Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Neonatal disorder, Prenatal screening test, Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: Gestational hypertension [without significant protein uria] in third trimester; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case, initially received on 18-Jun-2019, concerning a 19-year-old adult female pregnant subject of body weight: 110 lbs, height: 58 inches and body mass index (BMI): 23, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject had two previous elective abortion with no birth defects. The subject did not have any history of offspring with major congenital malformation. Also, the subject had a maternal family history of his brother had a congenital heart defect and pulmonary stonesis with major congenital malformations and the subject had no paternal history with major congenital malformations. The subject did not have prior history of use of tobacco, alcohol during pregnancy but subject had an history of marijuana, which was last used on 28-Oct-2018. The pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's current conditions included postural tachycardia syndrome (pots), migraine, arnold-chiari malformation, ehlers-danlos syndrome, allergies. The subject's concomitant medication included fluticasone for Allergies, cyclobenzaprine for Arnold-chiari malformation and Ehlers-Danlos syndrome and Prenatal vitamins (minerals nos; vitamins Nos) (minerals nos, vitamins nos) for Supplementation therapy (reported as supplement).  The subject's last menstrual period (LMP) date was 19-Aug-2018. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no malformations were noted.  On 15-Oct-2018, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 13-Dec-2018, the subject underwent Nuchal translucency, Ultrasound, prenatal cystic fibrosis mutation analysis, and spinal muscular atrophy were no major congenital malformations were noted.  On 18-Jan-2019, the subject underwent Prenatal test, and no major congenital malformation was noted.  On 01-Apr-2019, 5 months and 17 days after administration of study vaccine, the subject developed anemia and was treated with iron (dose: 1 tablet, frequency: BID, route: oral, start date: 02-Apr-2019 and stop date: 06-Jun-2019).  The outcome of the event anaemia was recovered on 02-May-2019.  At gestational age of 38.4 weeks, the subject gave a live birth to a normal female neonate by caesarean method of delivery. The characteristics of the neonate included birth weight: 2637 grams and APGAR (appearance, pulse, grimace, activity, and respiration) scores were 1 at one minute (APGAR score low) and 8 at five minutes. The subject's pregnancy complication included gestational hypertension without significant proteinuria in the third trimester. The were no major congenital malformations (MCMs) identified at birth.    The subject's estimated date of delivery (EDD) was reported as 25-May-2019 and corrected estimated date of delivery (CEDD) was reported as 01-Jul-2019.  This case is linked to the case 201904220 (baby case).  Follow-up received from other health professional on 23-Jul-2019: The subject's pregnancy outcome details (gestational age at outcome: 38.4 weeks, birth type: live birth, foetal outcome: normal) and neonatal characteristics [birth weight: 2637 grams, gender: female and APGAR scores: 1 at one minute (APGAR score low) and 8 at five minutes) were added in the patient tab. The subject's pregnancy complication included gestational hypertension without significant proteinuria in the third trimester. The new event 'gestational hypertension' was added in the event tab. Hence, the case was upgraded from non-serious to serious. The linking sentence was added in the narrative. It was reported that, no major congenital malformations (MCMs) were identified at birth. The narrative and case comment were amended accordingly.; Reporter's Comments: A 19-year-old female pregnant subject experienced anaemia, 5 months 17 days after receipt of Flu Vaccine Egg Split QIV (considered as vaccine exposure during pregnancy) at first trimester. The subject also reported to have gestational hypertension as third trimester complication of pregnancy. The time to onset of the reported events gestational hypertension and anaemia in association to study vaccine exposure is considered implausible. Also, pregnancy state of the subject provide more plausible explanation rather than study vaccine. Hence, causality assessed as not related to study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine.  The company assessed the case as serious (medically significant).