Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Gestational diabetes, Ultrasound antenatal screen normal
Clinical narrative: Anemia; Gestational diabetes; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Dec-2019, concerning a 24-year-old, female pregnant subject of body weight: 198 lbs, height: 64 inches and body mass index (BMI): 34.1 enrolled in a prospective observational safety study.  The subject's historical medical history included gonorrhoea, while the the subject's current medical history included high BMI, anxiety and depression.  The subject's concomitant medications included sertraline for anxiety and depression.  The subject had no previous pregnancies. 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 10-Feb-2019. The subject's estimated delivery date (EDD) was 17-Nov-2019 and corrected estimated date of delivery (CEDD) was 18-Nov-2019. The type of pregnancy was singleton.   On 12-Apr-2019 and 15-May-2019, the subject underwent ultrasound and no MCM was noted.  On 14-Jun-2019, the subject underwent maternal serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 28-Jun-2019, the subject underwent ultrasound and no MCM was noted.  On 20-Sep-2019, at gestational age of 31 weeks, the subject was administered with Afluria QIV  [influenza vaccine; batch number: P100115154, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On the same day, the subject underwent ultrasound and no MCM was noted.  On 07-Oct-2019, 17 days after vaccination, the subject developed gestational diabetes and was treated with Novolin NPH (insulin human injection, isophane), 36 units, every ante meridiem (am), subcutaneously.  On 08-Oct-2019, the subject started treatment with Novolin R (insulin human), at a dose of 20 units am, subcutaneously and 14 units, every post meridiem (pm), subcutaneously, for gestational diabetes.   On 11-Oct-2019, the subject developed anemia and was treated with iron, at a dose of 325 mg, once daily (qd), orally.  At gestational age of 38.9 weeks, the subject vaginally delivered live birth, female neonate. The neonate's birth weight was 3629 g, her head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 6 (one minute) and 9 (five minutes). There was no MCM identified at birth.  On 26-Nov-2019, the subject stopped treatment with Novolin NPH and Novolin R.   At the time of this report, the outcome of the event gestational diabetes was not reported, while the outcome of the event anemia was not resolved.  The event of gestational diabetes was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Afluria QIV.  Company comment: The subject experienced gestational diabetes and anaemia after administration of Afluria QIV. The patient was administered vaccine approximately at 31 weeks of gestation. Chronology seems plausible. Causality was highly confounded by medical history of high BMI. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for both events. Vaccine exposure during pregnancy is assessed as not related.; Sender's Comments: The subject experienced gestational diabetes and anaemia after administration of Afluria QIV. The patient was administered vaccine approximately at 31 weeks of gestation. Chronology seems plausible. Causality was highly confounded by medical history of high BMI. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for both events. Vaccine exposure during pregnancy is assessed as not related.