Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Delivery, Exposure during pregnancy, Foetal non-stress test, Hypertension, Ultrasound antenatal screen normal
Clinical narrative: Hypertension; Vaccine exposure during pregnancy; This is a serious observational study case initially received on 31-May-2019 and follow up 1 received on 04-Jun-2019 (initial and follow up versions are being processed together), concerning a 26-year-old adult female, pregnant subject, of body weight 350 lbs, height 65 inches and body mass index (BMI) 58.2, enrolled in V130_11OB, 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 obstetrical history noted that the subject had one previous pregnancy which included full-term live birth and no birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 12-Jul-2018. The type of pregnancy was singleton.   The subject's historical condition included bacterial vaginosis. The patient's historical drug included Metrogel for bacterial vaginosis. The subject's current condition included obesity and nausea since an unspecified date. The subject's concomitant medications included promethazine for nausea and prenatal vitamins (minerals nos, vitamins nos) for pregnancy.   On 28-Aug-2018, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy screening and no major congenital malformations were noted. On 05-Sep-2018, the subject underwent ultrasound scan and no major congenital malformations were noted.  On 03-Oct-2018, at 11 weeks 6 days of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.   On 01-Nov-2018, the subject underwent ultrasound scan and no major congenital malformations was noted.   On 28-Mar-2019, 5 months and 25 days after vaccination, the subject developed hypertension. On 05-Apr-2019, the subject underwent non-stress test for the hypertension and results were not reported.    The outcome of the event hypertension was not recovered (reported as ongoing).  At approximately 39.3 weeks gestation, the subject gave a live birth to a female neonate vaginally. The characteristics of the neonate included birth weight: 3345 grams, head circumference: 33.7 cm, length: 50.2 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and five minutes). No major congenital malformations (MCMs) were identified at birth. There were no pregnancy complications noted.   The subject's estimated date of delivery (EDD) was reported as 18-Apr-2019.  Significant follow up versions  2 and 3 received from the investigator on 16-Jul-2019 (both versions being processed together): The subject's current condition obesity' was added and lab test non-stress test' for the hypertension were added in the patient tab. The event unspecified pregnancy complication' was replaced with the event hypertension in event tab. Hence, the case was upgraded from non-serious to serious. The start date (05-Apr-2019) for the event hypertension was updated and outcome of the event was updated from not reported to not recovered in the event tab. The causality and listedness were amended accordingly in the event assessment tab. The narrative and case comment were amended accordingly.; Reporter's Comments: A 26-year-old pregnant subject experienced hypertension, 5 months 25 days after administration of study vaccine, at approximately 12 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event, no evidence for a biological mechanism that could cause the event, risk factors (obesity and BMI- 58.2) and hemodynamic changes associated with pregnancy, the event was assessed as not related to the 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 event 'hypertension' as serious (medically significant).