Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Oropharyngeal pain, Pain in extremity, Streptococcus test negative, Tenderness, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). Per the physician, the patient's mother reported that the patient used to have regular periods and now she is having periods every 2 weeks after receiving GARDASIL vaccine (yeast). At the time of this report, the adverse event is ongoing. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/14/2008; 1/7/2009. Follow-up information has been received from the reporting administration physician concerning a 16 year old female student with asthma and acne and a history of right otitis media, left otitis media. Who on 25-JUL-2007 received her first dose of GARDASIL (Lot# 656371/0161U) intramuscularly in the left arm. Concomitant vaccination administered on 25-JUL-2007 included the second dose of varicella virus vaccine live and a dose of MENACTRA. On 25-SEP-2007 received the second dose of GARDASIL (Lot# 658636/1063U) intramuscularly in the left arm. Concomitant vaccinations administered on 25-SEP-2007 included DTaP and a 0.5 ml dose of influenza virus vaccine (unspecified). On 19-OCT-2007 the patient was administered a dose of DTaP. On 25-JAN-2008 at 16:15 was vaccinated with her third dose of GARDASIL (lot# 659653/1448U) intramuscularly in the left arm. On 16-DEC-2007 the patient visit the office for an ear pain (from 04-DEC-2007) and still she could not hear, and mild upper respiratory infection symptoms and right thumb tenderness. The diagnosis was otitis media and asthma. The patient went to the office on 04-JAN-2008 with continued right thumb pain but with the asthma better. On 25-JAN-2008, the patient was seen for her third dose of the vaccine but she was "sick" with a sore throat and ear ache. The diagnosis was right otitis media and the patient was prescribed amoxicillin 500 mg. On 08-FEB-2008, the patient was seen because she was sick and for an ear check and the diagnosis was persistant right otitis media. The patient was prescribed AUGMENTIN 875 mg and Biaxin. On 08-AUG-2008, the patient developed an upper respiratory infection, without strep which was treated with albuterol HFA inhaler 2 puffs every 4-6 hours for wheezing. On 21-JUL-2008 the patient experienced constant period every two & 1/2 weeks and premenstrual stomach pain with each cycle. The patient was instructed to monitor her menstrual cycle history daily for 3 months listed as follow: 21-JUL-2008, 10-AUG-2008, 29-AUG-2008, 17-SEP-2008 and 03-OCT-2008 lasting 5-6 days each period. It was noted that the patient was regular prior to vaccination series with GARDASIL. It was also noted that the patient's menarche occurred 1 week before her 14th birthday and she had no history of sexual activity was not presently sexually active. The patient was referred to a gynecologist and seen on 14-OCT-2008. On 06-NOV-2008 the patient was seen at the reporting physician's office and it was noted the patient was started on oral contraception (unspecified) for the treatment of acne. The outcome was noted to be not recovered for constant menstruation and unknown for the patient's premenstrual stomach pain. It was noted that the patient had been seen for multiple visits for sports physical examinations for swimming and water polo activities. Follow-up noted in 2 weeks for patient to receive influenza virus vaccine (unspecified). Additional information is not expected.