Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Gene mutation identification test negative, Haemoglobin electrophoresis normal
Clinical narrative: Dysmature placenta; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 04-Oct-2019, concerning a 26-year-old, female pregnant subject of body weight: 160 lbs, height: 64 inches and body mass index (BMI): 27.5, enrolled in a prospective observational safety study.  The subject's relevant medical history included Candidiasis, Vaginitis and nausea. The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The concomitant medications of the subject included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and promethazine for nausea.   The subject's last menstrual period (LMP) date was 06-Jul-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 12-Apr-2019. The type of pregnancy was singleton.  On 06-Aug-2018, the subject underwent Cystic Fibrosis Mutation Analysis, Haemoglobin electrophoresis and Spinal Muscular Atrophy Screen and no MCM was noted.   On 20-Aug-2018, the subject underwent ultrasound and no MCM was noted.   On 29-Oct-2018, at gestational age of approximately 16 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.   On the same day, the subject ultrasound and First Trimester Screening and no MCM was noted.   On an unknown date, after vaccination, when pregnancy status was collected it was noted that the subject had dysmature placenta.  On 03-Jan-2019, two months and five days after vaccination, the subject experienced anemia and she was treated with oral ferrous sulphate ,325 mg administered twice a day from 03-Jan-2019 to 08-Apr-2019.    On 15-Feb-2019, 01-Mar-2019 and 15-Mar-2019, Ultrasound and no major congenital malformation was noted.  Five months and 10 days after vaccination, the subject vaginally delivered a live birth, male neonate at 39.4 weeks gestation. The neonate's birth weight was 3969 grams, his head circumference was 38.1 cm and body length 54.6 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   On the same day, the outcome of events anemia and dysmature placenta were resolved.   The reporter did not provide causality assessment. The case was assessed as serious (medically significant).; Sender's Comments: The subject was administered Flu Vaccine Cell Subunit QIV NVD at approximately 16 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  On an unknown date after vaccination, the subject developed placental disorder (reported as dysmature placenta). Chronology seems unclear. Reportedly, two months and five days after vaccination, the subject experienced anaemia, making temporal relationship plausible. Causality is assessed as not related for the events of vaccine exposure during pregnancy (per company's conventions) and for the event of placental disorder. Causality for anaemia is assessed as possibly related.