at C5-6 and C6-7. On 9/7/99, the PT told one of her MD''s that the aubluxations were "old". X-rays of the lumbosacral spine in 97 revealed "moderated to marked levoscoliosis of the lumber spine centered at L3-4. There is narrowing of all the interspaces with posterior spurs at L1-2, L2-3. There is sclerosis of the sygapophysoal joints at L4-5, L5-S1." After reviewing these x-rays in 97, the radiologi''s conclusion was "Extensive degenerative changes of the lumbar spine." She experienced pain in both arms from shoulder to elbow, muscle weakness, and decreased range of motion (98), a diagnosis of cervical sprain was made and the PT was treated with paracetamol/hydrocodone (Vicodin). The PTwas diagnosed with Lyme disease in 1989 and 1992. She was bitten by 2 ticks in June 97. On 6/11/97, she reported to her MD that she felt her "joints aren''t right". She was treated with doxycycline. On 6/23/97, she was seen by her MD for numbness in both legs. When she presented for treatment after receiving LYMErix, the MD noted a "strong" history of tick exposure. She was treated with prednisone, reportedly for Lyme-related arthritis, however, she was being treated by a neurologist. She had been initially referred to the neurologist for treatment of Lyme disease in 1998. Following the onset of transverse myelitis, the PT experienced osteopenia, urinary tract infections including one yeast infection requiring hospitalization, fungal infection, olitis media, acute paranoid achitophrania, dehydration w/one episode of associated hypercalcemia, sick euthyroid syndrome, insomnia, congestive heart faillure, anemia, Clostridium difficils related diarrhea/colitis, probable ilous, cough, allergic rhinitis, allergic conjunctivitis, and right ptosis. These were not reported as adverse due to vaccine administration, but were found during the course of review of the PT''s medical records. Therefore, they are not listed as adverse events. Concomittant medications included prednisone 5 mg daily, conjugated astrogone (Premarin), an unspecified herbal preparation for the treatment of arthritis, and chlordiasepoxide (Librium) as needed. On 2/7/99, the PT received her first injection of LYMErix. She was above the maximum recommended age for immunization with LYMErix. On 2/7/99, while driving home from the MD''s office, she experienced flashing lights from the sides of her eyes, and thought she was having a stroke. The lights disappeared, but then she experienced flu-like symptoms for several days. She reportedly advised her doctor of these symptoms. Initially the PT''s attorney reported that the PT received her 2nd injection of LYMErix on 3/7/99. At the time of presentation to the emergency rm, that PT reported that she had received the 2nd dose of LYMErix on 3/15/99. When she was transferred to the tertiary care center, her family reported that the 2nd dose of LYMErix was administered on 3/10/99. Medical records from the immunizing MD, documenting the date of immunization, have not been forwarded by the PT''s attorney. Her attorney reported that she experienced flu-like symptoms again. On 3/20/00, she experienced the sudden onset of aching and tightness of her chest, radiating up to her nook and then "downwards bilaterally". She also experienced "severe" frontal headache, "excruciating" occipital pain with radiation down the back, and weakness. A nurse in the local ER recorded the weakness as generalized, while an MD at the tertiary care center recorded it as right arm weakness. The PT''s attorney reported that the PT brought her symptoms to the attention of her MD. However, the MD at the tertiary care center stated, "PT tried to self-medicate - did not ask for help." On 3/21/99, the headache persisted and the PT developed photophobia and progressive lethargy. Her attorney reported that "she was rushed to a hospital", the ER record indicates that her family drove her to the local ER on the morning of 3/21/99. Blood was taken for analysis, and electrocardiogram (ECG) was perfoemd, and the PT was treated with nalbuphine (Nubain) 10 mg and prometharine (Phenergen) 25mg. White blood cell (WBC) could was normal w/a decreased proportion of lymphocytes and an increased proportion of granulocytes (please see Lab data section for detailed results of diagnostic evaluations). Erythrocyte sedimentation rate (ESR) was elevated. Troponin I level was normal. The ECG showed sinus rhythm with "frequent premature ventricular contractures with ventricular trigeminy. Incomplete right bundle branch block pattern... Non-specific ST-T wave abnormalities. The ER MD considered the events to be "due to vaccine." The PT was sent home. The PT''s attorney stated, "She has to literally be carried to her car and into her house by her family members." The attending MD at (the hospital) said the injection would wear off in several hrs. 12 hrs later, she was still not awake. An MD from the emergency dept. at (the hospital) called and asked about her condition. The MD was told that the PT was sleeping and then awakened and still complained about a terrible headache and weakness all over her body. The MD then said that perhaps something had been overlooked in their initial exam and had her brought back to the hospital via ambulance. When she returned to the ER, she complained of an occipital headache with radiation to the posterior neck and right arm weakness. It was noted that she had "1 x 0.5 inch healing would with redness, no drainage" on her right shin. It was reported that she had taken chlordiasepoxide and prednisone earlier in the day. The PT was hospitalized for neurologic evaluation. Upon admission, "she has a severe headache with ongoing photophobia and increasing lethargy. She is having difficulty swallowing", on neurologic examination, "Deep tendon reflexes were increased on the right upper extremity. The Pt was somnolent and did not answer appropriately to any questions. She had Bibinaki that were equivocal and she was very lethargy (sic)". The admitting MD''s impressions were "Early CVA and I am concerned about extension. Also I am concerned about the possibility this may be an underlying meningitis that does thus (sic)has not been able to be diagnosed. Rule out drug induced confusion. Rule out LYMErix as an otiology." The nurse noted that the PT had full range of motion of her left extremities, but "decreased mobility of her right lower extrimity and her marked inability to move right upper extremity." The headache was treated with acetaminophen. She was also administered one aspirin daily. Red blood cell (RBC) cound and hematocrit were decreased. Computed tomogram (CT) of the brain revealed "small infarct of the left internal capsule." On 3/22/99, the headache persisted. The PT was administered one tablen of incataninophan/caffeine/butalbital (Floricet). Approximately 20 mins later, the PT was "becoming increasingly solnolent" and "had progressive hypoventilation." She was transferred to the intensive care unit. On the way to the unit, she experienced respiratory arrest and was incubated and placed on mechanical ventilation. A neurologist was consulted. At the time the neurologist examined the PT, she had a stiff neck. The neurologist''s impressions were "Left IMCA stroke. Rule out bleed, CNS infection. CVA brain stem. Rule out upper cord lesion." The neurologist performed a lumbar puncture; the cerebrospinal fluid (CSF) contained no WBC, 3 HBC?, and elevated protein. After the procedure, the neurologist stated, "History suggests vasculitis as cause for prior signs and symptoms. Treated with prednisone. If red rate increased prescribe SoluMedrel (mythylprednisolone)." Magnetic resonance imaging (MRI) of the brain was ordered, but refused by the family because of concerns regarding supposed auditory canal implants. CT of the head revealed "A tiny are of low density in the left internal capsule... No mass or hemorrhage is evident. No interval change." Chest x-ray showed stelectasis in the right lung base and probable mild perihilar edoms(?). WBC count was elevated, with an increased proportion of granulocytes and decreased proportion of lymphocytes. Potassium, calcium, albusin, total protein, and albumin to globulin ratio were decreased. Globulin was increased. Antinuclear antibody (ANA) titer, total Lyme antibodies by EIA, Lyme IgG by Western blot, Lyme IgM by Western blot, Sjogren''s SSA antibody titer, and Sjogren''s SSB antibody titer were negative. Arsenic, ,mercury, and lead levels were within acceptable limits. Amounts of alpha-1, alpha-2, beta, and gamma glubuline measured by protein electrophorasis were normal: however, albumin was decreased. IgG levels were decreased; IgM levels were normal. No monoclonal protein was detected by immunofixation. Cultures of CSF, blood, and urine were negative. Sputum culture was positive for staphylococcus auraus. The PT was treated with albuterol (Proventil), ipratropium (Atrovent), and potassium chloride. That evening, the PT was "incontinent of green/clay color stool." On 3/23/99, the PT was noted to have green uring. It was noted that greenish stool was in the urine. Impression of a consulting MD was "Possible UTI. Possible Pyuria." The neurologist examined the PT and noted numbness and paresthesias of both arms and legs. She had right-sided muscle weakness and up-going toes. The respiratory therapist noted that the PT attempted deep breathing, but was "unable to generate any muscle power." The attending MD''s assessment was "1) Progressive neurologic weakness - ascending paralysis - could this be Guillsin-Barro syndrom - atypical. Persistent hypoventilation - secondary to CNS insult. Neurology feels that this is a vasculitic cerabritis - such as lupus cerabritis. 2) Respiratory acidosis secondary to hypoventilation syndrom - suspect all due to neurology insult. Central hypoventilation syndrome." The PT developed "non-cardiogenic pulmonary edema." Chest x-ray showed "mild increased markings in the right lung base most likely atelectosis. Other consideration would include early infiltrate." CT of the brain, with and without contrast, revealed "1. Subtle hypodensity in the left internal capsule which may be due to a subtle infarot. 2. Sinus disonso." CT of the cervical spine revealed "Extensive degenerative changes of the cervical spine. No cord lesion could be demonstrated." The PT was treated with methylprednisolone 1000 mg intravenously, followed by 250 mg every 6 hrs, "without any significant improvement." She was also given one dose of famobidine (Pepsid) 20 mg intravenously. The PT was transferred to a tertiary care center for further diagnostic evaluation. Nerve conduction velocities (NCV) and electromyelography (EMG) performed at the tertiary care center on 3/24/99 showed normal motor conduction velocities in the arm and leg, right carpal tunnel syndrome, and right ulnar slowing across the elbow. No denervation was seen in the EMG of the leg muscles. CT of the head was performed, the radiologist''s diagnosis was "Age appropriate volume loss with small vessel inchemic change. There is a vague lucency w/in the posterior limb of the left internal capsule which could be due to a lacunar infarct." X0ray revealed no radio-opaque implants in the auditory canals, no MRI of the cervical spine (with and w/out contrast) and magnetic reasonance arberiography (MRA) of the spinal canal were performed. The radiologist''s diagnosis was "abnormal signal seen within the spinal cord from the cervical medullary junocion to C4-5 level. There is no abnormal enhancement post Cadolinium injection and finding likely represents inflammatory etiology such as acute transference (sic) myelitis. Degenerative spine disease... Vertebral arteries and carotid arteries are patent." Lyme antibody screen was "non-reactive". Antinuclear antibody titer was 1:40 w/a speckled pattern. Mothylprednisolone 1000 mg was administered intravenously every 6 hrs for 5 days. The PT then received intravenous immune globulin and a tapered course of methylprednisolong. She then received a tapered course of prednisone. She was also treated with famotidine, furosemide (Lasix), gualfanssin, albutoral, ipratropium, and subcutaneous heparin. On 3/25/99, the PT c/o''d of generalized pain. Her right side was flaccid and she had spasms in her right leg. Left side strength was reduced. The neurologist stated "MRI consistent with transverse myelitia (longitudinal) goes from C3 to T1." The PT spent approximately 6 wks in the intensive care unit. Her hospital course was complicated by difficulty weaning from the ventilator; central respiratory disorder w/lack of drive and Cheyne-Stokes like breathing; pulmonary edema, pneumonia caused by methicillin-resistant Staphylococcus sureus and Bactoroides fragilis treated with nebulised cobramycin, metronidaxole (Flagyl), and nearly 4 wks of intravanous vanconycin, which required peripherally inserted central catheter (PICC) insertion; tracheobronchitis and airway edema, severe trachaomalacia secondary to trancheitis; necrosis of the anterior trachear; Escherichia coli, Klebsiella, and yeast urinary tract infections treated with ciprofloxacin (Cipro), amoxicillin/clavulanate (Augmentin), sulfamathoxasole/tramethoprim (Bactrim), and fluconasole (Diflucan); chicken pox treated with ecyclovir; premature ventricular contractions, premature strial contractions; cachyoazdin while weaning from the ventilator, treated with diltiazem (Cardirem), artial fibrillation treated with digoxin, aphthous ulcers, anemia requiring blood transfusion; one episode of agitation and hallucinations; and persistent diarrhea. The PT made slow neurologic improvement. On 3/26/99, the neurologist noted that the PT had improved; she could move her left arm and leg and shrug her shoulders. By 4/3/99, she could wiggle her toes and on 4/4/99, she could wiggle the fingers of her right hand. The PT remained axeflexic, and on 4/10/99, she was noted to have flaccid quadriparceis. On 4/17/99, rehabilitation medicine documented neurogenic bowel and bladder and quadriplegia. The PT continued to make slow improvement. Because her oral intake remained inadequate, a percutanous endoscopic gastroatomy (PEG) tube was placed on 4/20/99. On 4/28/99, she exhibited "slight movement right arm, little more on left." On 5/12/99, she was able to lift her left arm off the bed. On 5/18/99, she was successfully weaned from the ventilator and was able to sit in a chair. On 5/24/99, she was able to move her proximal upper arm and lift her left leg. On 5/26/99, the neurologist stated, "Everyday has slow improvement. More shoulder shrug, moving left arm horizontally." On 5/28/99, the PT was transferred from the tertiary care center to a rehab facility. Final diagnoses were "1. Transverses myelitis. 2. Status post MRSA (methicillin resistent Straphylocaccos aurenal pneumonia. 3. Anemia." She reportedly "went back and forth from the hospital to a rehab center for the next 8 mts". On 6/15/99, she "was rushed back to (the) hospital w/a suspected case of penumonia." Medical records indicated that she was readmitted to the tertiary care center on that date due to episodic dyspnea and hypoxia with increased mucus plugging. These episodes "apparently responded to suctioning." One episode of low-grade fever was noted. Medications on admission included furosemide, digoxin, famotidine, gualfemesin, paporacillin/tarodactam (Zocyn), vanoumyola, magnesium oxide, multivitamin, mubeutaneous heparin and chlordiazepoxide 10 mg 3 times daily. At the time of this admission, the rehab MD''s diagnoses were "1. Deconditioned. 2. Transverse myelitis with quadriparesis. 3. Acute pneumonia. 4. Status-post trach. 5. History of Orthostatic hypotension." The PT had persistent diarrhea. She had a stage IV secral pressure ulcer and bilateral stage IT lachoal pressure ulcers. She had thrush and aphthous ulcers. She was unable to talk, due to inadequate lung capacity to move the vocal cords. RBC, homoglobin, and hematocrit were decreased. Stool was ?? positive. On 6/16/99, duplex scan of the legs revealed "Probable small right knee effusion." Chest x-ray revealed "Moderate-sized bilateral pleural effusions with mild pulmonary edema." On 6/17/99, her WBC was elevated; the proportion of neutrophilo was increased and the proportion of lymphocytes was decreased. Potassium, protein, albumin, and iron saturation were decreased. Carbon dioxide was increased. Blood and urine cultures were negative. 2 stool samples were negative for Clostridium difficile toxin. Culture of tracheal aspirate was positive for moderate growth of methicillin-resistant straphylococcue aureus. Barium videofluoroscopic swallow study performed 6/18/99 demonstrated "delayed spiglottic inversion with aspiration w/thick and thin consistencies." There was "trace aspiration on thick liquid and moderate aspiration on thin liquids w/out ability to clear with cough." The pneumonia was initially treated with Zodyn and vancomygin. After culture results were rported, the pneumonia was treated with vancomvein and metronidezole. Respiratory acidosis was treated with aceterolamide (Iamox). Diarrhea was treated with acidophilus (Lactinex) and loperamide (Imodium). Thrush was treated with nystatin. Anemia was treated with a blood transfusion and ferrous sulfate. Docubis were treated with physical, then chemical/enzymatic, debridement. The PT''s family reported that she was "very sleepy", so the chlordiarepoxide dose was reduced to 10 mg twice daily. On 6/25/99, the PT was transferred back to the rehabilitation facility. Discharge medications included loperamide, Lactinex, furosemide 20 mg twice daily, gualfencein 600 mg twice daily, albuterol and ipratroplum every 8 hrs, famodidine, multivitamin, vitamin C, zine, magnesium oxide, ferrous sulfate, digoxin, and chlordiazepoxide 10 mg twice daily. The primary discharge diagnosis was "pneumonia versus aspiration pneumonitis." The PT''s diet was changed to "mechanical soft with some puddings. There was to be no thick or thin liquids." The PT''s attorney reported that "In August 99 [she] was admitted to [the hospital] w/a bone infection resulting from the bed sores." Medical records from the rehab facility indicated that cultures from sacral docubiti, obtained 8/13/99, were positive for "abundant Citrobacter species, moderate Klebsiella oxytoca, moderate Facudomonas aeruginose, moderate methicillin resistant Staphylococcus aureus, moderate Enterococcus." Triple-phase bone scan, performed on 8/17/99, revealed "evidence of probable sacral and possible pelvic cateomyelitis". The PT was transferred from that facility to an acute care hospital on 8/23/99 "for definitive cultures and institution of intravenous antibiotics." She was treated with intravenous vancomycin, tobramycin, and ceftazidime. CT of the pelvis, performed on 8/25/99, revealed "


VAERS ID: 150721 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:1999-04-15
Onset:0000-00-00
Submitted: 2000-03-22
Entered: 2000-04-03
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 12089 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt developed exacerbation of arthritis for a few months.


