Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: was notified and advised we were ordering an OB ultrasound less than 14 weeks; Information has been received from U.S. Food & Drug Administration (# 838709) on 25-SEP-2020.  This spontaneous prospective pregnancy report was received from a registered nurse (RN) referring to a 24 years old female patient. The patient's ethnicity was not Hispanic or Latino. The patient had no prescriptions, over-the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illnesses at the time of vaccination and up to one month prior and no chronic or longstanding health conditions. The patient had no adverse event following any previous vaccine.      On 26-SEP-2019 at 15:35, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1621934, expiration date not reported, but upon internal validation established as 29-JAN-2022; dose and frequency were not reported) intramuscularly (IM) in the left deltoid. Patient was for well woman exam, she reported last menstrual period (LMP) as 15-AUG-2019. She received the injection and waited for 15 minutes post injection to monitor for side effects. Patient was then taken to lab for the additional testing that was ordered. While the patient requested a pregnancy test from the lab staff, a beta-human chorionic gonadotropin (BHCG) was completed at that time. It was resulted on 27-SEP-2019 at a level of 32 (unit not provided). Patient was notified and instructed to recheck levels on 30-SEP-2019. Patient was unable to verify date of her LMP stating she did not know it was always somewhere in the middle like the 15th. Patient was transferred to make her appointment. She completed another BHCG on 03-OCT-2019 it was resulted on 04-OCT-2019 with a level of 1,943 (unit not provided) (exposure during pregnancy). Patient was notified and advised she was ordering an obstetric (OB) ultrasound less than 14 weeks as patient unsure of dates and was recommended she follow up with OB. The patient's estimated date of delivery (EDD) was 21-MAY-2020. The pregnancy outcome was outcome pending. The fetal outcome was unknown.  Follow up information was received from the RN on 26-OCT-2020, who was also the vaccine administer, referring to a 25 years old female patient. The operator was already trained. There was no product quality complaint. The vaccine/vaccine-device was used according to the instruction leaflet and not available for return/evaluation due to disposed of in sharps that day. There was no temperature excursion occur as a result of a reading from a digital data logger.  Human chorionic gonadotropin (HCG) on 26-SEP-2019 was low indicating early pregnancy. Another HCG on 03-OCT-2019, showed levels continued to rise. The prescription drug treatment for the experience was not required. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability