Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaemia, Caesarean section, Exposure during pregnancy, Gestational diabetes, Neonatal disorder
Clinical narrative: Gestational diabetes; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 09-Jun-2020, concerning a 33-year-old, pregnant female subject of body weight: 194 lbs, height: 63 inches and body mass index (BMI): 34.4, enrolled in, a prospective observational study.  The subject's medical history included body mass index high (BMI 34.4) and chronic hypertension.   The subject's concomitant medication included Prenatal vitamin (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 29-Jun-2019. Estimated delivery date (EDD) was reported as 04-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 13-Apr-2020. The type of pregnancy was singleton.  On 27-Aug-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCM was noted.  On 24-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.   On 30-Oct-2019, the subject underwent panorama test and ultrasound scan and no MCM was noted.    On 13-Nov-2019, at approximately 19 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 04-Jan-2020, the subject underwent ultrasound scan and no MCM was noted.   On 29-Jan-2020, two months and 16 days after vaccination, the subject developed anemia and started treatment with ferrous sulfate, at a dose of 325 mg, twice a day, administered via oral route.   On the same date, the subject underwent ultrasound scan and no MCM was noted.   On 06-Feb-2020, two months and 24 days after vaccination, the subject developed gestational diabetes.   On 13-Feb-2020, 19-Feb-2020, 04-Mar-2020, 11-Mar-2020 and 25-Mar-2020, the subject underwent ultrasound scans and no MCMs were noted.    at 39.3 weeks of gestation (as reported), the subject delivered live birth female neonate, by caesarean method of delivery. The neonate's birth weight was 3140 grams, head circumference was 34.3 cm and body length 48.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 3 at one minute, 8 at five minutes and 8 at ten minutes. There was no MCM identified at birth.   On the same date, the subject recovered from anemia and treatment with ferrous sulfate was completed.   At the time of this report, the subject did not recover from gestational diabetes.   The event of gestational diabetes was assessed as serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to 202003799 (corresponding baby case).  Company comment: A pregnant subject experienced gestational diabetes and anaemia more than two months after receiving Flucelvax QIV. The subject's medical history included body mass index high (BMI 34.4) and chronic hypertension, therefore causality was highly confounded for gestational diabetes. Anaemia is frequent during pregnancy and treatment with ferrous sulphate suggests iron-deficiency etiology. Causal role of the suspect vaccine is assessed as not related for both events. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced gestational diabetes and anaemia more than two months after receiving Flucelvax QIV. The subject's medical history included body mass index high (BMI 34.4) and chronic hypertension, therefore causality was highly confounded for gestational diabetes. Anaemia is frequent during pregnancy and treatment with ferrous sulphate suggests iron-deficiency etiology. Causal role of the suspect vaccine is assessed as not related for both events. Vaccine exposure during pregnancy assessed as not related per company's conventions.