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VAERS ID: 151905 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1999-06-08
Onset:1999-06-08
   Days after vaccination:0
Submitted: 2003-02-14
   Days after onset:1347
Entered: 2000-05-12
   Days after submission:1008
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 120D9 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin, Amoxicillin Trihydrate/C
Current Illness:
Preexisting Conditions: Allergic to morphine, alopecia areata, left ear pain, nasal congestion, pharyngitis, sinus pressure, bull''s eye skin lesion, obestiy, ulcerative colitis
Allergies:
Diagnostic Lab Data: Aldolase 4.9U/L 4/6/00; chemistry normal 4/6/00; erythrocyte sedimentation rate 5mm/hr; granulocyte count 3600/cu mm; platelet count 357000/cu mm. Complement CH50, 4/6/00: 148 CAE. HLA phenotyping, 8/24/00: HLA-DR antigens present:DR1, DR52, DR11; HLA-DQ antigens present-DQ5, DQ7. Lyme test NOS, March 2000 negative. Lyme IgG western blot negative; 41kD band present 5/18/00. Lyme IgM western blot negative 41kD band present 5/18/00. Lyme IgG western blot positive;93, 66, 60, 58, 45, 41, 31 ("blurred wide," 18kD bands present) 8/24/00. Lyme IgM western blot 8/24/00 positive, 41, 39, 23 ("faint positive" bands present). Lyme IgG western blot 12/14/00 negative 41kD band present. Lyme IgM western blot 12/14/00 negative zero bands present. Lyme IgG western blot 4/5/01 negative 66, 58, 41kD bands present. Lyme IgM western blot 4/5/01 positive 41, 39, 23kD bands present. Lyme IgG western blot 9/26/01 negative 45, 41, 39kD bands present. Lyme IgM western blot 9/26/01 positive 39, 23kD bands present.
CDC Split Type: 2000007075

Write-up: On 6/8/99, the pt received her first dose of Lymerix. Almost immediately post - vax, she experienced "achy" muscle pain in both thighs. Arthalgia, can''t stand for very long, pain. Can''t walk for very long, pain. Fatigue, hair loss, headaches, joint stiffness, joint swelling, muscle pain, pain in feet, pain in hands and pain in lower back. In November, 1999, the pt had surgery for twisted fallopian tube (left ovary). This event was not related to Lymerix per consumer. She was negative for endometriosis. Now she is having pain in hands, lower back and feet. In addition to headaches and fatigue. She cannot stand or walk for very long. She was treated with anti-inflammatory medication, which did not help. A neurologist was consulted. A recent Lyme test was neg. The most recent information received on 3/10/00 reports the condition of the pt is ongoing. The following info was obtained from medical records. From 5/18/00 to at least 3/21/02, the subject was under the care of an "emerging disease specialist." The subject reported that she experienced, beginning in June 1999, "from waist down musle and joint pain particularly upper legs and pelvic area. Feet, hands, shoulders, arms, lower back-aches, spasms, pain. Fatigue and feeling drained." On a questionnaire, the vaccinee indicated that she experienced the following additional symptoms beginning in June 1999: irregular heartbeat; joint pain involving the wrist, hips, knees, ankles and elbows; swelling of the ankle joints; back pain "below the waist"; sciatica; "radiating nerve root pain" of the shoulder; unexplained weight gain; increased Lyme symptoms during menstrual periods; headache; "weakness/paralysis legs severe"; "tingling, numbness hands feet"; and "depression/behavioral change." She indicated that all of these symptoms were on-going. She also indicated that she experienced incrreased menstrual bleeding from July 1999 until November 1999. While under the care of this specialist, the vaccinee also reported irritability, short-term memory loss, sharp pain in the elbows and toes, inability to close the right hand, feeeling of being off balance, headache accompanied by nausea, visual shadows, hair loss, a rahs on the spot of hair loss, "trauma to immune system," waking up in the middle of the night, and bizarre dreams. During this time period, the physician noted that the vaccinee appeared to be in pain, and had "abnormal" fingers. The finger abnormality was not specified. Lyme Western blots was positive three times, on 5/24/00, 4/5/01 and 9/26/01. The physician''s initial diagnosis was "History of Lyme-vaccine." On 12/13/00, the specialist made a diagnosis of Lyme disease. The physician prescribed Biaxin, Ceftin, Suprax, Zithromax, Motrin, and Bicillin L-A. As of 3/21/02, the vaccinee felt "washed out" whenever she would "do a lot." She was receiving therapy iwth clarithromycin at that time. Following the reported onset of Lyme disease, the vaccinee experienced hypertriglyceridemia, hypercholesterolemia, mitral valve prolapse, possible shingles, and torsion of the left tubo-ovarian complex. She underwent uterine hysteroscopy; dilatation and curettage; operative laparoscopy; lysis of multiple bowel, omental, and left tube and ovary adhesions; cautery of endometriosis lesions; and left partial salpingectomy. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the vaccinee''s medical records. Therefore, they are not listed as adverse events. The most recent info was received on 5/6/02. As of 3/21/02, the vaccinee reported that if she were to "do a lot" she would become "washed out." She was receiving therapy with clarithromycin at that time. Case 2000020536-1 has been identified as a duplicate record of this case. All info in case 2000020536-1 has been incorporated in this case A0322625A (formerly, 200007075-1) will stand as the case of record for this vaccinee.


