Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Placenta praevia, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; Low-lying placenta; This observational study case, initially received on 21-Dec-2020 from other health professional and concerned a 27-year-old pregnant, female subject of body weight 139.5 lbs, height 65 inches and body mass index (BMI) 23.2, enrolled in a prospective observational safety study.  The subject's concurrent conditions included morning sickness. The subject's past medication included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, while the subject's concomitant medications included unspecified probiotics as health supplement, unspecified prenatal vitamins and Vitamin C (ascorbic acid), both used for pregnancy and vitamin B complex used for morning sickness.   The subject's obstetrical history included two previous pregnancies with one full-term live birth and one elective abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no paternal or maternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was reported as 08-Mar-2020. The subject's estimated delivery date (EDD) was reported as 13-Dec-2020 and corrected estimated date of delivery (CEDD) was reported as 01-Apr-2021. The type of pregnancy was singleton.   On 12-Aug-2020 and 24-Aug-2020, the ultrasound scans revealed no MCMs.  On 08-Sep-2020, the ultrasound scan and counsyl chromosomes 13, 18, 21 plus sex chromosome analysis revealed no MCMs.  On 02-Nov-2020, at approximately 34 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100265371.  On the same day, the ultrasound scan revealed no MCMs.   On an unspecified date in 2020, an unknown amount of time after receiving Afluria QIV, the subject developed low laying placenta.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  The event of 'placenta previa' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A pregnant subject was administered Afluria QIV at approximately 34 weeks of gestation. On an unspecified date in 2020, an unknown amount of time after receiving Afluria QIV, low laying placenta was noted. Causal role of the suspect vaccine is assessed as not related due to chronological and biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A pregnant subject was administered Afluria QIV at approximately 34 weeks of gestation. On an unspecified date in 2020, an unknown amount of time after receiving Afluria QIV, low laying placenta was noted. Causal role of the suspect vaccine is assessed as not related due to chronological and biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.