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From the 10/7/2022 release of VAERS data:

Found 1,017 cases where Symptom is Chronic fati gue syndrome

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Case Details

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VAERS ID: 134519 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Washington  
Vaccinated:2000-02-05
Onset:2000-02-05
   Days after vaccination:0
Submitted: 2000-02-17
   Days after onset:12
Entered: 2000-03-03
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV047 / 3 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Anaphylactoid reaction, Arthralgia, Asthenia, Balance disorder, Chest X-ray normal, Chest pain, Chronic fatigue syndrome, Cognitive disorder, Disturbance in attention, Dizziness, Dry eye, Dry mouth, Dyspnoea, Electrocardiogram normal, Fatigue, Fibromyalgia, Gastric disorder, Hypertension, Irritability, Memory impairment, Muscle spasms, Muscular weakness, Myalgia, Neck pain, Nervousness, Oropharyngeal pain, Palpitations, Rash, Rotator cuff syndrome, Tachycardia, Thinking abnormal, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Hypertension (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow), 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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Muscle ache so bad he couldn''t get out of bed~Influenza (Seasonal) (no brand name)~UN~20.00~Patient
Other Medications: NONE
Current Illness: Mild URI 2 weeks prior
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EKG-nml, CXR-nml, Thyroid-nml, BP 180/100, Pulse 103
CDC Split Type:

Write-up: Atypical chest pain, 2 hours after Anthrax #3. No prior adverse events reported by pt. Still experiencing dizziness, extreme fatigue and shortness of breath as of 2/22/2000. 60 day follow up states patient sufferes from dizziness, disequilibrium, chronice fatigue syndrome, shortness of breath, cognitive difficulty, joint pain, tachycardia and palpitations. Annual follow up report received 8/18/2003 pt states he still has chronic fatigue syndrome, fibromyalgia, dizziness, balance trouble, joint/muscle pain, cognitive troubles: concentration, memory, decision-making. All of the symptoms/problems began with the start of the mandatory anthrax vaccinations, while in the military. This (on 02/05/2000) was the 3rd and last of the series of vaccinations. Diagnosed with chronic fatigue syndrome and fibromyalgia July 2003. Per annual report-Still has all these: 1)muscle pain and weakness 2)joint pain 3)dizziness/disequilibrium 4)cognitive problems:memory, concentration, computations, decision making, etc.. 5) extreme fatique (chronic fatigue syndrome). I operate at about 20% of normal in all areas. 6) shortness of breath 7)ringing in ears. These problems started 8 Jan 2000 (1st shot). Got worse 22 Jan 2000 (2nd shot). 3rd shot 5 Feb 2000 sent me to emergency room via ambulance. 2 hours after 3rd shot had anaphalaxis reaction. I have tried a number of therapies in the last few years. Nothing has improved my health. - 7/2/02 Anthrax Survey states pt not recovered. Continues to experience chronic fatigue, SOB, dizzy spells, extreme irritability, concentration/memory problems, "brain fog". He''s on full duty, missed 2 days work for the AE and has had no further anthrax doses as of 3/10/00. 02/05/2010 Follow up: Chronic Fatigue Syndrome-unrelenting fatigue, dizziness, disequilibrium, tinitus, shortness of breath, dry mouth/eyes, rash, sore throat, severe cognitive problems. Fibromyalgia-muscle pain/spasms/joint pain, tendinosis of rotator cuff, hip pain, neck pain, gastro problems.


VAERS ID: 236232 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Unknown  
Vaccinated:1999-05-28
Onset:0000-00-00
Submitted: 2005-01-25
Entered: 2005-04-18
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Antinuclear antibody negative, Arthralgia, Autoimmune neuropathy, Balance disorder, Biopsy skin abnormal, Blindness, Blood immunoglobulin G normal, Blood immunoglobulin M, C-reactive protein normal, Carpal tunnel syndrome, Chest X-ray, Chronic fatigue syndrome, Coccydynia, Computerised tomogram normal, Deep vein thrombosis, Disturbance in attention, Dizziness, Drug tolerance, Electromyogram abnormal, Fatigue, HLA marker study positive, Headache, Herpes zoster, Hypertension, Hyporeflexia, Immunology test, Impaired driving ability, Injection site erythema, Injection site pain, Insomnia, Intervertebral disc degeneration, Joint swelling, Leukoaraiosis, Lyme disease, Memory impairment, Mental disorder, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nasal septal operation, Neck pain, Nerve injury, Neuropathy peripheral, Non-cardiac chest pain, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Oedema peripheral, Osteoarthritis, Pain, Paraesthesia, Polyarthritis, Polyneuropathy, Post procedural infection, Prostatomegaly, Radiculopathy, Red blood cell sedimentation rate normal, Rotator cuff syndrome, Spinal X-ray abnormal, Spinal osteoarthritis
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ALCOHOL USE, AMPUTATION FINGERS HAND (TRAUMATIC), CHEST PAIN, CHRONIC SINUSITIS, ESOPHAGEAL STRICTURE, EX-SMOKER, GASTROESOPHAGEAL REFLUX DISEASE, HIATAL HERNIA, HYPERCHOLESTEROLEMIA, HYPERTENSION ARTERIAL, SLEEP APNEA, TENSION HEADACHE; A physical examination report conducted in September 1999 noted a history of arthritis and headaches (dates of diagnoses not provided). Family history of fatal brain tumor in the patient''s father.
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 03July2000, Negative; C-reactive protein, 03July2000, 6.2mg/L, 0, 4.9; C-reactive protein, 12Jan2001, 0.9mg/dL, 0.08, 0.80; Erythrocyte sedimentation rate, 16Oct2000, 12mm/hr, 0, 15; Erythrocyte sedimentation rate 15Oct2002, 5mm/hr, 0, 15; HLA marker study, 11Sep2000, positive; Rheumatoid factor, 03 Jul2000, <10.0IU/mL, 0, 9.9; 11 July 1999: Computed tomography scan of pelvis showed no evidence of bony fractures, coccyx intact, no evidence of para-coccygeal mass or inflammatory changes noted.; 09 August 1999: Magnetic resonance imaging of lumbar spine showed normal bone signal, degenerative disc changes noted with dessication of the discs; mild disc protrusion of L5-S1.; 15 September 1999: Pathological evaluation of coccyx tissue revealed external surface covered by variable thick fibrous cartilaginous tissue which showed focal degenerative change, fragmentation of surface cartilage noted. Actual inflammation or neoplastic process was not seen.; 17 December 1999: Status post coccygectomy, radiology showed no evidence of pelvic abscess, edema noted; no evidence of osteomyelitis of the sacrum.; 03 July 2000: Lyme IgG Western Blot positive, Lyme IgM Western Blot negative, B, Microti IgN and IgG negative. 16 October 2000: HLA DR4 positive, Lyme IgG Western Blot positive for the following bands: 31, 91, and equivocally positive at 41 and 45; Lyme IgM wan clinically positive at 37 and 66 which was nondiagnostic.; 05 November 2001: Lyme IgG and IgM Western Blot negative, Marlox and Immunities Western Blot IgG negative, Overall interpretation: No evidence of seroreactivity beyond that expected from the Lyme vaccine.; 21 January 2003: Radiologic examination of the cervical spine showed multilevel degenerative disc disease and spondylosis most severe at C5-6; bilateral significant foraminal stenosis and mild bony stenosis present at C5-6.; 03 February 2003: Magnetic resonance imaging of lumbar spine without contrast showed small right lateral disc hernia at L5-S1; mild degenerative disc bulging at L3-L4 and L4-L5 superimposed on facet arthropathy, sacral region "unremarkable". MRI of pelvis showed normal artioulation of hips bilaterally, and sacroiliac joints and sacrum "unremarkable. There was considerer to be "overall improvement" compared to previous MRI on 16 April 2001.; 03 June 2004: Thoracic spine x-rays showed advanced degenerative disc and degenerative joint disease throughout thoracic spine; normal bone mineralization.; 18 April 2005: X-rays of pelvis/hips showed mild osteoarthritis of the hips without acute abnormality noted.; 29 September 2005: Sacral MRI showed unremarkable sacrum with stable post-operative changes in the coccygeal area, L5-S1 degenerative disc and facet disease. MRI of the lumbar spine showed a new small right disc herniation causing new right lateral recess narrowing without central stenosis or foraminal narrowing at L5 to S1, stable T11 to T12 degenerative joint and facet disease, trace amount of broad-based bulge at L3 to L4 and L4 to L5 (unchanged), and mild multi-level facet arthropathy and ligamentum flavum hypertrophy (unchanged).; 17 April 2006: Needle EMG examination showed the presence of distal polyneuropathy with multifocal abnormalities and superimposed carpal tunnel syndrome. 18 April 2006: Skin biopsy (right arm) showed epidermal nerve fiber density of 12.4/mm; right thigh normal epidermal nerve fiber density, right leg "significantly low" epidermal nerve fiber density.; 10 May 2006: MRI of the brain indicated a normal brain pre and post contrast, mild subcortical deep white mass leukoaraiosis on the basis of chronic small vessel ischemic change, mild thickening of the ethmoid air cells, separated right sphenoid sinus, no evidence of any enhancing lesion of the brain post contrast, and mild inflammatory retention cyst involving the floor of the left maxillary measuring 1 centimeter.
CDC Split Type: A0527200A

