Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Exposure during pregnancy, Neonatal disorder, Ultrasound antenatal screen normal
Clinical narrative: Birth weight 4111g at gestational age 40.1 weeks/Large for gestational age; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case initially received from other health professional on 20-Jun-2019, concerning a 34-year-old, adult female pregnant subject of body weight: 140 lbs, height: 66 inches and body mass index (BMI): 22.6 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 included one full term live birth and had no history of previous birth defect. The subject's neither had family history of major congenital malformations nor offspring with major congenital malformations. The subject's concomitant medications included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy.  The subject's last menstrual period (LMP) date was 04-Aug-2018. The type of pregnancy was singleton. The subject did not consume alcohol, tobacco and illicit- drugs during pregnancy.  On 19-Sep-2018 and on 26-Sep-2018, the subject underwent ultrasound scan and no congenital malformations were reported.  On 10-Oct-2018, approximately at gestational age of 9 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, 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 of vaccination, the subject underwent ultrasound scan and no congenital malformation was reported. On 05-Feb-2019, 3 months and 26 days after vaccination, the subject was diagnosed with anemia and was treated with ferrous sulfate (dosing details: 1 tablet twice daily orally, from 05-Feb-2019 to 12-May-2019).   The subject's estimated delivery date (EDD) was 11-May-2019 and corrected estimated delivery date (CEDD) was 11-May-2019.  On 12-May-2019, at gestational age of 40.1 weeks the subject gave birth to female infant through vaginal delivery method. No pregnancy complications were observed. The infant's characteristics included, birth weight of 4111 g (explicitly coded as large for gestational age), head circumference was 33.7 cm and length was 54.6 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 8. No major congenital malformation was identified at birth.  The subject had recovered from the event anemia (on 12-May-2019) and the outcome of the event large for gestational age was unknown.  This case is linked with the ARGUS case ID 201904020 (parent-child link).; Reporter's Comments: A 34-year-old pregnant subject developed anaemia 3 months and 26 days after receipt of Flu vaccine cell subunit QIV at 9 weeks of gestation. Considering the fact that the event anaemia can be explained by pregnancy physiological state, the causal role of suspect vaccine was assessed as not related. The subject delivered at 40.1 weeks baby with large for gestational age weight (4111gm). The progressive age of the subject can explain the event rather than suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).