Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Headache, Muscle spasms, Tinnitus
Clinical narrative: This report describes chronic fatigue/ fibromyalgia syndrome in a 49 year old male who received Lyme disease vaccine recombinant OsoA (Lymerix). This report was received as part of the litigation proceedings, with forwarding of medical records. The medical history included Lyme disease in 1992 that was treated with doxyclcline.  There were no concurrent medications. On 05/04/00 and 06/07/00, the vaccinee received his first and second injections of Lymerix respectively. In a diary, the vaccinee provided to to his physician, he indicated that on 06/12/00, he experienced "knee tight, ringing in his ears, headache behind forehead, fatigue." He also recorded "headache, fatigue and worsening knee pain" on 08/13/00, after touring a major city. On 02/11/02, in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from daily headaches, ringing in his ears, joint pain and swelling in his knee, flu-like symptoms and fatigue. The following information was obtained from medical records. The vaccinee presented to his primary physician on 06/24/00 because he " was concerned enough that he might have Lyme Disease". Lyme antibody screen was positive, but IgG and IgM Western blot were negative. Please see laboratory Data section. The primary physician prescribed doxycycline 100 mg twice daily The vaccinee's symptoms persisted, and the primary physician referred him to an infectious disease specialist. The vaccine was evaluated by the infectious disease specialist on 08/28/00. The vaccinee reported at that time that he also experienced weakness. He also reported that he began to feel better after five days of doxycycline therapy and was "back to normal" after 20 days of therapy. Five or six days after completing doxycycline therapy, "Symptoms came back". The vaccinee reported that the primary physician then prescribed cefuroxime (Ceftin) 500 mg twice daily for 20 days. The vaccinee reported that his symptoms "got 100% worse" after two days of Ceftin therapy. He then "gradually improved but in mid-August, he developed the headache, fatigue and knee pain. He notes that these symptoms began to weakened after he toured (a major city). He has continued to have these symptoms off and on associated with fatigue and ringing in both ears." The infectious disease specialist prescribed doxycycline on 08/15/00, prior to examining the vaccinee. Also prior to the evaluation, serology for Lyme disease was repeated. Physical examination on 08/28/00 was unremarkable. The physician's impression was "Arthalgias and weakness, rule/out viral syndrome. Doubt Lyme Disease. Plan- The patient has been reassured that the symptoms he describes are not related to Lyme Disease. In addition, his Lyme titer as mentioned above is negative which would be positive if he had an acute infection. Based on the above, I have asked the patient to stop talking doxycycline. Have reassured him that his symptoms will resolve with time." The vaccinee was referred to another infectious disease specialist. On 09/12/00, antinuclear antibody titer and rheumatoid arthritis factor were negative. Cytomegalovirus IgM was negative, IgG was positive. Epstein-Barr virus serology was consistent with "Chronic or Reactivated " infection. Parovirus B19 IgG was Positive. IgM was negative. Total creatine kinase concentrations were elevated. In a report to the vaccinee's primary physician, this infectious disease specialist recorded his diagnosis/impression as 1) Chronic Fatigue/Fibromyalgia Syndrome 2) Post Lyme 3) r/o (rule out) Motrin  (ibuprofen)-associated GI (gastrointestinal) bleed (melena). He recommended that the vaccinee stop taking Motrin. He prescribed lansoprazole (Prevacid) 30 mg daily. He recommended magnetic resonance imaging (MRI) of the the brain, which was normal. He also recommended that the vaccinee be referred to a rheumatologist (Please note that melena was not reported as an adverse event due to vaccine administration but was found during the course of review of the vaccinee's medical records. Therefore, it is listed as an adverse event.) Pharmacy records indicated the primary physicians also prescribed butalbital/acetaminophen/caffeine and cyclobenzaprine. The most recent information on 07/03/02 did not provide the outcome of the reported events. The adverse events "ringing in the ears" does not meet serious criteria,but is being submitted  as an expedited report by special FDA request per the 06/28/00 letter.  