Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Foetal non-stress test normal, Placental disorder
Clinical narrative: Dysmature placenta; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Mar-2020, concerning a 30-year-old, pregnant, female subject of body weight: 154 lbs, height: 64 inches and body mass index (BMI): 26,4, enrolled in, a prospective observational safety study.    The subject's medical history included high BMI.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history included one previous full term live birth with no birth defects. The subject had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The subject did not use tobacco, illicit drugs and alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 05-Apr-2019, while the estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were both reported on 06-Feb-2020. The type of pregnancy was singleton.   On 17-Jun-2019, the subject underwent spinal muscular atrophy prenatal test and fibrosis mutation analysis and no MCMs were noted.  On 22-Jul-2019, the subject underwent ultrasound test and no MCMs were noted.  On 21-Aug, the subject underwent ultrasound test and no MCMs were noted.  On 25-Oct-2019, approximately at 29 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 26218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy') as influenza immunisation.  On 29-Oct-2019, the subject developed anaemia and was treated with ferrous sulfate at a dose of 325 mg, twice daily, orally.  On 13-Dec-2019, the subject underwent ultrasound and no MCMs were noted.  On 18-Dec-2019, (also reported on 13-Jan-2020), the subject experienced dysmature placenta.  On 13-Jan-2020, the subject underwent ultrasound and no MCMs were noted.  On 24-Jan-2020, the subject underwent non-stress test and ultrasound biophysical profile and no MCMs were noted.  At 39 weeks of gestation (as reported), the patient vaginally delivered a live male neonate. The neonate's birth weight was 3650 g, head circumference 34.3 cm and length was 52,7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores was 9 at one minute and five minutes and no data was provided for 10 minutes. No MCM was identified at birth. On the same day, the subject recovered from anaemia.  At the time of this report, the outcome of event of dysmature placenta was not reported.  The event of dysmature placenta was assessed as serious due to seriousness criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced placental disorder (dysmature placenta) 1 month and 23 days after receiving Flucelvax QIV. The patient also developed anaemia four days post vaccination. Vaccine was administered at 29 weeks of gestation. Chronology is plausible. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The patient experienced placental disorder (dysmature placenta) 1 month and 23 days after receiving Flucelvax QIV. The patient also developed anaemia four days post vaccination. Vaccine was administered at 29 weeks of gestation. Chronology is plausible. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.