Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Premature baby, Ultrasound antenatal screen normal
Clinical narrative: Pregnancy induced hypertension; Failed induction; Arrest of dilation; Vaccine exposure during pregnancy; This is an observational pregnancy study case initially received from other health professional on 24-Jan-2020, concerning a 26-year-old, adult, female pregnant subject of body weight: 151 lbs, height: 58 inches and body mass index (BMI): 31.6, enrolled in a prospective observational study.  The subject's current medical conditions included obesity. The subject was varicella non-immune.   The subject's concomitant medications included prenatal vitamins as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.    The subject's obstetrical history included no previous pregnancies. The subject did not have a history of offspring with major congenital malformation (MCM). The subject had no maternal history with MCMs. The subject's father had polycystic kidney disease.   The subject's last menstrual period (LMP) date was 22-Jun-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 28-Mar-2020. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The type of pregnancy was singleton.  On 19-Sep-2019, the subject underwent first trimester screen and nuchal translucency test and no MCM was noted.  On 24-Oct-2019, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and second trimester screen and no MCM was noted.  On 01-Nov-2019, the subject underwent anatomy ultrasound which was incomplete and rescan was scheduled in four weeks.   On 20-Nov-2019, at 21 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 252226, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On an unspecified date, an unknown amount of time after vaccination, the subject developed pregnancy induced hypertension.   On 27-Nov-2019, the subject underwent a follow up ultrasound, anatomy complete and no MCM was noted.    On 06-Jan-2020 the subject started treatment with labetalol, at a dose of 100 mg, twice a day, administered orally for pregnancy induced hypertension.  On 29-Jan-2020, the subject underwent a ultrasound growth and no MCM was noted.  At gestational age of 37.3 weeks (as reported), the subject delivered live male neonate by caesarean method due to arrest od dilation due to failed induction. The neonate's birth weight was 3039 g, head circumference and length were not reported. Appearance, pulse, grimace response, activity, respiration (APGAR) score at one minute and in five minutes were eight and no date for Apgar score in ten minutes. No pregnancy complications identified. No MCM noted at birth.  At the time of follow up report, the subject did not recover from pregnancy induced hypertension.   The events of 'failed induction of labour' and 'arrested labour' were assessed as serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  Follow up information received form other health professional on 11-Feb-2020: Labetalol added as treatment medication. New test added. Concomitant medication added. Narrative was amended accordingly.  Follow up information received from other health professional on 23-Mar-2020 with additional document received on the same day (being process together): It was provided that the start date for event pregnancy induced hypertension was unknown, and the outcome was ongoing. Pregnancy outcome received. 'Failed induction of labour' and 'arrested labour' were added as new events. Case upgraded to serious. The narrative was amended accordingly.  Company comment: The subject experienced gestational hypertension following vaccination with Flucelvax QIVc. The patient also experienced arrested labour and failed induction of labour 3 months 18 days post vaccination. Chronology is unsuggestive. Medical history of obesity (body mass index 31.6) may have contributed to development of the events. Vaccine exposure during pregnancy was assessed as not related to vaccine per company's conventions. Adverse event of hypertension was described as pregnancy-induced and other events were likely due to hypertension. In line with reported term and alternative aetiology, causality relationship between suspect product and gestational hypertension, arrested labour and failed induction of labour is assessed as not related.; Sender's Comments: The subject experienced gestational hypertension following vaccination with Flucelvax QIVc. The patient also experienced arrested labour and failed induction of labour 3 months 18 days post vaccination. Chronology is unsuggestive. Medical history of obesity (body mass index 31.6) may have contributed to development of the events. Vaccine exposure during pregnancy was assessed as not related to vaccine per company's conventions. Adverse event of hypertension was described as pregnancy-induced and other events were likely due to hypertension. In line with reported term and alternative aetiology, causality relationship between suspect product and gestational hypertension, arrested labour and failed induction of labour is assessed as not related.