Age: 12.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Infection, Laboratory test abnormal, Myalgia, Nervous system disorder
Clinical narrative: Report 2001012009-1 describes chronic fatigue syndrome in a 12 year old female who participated in a Lyme disease vaccine clinical trial (study vaccine 215274, protocol 022, center 008, patient number 02212). This report was received spontaneously from the patient's father and has not been verified by the investigator or other health care professional. Concurrent conditions included asthma and allergy to Sulfa. Concurrent medications included unspecified inhalers. The patient received three injections of study vaccine on unspecified dates. No adverse experiences occurred following these three injections. The patient received a booster dose of study vaccine in approximately October 2000. The pt's fahter reported that approximately one month after receiving the booster, in November 2000, she reportedly experienced headache and fatigue, and developed a sinus infection with a sore throat. Approximately two months  after receiving the booster, in December 2000, the patient's symptoms reportedly worsened. The headaches became "crushing" and the child reportedly experienced joint ache in her knees, elbows, and spine; the aches would move from joint to joint. Her joints were not red, swollen, or warm. The joint aches were not documented by a physician, and no fluid was aspirated from any other joints. The child also experienced muscle pains "all over", and "brain fog". In January or February 2001, the child was seen by a physician. An unspecified test for Lyme disease was reportedly negative. No treatment was administered at that time. On an unspecified date, the child developed a yeast infection and was treated with Nystatin. The patient's father indicated that the yeast infection was possibly related to study vaccine. The patient's father reported that the child was seen on an unspecified date by the study investigator, who reportedly made a diagnosis  of chronic fatigue syndrome. The child is currently being treated with Nystatin Acetaminophen w / Codeine (Tylenol #3), Amoxicillin (Amoxil), probenecid, trazodone (Desyrel), methylphenidate (Ritalin), and levothyroxine (Synthroid). As of 05/07/01, the sore throat had resolved. The headaches, joint aches, muscle pain, and "brain fog" persisted. The outcome of the sinus infection and yeast infection were not specified. The child sleeps 16 hours daily. She is unable to ambulate short distances without experiencing "pain and discomfort all over". She is not actively involved in sports or hobbies. Therefore, the chronic fatigue syndrome is considered incapacitating and this report is classified as serious. F/U additional info was rec'd from the investigator. other unspecified allergies, and intermittent sinus problems for which she was treated in the past with nasal steroid sprays, antihistamines, and decongestants. Family history is significant for chronic sinus problems in pt father. The pt was admitted to the hosp 5/21/01 with admitting dx of ataxia. The pt's chief complaint was weakness. The admitting physician stated that the pt was well until 8/00 when she became weak and developed headaches, she had opinion from pediatrics, infectious diseases and rheumatologly experts. Dx were not made.The investigator reported that as of 6/5/01, the sinusitis persisted. Sinusitis was the only serious adverse event reported by the investigator. Outcome of the events reported by the pt's father included the consultation notes of  the 5/01 hospitalization were not provided F/U The pt's 2 siblings also participted in the Lyme disease vaccine trial, they are doing absolutely fine, but their mother withdrew her consent for them to complete the trial. a diagnosis of anemia was made. Pt was seen by neurologst 5/23/01, the pt reported diffuse weakness, arthralgia, myalgia, low grade fever, nausea, chronic headaches, and gait ataxia. symptoms began 8/00. On 02/14/2002, the investigator forwarded medical records from a physician specializing in "pediatric and adolescent medicine, Lyme disease." On 06/20/2001, E. burgdorferi IgG by immuneflourescence essay was 1.64. Peripheral smear of blood collected 06/25/2001 demonstrated "slight anisocytosis, slight poililocytosis, occasional ovalocytes, and slight hypochromia. Platelets appear adequate. The pathologist also noted "three ring-forms" of Babesia containing food vacucles. Cytoplasm of monocyte containing morule of human monocytic ehrlichia. Treatment and outcome of babesiosis and ehrlichiemis were not provided. The most recent info received on 02/14/2002, did not provide outcome of any of the reported events.