Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a 21 year old female with rituximab allergy who in 2009 was vaccinated with a series of 3 doses of GARDASIL (lot # not unknown), as encouraged by her physician. Concomitant therapy included CELEXA, LAMICTAL, CONCERTA, lorazepam, rituximab and prednisone. The patient was tired after the first dose of GARDASIL. Six months after the vaccination series she experienced limbic encephalitis, shrinkage of the right hippocampus, short-term memory loss, tiredness and fluid build-up on the temporal lobe and was hospitalized and treated (not further specified). Lab and diagnostics studies were performed (results unknown). The patient stated that her physicians did not know if she could be healed. The patient reported that she was told that if the shrinkage of her brain were to continue, she would be required to have brain surgery. At the time of the report, the patient had not recovered. Information was received from a 21 year old female consumer with a history of dysmenorrhea and no drug allergies who in 2008 was vaccinated with "3 doses on schedule" of GARDASIL. Concomitant therapy included birth control for dysmenorrhea. The consumer reported she received all three doses of GARDASIL throughout 2008. The consumer reported her symptoms began full force in February 2009 and she was diagnosed with limbic encephalitis in September 2009 "a disease where a vaccine causes cells to attack themselves." The consumer reported that fluid builds up in her brain and the result is that it makes her very tired and it does not ever go away, even now that she has been treated for two separate incidents. The patient reported that flare-ups and seizures can and have occurred, but that she had been free from these conditions for about one year, since being hospitalized and treated last summer (July 2010). The consumer reported that physicians did not know enough about her condition to be able to say she is "cured" and that symptoms can last a lifetime. The consumer reported that she almost had unnecessary brain surgery because of her problem, but that a specialized MRI showed a clearer picture of what was happening in her brain and her neurologist was able to give her a diagnosis. The consumer reported she will need brain surgery if her "hippocampus" shrinks more and the seizures she has become life-threatening. The patient reported that in general, her condition has been known to cause lifelong problems and possibly cancer. The patient reported that she is under the care of a neurologist who believes there is a direct link between the GARDASIL and her medical condition. The patient reported treatment was given, "2nd treatment more than 1st time." The patient reported that her adverse experienced began in February 2009. CT scans, MRIs lumbar puncture was performed (no results were provided). The patient reported her present status as "recovering, but has flare-ups and seizures." The consumer reported she sought medical attention and that there was an intervention to prevent serious criteria. The patient reported she was hospitalized 4 times in the past two years, 2 hospitalizations in 2009 of an hours' long stay and a 4 night stay, and two hospitalizations in the summer of 2010, one for 5 days and one for 10 days. The patient reported her experienced was life-threatening. This is a consolidation of two reports concerning the same patient. Upon internal review, limbic encephalitis and seizures were determined to be another important medical events. Additional information has been requested. It has been determined that WAES#1109USA03092 is a duplicate of WAES#1109USA03415. Therefore, WAES#1109USA03092 is being deleted from our files and consolidated into WAES#1109USA03415. WAES#1109USA03092 was previously submitted to the FDA on 06OCT11.