VAERS ID: 151906 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1999-06-28
Onset:1999-08-09
   Days after vaccination:42
Submitted: 2000-04-21
   Days after onset:256
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM LY12389 / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Bone disorder
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Western Blot - neg, X-rays - some degenerative changes
CDC Split Type: 20000070801

Write-up: In 5/99 and on 6/28/99, the pt self-administered the first and second left thigh doses of Lymerix using pre-filled syringes. Six weeks after receiving dose 2, on 8/9/99, the pt experienced a new onset of shooting pains through multiple joints. An MD''s visit was required, and she was treated with an unspecified medication. The treating medication masks the pain but does not take it away. She has been to several MD''s and no one can come up with any cause other than Lymerix. She went to an infectious disease physician and the Western blot was negative. X-rays taken "recently" showed nothing but "some degenerative changes" but physicians feel that the joint pain is not from this. "They have narrowed it down to Lymerix." The most recent information received on 3/10/00 reports the condition of the pt as ongoing.


VAERS ID: 151907 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Indiana  
Vaccinated:1999-08-04
Onset:2000-01-01
   Days after vaccination:150
Submitted: 2000-04-21
   Days after onset:110
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Arthritis, Depression, Eye disorder, Fatigue, Nervous system disorder, Pain, Photosensitivity reaction, Sleep disorder
SMQs:, Systemic lupus erythematosus (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (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? No
Previous Vaccinations:
Other Medications: Lamisil, Prozac, Caltrate, Know Nutrojoint, Metamucil, Imodium, vitamin and mineral supplements
Current Illness:
Preexisting Conditions: Low back pain, dermatitis, poor close-up vision, knee and hemorrhoid surgery.
Allergies:
Diagnostic Lab Data: MRI, EMG
CDC Split Type: 20000070851