Reported on 03/04/2003: "The subject's medical history included recurrent low back pain (1975), fracture of mandible (1974), back spasms (1976), degenerative disc disease L5-S1(1976), bilateral spondylolysis at L5 with associated spondylolisthesis of LS on S1 (1976), tendonitis of the left hand (1998), carpal tunnel syndrome of the right hand (1998), head trauma resulting in a contusion in the right supra-orbital region at the base of the anterior cranial fosse (1985), chronic headaches (1995), deviated nasal septum, recurrent epistaxis (1984), venereal herpes (1987), hemangioma left shoulder (1991), epidermal cyst left neck (1994), tick bite (1992), Lyme disease treated with doxycycline (1992), hypertension, elevated cholesterol concentration (1997), elevated triglyceride concentration (1997), deconditioning (1998), sinusitis, otitis media, ringing in the ears associated with episodes of sinusitis and otitis media, and exposure to silica-containing dust.  The subject had no known drug allergies.  Surgical history included excision of the hemangioma on the left shoulder (1991).  Concomitant medications included valsartan/hydrochlorothiaside (Diovan), atorvastatin calcium (Lipitor), sustained-release metoprolol succinate (Toprol XL), mometasone furcate monohydreate (Nasonex), guaifenesin (Duratuss), polysaccharide-iron complex (Niferex Forte), lansoprazole (Prevacid), acyclovir (Zovirax), and loperamide hydrochloride (Imodium).  On 05/04/2000 and 06/07/2000, the subject received his first (lot # LY14439) and second (lot # LY146a9) injections of LYMErix, respectively.  IN a diary the subject provided to his physician, he indicated that on 06/12/2000 he experienced "knees tight, ringing in ears, headache behind forehead, fatigue."  He also recorded "headache, fatigue and worsening knee pain" on 09/23/2000, after touring a major city.  On 02/11/2002, in a statement of injuries, the subject's attorney alleged that the subject "suffers from daily headaches, ringing in his ears, joint pain and swelling in his knees, flu-like symptoms, and fatigue."  Following the reported onset of chronic fatigue/fibromyalgia syndrome, the subject experienced melena, anemia, allergic rhinitis, histal hernia, and possible superficial antral ulcer.  These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records.  Therefore, they are not listed as adverse events.  The following information was obtained from medical records.  The subject presented to his primary physician on 06/21/2000 with a complaint of knee pain.  The subject reported that he had been riding a horse on 05/20/2000; after this, he experienced increasing knee pain.  Physical examination revealed full range of motion of the right knee.  There was no effusion.  The physician's assessment was "knee pain" and he prescribed celecoxib (Celebrex).  In a letter dated 06/22/2000, the subject reported that he had been experiencing headaches.  the subject "was concerned enough that he might had Lyme Disease".  Lyme antibody screen was positive, but IgG and IgM Western blots were negative.  Please see Laboratory Data section.  On 06/26/2000, the physician prescribed doxycycline 100mg twice daily.  The subject telephoned the physician on 06/26/2000 and reported that he had been bitten by a tick between his first and second injections of LYMErix.  The subject "wants to know if this might be reason for the positive Lyme teter.  Patient told shots not 100% effective-hadn't had full series yet.  Will need to take doxy(doxycycline) to be safe."  On 07/16/2000, the subject reported that he was "much better" and that his "symptoms cleared quickly with doxy."  The subject remained under the care of this physician until at least 04/16/2002.  The following additional signs and symptoms were reported during this time: "symptoms of Lyme disease returning" including knee pain, ringing in the right ear, and headaches; clicking in the elbows; onset of herpes simplex type II; heartburn; fatigue; "severe" cramps in both thighs; "jet black stool" for one week after taking ibuprofen for three days; weakness; knee stiffness; nausea; diarrhea; "feeling crummy", "jittery" feeling; red faced, and feelings of "speeding".  Atorvastatin therapy was discontinued following the onset of muscle cramps and elevated creatine phosphokinase (CPK) concentrations.  Atrovastatin therapy was later resumed.  The elevation in CPK and muscle cramps recurred, and atorvastatin therapy was again discontinued on 09/16/2001.  Atorvastatin therapy was resumed on 10/16/2001, and the muscle cramps recurred.  Atorvastatin was once again discontinued, in 12/2001.  Therapy was resumed in 01/2002, and the cramps returned.  During this time period, the physician noted no edema in the extremities (07/26/2000), "knee pain 60% better" (08/03/2000), and warmth in the lateral aspect of the left thight.  He noted that the headaches resolved by 06/26/2001.  He also noted that the fatigue resolved by 09/11/2001.  After metoprolol therapy was discontinued.  HLA phenotyping revealed the presence of the HLA-DR4 antigen.  All other laboratory evaluations were within the reference ranges.  