Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Anti-Muellerian hormone level decreased, Blood follicle stimulating hormone increased, Hormone level abnormal, Infertility female
Clinical narrative: ABORTION SPONTANEOUS; ANTI-MUELLERIAN HORMONE LEVEL DECREASED; BLOOD FOLLICLE STIMULATING HORMONE INCREASED; HORMONE LEVEL ABNORMAL; INFERTILITY FEMALE; OESTRADIOL DECREASED; OVARIAN FAILURE; PREMATURE MENOPAUSE; This report was identified from a line listing obtained on request by the Company from the FDA (HA# 754541) under the Act, and refers to a 26 year old female patient. The patient had no current illnesses, no medical history and was taking none other medications.  On 27-SEP-2007, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as "needle and syringe (not specified further)" in the right arm for prophylaxis (lot# and expiration date were not reported).  On an unknown date, the patient became pregnant. last menstrual period (LMP) and estimate date of delivery (EED) could not be calculated. She had the exposure in approximately the first trimester. On 19-JAN-2018, the patient's anti-mullerian hormone (AMH) level was 0.98 (units not provided). On 31-JAN-2018, at the age of 26 years old was the onset of symptoms, when it became difficult for patient to carry a pregnancy. She experienced 5 miscarriages, as a result of imbalance of hormones and high levels of follicular stimulating hormone (FSH), decreased anti mullerian hormone (AMH) and poor egg quality. Additionally, the patient presented oestradiol decreased. The patient experienced infertility secondary to primary ovarian failure resulting in premature menopause at 27 years old. On 05-MAR-2018, the patient's estradiol level was 8 (units not provide) and FSH level was 162.2 (units not provided). On 26-APR-2018, the patient's FSH level was 111.7 (units not provided), and on 07-JUN-2018, the AMH level was less than 0.03 (units not provided).  The outcome of the events was reported as not resolved. The casuality assessment was not provided.  The regulatory agency considered the events to be serious due to disability criteria.  Follow up information has been received from the patient via the agency (HA# 754541) on 08-AUG-2019.  The patient was not pregnant at the time of vaccination. The patient had no allergies, and did not experience an adverse event following any previous vaccine. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on the previously reported date at 13:00. The patient's events started on the aforementioned date at 16:30. It was reported that doctor or healthcare professional office/clinic visit was required for the events. Laboratory reference ranges was provided: postmenopausal ranges for FSH level were from 23.0 - 116.3 (units were not provided), postmenopausal ranges for estradiol level were under 10, and reference ranges for AMH level were 0.76-11.34 (units were not provided) between 20 and 29 years old.  Follow-up information was received on 12-NOV-2019. A phone call was placed to the immunization nurse. The phone call was answered by the receptionist and it was transferred to a registered nurse, with whom the original report was shared. The requested information was not readily available. It was reported that a review was needed to be done with the staff.