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Found 2226 cases where Vaccine is LYME

Case Details

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VAERS ID: 151811 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Skin burning sensation
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 19990291851

Write-up: On an unspecified date, the pt received his first dose of Lymerix for prevention of Lyme disease. Subsequently, he experienced burning sensation at the injection site and knees, hands and feet. The most recent information received on 1/11/00, reports the condition of the pt as unknown.


VAERS ID: 151812 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Male  
Location: Minnesota  
Vaccinated:1999-12-28
Onset:1999-12-28
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:114
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM LY120P9 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pain, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), 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:
Current Illness:
Preexisting Conditions: allergy to bees
Allergies:
Diagnostic Lab Data:
CDC Split Type: 19990336121

Write-up: On 12/28/1999, the pt received the first IM-left deltoid dose of Lymerix. One hour later on 12/28/1999, the pt experienced chills, fever, body shakes and body aches. No treatment was given. Symptoms resolved on 12/28/99. The most recent information received on 12/29/99 reports the condition of the pt is resolved.


VAERS ID: 151813 (history)  
Form: Version 1.0  
Age: 73.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1999-03-01
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Facial palsy, Gastritis, Glossodynia, Oesophageal pain, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (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: hypertension
Allergies:
Diagnostic Lab Data: EGD-gastritis
CDC Split Type: 20000090771

