Age: 14.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Urine analysis abnormal, Urine leukocyte esterase positive, Vomiting, White blood cell count increased
Clinical narrative: Initial report received on 03 December 2009 from a health care professional, who is also the patient's parent. A female adolescent patient (age not reported) had received a first dose of MENACTRA "about one month ago" (lot number, route, site and date of administration not reported) and approximately one to two weeks later, she experienced two to four days of nausea and began to experience hypersomnolence which continued at the time of the report (outcome also reported as unknown). According to the reporter, the patient was sleeping about 20 hours a day. The patient had no known allergies, no concurrent illness, and she had not received any other vaccines within four weeks prior to MENACTRA vaccination. No additional information was provided at the time of the report. Follow-up information was received from another health care professional on 25 January 2010. Based upon this new information, the case has been upgraded to serious. The patient was 14 years old at the time of vaccination. Medical history included sinusitis (December 1996), upper respiratory tract infection (December 2003), reactive airway disease (April 2005), knee pain from overuse injury (April 2006), and back pain and muscle spasm (May 2006). She had no known allergies, and was 132 pounds on the day of vaccination. Two days prior to vaccination she began complaining of nose bleeds. On 22 September 2009 she complained of a headache during physical education class at school, and subsequently experienced a vasovagal faint, hitting her head on a tile floor and losing consciousness for approximately 30 seconds. Prior to fainting, she reported feeling nauseous, and had not had anything to eat that morning. She felt "frozen" when she was assisted up from the floor, and was shaking. She was seen by her physician, and upon examination was noted to be alert, with clear lungs and a temperature of 98.2 degrees F. She was diagnosed with a vasovagal faint and epistaxis. The physician ordered increased fluids and a urine HCG (later reported as negative), and she received a first intramuscular dose of MENACTRA (lot number U3047AA). On 29 October 2009, she was seen again by her physician for complaints of ongoing achiness, nausea, one episode of vomiting, loss of appetite, and fatigue. Upon examination she was noted to be 130 pounds, with pale skin and pink cheeks. Her mother noted the she had missed 2 days of school the previous week due to nausea and fatigue, and noted that the symptoms had begun prior to the fainting episode on 22 September 2009. She denied any school or family problems. At that time her physician diagnosed fatigue and possible depression, and the patient was started on KEFLEX and ordered to have labwork done. Laboratory testing on 29 October 2009 showed lymphocytes 45% (normal 20-45%); all other testing, including cytomegalovirus and heterophile, was negative. Follow-up laboratory testing on 02 December 2009 was also negative. She was seen by a cardiologist, who felt that the patient had likely experienced a vasovagal faint on 22 September 2009; a cardiac echo and EKG on 14 December 2009 were normal. On 15 December 2009 a urinalysis was cloudy, with positive nitrite, 2 + leukocyte esterase, WBC 10-20 per hpf (normal 0-5), epithelial cells 10-20 per hpf (normal 0-5), moderate bacteria, and moderate calcium oxalate. A urine culture showed greater than 10(5) E. coli. She was subsequently seen by a psychiatrist, who determined that the patient did not have depression. A rheumatologist felt that the disease was a "mono-like illness". Final diagnosis was Chronic Fatigue vs Mono-like illness. At the time of the report, the patient was slowly recovering but still slept 14-16 hours daily per her mother. Documents held by sender: None.