Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Hypertension, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This is a serious observational study case initially received on 22-Apr-2019, concerning a 42-year-old, adult female, pregnant subject of body weight 217 lbs, height 63 inches and body mass index (BMI) 38.4, enrolled in a study. The subject's obstetrical history noted that the subject had 3 previous pregnancies with 1 full term live birth, 1 preterm live birth and 1 pregnancy with spontaneous abortion. 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 02-Feb-2019. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and the pregnancy complication maternal age greater than 35' was noted. The subject's concomitant medication included prenatal (folic acid, iron) for general health. On 28-Mar-2019, at 7 weeks gestation age, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41608, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly considered as vaccine exposure during pregnancy) for an unknown indication. On 28-Mar-2019, the subject had undergone ultrasound antenatal screening and no major congenital malformations were noted. On 16-Apr-2019, the subject had undergone non-invasive prenatal testing and ultrasound antenatal screening and no major congenital malformations were noted. On an unspecified date in 2019, after vaccination, the subject experienced hypertension. The subject was treated with nifedipine [30 mg, frequency: once a day (qd), orally, from 16-Apr-2019], labetalol [200 mg, frequency: twice a day (bid), orally, from 18-Apr-2019], HCTZ (hydrochlorothiazide, stop date: 16-Apr-2019) and Procardia [nifedipine (reported as Procardia XL), 60 mg, frequency: once a day (qd), orally, from 22-Apr-2019]. The outcome of the event hypertension was not recovered (reported as ongoing). The subject's corrected estimated date of delivery (CEDD) was reported as 03-Nov-2019. The subject's estimated date of delivery (EDD) was reported as 09-Nov-2019.; Reporter's Comments: A 42-year-old pregnant subject experienced hypertension, on an unspecified day after administration of study vaccine at 07 weeks of gestation. The case lacks information on exact temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and presence of risk factors (advanced maternal age, gestational history, body mass index of 38.4 and ongoing pregnancy). Hence, 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 case as serious (medically significant).