Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Anxiety, Caesarean section, Exposure during pregnancy, Gestational diabetes
Clinical narrative: Anxiety; Anemia; Gestational diabetes; Vaccine exposure during pregnancy; This is a serious observational study case, initially received on 31-May-2019, concerning a 27-year-old adult, female pregnant subject of body weight: 196 lbs, height: 58 inches and body mass index (BMI): 40.5, enrolled prospective observational safety study.  The subject had no history of pregnancy. The subject had no history of offspring with major congenital malformation. The subject had no maternal and paternal history with major congenital malformations. The subject was tobacco smoker (1/2 cigarettes puff per day). The subject's current condition included bipolar (bipolar disorder) and schizophrenia. The subject's concomitant medications included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy.   The subject's last menstrual period (LMP) date was 29-Apr-2018. The type of pregnancy was singleton.  On 24-Sep-2018, the subject underwent spinal muscular atrophy screen, cystic fibrosis mutation analysis, haemoglobin electrophoresis, ultrasound scan and no congenital malformations were noted.  On 02-Oct-2018, at gestational age of approximately 11 weeks. the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 08-Oct-2018, the subject underwent ultrasound scan, and no major congenital malformation was noted.  On an unspecified date, after vaccination, the subject developed anaemia and anxiety. The subject was treated with Zoloft (sertraline hydrochloride, dose: 25 mg, frequency: qd, route: oral, from 24-Jan-2019 and it was ongoing) for anxiety and ferrorus sulfate (dose: 1 DF, frequency: bid, route: oral, from 30-Jan-2019 to 24-Apr-2019) for anaemia.    On 04-Feb-2019, 4 months and 2 days after vaccination, the subject developed gestational diabetes (pregnancy complication).   The subject was treated with glucometer strips (dose, route of administration: not reported, from 22-Feb-2019 to 24-Apr-2019).   At gestational age of 39.3 weeks, the subject gave a live birth to a male neonate by caesarean method. The characteristics of the neonate included birth weight: 3317 grams, head circumference: 33 cm, body length: 54.6 cm, appearance, pulse, grimace, activity, and respiration (APGAR) scores was 8 at one minute, 9 at five minutes and at ten minutes data was not provided. There were no major congenital malformations identified at birth.  The outcome of the event gestational diabetes was recovered on 24-Apr-2019. The outcome of the events anaemia and anxiety was not reported.  The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 29-Apr-2019.; Reporter's Comments: A 27-year-old female pregnant subject was administered study vaccine considered as exposure during pregnancy) at 11 weeks of gestation. On an unspecified date, after vaccination, the subject developed anaemia and anxiety. The subject also developed gestational diabetes, 4 months 2 days after administration of study vaccine. The events (gestational diabetes, anaemia and anxiety) were assessed as not related as there is no evidence of a biological mechanism that could cause the event, comorbid conditions (tobacco smoker, bipolar disorder and schizophrenia) and underlying pregnancy which appear to be a more likely explanation rather than study 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).