Please see Laboratory Data section.  ON 11/06/2001, the subject reported recurrence of the left knee pain.  The physician made additional diagnoses of "Recurrent Lyme - despite Doxy" (07/26/2000), HSV2 (herpes simplex virus, type 2) recurrent" (07/26/2000), "?symptoms due to LYMErix" (08/29/2000), "GI (gastrointestinal) bleed by history - severe anemia" (10/10/2000), "fatigue secondary to anemia" (11/30/2000), "DJD(degenerative joint disease) knees" (02/15/2001), and "persistent fatigue and joint pain 7 due to Lyme vaccine" (04/16/2002).  The physician prescribed cefuroxime axetil (Ceftin), acyclovir (Zovirax), butalbital/acepaminophen/caffine (Floricet), polysaccharide-iron complex (Niferex), cyclobenzaprine hydrochloride (Flexeril), paracetamol (Tylenol Arthritis Strength), and exercise.  He referred the subject to an infectious disease specialist and an orthopedist.  As of 04/16/2002, the subject was experiencing "increased knee pain, left greater than right....still tired and fatigued....headaches present."  The subject was evaluated by the infectioius disease specialist on 08/28/2000.  The vaccineee reported at that time that he also experienced weakness.  He also reported that he began to feel better after five days of doxycycline therapy and was "back to normal" after 20 days of therapy.  Five or six days after completing doxycycline therapy, "symptoms came back".  The subject reported that the primary physician then prescribed cefuroxime (Ceftin) 500mg twice daily for 20 days.  The subject reported that his symptoms "got 100% worse" after two days of Ceftin therapy.  He then "gradually improved but in mid-August, he developed the headache, fatigue and knee pain.  He notes that these symptoms began the weekend after he toured (a major city).  He has contined to have these symptoms off and on associated with fatigue and ringing in both ears."  The infectious disease specialist prescribed doxycycline on 08/15/2000, prior to examining the subject.  Also prior to the evaluation, serology for Lyme disease was repeated.  Physical examination on 08/28/2000 was unremarkable.  The physician's impression was "Arthralgias and weakness, rule out viral syndrome.  Doubt Lyme Disease.  Plan-The patient has been reassured that the symptoms he describes are not related to Lyme Disease.  In addition, his Lyme titer as mentioned above is negative which would be positive if he had an acute infection.  Based on the above, I have asked the patient to stop taking Doxycycline.  Have reassured him that ahis symptoms will resolve with time."  On 09/05/2000, the subject telephoned his primary physician and stated, "researched Internet - wants to have ANA (antinuclear antibody) done.  Thinks he's sick from vaccine not Lyme- Doxy isn't helping at all."  The subject completed a VAERS form on 09/06/2000.  On the form, he indicated that his symptoms began one week after the second injection of LYMErix.  He indicated that he had no pre-existing medical conditions and had not sought medical attention for the reported events.  The subject's primary physician completed a SmithKline Beecham Adverse Event form on 09/08/2000.  He listed the adverse events as "knee pain, headache, fatigue, ringing in ears".  He indicated that he considered these events to be "severe" in intensity and related to LYMErix administration.  he reported that the immunization series had been discontinued.  The subject was referred to another infectious disease specialist.  On 09/12/2000, antinuclear antibody titer and rheumatoid arthritis factor were negative.  Cytomegalovirus IgM was negative, IgG was positive.  Epsein-Barr virus serology was consistent with "Chronic or Reactivated" infection.  Parvovirus B19 IgG was positive; IgM was negative.  Total creatine kinase concentrations were elevated.  In a report to the subject's primary physician, this infectious disease specialist recorded his diagnosis/impression as "1)Chromic Fatigue/Fibromyalgia Syndrome. 2) Post Lyme. 3) R/O Motrin (ibuprofen)-associated GI (gastrointestinal) bleed (melena)."  He recommended magnetic resonance imaging (MRI) of the brain, which was normal.  He also recommended that the subject be referred to a rheumatologist.  The most recent information, received on 10/03/2002, did not provide the outcomes of the reported events.  This report has been determind to be a duplicate of report  A0334065A (formerly, 2000026164-1).  Report A0334065A has been voided, and all information merged into A0362496A, which will remain the report of record for this subject. Follow up on 02/26/04: "Information received on 08/07/03 indicated that, as of 05/19/03, "Fifteen days out of the month pt feels better-other 15 days-not so well." The most recent information received on 01/27/04 did not provide the outcome of the reported events."