Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaemia, Blood test normal, Constipation, Delivery, Exposure during pregnancy
Clinical narrative: Dysmature placenta; Constipation; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 09-Jun-2020, concerning a 24-year-old, female pregnant subject of body weight: 202 lbs, height: 66 inches and body mass index (BMI): 32.6, enrolled in a prospective observational safety study.   The subject's medical history included high BMI and herpes simplex virus.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal and paternal medical history with MCM. The subject did not use tobacco, illicit drug or alcohol during pregnancy.  The subject's last menstrual period (LMP) date was reported as 17-Jul-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) both were reported as 22-Apr-2020. The type of pregnancy was singleton.   On 03-Sep-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCMs were noted.  On 20-Sep2019, the subject underwent ultrasound and no MCMs were noted.  On 17-Oct-2019, at approximately 13 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. On the same day, the subject underwent panorama test, and no MCMs were noted.  On 07-Nov-2019, the subject underwent ultrasound and no MCMs were noted.  On 06-Jan-2020, two months and 20 days after vaccination, the subject developed anaemia and was treated with ferrous sulfate, at dose of 325 mg, twice a day (BID), orally.  On 30-Jan-2020, three months and 13 days after vaccination, the subject developed constipation and was treated with Colace (docusate sodium) at dose of 100 mg, BID, orally. On the same day, the subject underwent ultrasound and no MCMs were noted.  On 13-Mar-2020, dysmature placenta was noted. On the same day, the subject underwent ultrasound and no MCMs were noted.  On 19-Mar-2020 and 02-Apr-2020, the subject underwent ultrasound and no MCMs were noted.  At gestational age of 39.1 weeks (as reported), the subject vaginally delivered live birth, female neonate. The neonate's birth weight was 3118 g, her length was 50.8 cm and head circumference were 34.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores was 8 at one minute, 9 at five minutes and for ten minutes was not provided. No MCM was identified at birth. On the same day, the subject recovered from dysmature placenta, constipation and anaemia.  The event of dysmature placenta was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  Company comment: A pregnant subject experienced dysmature placentae 4 months 25 days after receiving Flucelvax QIV. The subject also developed anaemia 2 months 20 days after vaccination and constipation three months and 13 days after vaccination. Chronology is unsuggestive. Causal role of the suspect vaccine is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Causality for anaemia and constipation is highly confounded by pregnant state and treatment with ferrous sulphate suggesting iron-deficiency etiology. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced dysmature placentae 4 months 25 days after receiving Flucelvax QIV. The subject also developed anaemia 2 months 20 days after vaccination and constipation three months and 13 days after vaccination. Chronology is unsuggestive. Causal role of the suspect vaccine is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Causality for anaemia and constipation is highly confounded by pregnant state and treatment with ferrous sulphate suggesting iron-deficiency etiology. Vaccine exposure during pregnancy assessed as not related per company's conventions.