Write-up: On an unspecified date the pt received the Lymerix vaccine. Subsequently, he experienced electrical shock sensations in his nerves down his legs, photosensitivity, achiness, fatigue, and depression. Additionally, an ophthalmologist found white blood cells in the pt''s eyes. An ER or MD visit was required. An MRI and EMG were done. The most recent information received on 3/13/00, reports the condition of the pt as ongoing. A 15-day follow up report received 01/03/2001 adds: Report 2000007085-1 describes muscle spasms in a 54 year-old male who received Lymerix for the prevention of Lyme disease. This report was received from the daughter of the vaccinee and from a lawyer with follow-up medical records and has not been verified by a physician or other health care professional. Reportedly, the pt is allergic to Tylenol. Medical history includes low back pain, dermatitis (seborrhea), poor close-up vision, and knee and hemorrhoid surgery. His father has arthritis. On 06/29/1999 and 08/04/1999, the pt received his 1st and 2nd doses of Lymerix. Six days following dose 2 of Lymerix, on 08/10/1999, the pt reportedly started having pain in his wrists, flu-like symptoms and a sore spot on his left ribcage under his left arm for 7-10 days. A chest X-ray was negative. Subsequently, he experienced electrical shock sensations in his nerves down his legs, photosensitivity, achiness, fatigue and depression. Additionally an optometrist reportedly found "white blood cells were in the pt''s eyes". In Sept 1999 he developed pain in his left hip joint which was periodic, and also a weakness in his leg muscles. In Nov 1999 he first noticed weakness and had episodes of foot pain. In mid-December his hip pain worsened, so he went to his family doctor who did an X-ray which showed slight "osteo", but according to his physician, was not enough to be causing his pain. At this time, the pt started noticing activity-related thigh pain. He was treated with celecoxib (Celebrex). Through January 2000 he continued to get worse. He went to an orthopedist and underwent an MRI (which was negative). He then developed a burning and aching in this thighs/hamstrings, and flu-like chills that lasted several days at a time. On 01/05/2000 the orthopedist stated that the pt initially had right hip pain following a hemorrhoidectomy procedure. The pt was not sure if his physicians put him in an unusual position or not, but he had primarily lateral right hip pain following this. That seemed to resolve, and then he developed some low back pain following this for awhile, although this too resolved. He then injured his left hip when he was standing on a chair in Sept 1999. At that point as he stepped off, he caught the high back of the chair directly in his left groin, not involving his genitals. From that point forward he has had some sharp pain in his left hip primatily with positioning of the hip in adduction past the midline or internal rotation of the hip. The physician stated that the pt really did not have a great deal of pain necessarily with weight bearing. He denied any numbness or tingling with the left lower extremity. He did not have any increased pain with coughing or defecation. He had been taking an anti-inflammatory without significant relief. The pt did not feel that the pain had improved markedly since his injury. Impression: an unusual deep groin pain involving his left hip which is related more to position than muscle activation. At the end of January 2000 the pt experienced severe muscle spasms in both thighs. The next morning, his family physician referred him to neurologists, rheumatologist and psychiatric counselors. 02/04/2000: neurologist visit: the pt stated that he had muscle spasms and back pain, and was evaluated. The pt had leg muscle concerns in the last week with prior back, leg and hip pain. There was no antecedent trauma. Course has been one of improved spasms. The spasms started in the hamstrings and spread to the entire thighs bilaterally. The spasm can include burning or tingling. Severity is described as "awful" or "maddening" and limited what he did. He may have had increaseing or precipitating factors with exertion but no diurnal pattern or increase with change in temperature, cough, sneeze or valsalva. He improved with a warm bath, as well as celecoxib (Celebrex) and cyclobenraprine HCl (Flexeril). He was worse with exertion, so PT treatments were stopped. He might have had dysphagia (but only on awakening and due to a dry mouth and throat), and he had bilateral hip pain. On examination, he denied dysphagia, weakness, swelling, symptoms in upper extremities or cranial nerves, incontinence, or change in color or temperature. He had generalized weakness with "soreness from the spasms" and his muscles felt "rubbery". The pt reported having chills, weight change, night sweats, fatigue, visual flashes, decreased appetite, diarrhea, excessive thirst, frequent urination, joint pain, forgetfulness, tremor, hot flashes, depression, nervousness/tension, difficulty concentrating, disturbed sleep and mood changes. The neurologist reported that the most likely diagnosis was physiologic cramps after increased exertion in PT. However, an extensive list of differential diagnoses was provided which included 1. localized spasm due to spinal or nerve root process 2. central disorders including infections such as tetanus or stiff-man syndrome, spasticity secondary to structural lesion including MS 3. peripheral nerve disorders 4. muscle disorders 5. neuromuscular conditions. Assessment: muscle spasms with weakness. Plan: check EMG (electromyograph) with NCV (nerve conduction velocities) of the back and legs 2. Discontinue Lamisil: a small percentage of individuals may have musculoskeletal complaints on this medication, stated physician. 3. Continue present treatment otherwise (e.g. Tylenol and cyclobenzaprine). 4. Consider dependent on course biopsy of muscle and nerve. 5. The neurologist will defer to the primary physician concerning possible further evaluation and/or treatment of the ANA titer. 