Write-up: Following the second dose of Lymerix, the pt experienced a burning sensation of the stomach, esophagus, and tongue. An EGD was done. Stomach biopsy showed gastritis out 24 hour monitoring of gastric contents was normal. The MD felt that the pts condition was related to dysesthesia, neurologically caused. The pt was treated with Propulsid, Prevacid, and Carafate which did not alter his symptoms. Upon diagnosis it was found that the pt had a right sided facial droop. Cranial nerves were normal. The most recent information received on 1/4/00, reported the condition of the pt is ongoing. A 15-day follow up report received 04/19/2002 adds: Report 2000000077-1 describes dysesthesia and burning mouth syndrome in a 72-year-old male who received Lyme disease vaccine recombinant (Lymerix). Additional info was received as part of litigation proceedings. Medical history included difficulty sleeping, bilateral heel spurs, osteoarthritis of the left knee (1986), degenerative changes of the dorsal spine (T5-T8, 1991), gout (1995), benign prostatic hypertrophy (1996), hypercholesterolemia (1996), elevated triglycerides (1996), hypertension (1997), glucose intolerance (1997), elevated lactic dehydrogenase (1995), elevated SGOT (1995), elevated creatine kinase (1996), elevated eosinophil counts (1997) and elevated SGPT (1999). The pt has no known allergies and no history of Lyme disease. Surgical history included tonsillectomy (1964) and unspecified nasal surgery(1965). Family history was significant for his father dying at age 34 and his sister dying at age 56: the pt reported the cause of their deaths as "Liver". The pt reported that he jogged 3 miles per day, six days per week. Concurrent medications included fosinoprel (Monopril) 20 mg daily, colchicine 0.6 mg daily, and tomazepam 30 mg daily at bedtime. Following the reported onset of the dysesthesia and burning mouth syndrome, the pt experienced increased serum creatinine concentration, suspected prostatitis, first-degree atrioventricular block, and ringing in the ears. There were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt''s medical records. Therefore, they are not listed as adverse events. The pt received his first 0.5 mL intramuscular injection of Lymerix (lot LY12BD) on 02/11/1999. The pt was seen by his primary physician (the vaccine provider) on 02/23/1999. At that office visit, the pt reported that he "felt very tense, nervous" after receiving Lymerix, but "feels good now". The pt received his second 0.5 mL intramuscular injection of Lymerix (lot LY120BD) on 03/18/1999. No adverse experience was recorded in the vaccine provider''s office records following the administration of this injection. The pt received his third 0.5 mL intramuscular injection of Lymerix (lot LY120BD) on 04/22/1999, two months after the first injection, rather than the recommended interval of 12 months. The reporting physician stated that the pt experienced a burning sensation of the stomach, esophagus and tongue. The pt was treated with cisapride (Propulsid), lansoprazole (Prevacid) and sucralfate (Carafate), which did not alter his symptoms. On physical examination, it was noted that the pt had a mild right-sided facial droop. Cranial nerves were normal. The physician attributed the burning sensation to a neurologically-caused dysesthesia. The following info was obtained through review of medical records. On 05/21/1999, 30 days after the administration of the third injection of Lymerix, the pt was seen by his primary physician with a chief complaint of "stomach burn, nausea, diarrhea, epigastric pain", the pt reported symptom onset on 05/20/1999 (25 days post-immunization). The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid 30 mg daily. The pt was not seen again by the vaccine provider until 07/15/1999; reason for the visit was evaluation of hypertension and hypercholesterolemia. The pt reported that he still experienced "stomach burning sensation". The physician noted "He is having trouble with indigestion. He said that the Prevacid has helped before." The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid. The pt was seen by the vaccine provider on 09/20/1999 with a chief complaint of epigastric pain. At that time, the pt reported that the burning sensation started following receipt of Lymerix in Feb 1999. The pt reported that the burning sensation now extended "into throat and mouth". The physician made a diagnosis of gastroesophageal reflux disease (GERD) and prescribed rabeprazole (Aciphax) 20 mg daily. Antibodies against Helicobacter pylori were measured on 09/25/1999: IgC and IgM antibodies were negative. The pt was referred to a gastroenterologist. The pt underwent esophagogastroduodenoscopy (EGD) and colonoscopy on 10/15/1999. Mild gastritis, mild duodenitis, and hypertrophy were observed. The gastroenterologist''s impressions were "1. Mild gastritis, propyloric inflammation. 