Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Caesarean section, Exposure during pregnancy, Placental disorder, Ultrasound antenatal screen normal
Clinical narrative: Anemia; Dysmature placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 03-Apr-2020, concerning a 20-year-old, pregnant female subject (Ethnicity: not reported) of body weight: 100 lbs, height: 59 inches and body mass index (BMI): 20.2, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Flucelvax, seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's medical history was not reported.    The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history included no previous pregnancies. The subject did not have a history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 12-May-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 16-Feb-2020. The type of pregnancy was singleton.  On 30-Jul-2019, the subject underwent ultrasound scan and panorama test, and no MCM was noted.    On 04-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.   On 02-Oct-2019, at approximately 20 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261218, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On 22-Nov-2019, the subject underwent ultrasound scan, and no MCM was noted.   On 05-Dec-2019, the subject underwent ultrasound scan, and no MCM was noted.   On the same date, the subject's pregnancy status was collected and dysmature placenta was noted as pregnancy complication.    On 13-Dec-2020, 20-Dec-2020, 27-Dec-2020, 03-Jan-2020 and 17-Jan-2020, the subject underwent ultrasound scans, and no MCMs were noted.   On 25-Jan-2020, three months and 23 days after vaccination, the subject developed anemia, and started treatment with ferrous sulfate, at a dose of 325 mg, administered via oral route, three times per day.  At 39.6 weeks of gestation (as reported), the subject delivered live birth male neonate, via caesarean method of delivery. The neonate's birth weight was 3260 g, head circumference was 31.1 cm and body length 44.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 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 subject recovered from dysmature placenta and anemia, and the treatment with ferrous sulfate was stopped.   The event of placental disorder' was assessed as serious due to the criteria of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked to case 202002776 (the corresponding child case).  Company comment: A pregnant subject experienced placental disorder (dysmature placenta), 2 months after receiving Flucelvax QIV. The subject also developed anaemia three months and 23 days after vaccination. Chronology is unsuggestive. Anaemia is common during pregnancy, therefore causality is assessed as not related. For the event placental disorder, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced placental disorder (dysmature placenta), 2 months after receiving Flucelvax QIV. The subject also developed anaemia three months and 23 days after vaccination. Chronology is unsuggestive. Anaemia is common during pregnancy, therefore causality is assessed as not related. For the event placental disorder, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.