Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Initial solicited report received on 26 September 2017 and follow up information received on 27 September 2017, 10 October 2017 and 12 October 2017 from an investigator participating in a study. This is a prospective pregnancy registry case for Study. This case involves a 21-year-old female subject who had vaccine exposure during pregnancy and had spontaneous abortion during the study participation. The subject's medical history was not reported. The date of LMP was reported as 24 August 2017. The estimated date of delivery was reported as an unspecified date of June 2018. The mother and father's health status were reported as healthy. The father's age was 22 years at the time of report. The current pregnancy history was reported as, the subject had no alcohol, tobacco or recreational drug use. The subject was not currently on prenatal vitamins. The subject had two previous pregnancies with one live birth without congenital abnormality and one spontaneous abortion specified as miscarriage at 8 weeks of gestation. The subject had no maternal drug exposure and no concomitant therapy. On 01 October 2017, 16 days after receiving a first intramuscular dose of FLUZONE in the left deltoid on 15 September 2017 (batch number was reported as UT5899KA), the subject had spontaneous abortion. The event appeared after visit 1. At the time of enrollment, the subject reported that she was using condoms and spermicide for birth control. According to the investigator the event was considered as other important medical event specified as "on 26 September 2017 the subject reported positive pregnancy test. At enrollment, the subject had a negative urine pregnancy test. On 05 October 2017 the subject reported spontaneous abortion. No complications, no D and C indicated". The subject had no pregnancy complications. The subject had no treatment for infertility. The subject had no family history of congenital abnormality. The subject had no relevant non serious adverse event. The information on any other lab data was not reported. Prenatal testing was reported as, urine pregnancy test was positive. The information on corrective treatment was not reported. The subject recovered from the event spontaneous abortion on 01 October 2017. The pregnancy outcome was reported as on 01 October 2017 the subject had spontaneous abortion of a single fetus specified as "the subject reported spontaneous abortion on 01 October 2017, did not require Dilation and Curettage. Was seen only in the ER". According to the investigator the event was not related to the study vaccine or trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. This case is linked with AER# 2017SA187604 (study). Sender's Comments: A 21-year-old female subject had received a dose of study vaccine during pregnancy. She had a serious event spontaneous abortion 16 days after receiving a does of study vaccine. She had history of contraceptive use and one miscarriage. Based on data available the sponsor assesses this event as not related to study vaccine or procedure in agreement with investigator. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.