VAERS ID: 150747 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: New York  
Vaccinated:1999-04-22
Onset:1999-06-18
   Days after vaccination:57
Submitted: 2000-03-31
   Days after onset:287
Entered: 2000-04-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 42299 / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Back pain, Blood pressure increased, Chest pain, Disturbance in attention, Dizziness, Fibromyalgia, Gastrooesophageal reflux disease, Heart rate increased, Hypothyroidism, Injection site mass, Insomnia, Liver function test abnormal, Muscle spasms, Musculoskeletal stiffness, Myalgia, Neck pain, Odynophagia, Oedema peripheral, Paraesthesia, Pyrexia, Skin burning sensation, Skin ulcer
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Flu
Preexisting Conditions: Penicillin
Allergies:
Diagnostic Lab Data: Lyme disease-neg, rheumatoid-neg, CBC-neg, TSH-elevated, BP elevated, Lupus-neg, CT scan-lesions on liver, and many more test.
CDC Split Type:

Write-up: I went to the doctor more than 20 times between March 1999 and December, 1999. My symptoms included: neck pain,


VAERS ID: 150786 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: New Jersey  
Vaccinated:1999-09-01
Onset:2000-03-27
   Days after vaccination:208
Submitted: 2000-04-04
   Days after onset:7
Entered: 2000-04-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Demyelination, Dizziness, Nausea, Nervous system disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI, Cat Scan of Brain.
CDC Split Type: 20000094131

Write-up: In 8/99, the pt received his first injection of Lymerix with no adverse events. In 9/99, he received the second dose of Lymerix. 3/27/00 he experienced dizziness, nausea and vomiting. He was diagnosed with demyelination of the white matter of his brain and was hospitalized. Information received on 3/30/00 reports that symptoms are ongoing and the patient remains in the hospital. Additional information has been requested.


VAERS ID: 150909 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Connecticut  
Vaccinated:1999-06-02
Onset:0000-00-00
Submitted: 2000-04-04
Entered: 2000-04-12
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 120F9 / 2 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Amnesia, Back pain, Chest pain, Chills, Cough, Disturbance in attention, Headache, Musculoskeletal stiffness, Myoclonus, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CT scan and lupus test-neg.
CDC Split Type:

Write-up: After 1st Lymerix, pt did not feel well. Pt was informed that this was normal and to go ahead with 2nd shot. After the 2nd Lymerix, pt was bedridden-could not function. She had memory loss, shooting pains, chills, cough, myoclonic jerks, headache, stiffness, lack of concentration, rib pain, burning in head and spinal column.