2. Hypertrophy." The pt then underwent colonoscopy. One to 3 diverticulums were identified and 3 polyps were removed. The gastroenterologist''s impression was "Polyps of the right colon." The pathologist''s diagnoses, based upon specimens obtained during EGD and colonoscopy, were "A. Stomach, antrum: Benign hypertrophic gastric mucosa. No H. pylori organisms identified. B Colon, proximal secum: Tubular adeonma. C. Colon, distal cecum: Mildly edematous colonic mucosa. D. Colon ascending: Hyperplastic polyp." The pt was seen by his primary physician on 11/4/1999. At that time, he reported that the gastroenterologist had prescribed Propulsid 10 mg daily, but it was "not helping". The pt stated that he had been experiencing "abdominal pain, burning feeling" since receiving Lymerix in April 1999. On physical examination, the physician observed a ventral hernia when the pt flexed his abdomen. The hernia was "about 3 to 4 inches up from xyphoid to above umbilicus." It was not tender. The physician''s assessment was "Abdominal pain - secondary to ventral hernia?" An esophogram was performed on 11/08/1999. The radiologist''s impression was "unremarkable esophogram." Ultrasound of the gallbladder was performed on 11/26/1999, which "shows a normal appearing gallbladder, which is free of stones. There is also no evidence of bile duct dilatation." The pt was seen by a gastroenteroloist on 11/12/1999 for "evaluation of chronic reflux symptoms." The pt reported that he "has been free of any digestive symptoms until April of this year after he received the Lyme disease vaccination and subsequently developed heartburn, burping and acid regurgitation, occurs day and night, not necessarily related to meals, for which he has been treated with antiacids, Prevacid and Prilosec in the past with no significant relief. He has been treated with Aciphex and Propulsid with marginal relief. His appetitie is well maintained. There is no recent history of dysphagia, odynophagia, significant abdominal pain, alteration of bowel movement or weight loss...Physical examination in the office is unremarkable including abdominal examination." In a letter to the vaccine provider, the gastroenterologist stated, "Per phone conversatio with (the pt) on 12/2/1999, his ''reflux symptoms'' have been significantly improved while on Aciphex therapy lately." On 11/18/1999, the pt underwent an esophageal manometry study and 24-hour pH probe was inserted. The gastroenterologist''s impression of the esophageal manometry study was "Normal esophageal manometry study". No gastroesophageal reflux was observed with the 24-hour pH probe. The pt was seen by the reporting physician on 01/03/2000. At that time, he reported his chief complain as "Acid Reflux". He indicated that the pain was a constant burning and was located in his abdomen. On a scale of zero to ten, he rated that pain as "7 to 8". At that time, he also reported ringing in his ears. In his review, the physician wrote, "Pt described sensations as dysesthesia. Pt is able to identify this symptom as dysesthesia." On 01/04/2000, total Lyme antibodies by RIA were 2.15 (seropositive $g0.99). Lyme IgG by Western blot analysis was negative; only a 31 kDa band was present. Lyme IgM by Western blot analysis was negative; only a 31 kDa band was present. On 01/14/2000, serologies for hepatitis B and C were negative. Total hepatitis A antibody was reactive. The pt was seen by the reporting physician on 04/13/2000 "for increased sensation of burning to tongue and into throat. Pt denies GERD (gastroesophageal reflux disease), gas symptoms. Sense of smell is unaffected. No dysphagia with food/fluids. Pt admits to increased pain with numbness/tingling sensation to upper lip area and radiates to roof of mouth, bilateral nares, and chest area. Pt describes as furnace burning." On physical examinatino, the physician noted "right facial droop persists/unchanged". The physician''s impression was "Dysensation to glossal/pharyngeal/nares area". The pt reported that a rapidly tapering course of methylprednisolone (medrol dosepak) "had helped in past". The physician prescribed another course. The reporting physician saw the pt on 07/11/2000 for a routine physical examination. The pt reported that his only complaint was "chronic burning pain to throat/chest". The physician''s impression was "chronic complaint of dyspepsia/retrosternal pyrosis. Elevated concentrations of liver enzymes and creatinine were noted. On 07/21/2000, the physician''s assessment was "rule out hepatitis". The pt was seen in a pain management clinic on 08/22/2000, with a chief complaint of "burning pain in his throat, mouth and chest". The pt told the pain management physician that "he was in his usual state of health until February of 1999 when...he received 3 Lyme disease vaccine intramuscular injections one month apart. He states that a few days after the first injection, he began to experience burning sensation in this stomach. After the second injection, the burning worsened. After the third injection, the burning progressed to his throat and mouth and nose...He describes his pain as burning, constant, not aggravated and not relieved by any medications or maneuvers...He denies having problems with sense of taste and smell." On physical examination, the physician "could not aggravate his pain by light palpation of his lips and face. I could not reproduce his anterior chest wall pain on percussion and palpation of his sternum and costochondral joints. Sensation to pinprick is within normal limits in his face, neck and anterior chest wall." The physician''s impressions were "1. Chronic neuropathic pain. 2. Rule out burning mouth syndrom." The physician prescribed gabapentin (Neurontin) 100 mg three times daily. On 08/24/2000, folic acid and vitamin B12 concentrations were normal. The pt was seen by the gastroenterologist on 09/26/2000 for follow-up regarding the colonic polyps which had been removed on 10/15/1999. His medications at that time included Monopril 20 mg daily and colchoine 0.6 mg daily. The pt reported persistent burning in his chest. The physician''s impression was "Atypical chest pain". The pt underwent EGG on 10/23/1999. The gastroenterologist''s impressions were "1. Small gastric ulcer involving the antrum of the stomach. 2. Grade I reflux esophagitis." No Helicobacter-like organisms were seen in the biopsy specimen. The pt also underwent colonoscopy. The gastroenterologist''s impressions were "1. Mild left-sided diverticulosis. 2. No polyps, masses or colitis." The gastroenterologist stated "Certainly the reflux changes can account for the pt''s atypical chest pains. The pt should be on a proton pump inhibitor for a minimum of 2 months and I have given him a prescription for Prevacid 30 mg once a day...Lifestyle modification has been discussed with the individual. He also recommended a high-fiber diet. The pt was seen by the reporting physician on 01/22/2001 "for complaint of diffuse arthralgias since November". The pt reported that the burning and dysesthesia persisted. However, "Pt relates he feels fine." The physician''s assessment was arthralgia and gout. He prescribed indomethacin 50 mg twice daily. Serologies for hepatitis had been repeatedd on 01/16/2001. Serologies for hepatitis B and C were negative. Hepatitis A IgM was non-reactive. On 02/27/2001, the pt saw the reporting physician "for complaint of increased burning mouth syndrome." On physical examination, the physician noted "right platysmal muscle deformity and right facial asymmetry. The physician''s assessment was burning mouth syndrome and facial asymmetry. On 02/18/2001, total Lyme antibodies by RIA were <1.00 (negative, <1.00). The pt underwent computed tomograph (CT) of the brain, neck and chest, with and without contrast, on 03/03/2001. The results were "Unremarkable". On 03/18/2001, the pt was referred to a neurologist. On 04/02/2001, Erythrocyte sedimentation rate was 21 mm/hr. The pt was seen by the gastroenterologist on 05/01/2001 with a chief complaint of "trouble swallowing". At that time, the pt reported that he had "Lyme disease secondary to vaccination". The physician noted "recent onset of dysphagia over the past 2 months, mostly with solids but more of difficulty initiating swallow consistent with oropharyngeal dysfunctional process." His impression was "Dysphagia, most consistent with oropharyngeal process quite possibly related to Lyme disease from vaccine." A formal swallowing study was recommended. The pt stated that, following receipt of the third injection of Lymerix, he was told he had "acid reflux" which "was coincidental" to Lymerix administration. The pt alleged that he "developed a severe and permanent burning sensation along his entire oropharyngeal/esophageal tract". He also claimed that he sustained "severe and permanent injuries to his mouth, tongue, throat, esophagus, stomach and digestive tract". The pt claimed that he is also "suffering from osteoarthritis". The onset of this event, affected joint and treatment were not provided. Info received on 03/02/2001 did not specify treatment of the facial droop or osteoarthritis. The burning sensation along the pt''s oropharyngeal/esophageal tract was reportedly worsening. The facial droop and osteoarthritis were ongoing. The most recent info received on 11/30/2001, did not provide the outcomes of the dysphagis, facial droop, osteoarthritis, or Lyme disease. The dysesthesia and burning mouth syndrome persisted as of 03/19/2001. The adverse events of dysesthesia, burning mouth syndrome, facial droop, and osteoarthritis do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/2000 letter. Case number 2001004203-1 has been identified as a duplicate record to this case (2000000077-1) and all relevant info has been merged into this case. Case number 2001004203-1 will be logically deleted from the database and this case, number 1000000077-1, will stand as the case of record for this patient.


