Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Delivery, Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Preterm delivery at 35.9 weeks of gestation; Pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 05-Aug-2020, concerning a 38-year-old, pregnant, female subject of body weight: 198 lbs, height: 68.4 inches and body mass index (BMI): 29.8, 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 obesity, hypothyroidism, asthma, genital herpes simplex, pregnancy with advanced maternal age and allergies.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as obstetrical (OB) supplement, levothyroxine for hypothyroidism, Advair (fluticasone propionate, salmeterol xinafoate) for asthma, cetirizine for allergies, acyclovir for genital herpes simplex and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history included no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 15-May-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 19-Feb-2020. The type of pregnancy was singleton.  On 26-Jul-2019, the subject underwent MaterniT21 and no MCMs were noted.  On 10-Sep-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers and second trimester screen and no MCMs were noted.  On 03-Oct-2019, the subject underwent anatomy ultrasound and no MCMs were noted.  On 31-Oct-2019, approximately at 24 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; batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.  On an unspecified date in Jan-2020, reported as either week of 06-Jan-2020 or 17-Jan-2020, the subject developed pre-eclampsia.  At gestational age of 35.9 weeks (as reported), the subject delivered a live birth, female neonate via vaginal method of delivery. The neonate's birth weight was 2977 grams. The neonate's length was 49.5 cm, while head circumference was not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute, five and ten minutes were not reported. No MCMs were identified at the time of birth.   On the same date, the subject recovered from the event of pre-eclampsia.  At the time of this report, the outcome of event premature delivery' was not reported.  The events of premature delivery' and pre-eclampsia were considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to the case 202004085 (the corresponding baby case).  Company comment: A pregnant subject was administered Flucelvax QIV at 24 weeks of gestation. The subject experienced pre-eclampsia approximately two months after vaccination. The subject developed premature delivery 2 months and 21 days after vaccination. The subject's medical history included obesity, hypothyroidism and advanced maternal age (38). Causality was confounded. Causal role of the suspect vaccine is assessed as not related for both events, due to presented confounders, biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV at 24 weeks of gestation. The subject experienced pre-eclampsia approximately two months after vaccination. The subject developed premature delivery 2 months and 21 days after vaccination. The subject's medical history included obesity, hypothyroidism and advanced maternal age (38). Causality was confounded. Causal role of the suspect vaccine is assessed as not related for both events, due to presented confounders, biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.