Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Amenorrhoea, Anti-Muellerian hormone level, Antibody test, Antinuclear antibody
Clinical narrative: Anti-Muellerian hormone level; Antibody test; Antinuclear antibody; Blood follicle stimulating hormone; Blood oestrogen; Blood testosterone; Blood thyroid stimulating hormone; DNA test for fragile X; Hysteroscopy; Karyotype analysis; Laboratory test; Ultrasound pelvis; Nuclear magnetic resonance imaging abdominal; abdominal pain; amenorrhoea; Ovarian function insufficiency; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from a consumer referring to his/her daughter, a 11 year old female patient. The patient had no concurrent illness, concomitant medication or historical medicine.   On 09-SEP-2013 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route, lot# and expiration unknown) for prophylaxis. On 01-FEB-2014, (reported as months after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient experienced abdominal pain, ovarian failure and amenorrhoea. On 09-AUG-2014 and 19-AUG-2015 the patient was vaccinated with second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(route, lot# and expiration unknown) for prophylaxis.   In 2017 the patient was diagnosed with primary ovarian insufficiency after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging. Diagnostic imaging included pelvic ultrasound (US), pelvic Magnatic Resonance Imaging (MRI), hysteroscopy and labwork included blood thyroid stimulating hormone (TSH), blood follicle stimulating hormone (FSH), blood oestrogen, testosterone levels, antinuclear antibody(ANA), anti-muellerian hormone level, karyotype, fragile X, adrenalantibodies and multiple other tests.   All events were considered to be disability by the agency. The outcome of the events was reported as not recovered. The reporter considered abdominal pain to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the causality between other events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information was received from the FDA (HA# 740632) under the Freedom of Information Act on 23-MAY-2019.  The reporter was the patient's parent or guardian or caregiver. The patient was not pregnant at the time of vaccination. The patient's past medical history included labial adhesion as child and hypothryroidism. According to gynecologist records she had normal uterus, autoimmune primary ovarian failure, primary amenorrhea. The patient had no menses, sparse pubic/axillary hair, no breast budding. She was seen by endocrinologist and started therapy with synthroid and estradiol, monitoring was continued. The result of US pelvis was reported as unable to visualize uterus and ovaries, abnormal; MRI pelvis: no discrete ovarian tissue seen, abnormal; thyroid antibodies; plus (+); FSH: 57 (increased, H). She had no allergies to medications, food or other products. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and no other illnesses at the time of vaccination and up to one month prior. The patient had not had an adverse event following any previous vaccine. The information about the facility where vaccine was given was updated.  Follow up information was received from a registered nurse on 08-AUG-2019. The reporter had no way to identify the patient back in 2013. No additional information was provided.