VAERS ID: 151814 (history)  
Form: Version 1.0  
Age: 73.0  
Gender: Male  
Location: Kansas  
Vaccinated:1999-04-14
Onset:1999-06-07
   Days after vaccination:54
Submitted: 2000-04-21
   Days after onset:319
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dermatitis, Hypoacusis, Iritis, Tinnitus, Vasculitis
SMQs:, Hearing impairment (narrow), Vasculitis (narrow), Ocular infections (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000001021

Write-up: Approximately 3 weeks post vax, the pt experienced iritis, followed by dermatitis and arthralgias. The iritis resolved, the dermatitis is ongoing and the arthralgias are now intermittent. Both symptoms recur. The most recent information received on 1/27/00, reports the condition of the pt is ongoing as of 1/14/00. The most recent information, received on 4/28/00, reports the condition of the pt as unknown. The follow up received on 7/27/00 states concurrent medical conditions included "arthritic shoulders," ischemic heart disease status post angioplasty, diabetes, colon cancer with persistent colostomy, and history of anemia. The pt had no previous rheumatological disorders or previous episodes of iritis. Serology testing for Lyme disease did not show any evidence of prior or concurent infection with Lyme disease. Concurrent medications include aspirin. On 5/14/99 the pt received his first injection of LYMErix. Approximately two hours later, the vaccinee had chills and sweats. He later develped a rash from his knees down which came and went, swollen leg veins causing pain, and joint swelling. Approximately three weeks alter, on 6/7/99, the pt experienced a red, painful eye and photophobia. On 6/14/99 he was diagnosed with ritis and started on steroid eye drops. He tapered down and his condition was much improved. The iritis was followed by dermatitis and migratory arthralgias. Additionally, pt complained of diminished hearing in the left ear. On 6/11/99 the vaccinee had a tick bite on his right lateral ankle. He then developed a bull''s-eye rash that faded over several days and had diminished appetite (considered non-events). June 1999 physiican visits: the vaccinee had some increased dependent edema in his left leg and his sedimentation rate was noted to be elevated. For two and a half weeks in June, the vaccinee had symptoms including migratory arthralgias including the wrist, elbows, ankles, but no hot joints or effusions. Vaccinee develpoed ringing in his ears and diminished hearing which started first in his left ear and then affected his right ear without vertigo or marked balance disroder. He had develped some mild jaw discomfort. He had developed non-blanching splotchy purpuric lesions on his lower legs, right greater than left, but he stated that he had been "walking with a cane to keep pressure off his right leg, because it just felt better that way." Assessment included: 1. VAccinee had 2-3 week episode of infectious or immunologic disorder with findings of elevated sed rate, elevated muscle enzymes, CPK, SGOT and SGPT, mild anemia and possible developing vasculitis. 2. Diminished hearing with no structural ear findings, unclear relationship to tick borne diseaes, no Bell''s palsy. Finding of Q-tip trauma to right ear canal. 3. Recent iritis possibly triggered by idiopathic or infectious process. Seemingly adequately responsive to tapering steroid eye drops completed approximately 6/25/99. August 1999 physician visit: Western blot and "other" serology was done, and it was concluded that the vaccinee did not have any progressive active infection. The vaccinee was told to wean the tetracycline. He had some arthralgia around the knee and left heel. He still got a few non-blanching circular lesions on his legs, but his iritis had not returned. His hearing was improved. The edema in his legs had essentially gone away and he was feeling overall much better. Assessment included: 1. Apparent immunologic response to some stimuli either Lyme diseaes or the Lyme injection with iritis and associated symptoms included hearing loss currently improving. 3. Dependent edema currently resolved although he still had some non-blanching vascular raised purple lesions scattered on his legs. 4. Mild anemia. Remains off aspirin. Vaccinee may just have a non-specific anemia of hte aged. 11/3/99 physiican visit: Vaccinee was placed on colchicios but couldn''t tolerate it and discontinued. He then again was having some mild arthralgia complaints, no hot joints or swelling. He also was still having recurring prupuric lesions on his lower extremities. Assessment: 1. A post lyme vaccine by hisotry polymyalgia syndrome, possible palindromic rheumatism. 2. Elevating blood pressure. Vaccinee may have component of nephrosclerosis or vasculitis affecting the renal function. Plan: start on Cozaar 50mg once a day. 12/2/99 physician visit: the pt was seen by a different physician who felt that the pt did not have any evidence of active renal vasculitis. Complement levels were normal, creatinine clearance was 63ml per minute (normal) with a non-nephrotic range proteinuria at 148mg per 24 hrs. Vaccinee was doing well on Cozaar. He felt like his arthritic discomforts were better on colchicine which he was placed back on and could only tolerate at .6mg. Vaccinee still got small capillary hemangioma type bleed on his legs periodically that resolved over time and were replaced by new lesions. He stated that he had not gotten back to his usual lifestyles following his response to the vaccine. Assessment included: 1. Some form of palindronic rheumatism, possibly triggered by Lyme vaccination. 2. Erythematous lower extremity non-palpable purpuric lesions. 3. Pt appeared to be tolerating colchicine with some tendency toward diarrhea. 4. Hypertension. 5. Non-nephrotic range proteinuria with normal creaminine clearance. 1/4/00 physician visit: Vaccinee saw a specialist regarding his lower leg skin lesions, but he apparently had no active skin lesions on that day. 1/20/00 physician visit: Vaccinee reports that his bronchitis (non-event) was resolved. He did have some fluctuation in hearing in his left ear. He had discomfort around his right jaw and he had increased back and extremity over his lower extremities. Assessment included 1. Post Lyme vaccine arthralgia syndrome presenting at first with iritis; followed by arthralgias that tend to recur associated with recurring hearing fluctuation and recurrent apparent non-palpable, non-blanching possible vascultiis lesions. 3/20/00 physician visit. Vaccinee stated that he experienced fleeting pain anywhere on his extremities several times daily. Sometimes he had joint aches which bothered him for a day or two and then went away. He stated that he had been able to stay active and has been feeling generally pretty well. He still got occasional erythematous oval rashes on his lower extremities that came and went. Assessment included: 1. History of possible ischemic realted arthralgias, recurring lower extremity dermatitis. Continued on colchicine to try and supress a possible inflammatory chornic response to Lyme vaccine. 3/29/00 physician visit: vaccinee had a continued "flare of symptoms," burning in his ears and more rash on his legs (one lesion was biopsied). Vaccinee was no longer having headaches, and just as quickly as the symptoms flared including increased edema in his left leg and arthritic discomfort, stiffness, and swelling in his knee, the symptoms have again imroved. Physiican stated that many of the pt''s symptoms were immunologically mediated. Assessment: 1. Status post biopsy lesion left leg, awaiting pathology report. 2. Inflammatory condition post Lyme titer vaccine syndrome. 3. On colchicine to supress possible inflammatory response to this stimulant. 4. Hypertension improved back on Cozaar therapy. 5/4/00 physician visit: The vaccinee continued to have arthralgias. He was not as energetic as he used to be. He had some recurring of small painful hemorrhagic skin lesions. They start out as a little tneder nodule and then form a reddish non-pitting macular and resolve over a 7 to 10 day period. A week or two may pass with no lesions an then the lesions recur. A biopsy was done and th epath report returned showing a diagnosis of leukocytoclastic amoiiris. Specialist said that no particular therapy was indicated, except for short burst of sterodis, if needed. Vaccinee continued to have arthritic joint stiffness and flares of discomforts primarily in his knees and ankles, occasionally hips. He had pre-existing history of arthritic discomforts in his shoulders that were still there. He denied any obvious joint effusion. The joints sometimes got warm, but not particularly hot, no erythema, redness, nothing to suggest active infection. Assessment: 1. Leukocytoclastic vasculitis of unknown etiology. May represent a non-specific idiopathic vasculitis. 2. Polyarthralgia, historically with onset following Lyme vaccination. The most recent info, recieved on 7/27/00 reports the condition of the polyarthralgias and leukocytoclastic vasculitis as ongoing. This report is considered as medically serious (OMIC).