Write-up: This case was reported by a lawyer and described the occurrence of loss of concentration in a 61 year old male patient who received LYME disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced " severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. This report describes a 61-year-old male subject who received LYMERIX injection. A physician or other health care professional has not verified this report. On an unspecified date, the subject received LYMERIX. At an unknown time after receiving LYMERIX, the subject experienced "severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. A statement of injuries was received on 05 May 2006 via medical records. The subject received LYMERIX on 28 April 1999 and 28 May 2009. Following the initial vaccine, the subject developed hip soreness. By June 1999, "shortly" after receiving LYMERIX, the subject developed sacrococcygeal pain, burning pain in the shoulders and arms, and some sharp pains in the fingers and toes, followed by neuropathic pain. It was noted that he intentionally attributed symptoms to injury after sitting on hard/cold ground and leaning against a tree for a prolonged time. He was diagnosed with chronic coccydynia in cold September 1999, initially treated with injections of XYLOCAINE and DEPOMEDROL. Other diagnosis at that time included osteoarthritis and insomnia. In October 1999 or November 1999, he underwent resection of the coccyx which was unsuccessful at alleviating his pain, and was complicated by a postoperative infection that "may actually have increased (his pain)". On examination on 18 February 2000, the subject continued to experience sacrococcygeal pain following a regimen of physical therapy. The evaluating physical noted that the pain was likely multifactorial in etiology, probably caused by a combination of "the precipitation condition, the surgery, and the post-surgery complications". On 03 November 2000, assessment included coccydynia, arthralgias and myalgias, HLA DR4 positive, positive IgG bands on Western Blot, fatigue, and sleep disturbance. Treatment involved AMYTRIPTYLINE which was noted to be working better that pain medicines. He was diagnosed with fibromyalgia, and the evaluating physician stated "my hypothesis is that he had a reaction to the infection he had with coccydynia. I doubt that it relates to Lyme vaccine and his genetic predisposition, although I cannot be confident about that." In July 2000, the subject was reportedly diagnosed with Lyme disease characterized by chronic fatigue syndrome, and chronic pain and swelling in his fingers and knees. No reportedly also experienced mental health/memory problems. In May 2001, the subject presented with neuropathic pain in the sacrococcygeal region, with radiculopathy and neuropathic pain of the S2 nerve root, which was treated with epidural nerve bloc with subsequent relief. Other treatment included NEURONTIN and RELAFEN. The subject was hospitalized from 16 July 2002 to 18 July 2002 for evaluation of noncardiac chest pain and to rule out possible myocardial infarction. While hospitalized, the subject complained of chronic shooting neuritic type pain and body stiffness. At the time of discharge, diagnosis included "inflammatory arthritis secondary to LYMERIX vaccine" and chronic pain. In January 2003 and February 2003, complaints included neck and upper back pain, and diagnostic evaluations revealed degenerative disc disease, spondylosis, and osteoarthritic changes. On 02 May 2003, the subject was diagnosed by magnetic resonance imaging with a small right lateral disc hernia at L5-S1 and mild degenerative disc bulging superimposed on facet arthropathy. On 27 May 2003, the subject was seen in follow up by a pain management specialist. The pain was characterized as "extremely debilitating", and treatment included NEURONTIN, VICODIN, and CELABREX. In June 2003, chronic sacrococcygeal pain was treated with a trial of dorsal column stimulation. By 25 June 2003, he experienced approximately 20 percent pain relief, and on 02 July 2003 the dorsal column stimulator was removed. On 07 January 2004, the subject was referred to a neurologist for re-evaluation of sacral pain, in addition to complaints of hand pain and "burning numbness" in his shoulders. The subject reported past treatment that included OXYCONTIN, HYDROCODONE, PROPOXYPHENE, CYCLOBENZAPRINE, IBUPROFEN, PREDNISONE, and LORAZEPAM. Sensory testing showed generally normal pinprick sensation in the extremities. Impression was coccydynia, without identification of any changes that might be suggestive of a neurologic process. According to a progress note dated 22 June 2004, the subject had been diagnosed with chronic pain syndrome and advanced arthritis of the thoracolumbar spine, and chronic inflammatory arthritis secondary to Lyme vaccine. Additional problems included pelvic pain, low back pain, and peripheral neuropathy. The subject received physical therapy in June and July 2004, and underwent a nerve block in October 2004, According to a letter written by his primary care physician on 16 March 2005, the subject was "unable to drive, let alone sit or stand for long periods of time" due to severe back pain and chronic medical illness. Treatment with LIDODERM PATCH was prescribed. On 23 September 2005, diagnostic testing demonstrated L5-S1 degenerative disc and facer disease. In March 2000, the subject was diagnosed with a herpes zoster rash on his chest. On 28 May 2002, the subject underwent a septoplasty for treatment of sinusitis. Other events included chest pain for which the subject was hospitalized in February 2001 and July 2002, intermittent dizziness, hearing loss, and vision loss. There were considered to be incidental findings upon review of medical records. Follow up information was received on 30 January 2007 via medical records. Medical history included traumatic amputation of left hand digits 2 through 5 in 1977. On 10 May 2006, the subject underwent magnetic resonance imaging of the brain due to continued memory loss, stinging sensation in his fingers and nerve damage. The results of the MRI indicated a normal brain pre and post contrast, mild subcortical deep white matter leukoaraiosis on the basis of chronic small vessel ischemic change, mild mucosal thickening of the ethmoid air cells, separated right sphenoid sinus, no evidence of any enhancing lesions of the brain post contrast, and mild inflammatory retention cyst involving the floor of the left maxillary measuring 1 centimeter. Follow up information was received on 07 February 2007 via medical records. According to an information sheet completed by the subject, he was diagnosed with Lyme disease in July 2000 with symptoms including chronic fatigue, mental health/memory problems, joint swelling and pain in the fingers, knees, toes, and hips, and inability to sit due to sacral area pain. Additionally, the subject noted that he had experienced pain and redness at the injection sites, lasting