Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: Delivery at 36.6 weeks; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 18-Dec-2019, concerning a 36-year-old, female pregnant subject of body weight: 160 lbs, height: 61 inches and body mass index (BMI): 30.2 enrolled in a prospective observational safety study.  The subject's medical history included high body mass and pregnancy with advanced maternal age.  The subject's concomitant medications included Prenate Pixie (folic acid, iron, unspecified minerals and vitamins) for pregnancy.  The subject's obstetrical history included one previous preterm delivery. The subject had no history of offspring with major congenital malformations (MCMs). The subject had no maternal or paternal history with MCM as well. The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The subject's last menstrual period (LMP) date was 05-Mar-2019.The subject's estimated delivery date (EDD) was 10-Dec-2020 and corrected estimated delivery date (CEDD) was 21-Dec-2020. The type of pregnancy was singleton.  On 30-May-2019, the subject underwent first trimester screen and no MCM was noted.  On 18-Jun-2019, the subject performed ultrasound and no MCM was noted.  On 15-Oct-2019, at gestational age of 32 weeks, the subject was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261226, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   At the gestational age of 36.6 weeks, the subject delivered male neonate by caesarean method. No pregnancy complications were noted. The neonate's birth weight was 2863 g, head circumference was 31.8cm and length was 45.7 cm. No data was reported for APGAR (appearance, pulse, grimace, activity and respiration) score at one, five and ten minutes. No MCM was identified at birth.  The event of premature labour 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 201907380 (the corresponding child case).  Company comment: A female subject experienced premature labour, 1 month 12 days after administration of Flu Vaccine Cell Subunit QIV NVD. The vaccine was administered at 32 weeks of gestation. Chronology is plausible. Although causality was confounded by medical history of previous preterm delivery and advanced maternal age, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.; Sender's Comments: A female subject experienced premature labour, 1 month 12 days after administration of Flu Vaccine Cell Subunit QIV NVD. The vaccine was administered at 32 weeks of gestation. Chronology is plausible. Although causality was confounded by medical history of previous preterm delivery and advanced maternal age, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.