Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound abdomen normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning her 18 year old daughter with no known allergies and a history of infectious mononucleosis ("a few years ago") who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot number not reported). Around 24-JUL-2009 (also reported as 26-JUN-2009) the patient was vaccinated with the third dose of GARDASIL (lot number not reported). The patient experienced a little fatigue and pain after the first and second dose of GARDASIL. Same day therapy included a "HTP" vaccine (unspecified) ("a tetanus or other usual vaccine that is given before someone enters college"). Concomitant therapy included LEXAPRO. On approximately 28-JUN-2009, 2 to 3 days after the administration of the third dose, the patient experienced low grade fever, diarrhea (still occurred periodically), rapid resting pulse up to 150 (still occurred periodically), headache (occurred every day), chronic severe abdominal pain and severe fatigue. The patient got her tonsils out 2 weeks prior to receiving the third dose of GARDASIL and experienced fatigue after the tonsils were removed. The fatigue became worse after the administration of the third GARDASIL. Test for mononucleosis, complete blood cell count, Lyme disease, abdominal ultrasound and sedimentation rate were performed and every test had been coming back negative. As of 05-AUG-2009 the patient had not recovered. Additional information has been received from a physician and a head nurse concerning the 18 year old female patient. On 08-JUN-2009 the patient was seen by the physician for a physical prior to college admittance. On 30-JUL-2008 she was vaccinated with the first dose of GARDASIL (lot number reported as 0070K, invalid for GARDASIL, but is a valid lot number for VARIVAX (Merck) ). On 05-NOV-2008 the patient was vaccinated with the second dose of GARDASIL (lot number 661530/0575X). On 25-JUN-2009 (reported by the patient's mother as around 24-JUN-2009 and 26-JUN-2009) the patient was vaccinated with the third dose of GARDASIL (lot number 662518/0087X). Same day therapy included BOOSTRIX (lot number AC52B030AA). It was confirmed that 2 weeks prior to the administration of the third dose the patient had her tonsils removed. The nurse did not know the name of the hospital or if the patient had been hospitalised for the removal of her tonsils. On 08-JUL-2009, the patient was seen by the physician with complaints of a sore throat. Result of the strep test was negative. On 20-JUL-2009, the patient was seen by the physician with complaints of sorer throat, Headache and abdominal pain. The patient had the following laboratory tests: CBC, metabolic marker test (CHEM-7), plasma Epstein-Barr virus viral load test (EBV). The laboratory test results were normal. On 24JUL-2009, the patient had the following laboratory tests: Lyme disease, plasma thyroid-stimulating hormone test (TSH), and repeat CBC. The laboratory tests results were normal. On 01-AUG-2009 and 03-AUG-2009, the patient was seen by the physician with complaints of worsening Headache, nausea and intermittent abdominal pain. The patient had the following laboratory tests: lipase, Amylase and SED rate. The laboratory tests results were normal. The patient did not have any follow-up visits with the physician. Follow-up information received from a physician concerning the 18 year old female patient who was vaccinated with the third dose of GARDASIL. Post vaccination the patient developed headache, abdominal pain, chronic fatigue, and fatigue with exercise. The patient had not recovered. Additional information has been requested.