VAERS ID: 151002 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:1999-06-08
Onset:1999-06-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2000-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Hypothyroidism, Ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 4 days of 2nd dose, pt experienced pains and stiffness in joints of all fingers, both hands, pains in upper arms and stiff neck. Vaccine given 6/99. To date, pt still experiences these pains, although, less severe. The letter from a rheumatologist received on 10/3/00 states, "thank you for referring pt for rheumatologic consultation. I saw pt in my office on 8/12/99. The pt is a 55 year old female who complains of generalized muscle and joint pain. The pt ws well until December 1998 when she was diagnosed ulcerative colitis after presenting with bloody diarrhea. 20 years ago she had a brief episode of ulcerative proctitis but ahs been generally well until this past December. She received Prednisone 40mg daily which was tapered, and her diarrheal symptoms have not returned. She is maintained on Pentasa. She is also maintained on Synthroid for hyperthyroidism. She was generally well with no muscle or joint pain until 6/8/99 when she had her second dose of Lyme vaccine. Four days later she developed sever pain and swelling in the hands and wrists along with an aching in the bending her hands. She states her neck is slightly stiff. She also had some aching in the lower back. She denies rash, dry eyes, dry mouth, fevers of fatigue. She states her appetite is good. She has a long history of Raynaud''s pphenomenon but this is mild. She denies eye symptoms. She has never had Lyme disease. The pt''s physical exam was significant for a supple neck with full range of motion. Heart, lung, and abdominal exams were normal. Extremities were without edema. Nailbed capillaries were normal. There was full range of motion at all joints without synovitis. There was no specific muscle tenderness. The neurologic exam was normal. No skin rashes were seen. I believe this pt''s myalgias and arthralgias are related to the LYme vaccine. I have seen a number of patients who devleoped similar symptoms after receiving a Lyme vaccine, and symptoms persisted for a number of months before resolving. This is differnt than the reports of reactive arthritis which have occurred after Lyme vaccine. These typically occur in genetically susceptible patients who developed frank synovitis after the vaccine, which require more aggressive therapy. I do not believe her symptoms are related to the ulcerative colitis. Despite this pt''s low-positive ANA, I do not believe she has lupus or Sjogren''s syndrome. The pt was placed on Vioxx 12.5mg daily. She recently had an extensive lab evaluation done by Dr. and I will be reviewing the final results. I will follow her clinically and further treatment will be based on her clinical course. I expect her to improve rapidly and that no other treatment will be necessary. Thank you for placing your confidence in me by referring your pt for consultation. Please call me if there are any questions or I can be of any further assistance." The follow up received on 7/9/02 states medical history included allergy to sulfa, ulcerative colitis, hemorrhoids, inflammatory bowel disease, hyperlipidemia, hemorrhoids, hypothyroidism, fibroids, ulcerative proctitis, Raynaud''s phenomenon, sinusitis, upper respiratory infection, postnasal drip, viral pharyngitis, viral illness, bronchitis, scoliosis with lumbago, spastic diverticulosis, skin lesions, endocervical polyp, and osteopenia of left hip and left femoral neck. Surgical history included multiple clonoscopies with biopsies, sutures below left eye, total abdominal hysterectomy, laparoscopy, and dilatation and curattage. Concomitant medications included Evista, Pentasa, Synthroid, and Premarin. On 5/5/99, hte pt received her first injection with Lymerix at an unspecified dose for prophylaxis. She immediately experienced a sore arm at the injection site, which resolved in 3-4 days. On 6/8/99, the pt received the second dose. On 6/10/99, the pt had pain in all her joints of her hands and had upper arm achiness. Blood work was done including lupus antibody test, all of which were negative. No treatment was given. After the reported onset of arthralgia, the vacicnee was diagnosed with focal active colitis, hyperparathyroidism, pharyngitis, sinusitis, and "chostrochondronodrlaris helices." These events were not reported as adverse events due to vaccine administration, but were found during the review of the vacicnee''s medical records. The following info was obtained from medical records. On 6/7/99, the vaccinee was seen by her gynecologist. The vaccinee was prescribed Evista. On 7/27/99, Lyme IgM Western blot was "negative" and Lyme IgG Western blot was "indeterminate, 41, 45, 66 kD bands were present." On 8/27/99, the vaccinee''s rheumatologist wrote a letter to her internist. THe rheuamtologist noted he had a consultation with the vaccinee on 8/12/99. He wrote, "The pt is a 55 year old white female who complains of generalized muscle and joint pain. The pt was well until December 1998 when she was diagnosed with ulcerative colitis after presenting with bloody diarrhea. 