approximately two weeks after vaccination with LYMERIX. The subject was evaluated 13 February 2003 for a four to six-week history of "rather insidious" onset of neck pain, scapula pain, and headaches with some paresthesias in the right upper extremities. Electromyographic findings included cervical paraspinal irritability with normal findings throughout the right upper extremity and shoulder girdle musculature, considered to be suggestive of right cervical radiculitis. Electrical findings were suggestive of mild median neuropathy at the wrist, without electrical evidence of significant ulnar neuropathy. The subject underwent an initial physical therapy evaluation, but did not return for scheduled therapy visits. On 07 June 2004, he was again evaluated for physical therapy due to complaints of back pain, decreased active lumbar range of motion, decreased flexibility, increased pain, tenderness to palpation, and decreased strength. Physical therapy was planned for twice weekly for five weeks duration. In August 2006, the subject received intravenous Immunoglobulin. Follow up information was received on 31 March 2007 via medical records On 17 April 2006, electrodiagnostic studies showed polyneuropathy with multifocal abnormalities and superimposed carpal tunnel syndrome. On 18 April 2006, a skin biopsy showed low epidermal nerve fiber density in the right leg, with normal right thigh and borderline normal forearm epidermal nerve fiber density results, assessed to be consistent with small fiber neuropathy. Neurological examination showed pain in the seated and supine positions, with stocking and glove sensory lose to vibration, cold temperature, and light touch, imbalance of stance and gait, mild weakness in the proximal and distal leg muscles, inability to hop, mildly hypoactive tendon leg reflexes, and intact cognition and cranial nerves. According to the evaluating neurologist, findings were consistent with "post-LYMERIX peripheral small and large fiber neuropathy and dysautonomia". In July 2006, his primary care physician characterized his condition as "chronic pain syndrome status post LYMERIX vaccination", and noted that the subject continued treatment with "chronic narcotics, anticonvulsants, anti-inflammatories with minimal relief to the point that he is unable to work, disabled". Follow up information was received on 25 April 27 via orthopaedists records. On 15 September 1999, pathological diagnoses based on evaluation of coccyx tissue included focal degenerative change and fragmentation of surface cartilage. In October 1999, he experienced pain and some serious drainage around the surgical site. Following coccygectomy, the subject did not return to work until approximately November 1999. 3/25/2010 Follow up information was received on 17 may 2007 via medical records. On 26 April 2007, the subject''s neurologist provided an expert opinon summary to the subject''s lawyers following reveiw of medical records, stating "It is my expert opinon to a degree of medical certanity that this patient suffered from painful large and small fiber peripheral neuropathy and coccydynai caused by LYMERIX vaccination. These injuries are permanent and disabling. "Accordign to a letter written by the neurologist dated 12 June 2006, the subject developed hip and nuropathic complaints "several weeks" following vaccination with LYMERIX on 26 April 1999, with an exeacerbation following the second LYMERIX vaccine on 28 May 1999. The neurologist stated that finding were "consistent with post-LYMERIX dysimmune peripheral small and large fiber neuropathy and dysautonomia". Follow up information was received on 16 november 2007 via medical records, which confirmed tha tthe subject''s coccygectomy was performed on 15 September 1999. Between February 2000 and Pril 2000 the subject was examinde for myalgias and back pain, and on 04 February 2000 Lyme testing (ELISA) was positive. Follow up information was received on 07 January 2007 via medical records. THe subject was diagnosed with bilateral deep vein thrombosis characterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Intake records indicated that the subject underwent a coccygectomy in 1999 due to "back and sacral pain secondary to LYMERIX vaccination and immune stimulation". At the time of discharge, it was also noted that the subject had "chronic pain with inflammatory polyneuropathy secondary to LYMRIX vaccination and exposure and immune mediation", as well as degenerative joint disease. He had previously been treated with immunoglobulin for chronic pain and inflammatory autoimmune polyneuropathy secondary to LYMERIX vacciantion, and was reported to have undergone back stimulation, epidurals, and pulse frequency ablation for back pain, Notes indicated that the subject also experienced leg/ankle swelling. Concurrent diagnoses included chronic pain syndrome, chronic neuropathy, and limb and back pain. According to an anticoagulation clinic visit noted dated 24 September 2007, the subject was being followed by pain clinic, and his dose of gabapentin had been recently increased. Other medications included Oxycodone and Neurontin. In late march 2007 or early April 2007, the subject experienced a "sharp intense pain in his shoulders'' after "shoveling sidewalks out of his yard", and reported that magnetic resonance imaging of the shoulder was negativie fora tear but showed tendonitis of the rotator cuff. He was subsequently enrolled in physical therapy from 11 April 2007 and 30 April 2007, and was also treated with oxycodone, Celebrex, and pain patches. The subject was diagnosed with bilateral deep vein thrombosis chareacterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Dep vein thrombosis was treated with Coumadin and Lovenox. These events were assiesed to be incidental findigns upon review of medical records. Follow up information was received on 04 June 2009 via medical records. on 20 March 2007, impression of the subject''s condition by a pain clinic physician included "neuropathic type pain related to LYMERIX vaccine", and he was instructed to increase gabopentin. By 09 April 2007, the subject ahd completed intravenous immunoglobulin injections for post-LYMERIX vaccination with snsory neuropathy "thought to be secondary to that process". There was no change in symptoms with IVIC. Impressions included small fiber snsory plyneuropathy "possibly a post LYMERIX vaccination reaction", and chronic low back and coccya pain. On 12 September 2007, the subject was seen for evaluation at a pain clinic with an impression of worsening low back pain following discontinuation of Lidoderm, recent deep vein thrombosis, status post LYMERIX vaccine with associated pain, hypertension, enlarged prostate and opioid tolerance. Medications at the time included OxyContin, and Lidoderm was restarted. On 23 February 2008, the subject re ported discomfort in his legs since being off Coumadin, stating that it felt like deep vein thrombosis did.


