Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus antigen positive, Epstein-Barr virus test negative, Headache, Herpes simplex, Herpes simplex serology positive
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician's office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28-AUG-2006 was vaccinated IM in left deltoid with her first dose of GARDASIL lot #653736/0689F.  Concomitant therapy included ORTHO TRI-CYCLEN.  On 22-SEP-2006 the patient developed fever, which she reported was "off and on".  She described the fever as spiking at night after 6-7 p.m.  Her fevers would reach 101-103 F and they resolved with rest plus the use of TYLENOL.  After "a couple days or so", the fevers would reappear.  Other symptoms included headache, hot and cold chills, body aches, and waking in the night.  The CMA stated that the patient also took unspecified allergy and cold medicine for a runny nose during the past month.  The patient reported these symptoms to the physician's office on 23-OCT-2006.  Laborary tests performed on that date included HSV (herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative) ; and EBV (Epstein-Barr virus) (negative).  It was reported "EBN was positive".  Also reported was "sed-rate and CBC = white blood cell count was normal".  The patient was to be seen the following week to determine whether the fevers continued.  Follow up information indicated that when the patient was seen on 30-OCT-2006 she received a second dose of GARDASIL.  The CMA noted that the patient was fine "so far".  Additional follow up information has been received from a physician concerning the 21 year old black female student who on 28-AUG-2006 at 11:30 a.m. was vaccinated IM in left arm with her first dose of GARDASIL lot #653736/0689F.  The physician reported that the patient made an appointment on 23-OCT-2006 with fever X 2 weeks.  Diagnostic laboratory tests were performed, including positive EBNA (Epstein-Barr virus nuclear antigen antibody) and EBV VCA IgG (Epstein-Barr viral capsid antigen immunoglobulin G antibody), which indicated past infection.  EBV VCA IgM (Epstein-Barr viral capsid antigen immunoglobulin M antibody) was negative (see laboratory data section for other results).  The patient had mononucleosis.  The physician indicated she had recovered.  Additional information is not expected.