6. Return to clinic in 3-4 weeks. Nerve conduction studies and EMG needle examination were performed. See laboratory results section for details. He has continued to worsen and has been out of work since 01/30/2000. His eyesight is now extremely photo-sensitive (he must wear sunglasses and a hat in order to be able to go out in the sunlight) and his hearing is also very sensitive. 02/15/2000 (rheumatologist visit). The physician believed that the pt may be having some inguinal pain from early osteoarthritis. The X-ray was not terribly remarkable. However, there were some subtle changes that might explain his discomfort in the groin. The physician asked the pt to stop celecoxib (Celebrex) and try rofecoxib (Vioxx) for a week or two. The physician believed that the ANA result was probably a nonspecific finding. He did not find any evidence of muscle weakness or other automimmune disease on the pt''s physical exam. He believed that the pt was suffering from depression that has not fully responded to Prozac. Impression: 1. Probably early osteoarthritis, left hip. 2. Depressive reaction. 02/25/2000 physician states that the pt had acutely worsening symptoms of anxiety and depression, including changes in his sleep, anhedonism, and not wanting to dress or shave at times. He reported that he was uncomfortable being around windows and mirrors and "I don''t feel right". "My thought processes are not right". He had anxiety attacks with feelings of hopelessness, extreme nervousness, weight loss, fatigue, weakness, extreme thirst, sleeplessness, burning and aching, red palms, no interests, anxiety and hip pain. The location of the muscle spasm remained in the hamstrings and spread to the entire thighs bilaterally. In addition, his left leg felt "wobbly when I walk". The quality remained a spasm, burning or tingling. His symptoms improved with a warm bath, as well as celecoxib (Celebrex) and cyclobenzaprine hydrochloride (Floxeril). His symptoms are worse with exertion. Assessment: positive ANA evaluated by rheumatologist. On 03/01/2000, the pt first noted the sensitivity to light and has since become progressively worse. He has also experienced tinnitus, vertigo and rigidity. The ophthalmic examination appeared essentially normal. He was treated on 03/06/2000 for muscle pain, generalized aches, joint pain, blurred vision, depression and paresthesias. The pt had experienced a 20 pound weight loss during the past 3 months. Since January 2000 his appetite has been poor and he felt perisitently nauseated. The pt was formerly an active outdoorsman and athlete who worked for the Park Service. The pt denied headache, memory problems, or any difficulty with normal thought processes. He does acknowledge marked anxiety and depression and he has multiple somatic complaints. His medications on 03/06/2000 were fluoxetine (Prozac), celecosib (Celebrex) and rofecoxib (Vioxx). Impression: The pt has multiple somatic complaints and normal neurological examination. There is no evidence of muscular disease on exam. The pt had a prominent anxiety component. There was no evidence that the pt has a motor neuron disease, such as ALS. He was treated on 03/24/2000 for arthritis, fatigue and joint pain. The physician stated that the pt has complained of arthritis for 8 weeks which developed in his left hip and now involved both hips and both knees. The pt was now on disability. The pt complained of fasciculations in his muscles. He has had some difficulty sleeping. # people who were close to him died recently. He has multiple bodily complaints and muscle aches and joint aches. He was currently taking celecoxib (Celebrex) 20 mg qd, rofecoxib (Vioxx) mg qd, and zolpidem hemitartrate (Ambien). 03/27/2000: Physician stated that the pt has improved from the standpoint of his eyesight, energy level and headaches. An ophthalmologist evaluated the pt and stated that he did not have iritis. Assessment: photophobia and phonophobia: ongoing. Muscle spasms with weakness: ongoing. No neuromuscular concerns identified. Sleep disturbance of "I just can''t go to sleep or stay asleep": ongoing. Anxiety and depression: ongoing. Test results out of range: MRI of the lumbar spine (02/09/2000): far right lateral disc herniation without nerve root impingement at L4-5. ANA 1:80 speckled. EMG with complex repetitive discharges in leg and paraspinal muscles (but no NRC per MRI). April 2000: A Western blot revealed the presence of IgM 23, 39 and 41 and RgG bands 93, 66, 58, 45, 41, 39 and 23. He is now taking cefuroxime axetil (Ceftin) and clarithromycin (Biaxin). 05/01/2000 live cell fluorescent antibody technique for Borrelia burgdorferi-positive. 05/19/2000 physician visit: current medications: rofecoxib (Vioxx), mirtazapine (Romeron) 30 mg for depression, zolpidem hemitartrate (Ambien) 2 at HS for insomnia, valacyclovir hydrochloride (Valtrex) 1 bid for Epstein-Barr virus, liothyronine sodium (Cytomel) for fatigue, and vitamin B12 1000 mcg IM-left deltoid for B12 deficiency. The pt complained of some testicular tenderness, fatigue ("almost chronic") chest pain around sternum (none while playing golf), ringing in ears, improved photophobia ("but still sensitive"), mild tingling/numbness in lower legs and feet, red throat and depression. This case is considered serious because the pt has been disabled since he has been out of work. Info received on 12/19/2000 reports the condition of the pt an unknown. A 15-day follow up report received 03/23/2001 adds: (Medical history includes) torn labrum right shoulder (1994), torn biceps tendon left shoulder (1994), torn cartilege right shoulder (1991), headaches since at least 1988, stiff joints since at least 1988, intermittent aching of joints and swelling of knee following exercise on hard surface, sinus infections, "cartilege injury of the sternum", "joint weakness", urinary incontinence, right knee surgery (1964), chronically prolapsed bleeding external and internal hemorrhoids (01/19/1994 to Feb 1999). ... Info received on 03/08/2001 reports the condition of the pt as unknown. A follow up report received 4/4/2001 adds no new info. A follow up report received 4/20/01 adds: Info received on 04/16/2001 reports the condition of the pt as unknown.