VAERS ID: 251317 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: Florida  
Vaccinated:2003-07-22
Onset:0000-00-00
Submitted: 2006-02-02
Entered: 2006-02-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV076 / 6 UN / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 1 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Aldolase normal, Blood creatine phosphokinase normal, Blood folate normal, Blood glucose decreased, Blood thyroid stimulating hormone decreased, C-reactive protein decreased, CSF glucose normal, CSF immunoglobulin increased, CSF protein normal, CSF test normal, Chest X-ray normal, Chronic fatigue syndrome, Cognitive disorder, Cough, Disturbance in attention, Dysphonia, Electromyogram abnormal, Fatigue, Hyperhidrosis, Irritability, Myalgia, Nuclear magnetic resonance imaging normal, Paraesthesia, Red blood cell sedimentation rate normal, Red blood cells CSF positive, Reflux laryngitis, Rhinitis, Rhinitis seasonal, Scintillating scotoma, Sleep disorder, Tension headache, Visual disturbance, Vitamin B12 normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (narrow)

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: NONE
Current Illness: Fatigue
Preexisting Conditions: Myopia (Active);Lumbago (Active) ;Rhinitis, allergic NOS (Active) ;Fx closed radius, distal end NEC (Resolved);Appendectomy 1970;Vasectomy 1994;Right inguinal hernia 1995;Distal right radial osteotomy 1996;Removal of right ulnar styloid process 1996 Allergies: Mite Mix;AP Cat Pelt;Cypress, Arizona;Cypress, Bald;Other: roaches;Cats Dander;Dust Mites;Molds possible
Allergies:
Diagnostic Lab Data: Endocrinology - with 72 hr fast and mixed meal test. Plasma glucose, insulin and C-peptide were checked q6h during fast with lowest glucose level being 63. Insulin, C-peptide, sulfonylurea, beta-hydroxybutarate levels where checked at end of fast per 72 hr fast protocol. Pt 72 hr fast showed negative results for insulinoma. Mixed meal test performed by Endocrinology was found to be normal. In light of these findings it is unlikely that pts symptoms are related to blood glucose levels. Neurology - "MRI results were negative for masses, plaques, or any acute disease process. Lumbar puncture was performed to evaluate for presence of Oligoclonal bands as marker of MS. Results of Lumbar Puncture: CSF studies: Glucose 55, Protein 36, Lymphocytes 13, RBC<1, Albumin 4.2, IgG 865 which are all within normal ranges. Oligoclonal bands testing is pending. Due to these preliminary results and the fact that pts symptoms are constant which would be very unusual in the setting of MS. Neurology feels that it is extremely unlikely that pts symptoms are due to MS." Rheumatology "recommended: Chest x-ray (no significant findings), ESR (#), CRP (<0.3) Creatinine kinase (155), aldolase (3.2), B12 (388), folate ($g20). TSH (0.78) to rule out inflammatory/metabolic/inherited muscle disorder. All were within normal ranges. Symptoms possible due to fibromyalgia syndrome. Pt received an article from PCM concerning possible macrophagic myofasciitis in pts receiving anthrax vaccination. Rheumatology was unaware of this condition and will do further research and make recommendations as necessary." Ophthalmology - "found no ocular deficits or disorders that would explain symptoms. MRI showed no lesions or defects in optic nerve." ENT - "revealed a diagnosis of laryngopharyngeal reflux and seasonal allergic rhinitis. Recommended Prevacid 30mg PO bid and to follow up with allergies as and outpatient at permanent station for evaluation for immunotherapy." Infectious Disease: "Infectious diseases consultant found normal physical exam with lack of significant exposure history and normal laboratory evaluation. Therefore, infectious process is very unlikely. Infectious diseases consultant concluded that it is very unlikely that symptoms are due to receiving anthrax vaccine." Psychiatry - "psychiatry recommended continued medicine work up to explain pts symptoms. States somatoform disorder is unlikely with no current evidence of psychiatric component to pts symptoms. In early Nov 05 patient had an EMG of the bilateral arms and legs that showed "mild carpal tunnel in both arms." Results of EMG of the lower extremities were normal although service member reports having mild tingling in hands and toes for the last couple months. (Reports not available) a muscle biopsy of the left deltoid was also done with normal results. Follow-up Information 09-OCT-2007: Neuropsych testing showed cognitive deficits. Labs: Elevated C1 Q binding x 3 years only lab abnormality
CDC Split Type:

Write-up: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above. 2. Sleep Disturbance - sleeps 8 hours/night - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it. 4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day. 6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.


VAERS ID: 264893 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Nevada  
Vaccinated:1998-10-01
Onset:1998-10-01
   Days after vaccination:0
Submitted: 2006-10-18
   Days after onset:2939
Entered: 2006-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV017 / UNK - / -

Administered by: Military       Purchased by: Other
Symptoms: Arthralgia, Chronic fatigue syndrome, Dyspnoea, Erythema, Fatigue, Headache, Idiopathic urticaria, Injection site erythema, Laboratory test, Mental impairment, Neuralgia, Pain in extremity, Paraesthesia, Pruritus, Rash papular, Skin lesion, Urticaria, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Numerous labs performed to rule out anything else.
CDC Split Type:

Write-up: 1st Vaccine (17 Sep 98) ? 12 hours later - sore arm, redness about 4 inch in diameter, feeling of being tired (this fatigue went away after one week); common side effects according to doctor when asked the next day while at lunch; no entry in medical records of this reaction. 2nd Vaccine (1 Oct 98) ? 8 hours later - sore arm, greater redness with raised bumps on most of upper arm, lasting about a week, continued feeling of being tired, slight headaches; common side effects according to doctor, no entry in medical records. Fatigue started again, but this time never went away and continues to present. 3rd Vaccine (26 Jan 99) ? extremely sore arm within 12 hours, 24 hours later, severe hives started appearing all over body ? extreme fatigue, headaches; 48 hours after vaccine the raised patches started to subside but itching, hives and fatigue increased; 72 hours (29 Jan 99) after vaccine, informed doctor that "this can''t be normal", doctor noted zero raised lesions even though there was slight evidence and severe redness over most of my body; doctor prescribed Benadryl and Atarax; follow up appointment (22 Feb 99), still taking Atarax to keep hives / itching away. Never was referred to an allergy clinic. Never was reported by doctors. This was the first time I asked to be taken off the Anthrax program. 4th Vaccine (9 Apr 99) ? No hives due to the fact that I was taking Atarax ? still suffering from fatigue and headaches. Early June 99 - Saw doctor (visit not found in my records anymore) starting to need Atarax less and less..eventually not needing it anymore and moved to creams ? still slightly fatigued but improved. Asked once again to be released from vaccine program ? declined by doctor. Doctor made note in records of the visit and that the reaction must have been from eating shellfish; which I had not done since mid-tour in Dec 98. 9 Aug 99 ? Granted waiver for (among other issues) Idiopathic Urticaria possibly due to "shellfish / iodine allergies" ? even though I had not consumed ANY shellfish for months prior to the allergic reaction to the vaccine ? at this point, I clearly should have taken off the Anthrax Vaccine program ? still fatigued. Of note, had difficulty breathing in 1991 after receiving IVP dye, prior to an XRay, and received epinephrine and steroids vaccine; had immediate recovery and left the hospital 45 minutes later. Never had another problem again until Anthrax Vaccine. See no correlation between this experience and the anthrax vaccine problems. Have never experienced any difficulty when eating shellfish and was skin test negative to shellfish in 2000. Because of this reaction, on 24 Oct 1991, I received an indefinite waiver from HQ ATC for Chronic Urticaria. Other waivers at this time were Hearing Loss, Microscopic Hematuria and Ulcers. See 13 Jun 96 Aeromedical Summary, pages 7-10. This was a one time problem (IVP Dye) waiver and no mention of Urticuria problems on the 20 May98 Aeromedical Summary. Jan 00 ? Entered a Memo for Record into my medical records to try to stop the vaccine program. Nobody in the medical community would even discuss the subject. I would mention it to the flight surgeon''s when they would come to the squadron to fly and it was quite apparent that they did not wish to discuss the subject. 5th Vaccine (17 Feb 00) ? 22 hours later, 18 Feb 00, in to see doctor for, as doctor stated, "reaction to Anthrax shot", lesions noted by doctor ? extreme fatigue. Five minutes prior to receiving this vaccine, I told the administering tech that I have a history of reactions to this vaccine. He asked if I was waived and I replied no. I asked what my options were and he replied, "Well sir, unfortunately it is either the vaccine or Article 15". I visited him a couple of weeks after the vaccine and showed him what the vaccine had done and I am sure he would remember me even to this day. He was only doing his job. Numerous appointments tested for shellfish and other allergies and Anthrax serum (formaldehyde / chloride) ? all negative. 14 Aug 00 ? oral prednisone burst, doctor noted lesions. 15 Sep 00 ? MC Allergy Clinic assessment ? urticuria associated with anthrax vaccine. 21 Feb 01 ? Again, doctor mentions shellfish (this time specifically lobster) as possible reason for hives ? and again, I stated that I never consumed any shellfish. Late summer of 2001, symptoms start to go away and waiverable drugs are working to keep the rash / hives away, still moderately fatigued, slight headaches, joint pain, loss of feeling in feet/legs. 17 Sep 01 ? Back on flying status through waiver process. Still taking Claritin, only flying once a day due to fatigue, headaches, joint pain, loss of feeling in feet/legs. Please see letter from my Squadron Commander. Dec 2002 ? Started working less than full days due to fatigue. 17 Apr 03 ? DNIF again, permanently this time, because the waiverable drug (Claritin) not working, started taking Zyrtec and later needed to go back on Atarax; experiencing more severe fatigue, headaches, joint pain, loss of feeling in feet/legs. Nov 03 ? Transferred to non-flying job, started working 4-6, then 3-4 hour days due to Chronic Fatigue (Please see letters from General Officers and supervisors ? this is my work schedule to this day. Approximately 2 to 2.5 hours after waking, while sitting at my work station, my mental capacity declines rapidly and fatigue increases. On a couple of occasions, my supervisor has offered to drive me home, fearing a safety (driving) factor. Fatigue is well documented in numerous OPRs and letters from supervisors. -Chronic Fatigue Syndrome/Chronic Urticuria/Joint Pain ? all due to anthrax vaccine, noted numerous times in medical records. Sometime in late summer 2005, the flight surgeon''s office promised to initiate a MEB followed by a PEB medical retirement due to my obvious unemployable status. It is now Oct 2006 and I am still asking that the medical community be honest and state the obvious during my medical retirement. Per information received from the annual follow up: I still suffer from chronic fatigue syndorme, severe painful neuropathy of the lower extremities, and knee & elbow pain.


