Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Streptococcus test positive, Ultrasound antenatal screen normal, Vaginal infection
Clinical narrative: GBS; GBS positive; Hypertension/chronic hypertension; Acute vaginitis; Vaccine exposure during pregnancy; This is a serious observational study case initially received from other health professional on 21-Jun-2019, concerning a 29-year-old adult female pregnant subject of body weight 278 lbs, height 63 inches and body mass index (BMI) 49.2, 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 had one previous pregnancy with full term live birth. The subject did not have a history of offspring with major congenital malformation. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal or paternal history with major congenital malformations. The subject's current condition included obesity.   The subject's last menstrual period (LMP) date was 06-Jul-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  On an unknown date, the pregnancy status of the subject was collected, and no pregnancy complications were noted.   On 25-Sep-2018, at 3 weeks of gestational age, the subject was administered prenatal vitamins (concomitant medication; dose: 1, unit: tablet, frequency: QD, route: oral; stop date: 29-Mar-2019) for pregnancy.   On 17-Oct-2018, at approximately 14 weeks of gestation, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 17-Oct-2018, the subject underwent ultrasound test and no major congenital malformation was noted.  On 31-Oct-2018, 14 days after vaccination, the subject was diagnosed with acute vaginitis and was recovered on an unspecified date in 2018.   On 28-Nov-2018, 1 month and 11 days after vaccination, the subject experienced chronic hypertension.   On 19-Dec-2018, the subject underwent quadruple screening along with ultrasound test and no major congenital malformation was noted.  On 31-Dec-2019, the subject underwent ultrasound test and no major congenital malformation was noted.  On 09-May-2019, 6 months and 22 days after vaccination, the subject was found to be positive for group B streptococcus infection.    On 23-May-2019, the subject had recovered from the events chronic hypertension and bacterial infection due to streptococcus, group B.   At 39 weeks of gestational age, the subject gave a live birth to a normal male neonate. The delivery method was caesarean and no complications or no major congenital malformation (MCM) was identified at birth. The neonate's birth weight was 3625 grams, head circumference was 34.3 cm and body length were 53.3 cm. The APGAR scores were 9 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes.   The subject's estimated date of delivery (EDD) was reported as 12-Apr-2019 and corrected EDD was reported as 05-Jun-2019.; Reporter's Comments: A 29-year-old pregnant subject experienced hypertension, one month 11 days after administration of study vaccine, at 3 weeks of gestation (coded to Exposure during pregnancy). The subject also experienced acute vaginitis 14 days after study vaccine and Beta haemolytic streptococcal infection 6 months and 22 days post vaccination. Considering the inactivated nature of the suspect vaccine and infectious aetiology of the reported events (acute vaginitis and Beta haemolytic streptococcal infection ) the causal role of study vaccine was assessed as not related. The GBS positive was investigation supporting the diagnosis.Considering that there is no evidence for a biological mechanism that could cause the event and hemodynamic changes associated with pregnancy due to vaccination, the event (hypertension) was more likely associated with underlying pregnancy and was assessed as not related to the study vaccination. 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).