VAERS ID: 151908 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Idaho  
Vaccinated:1999-02-01
Onset:1999-02-01
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:444
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Headache, Influenza, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000072601

Write-up: At the end of February, 99, the pt received his first injection with Lymerix. Sometime thereafter, the pt experienced a "full blown flu", headache, severe body aches, general lack of energy, and a low fever. No treatment was given, and the symptoms resolved after one week. In late March, 99, the pt received the second dose of Lymerix with no ill effects.


VAERS ID: 151909 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: New York  
Vaccinated:2000-01-30
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Fatigue, Influenza, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000074131

Write-up: On approximately 1/8/00, the pt received his first IM dose of Lymerix. A few days post vax, he experienced malaise, fever of 103 degrees for one week, chills, exhaustion, arthralgia, and myalgia. He was diagnosed and treated for influenza. Symptoms resolved after three weeks. On approximately 3/1/00, the pt received his second IM dose of Lymerix. A few days post vax, the pt experienced a fever of 100, myalgia and arthralgia. The most recent information, received on 3/13/00, reports the condition of the pt as resolving.


VAERS ID: 151910 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthritis, Condition aggravated
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)

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:
Preexisting Conditions: arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000078151

Write-up: At an unspecified time in 1999, the received the first injection with Lymerix. Sometime thereafter, she experienced an exacerbation of her arthritis. The second dose of Lymerix was given in 1999 while the symptoms were ongoing. The information received on 3/21/00, reports the symptoms remain ongoing.


VAERS ID: 151911 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: Unknown  
Vaccinated:2000-03-07
Onset:2000-03-07
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:44
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM LY1369 / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Influenza like illness, Pain
SMQs:

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: allergy to cephalosporins and codeine
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000078171

Write-up: On 3/26/99, the pt received her first injection of Lymerix. She received her second injection on 4/27/99 and her third on 3/7/00. Three hours post vax (3rd), the pt experienced flu-like symptoms, body aches, and fatigue. The most recent information received on 3/15/00 reports the outcome of the events as resolved after one day.


VAERS ID: 151912 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1999-07-01
Onset:1999-07-09
   Days after vaccination:8
Submitted: 2003-02-14
   Days after onset:1316
Entered: 2000-05-12
   Days after submission:1008
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS 120D9 / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Medication error, Raynaud's phenomenon
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Medication errors (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: Claritin-D, Levoxyl, Fosamax, Lodine XL, Premarin, and melatonin.
Current Illness:
Preexisting Conditions: allergies to morphine and intravenous pyelogram dye, allergic rhinitis, poor sleep and fatigue (May 1999), arthritis, osteopenia, chronic neck pain after fallng down stairs (1995), "Raynaud''s" (1998), hypercholesterolemia, hypothyroidism, bladder polyps (1997), recurrent urinary tract infections, chronic cystitis, constipation, hemorrhoids, irritable bowel syndrome, mitral valve prolapse, palpitations, uterine fibroid, fibrocystic breast disease, and tick bite (1998). In December 1998, the subject complained of joint pian in her shoulders, hands, and hips. She also reported cramps in her feet. The physician noted swelling of the knuckles, "Raynauds''s," and hip tenderness at full extension. The subject reported that she had x-rays performed, but did not recall the results. She was "unsure" if she was told that she had arthritis. Dual-energy x-ray absorptiometry (DEKA) scan revealed osteopenia. The diagnosis of arthritis was later confirmed. Family history was significant for unspecified arthritis. Surgical history inclued tonsillectomy, breast lumpectomies, and partial hysterectomy.
Allergies:
Diagnostic Lab Data: Antinuclear antibody negative; antistreptolysin antibodies 85.5IU/mL; C-reactive protein, serum negative; erythrocyte sedimentation rage 5mm/hr; rheumatoid factor negative; serum uric acid 2.5mg/dL. Lyme total antibodies 9/9/99 4.23 (positive $g1.10). X-rays bilateral feet 4/4/00: arthritic changes of the left great toe and minor arthritic changes of the right great toe. Parovirus B19 IgG 4/5/00 0.99, parovirus B19 IgM 4/5/00 0.00; Lyme IgG western blot 4/5/00 negative zero bands present; Lyme total antibodies 9/8/00 positive ($g1.10).
CDC Split Type: 2000007818

