Age: 22.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Delivery, Exposure during pregnancy, Gestational hypertension, Premature delivery
Clinical narrative: Delivery at gestational age of 36.7; Vaccine exposure during pregnancy; Gestational hypertension; This is an observational study case, initially received from other health professional on 23-Dec-2019, concerning a 22-year-old, female pregnant subject of body weight: 136 lbs, height: 63.6 inches and body mass index (BMI): 23.6 enrolled in a prospective observational safety study on pregnancy utcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's historical condition included bacterial vaginosis.   The subject's current conditions included nausea, depression, epilepsy and anxiety. The subject was RhD negative.   The subject's concomitant medications included folic acid as supplement, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea, Rhogam (anti-D immunoglobulin) as Rh-negative vaccine, Lamictal (lamotrigine) for epilepsy, Zoloft (sertraline hydrochloride) for depression, Flagyl (metronidazole benzoate) for bacterial vaginosis and hydroxyzine for anxiety.  The subject had one previous pregnancy which ended as spontaneous abortion. The subject had no maternal/paternal history with major congenital malformations (MCM).    The subject's last menstrual period (LMP) date was 10-Mar-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 15-Dec-2019. The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  On 03-Jun-2019, the subject performed nuchal translucency and first trimester screen and no MCM was noted.  On 01-Jul-2019, the subject performed second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers) and no MCM was noted.  On 22-Jul-2019, the subject performed anatomy ultrasound and no MCM was noted.  On 17-Sep-2019, at gestational age of 27 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 mL, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On the same day, the subject was also administered a non-company co-suspect vaccine TDAP [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] for vaccination.  On an unspecified date in 2019, after vaccination, the subject developed gestational hypertension.   On 22-Nov-2019, at gestational age of 36.7 weeks, the subject vaginally delivered live male neonate. The birth weight of the neonate was 3232 g, no data reported for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No MCM was identified at birth.  The event of preterm delivery was considered serious due to the criterion of medically significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case 201907469 (corresponding child case).  Company comment: Reportedly, gestational hypertension and premature delivery were associated with Flucelvax QIVc. Vaccine was administered at 27 weeks of gestation. Chronology is plausible. Causality was confounded by patient's obstetrical history of previous spontaneous abortion, non-company co-suspect vaccine TDAP administered on the same day and concomitant drugs used during pregnancy. Causal role of the suspect vaccine cannot be excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, gestational hypertension and premature delivery were associated with Flucelvax QIVc. Vaccine was administered at 27 weeks of gestation. Chronology is plausible. Causality was confounded by patient's obstetrical history of previous spontaneous abortion, non-company co-suspect vaccine TDAP administered on the same day and concomitant drugs used during pregnancy. Causal role of the suspect vaccine cannot be excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.