VAERS ID: 266881 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2005-03-22
Onset:2005-03-25
   Days after vaccination:3
Submitted: 2006-10-31
   Days after onset:585
Entered: 2006-11-15
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Atrial flutter, Chest pain, Chronic fatigue syndrome, Complement factor abnormal, Fatigue, Headache, Hyperaesthesia, Impaired work ability, Malaise, Myocarditis, Pleural effusion, Presyncope, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
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? No
Previous Vaccinations:
Other Medications: Wellbutrin, Zoloft, Fosamax.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Myopericarditis and pleural effusion after Hep A. In the past year has developed CFS and is clearly impaired. Meets criteria for Chronic Fatigue Syndrome now. Also has chronic complement activation. Chest pain, sub sternal, pre syncope, tachycardia comment atrial flutter, fatigue, malaise $g60 days. Continued with chronic fatigue syndrome & inability to function at a full time job. This pt developed CFS secondary to the pericarditis that she developed post HEP A vaccine. Per 60 day follow up: Continues with debilitating fatigue, hyperesthesias, headaches, necessitating retirement from job.


VAERS ID: 276057 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-11
Entered: 2007-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amnesia, Antinuclear antibody, Arthralgia, Autoimmune disorder, Back disorder, Back injury, Back pain, Basophil count increased, Borrelia infection, Chest X-ray, Chest injury, Chest pain, Chills, Chlamydia serology positive, Chronic fatigue syndrome, Clostridium difficile colitis, Cognitive disorder, Confusional state, Decreased activity, Disturbance in attention, Dizziness, Ear pain, Electromyogram normal, Encephalopathy, Eosinophil count increased, Epstein-Barr virus test, Eye disorder, Fatigue, Fibromyalgia, Gastrointestinal disorder, Haematocrit normal, Haemoglobin normal, Haemorrhoids, Headache, Herpes simplex, Hyperhidrosis, Hyperlipidaemia, Hypoaesthesia, Immune system disorder, Injury, Insomnia, Intervertebral disc protrusion, Irritable bowel syndrome, Joint injury, Joint lock, Joint sprain, Lyme disease, Monocyte count normal, Muscle tightness, Musculoskeletal stiffness, Myalgia, Mycoplasma serology, Myositis, Nervous system disorder, Neutrophil count normal, Nuclear magnetic resonance imaging normal, Osteoarthritis, Pain, Palpitations, Paraesthesia, Peripheral coldness, Polymerase chain reaction, Pyrexia, Radiculopathy, Rectal haemorrhage, Red blood cell count decreased, Rheumatoid factor, Speech disorder, Thyroid disorder, Tinnitus, Tremor, Trismus, Vertigo, Vision blurred, Weight increased, White blood cell count decreased, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (narrow), Dystonia (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (narrow), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Lipodystrophy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (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: Unknown
Preexisting Conditions: ACID REFLUX, ANGINA (NOS), BEE STING ALLERGY, CARDIAC CATHETERIZATION, MENISCECTOMY, SURGERY FOR TENNIS ELBOW, THYROIDECTOMY. The subject was described as an Avid camper who had experienced numerous tick bites followed by rashes, all of which were untreated with antibiotics. In 1976 the subject underwent removal torn cartilage from the right knee; in January 1999, the subject was hospitalized for right tennis elbow surgery. The subject admitted to smoking tobacco when she drinks alcohol, and reported social alcohol use.
Allergies:
Diagnostic Lab Data: Absolute neutrophil count 22Jul2003 2.9, Absolute neutrophil count 13AUG2003 2.1, Absolute neutrophil count 28Aug2003 2.7, Antinuclear antibody 22Jul2003 0.28, Basophils 22Jul2003 0.8 percent, Basophils 13AUG2003 0.9 percent, Basophils 28AUG2003 1.9 percent(NL 0-1.0), Eosinophils 22Jul2003 2.2 percent, Eosinophils 13AUG2003 3.2 percent (NL 0-3), Eosinophils 28Aug2003 2.9 percent, Hematocrit 13-Aug2003 37.8 percent, Hemoglobin 13Aug2003 12.6 g/dl, monocytes 13Aug2003 9.1 percent, Neutrophil count 22Jul2003 49.1 percent, Neutrophil count 13Aug2003 53.8 percent, Red blood cell count 22Jul2003 3.8 M/ul (NL 4.2-5.4), Red blood cell count 13Aug2003 3.94M/ul, Red blood cell count 28Aug2003 4.16M/ul, White blood cells 22Jul2003 5.8 K/ul, White blood cells 13Aug2003 3.9K/ul, White blood cells 28Aug2003 5.2K/ul, 02 June 2003: Lyme IgG and IgM Western Blot positive, Chlamydia subtype qualitative PCR positive; Lyme IgG/IgM detection kit (recombinant antigen) positive; Basesia, Herpes simplex virus, Epstein Barr virus, cytomegalovirus, human herpes virus 6 & 8, mycoplasma subtyping, and Lyme disease (B. Burgdorferi) DNA by qualitative PCR all negative, Babesia microti IgG by ELISA negative. 06 June 2003: Magnetic resonance imaging MRI of the brain with and without contrast was normal. 01 Mach 2004: Electromyogram (EMG) study revealed normal motor and sensory nerve testing with no clear evidence of radiculopathy or neuropathy. 31 March 2004: Chest x ray showed no radiographic evidence for acute cardiopulmonary disease. 22 November 2004: Magnetic resonance imaging of pelvis and computed tomography Scan of the chest were performed due to fatigue and abnormal weight gain; findings were normal. 26 May 2005L X-rays of lumbar spine showed no degenerative changes; disc spaces were noted to be preserved; no spondylosis or spondylolisthesis; no soft tissue abnormalities noted, no evidence of fractures; "satisfactory" alignment of vertebral bodies. 28 May 2005: Magnetic resonance imaging of the lumbar spine without contrast showed degenerative disc changes at L4-5 and L5-S1 with mild central prominence without focal herniation and without cord or root impingement; hypertrophic changes at L4-5 and L5-S1 in the facet joints contributing to some narrowing of the central canal; no acute bone or soft tissue changes noted; no evidence of hemorrhage or edema.
CDC Split Type: A0603290A

