Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Placental disorder, Prenatal screening test
Clinical narrative: Dysmature placenta; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case initially received on 07-Jun-2019, concerning a 33-year-old adult female, pregnant subject  of body weight 156 lbs, height 67 inches and body mass index (BMI) 24.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's obstetrical history noted that the subject had 4 previous pregnancies including 3 full-term live births and 1 spontaneous abortion. No birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of alcohol or illicit drugs during pregnancy. The subject's current condition included cigarette smoker and used half (1/2) pack of cigarettes per day.  The subject's last menstrual period (LMP) date was 23-Jun-2018. The type of pregnancy was singleton.   The subject's historical condition included trichomonas (started on 28-Aug-2018 and stopped on 08-Sep-2018) and bacterial vaginosis (started on 28-Aug-2018 and stopped on 08-Sep-2018). The patient's historical drug included Metrogel for trichomonas and bacterial vaginosis. The subject's current condition included herpes simplex virus 1 and 2 (HSV infection) since an unspecified date. The subject's concomitant medication included prenatal vitamins (minerals nos, vitamins nos) for pregnancy.    On 28-Aug-2018, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy screening and no major congenital malformations were noted. On 30-Aug-2018, the subject underwent ultrasound screening and no major congenital malformations were noted.   On 18-Oct-2018, at approximately 16 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day (18-Oct-2018), the subject underwent ultrasound screening and quadruple screening and no major congenital malformations were noted. On 10-Jan-2019 and 08-Feb-2019, the subject underwent ultrasound screening and no major congenital malformations were noted. On 01-Mar-2019, 4 months and 11 days after vaccination, the subject was diagnosed with anemia.  at 39.3 weeks of gestation, the subject gave live birth to a male neonate vaginally. The characteristics of the neonate included birth weight: 2892 grams, head circumference: 33 cm, length: 47 cm and appearance, pulse, grimace, activity, respiration (APGAR) scores were 8 at one minute and 9 at five minutes). No major congenital malformations (MCMs) were identified at birth. Dysmature placenta was reported as the subject's pregnancy complication.   On 25-Mar-2019, the subject had recovered from the event anemia and the outcome of the event dysmature placenta was not reported.   The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) was reported as 30-Mar-2019.; Reporter's Comments: A 33-year-old pregnant subject was diagnosed with anemia, 4 months 11 days after receipt of Flu vaccine cell subunit QIV at approximately 16 weeks of gestation (considered as vaccine exposure during pregnancy). The subject was diagnosed with dysmature placenta (placental disorder), unspecified period post vaccination (reported as pregnancy complication). Considering the implausible temporal relationship, the event anaemia assessed as not related to study vaccine. The pregnant state of the subject is considered as an alternative aetiology for the event anaemia. The event dysmature placenta assessed as not related, as it can be alternately explained by anaemia and cigarette smoking, rather than study vaccine. The subject's current condition herpes simplex virus 1 and 2 (HSV infection) is considered as known risk factor for dysmature placenta. The event vaccine exposure during pregnancy assessed as not related considering the intended use of vaccine.  The company assessed the events 'placental disorder' as serious (medically signiifcant).