VAERS ID: 151815 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2000-01-04
Onset:2000-01-04
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:107
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM LY123B9 / 2 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Dizziness, Nausea, Neck pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antihypertensive
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: BP-130/80, Pulse-76
CDC Split Type: 20000001101

Write-up: On 1/4/00, the pt received the second dose of Lymerix. One hour following vax the pt experienced vague lightheadedness, left neck pain, and queasiness. The queasiness and lightheadedness persisted. The left neck pain resolved. The most recent information received on 1/4/00, reported the condition of the pt is ongoing.


VAERS ID: 151816 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Male  
Location: Virginia  
Vaccinated:1999-12-30
Onset:1999-12-30
   Days after vaccination:0
Submitted: 2000-04-21
   Days after onset:112
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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:
CDC Split Type: 20000001161

Write-up: On 12/30/99, the pt received his first IM-left deltoid dose of Lymerix. A few hours later on 12/30/99, the pt experienced injection site soreness and a tingling prickly sensation on his whole body. An MD visit was required and anti-inflammatories were prescribed. The symptoms lasted a few days and then subsided. However they reoccurred and persist. The most information received on 1/5/00 report the condition of the pt is ongoing.


VAERS ID: 151817 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: New Jersey  
Vaccinated:1999-11-23
Onset:1999-11-26
   Days after vaccination:3
Submitted: 2000-04-21
   Days after onset:146
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site hypersensitivity
SMQs:, Hypersensitivity (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: Ortho-tri-cyclen
Current Illness:
Preexisting Conditions: allergy to PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000001341

Write-up: On 11/23/99, the pt received her first dose of Lymerix for prevention of Lyme disease. Three days later, on 11/26/99, the pt experienced an 8cm local reaction. No treatment was given. The most recent information received on 1/5/00, reports the condition of the pt as resolved.


VAERS ID: 151818 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000002201

Write-up: On an unspecified date, the pt received an unspecified dose of Lymerix. Subsequently, she experienced induration the size of a golf ball, swelling, redness and tenderness at the injection site. The most recent information, received on 1/7/00, reports the condition of the pt is unknown.


VAERS ID: 151819 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000002281

Write-up: On an unspecified date,the pt received a dose of Lymerix. Subsequently, he experienced induration the size of a golf ball, swelling, redness and tenderness at the injection site. The most recent information received on 1/7/00 reports the condition of the pt is unknown.


VAERS ID: 151820 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Maryland  
Vaccinated:1999-06-01
Onset:0000-00-00
Submitted: 2000-04-21
Entered: 2000-05-10
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscle disorder, Musculoskeletal stiffness, Tendonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000006431

Write-up: Following dose 2 of Lymerix, the pt experienced tightness and stretching sounds in her knees. She was stiff and believed she possibly had tendonitis. She did not believe that these symptoms were coincidental. She did not have any serious pain to speak of. She had stiffness when going from a sitting or squatting position to standing and climbing stairs. Once she got moving she was fine. The most recent information received on 1/12/00, reports the condition of the pt is ongoing.


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