Write-up: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified experienced arthralgias, myalgias, numbness and tingling, eye problems, headaches, cold feeling in extremities, memory loss, loss of concentration, fatigue, dizziness, confusion, sweats, neck locking, jaw locking, stabbing pains, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly cause by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of Injuries. Follow up information was received on 09 April 2007 via medical records. The subject was a female in her forties. On an unknown date, the subject reportedly developed vertigo and encephalopathy. She indicated that she developed vertigo and confusion which worsened. According to internal medicine physician''s notes, she was evaluated weekly between 02 June 2003 and 13 August 2003 for a diagnosis of Lyme disease with associated physical findings of encephalopathy and fatigue. At the time of the initial examination, the subject reported fevers, chills, and sweats since June 2002, ear ringing and ear pain, and tremor since May 2003. Lyme symptoms of approximately one year duration, including dizziness, heart palpitations, fever, sweats, chills, fatigue, memory loss, headache, joint and muscle pain, blurred vision, and difficulty with speech. Treatment up to that time included Zithromax, Bextra, and Effexor; Zithromax was discontinued after the subject developed associated gastrointestinal symptoms. The physician expressed the opinion that the subject was "suffering with an active infection of Borrelia Burgdorefi" with repeated positive testing, and oral antibiotic therapy failure. In July 2003, a diagnosis of osteoarthritis was identified. On 25 July 2003, she received her initial dose of intravenous Rocephin via a peripherally inserted central catheter (PICC). In September 2004, she presented with a chief complaint of vertigo for a few months duration, and Antivert was prescribed. On 01 March 2005, she was evaluated by an orthopedist with complaint os whole body pain, Lyme disease, fibromyalgia, and chronic fatigue syndrome, with chronic pain and insomnia. She reported previous treatment including antidepressants, Lidoderm, and cervical injections, and at the tiem pain was poorly controlled and Flexeril. Physical examination revealed "greater than 11/18 fibromyalgia points bilaterally above and below the waist:, with an otherwise normal neurologic examination. Impression was that she fulfilled the criteria for fibromyalgia, and trial of Skelaxin, Zanaflex, and Ambien were initiated. According to physician''s billing summaries, the subject was evaluated on 02 June 2003, and was diagnosed with arthralgia (multiple sites), fatigue, encephalopathy (unspecified), and encephalopathy (unspecified). In March 2004 she was evaluated for Lyme disease, myalgias and myositis. In September 2004, she experienced dizziness/giddiness. On 16 June 2005, the subject was evaluated by an orthopedist following her work place injury in May 2005. At that time, she was assessed with degenerative disc disease and fibromyalgia by history, in addition to injury associated events of lumbosacral strain and possible left knee sprain. Examination did not reveal focal disc herniation, and it was noted that the degenerative changes identified by magnetic resonance imaging were chronic. It was also noted that the subject''s complaint of numbness in the arms and legs was "difficult to explain on the basis of the trauma". Treatment included physical therapy and Naproxen. This event of encephalopathy was assessed to be medically significant by manufacturer. On an unknown date in 2000, the subject was hospitalized for a right thyroid mass. The subject also experienced abnormal weight gain, hyperlipidemia, irritable bowel syndrome, rectal bleeding with possible hemorrhoids, clostridium difficile colitis due to long term antibiotic use, and chest pain. On 17 May 2005, the subject experienced an injury to her lower back, left knee, and chest when assisting a subject who had collapsed in the course of her employment in home health care. Symptoms included acute onset of lower back and chest pain, and hand numbness. She was assessed as a having a lumbar sprain/lateral radiculopathy with bilateral paresthesias in the feet. The subject subsequently initiated a workman''s compensation claim for a herniated disc. These were considered to be incidental findings upon medical record review.


VAERS ID: 296220 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: D.C.  
Vaccinated:2005-07-14
Onset:2005-07-14
   Days after vaccination:0
Submitted: 2007-11-02
   Days after onset:841
Entered: 2007-11-09
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV095 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Chronic fatigue syndrome, Fatigue, Full blood count normal, Insomnia, Malaise, Metabolic function test normal, Migraine, Myalgia, Poor quality sleep, Thyroid function test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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: None
Current Illness: None
Preexisting Conditions: Seasonal allergies, history of nephrolithiais endometriosis umbilical hernia repair.
Allergies:
Diagnostic Lab Data: Tests: None Labs: Thyroid. CBC and metabolic panels normal.
CDC Split Type:

Write-up: Developed her first migraine headache 12 hours after vaccine receipt. Within the next few weeks developed fatigue, restless sleep, myalgias and arthralgias that have continued to the present. Also has headaches 1 time a week and a migraine headache every 2 months. Currently has a diagnosis of Chronic fatigue syndrome. Fatigue, Malaise greater 60 days, insomnia, headache, migraine, headache, general, muscle pain, joint pain, multiple joints.


VAERS ID: 300415 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-29
Entered: 2007-12-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RUB: RUBELLA (MERUVAX II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chronic fatigue syndrome, Fibromyalgia, Rash, Thyroid disorder
SMQs:, Anaphylactic reaction (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04161

Write-up: Information has been received regarding a case in litigation concerning a male who in 1999 was vaccinated with a dose of MERUVAX II. The patient was not sure if the rubella vaccine he received was rubella virus vaccine live or not. On an unspecified date (after receiving the vaccine) the patient developed "a lot of problems", a rash, fibromyalgia, chronic fatigue syndrome and "thyroid problems". At the time of the report the patient''s status was unknown. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 310254 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2008-02-27
Onset:2008-02-27
   Days after vaccination:0
Submitted: 2008-04-07
   Days after onset:39
Entered: 2008-04-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chronic fatigue syndrome, Dizziness, No adverse event, Temporomandibular joint syndrome
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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: herbs (unspecified)
Current Illness: Chronic fatigue syndrome; Temporomandibular joint syndrome
Preexisting Conditions: Rigidity
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA00549

Write-up: Information has been received from a registered nurse concerning a 20 year old female with chronic fatigue syndrome, and temporomandibular joint syndrome and a medical history of hyperrigidity of the right shoulder, who on 03-JUL-2007 was vaccinated with the first dose of Gardasil, and on 30-OCT-2007 and 27-FEB-2008 was vaccinated intramuscularly in the left arm with the second and third 0.5 mL doses of Gardasil, respectively. Concomitant therapy included herbal supplements (unspecified). On 27-FEB-2008 immediately after receiving the third dose, the patient felt lightheaded and experienced left arm pain. The patient sought unspecified medical attention. No diagnostic laboratory studies were done. As of 03-MAR-2008 the patient had not recovered. No product quality complaint was involved. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. On 15-APR-2008 the nurse reported that the left arm pain has resolved (specific date not given). No product quality complaint was involved. Additional information has been requested.


