Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Complication of pregnancy, Exposure during pregnancy, Hypertension
Clinical narrative: Chronic Hypertension; Vaccine exposure during pregnancy; This is a serious observational study case initially received on 31-May-2019, concerning a 36-year-old, adult female, pregnant subject of body weight: 135 lbs, height: 65 inches and body mass index (BMI): 22.5 enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's historical condition included bacterial vaginosis (since unspecified date) and was treated with Metrogel. The subject's obstetrical history included no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations. The subject's current conditions included anxiety, acid reflux and nausea. The gestational risk factor of the subject included pregnancy with advanced maternal age. The subject's concomitant medications included Lovenox (enoxaparin sodium) as anticoagulant, Zoloft (sertraline hydrochloride) for anxiety, Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and promethazine for nausea.  The subject's last menstrual period (LMP) date was 01-May-2018. The type of pregnancy was singleton. The subject did not use alcohol or illicit drugs during pregnancy. The subject was smoking half pack cigarettes per day during pregnancy.  On an unknown date, the pregnancy status of the subject was collected, and no major congenital malformations were noted.  On 24-Jul-2018, the subject underwent hemoglobin electrophoresis, cystic fibrosis mutation analysis and spinal muscular atrophy screen and no major congenital malformations were noted.  On 25-Jul-2018, the subject underwent ultrasound scan and no major congenital malformation was noted.  On 02-Oct-2018, at gestational age of approximately 22 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. 3 months and 21 days after vaccination, the subject vaginally delivered a full-term female neonate at 38.1 weeks gestation. At the time of birth, pregnancy complication was noted as chronic hypertension. The neonate's birth weight was 2948 grams, head circumference was 33 cm and body length was 53.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (at one minute) and 8 (at five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  The outcome of the event chronic hypertension was not reported.  The subject's estimated date of delivery (EDD) was 05-Feb-2019.; Reporter's Comments: A 31-year-old pregnant subject with history of anxiety, acid reflux, reported chronic hypertension at the time of delivery (more than 3 months post-vaccination with Flu Vaccine Cell Subunit QIV NVD). Considering no known biological mechanism following vaccination, and as the condition can be explained by maternal medical history (smoking, anxiety), pregnancy, the causality was assessed as not related to suspect vaccine. The concurrent medications lovenox, zolosoft, promethazine were considered as co-suspect. 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 this case as serious (medically significant).