20 years ago she had a brief episode of ulcerative proctitis but has been generally well until this past December. She received Prednisone 40mg daily which was tapered and her diarrheal symptoms have not returned. She is maintained on Pentase. She is also maintained on Synthroid for hypothyroidism. She was generally well with no muscle or joint pain until 6/8/99 when she had her second dose of Lyme vaccine. Four days later she developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thigh. The pt feels very stiff in the morning and describes difficulty bending her hands. She states her neck is slightly stiff. She also has some aching in the lower back. She denies rash, dry eyes, dry mouth, fevers, or fatigue. She states her appetite is good. She has a long history of Raynaud''s phenomenon but this is mild. She denies eye symptoms. She has never has Lyme disease. The pt''s physical exam was significant for supple neck with full range of motion. Heart, lung and abdominal exams were normal. Extremities were without edema. Nailbed capillaries were normal. There was full range of motion at all joints without synovitis. There was no specific muscle tenderness. THe neurologic exam was normal. No skin rashes were seen. I believe this pt''s myalgias and arthralgias are related to the Lyme vaccine. I do not believe her symptoms are related to the ulcerative colitis. Despite this pt''s low-positive ANA, I do not believe she has lupus or Sjogren''s syndrome." The pt was prescribed Vioxx 12.5mg daily. On 10/9/99, bone densitometry revealed the following impression, "At the left hip and left femoral neck, there is diminished bone mineral density with severe osteopenia at the femoral neck and generalized milder degree of osteopenia at the rest of the hip. Compared with the previous examinations, there has being a statistically significant decrease in the bone mineral density is borderline on the osteopenic range and is lower limits of normal for pt''s age. There has being an overall slight decrease in the bone mineral density at the lumbar spine compared with the previous examinations and this is statistically significant." On 12/8/99, the vaccinee telephoned her gynecologist''s office. She stated she has felt "achiness in neck and arms since she started Evista." The vaccinee was instructed to stop Evista for two weeks to see if she felt better, if not she was on telephone the office. Various types of Lyme IgG Western blot analyses were performed on 10/24/01. The laboratory''s overall interpretation was "no evidence of seroreactivity beyond that expected from the Lyme vaccine." In a Statement of Injuries, her attorney alleged that the vaccine "suffers from myalgias and arthralgia secondary to vaccinatio with LYMErix, which manifests itself in pain and swelling in multiple joints. In particular, she experiences pain and swelling in the joints in her hands, and wrists, as well as pain and aching in her back, arms and thighs. She also expereinces pain and stiffness in her neck." Information received on 8/23/99 reports the symptoms have lessened significantly. The most recent info received 7/9/02, did not provide the outcomes of the reported events. The adverse events "arthralgias," "myalgias," and "joint swelling" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.


VAERS ID: 151003 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: New York  
Vaccinated:1999-03-04
Onset:1999-03-15
   Days after vaccination:11
Submitted: 2000-03-31
   Days after onset:382
Entered: 2000-04-19
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 120B9 / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tetracycline, Lipitor, Zoloft, Benadryl
Current Illness: NA
Preexisting Conditions: High cholesterol, acne, allergies, depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt experienced joint pain in both knees, left hip and right shoulder.


VAERS ID: 151029 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: New York  
Vaccinated:1999-03-01
Onset:1999-03-01
   Days after vaccination:0
Submitted: 2000-03-29
   Days after onset:394
Entered: 2000-04-20
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 104A2 / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthritis, Condition aggravated, Joint swelling
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: mild osteoarthritis
Preexisting Conditions: osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sever arthritic disablement. Swelling of joints. 60 day follow-up dated 09/27/00 provided no additional data.Doc 210794, annual follow up states that patient still has severe arthritic symptoms.


VAERS ID: 151030 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: New York  
Vaccinated:1999-08-01
Onset:1999-08-01
   Days after vaccination:0
Submitted: 2000-03-29
   Days after onset:241
Entered: 2000-04-20
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 123B9 / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Back pain
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pains in knees, back.


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