VAERS ID: 312268 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Connecticut  
Vaccinated:1999-05-17
Onset:1999-05-17
   Days after vaccination:0
Submitted: 2008-05-13
   Days after onset:3284
Entered: 2008-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS LY123A9 / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Amnesia, Anorexia, Antinuclear antibody negative, Anxiety, Arthralgia, Asthenia, Autoimmune disorder, Back pain, Biopsy colon normal, Biopsy small intestine normal, Borrelia burgdorferi serology positive, Breath sounds, CSF test normal, Chills, Chronic fatigue syndrome, Cognitive disorder, Congenital neurological disorder, Constipation, Cough, Depression, Diarrhoea, Dissociation, Disturbance in attention, Dizziness, Dysphagia, Dysthymic disorder, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Family stress, Fatigue, Feeling abnormal, Fibromyalgia, Flight of ideas, Gait disturbance, Gastrointestinal disorder, Gastrooesophageal reflux disease, Gram stain negative, Groin pain, Haematuria, Headache, Helicobacter pylori identification test negative, Hyperacusis, Hyperhidrosis, Hypoaesthesia, Influenza like illness, Insomnia, Irritable bowel syndrome, Joint swelling, Lyme disease, Major depression, Memory impairment, Mental disorder, Mood altered, Muscle spasms, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Neurological symptom, Pain in extremity, Palpitations, Paralysis, Pharyngolaryngeal pain, Psychomotor hyperactivity, Psychotherapy, Pyrexia, Red blood cell sedimentation rate normal, Scoliosis, Serology negative, Single photon emission computerised tomogram abnormal, Sleep disorder, Sleep study normal, Spinal osteoarthritis, Stomach discomfort, Stress, Stress at work, Syphilis test negative, Tinnitus, Ultrasound abdomen normal, Vision blurred, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (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: Unknown
Preexisting Conditions: MYOFASCIAL PAIN, NAUSEA, NECK PAIN, NERVE PALSY, PILAR CYST, RECURRENT RHINITIS, SKIN LESION, UPPER ABDOMINAL PAIN, UPPER RESPIRATORY INFECTION, WEARS GLASSES; In 1994, the subject was evaluated by a pain rehabilitation physician due to an impression of postural neck pain with evidence of myofascial related pain within the cervicoscapular musculature. The subject underwent removal of an "erosive" skin lesion of his left cheek on 23 March 1999; diagnosed as a benign compound nevus.
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 23Sep2002, negative; Erythrocyte sedimentation rate, 24Nov1999, 5mm/hr; Erythrocyte sedimentation rate, 28Jul2000, 12mm/hr; Erythrocyte sedimentation rate, 29May2001, 0mm/hr; Erythrocyte sedimentation rate, 17Jun2002, 1mm/hr; Erythrocyte sedimentation rate, 23Sep2002, 1mm/hr; Diagnostic tests: 31 October 1999, Borrelia burgdorferi AB screen 2.88, positive interpretation; 24 November 1999, EBV-IgG 1:1280 (abnormal), EBV-IgM <1:10, EBV-EA <1:20 (abnormal), and EBNA <1:10 (abnormal); 15 March 2000, Small bowel, gastric antrum, terminal ileum, and random colon biopsies showed no significant histopathologic changes, gastric antrum biopsy was negative for Helicobacter pylori, and random colon biopsies showed no evidence of microscopic colitis; 24 July 2000, Cerebrospinal fluid gram stain showed no organisms, no growth at 72 hours, VDRL (syphilis) screen negative, B. burgdorferi IgG less than 0.1 mg/dL (within reference range), IgG index less than 0.7 (within reference range), B. burgdorferi IgG Ab serum 1.5 (index less than 0.8); 15 February 2001, Lyme IgG was reactive, bands 62, 41, 39, 34, 31, Lyme IgM was equivocal, bands 66, 62, 37, 34, 31, 23, Cerebral SPECT showed small right temporal and left parietal defects, Questionable left front defect as well; 08 March 2001, Sleep disordered breathing study results were within normal limits, with comment "he may have slept better than usual on this night because of his poor night on a the prior night"; 25 May 2001, Abdominal ultrasound normal; 19 October 2001, Lyme serology results revealed no evidence of seroreactivity beyond that expected from the Lyme vaccine; 03 May 2007, Helico pylori negative
CDC Split Type: A0603933A

