Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Amniotic cavity infection, Delivery, Exposure during pregnancy, Gestational hypertension, Neonatal disorder
Clinical narrative: Pregnancy induced hypertension/Gestational hypertension; Chorioamnionitis; Spontaneous rupture of membrane; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jul-2020, concerning a 29-year-old, female pregnant subject of body weight: 173 lbs, height: 64 inches and body mass index (BMI): 29.7, 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 medical history included high body mass index.  The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM) nor maternal or paternal history with major congenital malformations. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 01-Aug-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was reported as 07-May-2020 and corrected estimated date of delivery (CEDD) was 22-May-2020.  On 25-Oct-2019, approximately at 12 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On 27-Dec-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 13-Apr-2020, 5 months 19 days after vaccination, the subject developed pregnancy induced hypertension.  On 16-Apr-2020, the subject underwent growth ultrasound and no MCM was noted.  On unspecified dates in 2020, chorioamnionitis and spontaneous rupture of membrane (reported as 24 hours prior to admission) were noted as pregnancy complications.  At 37.4 weeks of gestation (as reported), the subject vaginally delivered a male neonate. The neonate's birth weight was 3544 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 2, at five minutes was 4 and at ten minutes was 7. Therefore, the neonate was transported to neonatal intensive care unit (NICU). There was no MCM identified at birth.  At the time of initial reporting, the outcome of the event of pregnancy induced hypertension/gestational hypertension was not resolved, while the outcome of the events of chorioamnionitis and spontaneous rupture of membrane was not reported.  Per company, the events of chorioamnionitis and spontaneous rupture of membrane were assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  The case is linked to the case 202003890, corresponding baby case.  Company comment: A 29-year-old pregnant subject experienced gestational hypertension 5 months 19 days after administration of Flucelvax QIVc. The subject also developed amniotic cavity infection and premature rupture of membranes on unspecified dates in 2020 (reported as 24 hours prior to admission, suggesting that it was approximately six months after vaccination). The subject's current medical conditions included high body mass index, which may have contributed to development of the event of gestational hypertension. Causal role of the suspect product is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy was assessed as unrelated per company's conventions.; Sender's Comments: A 29-year-old pregnant subject experienced gestational hypertension 5 months 19 days after administration of Flucelvax QIVc. The subject also developed amniotic cavity infection and premature rupture of membranes on unspecified dates in 2020 (reported as 24 hours prior to admission, suggesting that it was approximately six months after vaccination). The subject's current medical conditions included high body mass index, which may have contributed to development of the event of gestational hypertension. Causal role of the suspect product is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy was assessed as unrelated per company's conventions.