Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Vaccine foetal exposure during pregnancy; Preterm birth at gestational age of 36.7 weeks; This is an observational study case, initially received from other health professional on 23-Dec-2019, concerning a neonate male subject, whose mother was 22-year-old, pregnant, female subject of body weight: 136 lbs, height: 63.6 inches and body mass index (BMI): 23.6  enrolled in, a prospective observational safety study.  The mother's historical medical condition included bacterial vaginosis. The mother's current medical conditions included nausea, depression, epilepsy, anxiety and gestational hypertension. The mother was RhD negative.   The mother'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 mother's obstetrical history included one previous pregnancy that ended as spontaneous abortion. The mother had no maternal/paternal history with major congenital malformations (MCM).    The mother's last menstrual period (LMP) date was 10-Mar-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 15-Dec-2019. The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  On 03-Jun-2019, the subject's mother performed nuchal translucency and first trimester screen and no MCM was noted.  On 01-Jul-2019, the subject's mother performed second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers) and no MCM was noted.  On 22-Jul-2019, the subject's mother performed anatomy ultrasound and no MCM was noted.  On 17-Sep-2019, at gestational age of 27 weeks, the mother was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261200, route of administration, anatomical location and expiration date: not reported) (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On the same day, the mother was also administered a 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 expiration date: not reported] for vaccination.  At gestational age of 36.7 weeks, the mother vaginally delivered 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.  At the time of initial report, the outcome of preterm birth was not reported.  Per company, the event of preterm birth 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 the case 201907468 (the corresponding mother case).  Company comment: The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 27 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of gestational hypertension, depression and anxiety may provide alternative aetiology for the event. Causality is also confounded with co-suspect product Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) and multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event premature baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 27 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of gestational hypertension, depression and anxiety may provide alternative aetiology for the event. Causality is also confounded with co-suspect product Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) and multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event premature baby is assessed as unlikely related (defaults to related for reporting purposes).