Write-up: This case was reported by a lawyer and described the occurrence of joint pain and swelling in an adult male subject who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain and swelling, fatigue, sleep disorder, gastrointestinal problems, dizziness, headaches, ringing in ears, muscle pain and weakness, neck pain, memory loss, cognitive problems, numbness in extremities, and decreased activities of life. In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information was received on 07 January 2008 via medical and pharmacy records. According to a Lyme serology information sheet completed by the subject, he was vaccinated with LYMErix in April 1999 and May 1999, but did not receive additional doses because he was "too sick." LYMErix was administered at the subject''s place of employment, and the subject reported no history of Lyme disease prior to vaccination. Following his second vaccination with LYMErix, beginning in May 1999, the 34-year-old subject developed fever and/or flu-like symptoms and joint pain. In November 1999, the subject was diagnosed with Lyme disease. Additional events included neck stiffness, nausea, chronic fatigue syndrome, fibromyalgia, chronic insomnia, stress, anxiety, depression, and mental health/ memory problems. The subject reported that he received unspecified antibiotics for Lyme disease between November 1999 and January 2000, and from January 2001 through the time of completion of the Lyme serology information sheet. He reported that treatment was not successful, and that his symptoms began and slowly escalated following his second LYMErix vaccine. His symptoms reportedly remained constant, but with changes in severity. At the time of completion of the information sheet (date not provided), the subject''s joint pain and fever/ flu-like symptoms were unresolved. Follow up information was received on 18 February 2008 via medical records. On 15 March 2000, the subject was evaluated for nausea, epigastric pain, and diarrhea, and diagnostic testing was negative for Helicobacter pylori and showed no evidence of microscopic colitis. In July 2000, he was evaluated in the emergency room, and underwent a lumbar puncture to rule out central nervous system (CNS) Lyme disease. Medications at that time included amitriptyline and Ambien. On 08 March 2001, he underwent a sleep study which revealed normal results; however, the previous night he reported that he had approximately three hours of sleep. Follow up information was received on 12 March 2008 via medical records. The subject was treated for Lyme disease with intravenous Rocephin beginning on 08 May 2001. The patient was discharged from the home health services on 06 June 2001, after reporting that he was instructed by his physician to "pull PIV (peripheral IV) and stop treatment, goals not being met". Follow up information was received on 21 March 2008 via medical records. The subject had a history of persistent nausea and upper abdominal discomfort in 1990. He subject was vaccinated with LYMErix on 15 April 1999 and 17 May 1999 through an employee health program. Following his second injection he developed some unexplained fatigue. In June or July 1999, he developed lightheadedness and minor stomach upset. While traveling by airplane in August 1999 he experienced "unexplained" vomiting which he had never had before. On 30 October 1999 he developed exacerbation of fatigue and onset of headaches, follow that night by a fever of 102 degrees Fahrenheit. The following day he experienced difficulty walking, and subsequent Lyme titers by ELISA were positive as "expected after the Lyme vaccine". He was evaluated on 31 October 1999 for complaints of severe headaches, sweats, and rigors. On that date he was assessed as having 1) congenital nerve palsy right side "incidental finding", 2) headache with febrile illness, questionable Lyme or ehrlichiosis, and 3) hematuria. Doxycycline was initiated on that date empirically. He was reportedly diagnosed with Lyme disease, fibromyalgia, and chronic fatigue syndrome. Treatment included doxycycline and Prilosec, and he experienced resolution of headaches and fever. In late November 1999 he developed insomnia. He received Elavil for sleep and exhibited symptoms suggestive of irritable bowel syndrome. He was seen for a gastrointestinal consult on 25 February 2000 due to altered bowel habits including diarrhea and constipation, with additional symptoms of headaches, bilateral low back pain, fatigue, weakness, anorexia without weight loss, insomnia and nausea. The evaluating gastroenterologist questioned "whether or not he has underlying inflammatory bowel disease with prominent extraintestinal manifestations such as arthritis and fatigue, versus irritable bowel syndrome worsened by the stress of some unknown intercurrent disease". Following his lumbar puncture on 23 July 2000, he experienced a fever of 100.2 degrees Fahrenheit which had "settled down" by 28 July 2000, and he continued to experience nausea, significant insomnia, and difficulty focusing (he also complained of a slight cough). A chest x-ray on 28 July 2000 revealed mild scoliosis. He was advised by his physician that he "probably does not have any underlying physical abnormality at the moment", and Paxil therapy was suggested for anxiety/ depression. Klonopin was initiated at that time. In December 2000, he complained of neck discomfort extending to the upper shoulder area, and was referred for physiotherapy. Assessment also included chronic fatigue and insomnia as well as possible Lyme disease. In approximately April 2001 the subject was diagnosed with disseminated Lyme disease and intravenous Rocephin was prescribed. In a letter dated 07 May 2001, the internist wrote "I believe (subject) has a combination of partially treated Lyme disease, exacerbated by vaccine, which triggered an autoimmune-like reaction". On 23 April 2002, examination of the cervical spine showed moderate degenerative spondylosis at the C5 to C6 level. According to a neurologist''s summary dated 29 May 2002, the subject''s symptoms developed after he received his second LYMErix vaccination and included difficulty sleeping, nausea, diarrhea, joint pain (mostly in knees), fatigue, low back pain, fluctuating cognitive difficulties, depression and mood swings, possible fibromyalgia, headaches, loss of appetite, upper gastrointestinal upset, "sharp" pains in his thighs, and anxiety. Treatment included doxycycline, amitriptyline, Celexa, Paxil, clonazepam, Ambien, tetracycline, Biaxin, Ceftin, and penicillin. In March 2001, the subject was assessed as having disseminated Lyme disease, and was treated with intravenous Rocephin which was discontinued due to abdominal pain. During the summer of 2001 he was off antibiotics and experienced improved sleep and headaches; however, in September 2001 his "symptoms were fully blown again". Mepron and Zithromax were started with an initial exacerbation of symptoms followed by improvement following discontinuation of this therapy regimen four weeks later. Biaxin and Plaquenil were started in October 2001 for approximately ten weeks with "some general improvement". A "significant deterioration" followed discontinuation of these medications. In January 2002 Mepron and Zithromax were re-started with the "same pattern of initial deterioration and later improvement". The subject was noted to be DR4 positive. A recent x-ray demonstrated some calcification and osteoarthritic changes. The physician commented that the subject "might have developed a post-vaccine immune disease". In late 2001 and 2002, the subject received physical therapy for neck pain that was assessed as "most likely arthritic in nature". A progress note dated 12 September 2002 indicated that the subject experienced continued fatigue, muscle aches, and insomnia and had received "an incredible amount of medications in the last couple of years" including tetracycline, penicillin, Ceftin, Biaxin, Rocephin, Zithromax, Mefloquin, and Plaquenil. The physician stated "I still do not believe that he has underlying Lyme disease and since he does have a low serum complement level, I think it is very reasonable for him to see a rheumatologist". He was noted to be HLA-DR4 positive. On 05 April 2003, the subject presented for follow up of back pain, cervical pain, and neck spasm that had been ongoing for approximately one year. He had been received Flexeril, and Bextra was added. The events of congenital nerve palsy, hematuria, and possible irritable bowel syndrome were assessed to be incidental findings upon medical record review. Follow up information was received on 28 March 2008 via medical records. The subject was evaluated on 17 June 2003 for "another opinion" regarding his symptoms including ongoing difficulty sleeping, fatigue, upset stomach, depression, anxiety, palpitations, neck pain, and joint pains and a recent diagnosis of chronic Lyme disease. Impression included "dizziness, suspect labyrinthitis". He returned for follow up on 08 July 2003, at which time the physician''s impressions were 1) multiple constitutional symptoms, 2) suspected post-LYMErix vaccine syndrome, 3) suspected anxiety, depression, and 4) elevated ACE level, questionable etiology. On 25 August 2003, the subject reported increased fatigue that was possibly due to a higher dose of Zoloft, and he continued Klonopin, Flexeril, and Bextra. Upon follow up on 11 August 2005, he was "doing well at home and work", with a good appetite. He was sleeping well and admitted to an approximately 20 pound weight gain. Anxiety and depression were well controlled on Zoloft, and he was advised that an eventual taper and discontinuation of Zoloft could be implemented but "preferably under psychiatrist supervision". In December 2005 he expressed no arthritic complaints and was doing well with respect to anxiety while noting "some stress at work". On 13 February 2006, after decreasing his dose of Zoloft, he continued to do well with respect to anxiety. On 03 April 2007, he complained of stomach discomfort attributed to "increased stress and anxiety related to a new position" at work. He also experienced difficulty sleeping, inability to fall asleep, and "waves of depression". Impression included gastroesophageal reflux disease (GERD) and anxiety, and Zoloft was re-initiated in addition to initiation of Protonix. He continued to experience epigastric discomfort and anxiety, and Zoloft was re-filled in January 2008. Following discontinuation of Zoloft he admitted to some headaches and increased temper that subsequently improved. On 10 February 2004, the subject experienced sore throat and dysphagia and noted that his daughter had scarlet fever and strep throat approximately ten days earlier. On 20 April 2006 he developed aching in his groin that was possibly attributable to riding his bicycle. These events, and the events of suspected labyrinthitis, elevated ACE level and gastroesophageal reflux disease, were assessed to be incidental findings upon medical record review. Follow up information was received on 18 April 2008 via medical records. The subject was evaluated in a sleep disorder clinic on 03 November 2000 with complaints of sleep problems (insufficient and poor quality sleep), fatigue, and depression. He also admitted to some physiological hyperarousal with neck muscle tension, headaches, and overreacting to loud sounds, as well as some hyperarousal including worry. Impression was that "previous diagnoses that need to be considered in this current sleep presentation are chronic fatigue syndrome and dysthymic disorder". The sleep specialist also noted inadequate sleep hygiene with the patient spending "too much time in bed". Follow up information was received on 30 April 2008 via medical records. The subject presented for initial psychiatric evaluations on 03 and 17 September 2003 due to complaints including sleep problems, chronic illness, depression, and anxiety. He reported feeling fatigued since 1999 with trouble at work, nausea, severe headaches, and fever. He had previously received Celexa, and was on Zoloft at the time of examination. He described difficulty falling back to sleep, "brain fog", racing thoughts, increased anxiety, increased fatigue and decreased concentration, and reported that he had two "breakdowns" during business trips with a feeling of detachment and anxiety. The subject reported that his symptoms were only partially relieved by treatment for Lyme disease, and that his physician hypothesized that it was a possible reaction to LYMErix. Additionally, the subject described family and work stressors. Medications included Zoloft. Diagnoses included major depressive disorder (moderate), with notes to rule out hypochondriasis and/or obsessive compulsive disorder, and he was enrolled in regular psychotherapy sessions. On 03 December 2003, mood and functioning were improved, and he had reportedly discontinued Klonopin. By 14 January 2004, he reported that he continued to feel well with some occasional sleep disturbances. A follow up noted dated 27 April 2005 indicated that the subject was "feeling well" with good sleep, energy and appetite, increased weight, "adequate" libido, good functioning, euthymic mood, and no somatic concerns. He was released from psychiatric therapy at that time. The event of major depressive disorder was assessed to be medically significant by GSK.


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