Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture normal, Malaise, Mydriasis, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: Information has been received from a healthcare worker concerning her 18 year old daughter with irritable bowel and a history of attention deficit disorder who on unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). The patient felt sick after the vaccination. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). Concomitant therapy included amphetamine aspartate/amphetamineS04/dex (ADDERALL TABLETS) and birth control pill. On 07-JUN-2007 the patient experienced faint and shortly afterwards she developed a problem with her eye; it became dilated more than the other. The caller took her daughter to an optometrist who performed some tests that came back abnormal and determined it was optic neuritis. The caller went to other specialists to find out if it was MS related and the patient had an MRI done which came back abnormal and showed 11 to 14 lesions on her brain, spine tap came back negative. A MS specialist did not feel it was MS however suggested not receiving the 3rd dose and determined it was probably a response to the vaccine. The patient's optic neuritis persisted. The caller also mentioned that her daughter also had a behavioral problem on Periaction when she was little. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008.  Initial and follow-up information has been received from a healthcare worker and a physician concerning a 18 year old female patient with irritable bowel, attention deficit disorder and a history of aggressive behavior/behavioral problems after she received PERIACTIN who on19-MAR-2007 was vaccinated with a first dose of GARDASIL (lot number 655619/1427F) (injection site and route not reported). The patient felt sick after the vaccination. Immediately some time afterwards the patient had anisocoria (left pupil enlarged), also reported as she developed a problem with her eye; her one pupil was 3 times the size of the other pupil after the second dose. On 04-JUN-2007, the patient was vaccinated with a o second dose of GARDASIL by intramuscular injection (lot number 656371/0181U) (injection site not reported). Concomitant therapy included ADDERALL TABLETS and a low dose hormonal contraceptive for excessive bleeding. On 04-JUN-2007 the patient felt very dizzy and weird. The patient got a headache and fainted and passed out for less than 1 minute. The following day, the patient was still not feeling well. The caller took her daughter to an optometrist who performed some tests that came back abnormal and determined it was optic neuritis. The optometrist was not sure if it was related to GARDASIL. It was re ported that the size of the pupil "did go down". The patient was referred to a neurologist who determined she did not have MS. The patient was seen by another neurologist who also did not think she had MS and he was also not sure what the lesions could be. He determined it was probably a response to the vaccine. The patient was instructed to come back in one year. On 21-AUG-2007, the patient had an MRI done which came back abnormal and showed 11 small subcortical white matter lesions. In December 2007, spine tap came back negative. A MS specialist did not feel it was MS however suggested not receiving the 3rd dose and determined it was probably a response to the vaccine. ON 24-MAR-2008, the patient had another MRI done showed 10-14 white matter lesions noted, no new findings. On 03-JUN-2008, the physician saw the patient for the first time in the office and stated that the patient had recovered. Additional information is not expected.