Write-up: In April, 99, the pt received her first injection of Lymerix, with no adverse effects. In June, 99, she received the second dose and experienced no ill effects. In July, 1999, the pt received the third injection of Lymerix and approximately 4 months post vax the pt experienced severe joint pain in her hands and feet. The pt took a pain medication and plans to see her MD on 3/21/00. The information received on 3/20/00 reports the symptoms are ongoing. The subject''s medical history included allergies to morphine and intravenous pyelogram dye, allergic rhinitis, poor sleep and fatigue (May 1999), arthritis, osteopenia, chronic neck pain after fallng down stairs (1995), "Raynaud''s" (1998), hypercholesterolemia, hypothyroidism, bladder polyps (1997), recurrent urinary tract infections, chronic cystitis, constipation, hemorrhoids, irritable bowel syndrome, mitral valve prolapse, palpitations, uterine fibroid, fibrocystic breast disease, and tick bite (1998). In December 1998, the subject complained of joint pian in her shoulders, hands, and hips. She also reported cramps in her feet. The physician noted swelling of the knuckles, "Raynauds''s," and hip tenderness at full extension. The subject reported that she had x-rays performed, but did not recall the results. She was "unsure" if she was told that she had arthritis. Dual-energy x-ray absorptiometry (DEKA) scan revealed osteopenia. The diagnosis of arthritis was later confirmed. Family history was significant for unspecified arthritis. Surgical history inclued tonsillectomy, breast lumpectomies, and partial hysterectomy. Concurrent medications included Claritin-D, Levoxyl, Fosamax, Lodine XL, Premarin, and melatonin. The subject recceived injections of LYMErix on 4/7/99 (120E9), 5/5/99 (120D9), and 6/30/99 (1209D). The third injection was administered two months after the first injection, rather than the recommended interval of 12 months. Initially, the subject reported that she received LYMErix in April 1999, June 1999, and 7/30/99. She reported that approximately four months later, she experienced "severe" joint pain in her hands and feet. On 7/7/00, the vaccinee provider stated that lab analyses revealed an elevated concentation of parovirus B19 IgG. X-rays were compatible with osteoarthritis. The vaccine provider made a diagnosis of osteoarthritis and prescribed Tylenol. The subject was referred to a rheumatologist. On 2/12/02, in a Statement of Injuries, the subject''s attorney alleged that the subjet "has suffered pain in the joints of both hands, knees and feet. The pain in her knees has been particularly acute. In addition, she has suffered swelling in the joints of her hands and feet." The following info was obtained from medical records. The subject telephoned the vaccine provider on 7/9/99, nine days following receipt of the third injection of LYMErix, and reported "pain in joints and fingers and toes. Pt taking Fosamax, Lodine but not really using it. No swelling. Unable to wiggle toes flexion upward." The subject was instructed to take etodolac and go to the physician''s office for evaluation. The subject did not present for evaluation until 9/8/99. At that time, she reported htat she was taking etodolac and glucosamine. The physician noted, "Arthritis better." Lyme total antibody screen was positive; all other lab analyses were within the reference ranges. The subject remained under the care of the vaccine provider until 7/2/01. On 3/29/00, the subject reported pain in the proximal interphalangeal, metacarpophalangeal, and metatarsophalangeal joints, as well as morning stiffness. She reported that these symptoms began in "October/November" 1999. Lab analyses revealed increased total Lyme antibodies and elevated parovirus B19 IgG concentration. X-rays of the hands and feet demonstrated osteoarthritis. The subject was referred to a rheumatologist. On 5/4/00, the subject was evaluated by a rheumatologist for "complaints of hand and metatarsal pain for approximately eight months time. She denies any significant morning stiffness or swelling of the hands or wrists. She gives a history of metatarsal pain. She denies any dactylitis nor does she compain of any plantar fascia or Achilles tendonitis. She denies any hip or knee pian. There is no history of psoriasis or inflammatory bowel disease. The pt denies any lupus-like symptoms nor any myositic symptoms. She gives a history of poor sleep, for one year, as well as fatigue." On physiican examination, the rheumatologist noted "Right and left second and third MCP tenderness without associated synovitis noted. Bialteral PIP, DIP tenderness noted, without associated synovitis. Bilateral metatarsal tenderness noted." lab analyses were within the reference ranges. The rheumatologist reviewed x-rays taken on 4/4/00. The rheumatologist''s impression was "early osteoarthritis of the hands and feet." He prescribed Vioxx and S-adenyl-methionine. The subject remained under the care of this rheumatologist until at least 4/23/02. On 3/29/01, the rheumatologist noted "significant Raynaud changes of the pt''s feet." During this time, the rheumatologist prescribed Mobic, Procardia XL, and Voltaren. As of 4/23/02, the subject continued to complain of hand and foot pain. On 7/30/01, the subject came under the care of a new primary physician. She reported that she had "arthritis from Lyme injections." She requested referral to a different rheumatologist. The subject was evaluated by a second rheumatologist on 5/22/02. He noted that the pt reported "significant" pain and swelling in her hands six months after third LYMErix injection. "More recently, she has had some discomfort in her wrists, elbows, hips, ankles, and across the metatarsal heads, but it has been primarily the hands that bother her the most." The subject reported that her first rheumatologist ahd prescribed Lodine, Vioxx, Mobic, Celebrex, diclofenac acid, and Bextra. "All of these drugs seem to work for a while but then becam less effective. Other recent complaints included Raynauds'' syndrome that has been present over the last year and that has responded well to Nifedipine XR. She is now off that with the warmer weather." On physical examination, "Upper extremities revealed some slight puffiness and tenderness of the MCP, PIP and DIP joints. The DIP joints were consistent with Heberden''s nodes. Her wrists had some pain on movement but did not appear to be swollen. Elbows and shoulders moved well without any pain. Lower extremities revealed good range of motion of her hips, knees, ankles, and toes. There did not appear to be any swelling, but she was somewhat tender across the metatarsal heads." Lab analyses were within the reference ranges. The rheumatologist prescribed diclofenac sodium. Following the reported onset of osteoarthritis, the subject experienced depression. This event was not reported as an adverse event due to vaccine administration, but was found during the course of review of the suject''s medical records. Therefore, it is not listed as an adverse event. The most recent info, received 8/23/02, did not provide the outcomes of the reported events. Info received on 7/25/02 indicated that hand and foot pain persisted as of 4/23/02.


VAERS ID: 151913 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: New York  
Vaccinated:1999-08-01
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bone pain
SMQs:, Osteonecrosis (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:
Preexisting Conditions: hx of rib fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000078261

Write-up: In February, 99, the pt received her first injection of Lymerix. (She had spent 6 months in a high tick area.) She received her second injection in August, 99, and the third injection in February, 2000. About 2-3 months ago, the pt experienced achiness in her rib (where old fracture was). The achiness occurs while either sitting or lying down. The most recent information received on 3/15/00 reports the outcome of the achiness as ongoing.


VAERS ID: 151914 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Unknown  
Vaccinated:2000-03-15
Onset:2000-03-15
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:36
Entered: 2000-05-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypersensitivity, Pain, Tremor
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: vitamins
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000078301

Write-up: On 3/15/00, the pt received his third injection of Lymerix. Two hours later, the pt experienced uncontrollable trembling and his body ached. He called the ER and was told he was having an allergic reaction. The pt was treated with Benadryl. The most recent information received on 3/16/00 reports the outcome of the events as resolved.


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