Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Delivery, Exposure during pregnancy, Foetal growth restriction
Clinical narrative: Exposure to influenza virus; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a 27-year-old, female pregnant subject of body weight: 125 lbs, height: 65 inches and body mass index (BMI): 20.8, enrolled in a prospective observational safety study.  The subject's medical history was not reported.   The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation.    The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 16-Apr-2019. The type of pregnancy was singleton. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) was reported as 21-Jan-2019. The pregnancy was complicated with intrauterine growth restriction.  On 12-Jul-2019, the subject underwent first trimester screen and no MCM was noted.   On 28-Aug-2019, the subject underwent second trimester screen, anatomy ultrasound scan and maternal serum alpha-fetoprotein screening and no MCM was noted.   On 21-Oct-2019, approximately at 26 weeks of gestation, the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD ) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as ''Vaccine exposure during pregnancy'').  On 18-Dec-2019, one month and 27 days after vaccination, the subject was exposed to influenza virus and was treated with oseltamivir at dose of 75 mg, every day, orally form 18-Dec-2019 to 28-Dec-2019.   Approximately at 39.1 weeks of gestation, the subject vaginally delivered a normal, female neonate of birth weight 2722 grams. The characteristics of neonate such as head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 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.  The outcome of exposure to communicable disease' was not reported.  The event of exposure to communicable disease' was considered 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 202000572 (the corresponding baby case).  Company comment: A subject was administered Flucelvax QIV at gestation age of 26 weeks. Reportedly, one month and 27 days after vaccination, a subject was exposed to influenza virus and was treated with oseltamivir (coded as Exposure to communicable disease). Causal role of the suspect vaccine is assessed as not related for Exposure to communicable disease. Vaccine exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A subject was administered Flucelvax QIV at gestation age of 26 weeks. Reportedly, one month and 27 days after vaccination, a subject was exposed to influenza virus and was treated with oseltamivir (coded as Exposure to communicable disease). Causal role of the suspect vaccine is assessed as not related for Exposure to communicable disease. Vaccine exposure during pregnancy is assessed as not related per company's conventions.