Sex: M
Vaccine: UNK
Symptoms: Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Vaccine foetal exposure during pregnancy; Pre-term birth; This is an observational study case, initially received from other health professional on 18-Dec-2019, concerning a male neonate subject, whose mother was a 36-year-old female of body weight  160 lbs, height 61 inches and body mass index (BMI) 30.2, 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 father was 44-year-old.  The mother's medical history included high body mass index. Pregnancy with advanced maternal age was considered as risk factor.  The mother's concomitant medication included Prenate Pixie [unspecified vitamins and minerals] for pregnancy.  The mother's obstetrical history included one previous preterm delivery. The mother had no history of offspring with major congenital malformations (MCMs), nor maternal or paternal history with MCM. The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The mother's last menstrual period (LMP) date was 05-Mar-2019.The mother's estimated delivery date (EDD) was 10-Dec-2019 and corrected estimated delivery date (CEDD) was 21-Dec-2019. The type of pregnancy was singleton.  On 30-May-2019, the subject's mother underwent first trimester screen and no MCM was noted.  On 18-Jun-2019, the subject's mother performed ultrasound and no MCM was noted.  On 15-Oct-2019, at gestational age of 32 weeks, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261226, dose, route of administration, anatomical location and expiration date: not reported) (explicitly coded as Foetal exposure during pregnancy, third trimester') for influenza immunisation.   At the gestational age of 36.6 weeks, the subject's mother delivered a male neonate by Caesarean method. No pregnancy complications were noted. The neonate's birth weight was 2863 g, head circumference was 31.8 cm 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.  Per company, the event of premature birth was considered serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case was linked to the case 201907378 (the corresponding mother case).  Company comment: Reportedly, the male neonate subject was delivered as premature baby after foetal exposure to the suspect product Flu Vaccine Cell Subunit QIV NVD. The vaccine was administered at 32 weeks of gestation. Chronology is plausible. Although causality was confounded by mother's 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. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, the male neonate subject was delivered as premature baby after foetal exposure to the suspect product Flu Vaccine Cell Subunit QIV NVD. The vaccine was administered at 32 weeks of gestation. Chronology is plausible. Although causality was confounded by mother's 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. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.