Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Vaccine fetal exposure during pregnancy; Preterm birth at gestational age of 36.9 weeks; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a male, neonate subject, whose mother was 31-year-old, pregnant, female subject of body weight: 192.5 lbs, height: 62.8 inches and body mass index (BMI): 34.3 enrolled in a prospective observational safety study.  The mother's medical history included high body mass index, anemia, nausea and acid reflux.  The mother's concomitant medications included Prenatal (unspecified vitamins and minerals) + DHA (docosahexaenoic acid) for pregnancy, iron for anemia, Nexium (esomeprazole magnesium) for acid reflux and Zofran (ondansetron hydrochloride) for nausea.  The mother's obstetrical history included three previous pregnancies: one full term live birth and two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformation (MCM), nor relevant maternal or paternal history. The subject's mother did not consume tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) date was 23-Apr-2019. The mother's estimated date of delivery (EDD) was 28-Jan-2020 and corrected estimated date of delivery (CEDD) was 30-Jan-2020. The type of pregnancy was singleton. The father's age was 35.  On 05-Nov-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 06-Nov-2019, at gestational age of 28 weeks, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100126099, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy, third trimester') for influenza immunisation.  At gestational age of 36.9 weeks, the subject's mother vaginally delivered male neonate. The birth weight of the neonate was 2750 g, head circumference was 34 cm and length were 44.5 cm. 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 pregnancy complications were noted and no MCM was identified at birth.  At the time of this report, the outcome of preterm birth was not reported.  The event of preterm birth was considered serious due the criterion of medical significance.  The reporter did not provide the causality assessment to Afluria QIV.  This case is linked to case 201907402 (the corresponding mother case).  Company comment: Reportedly, the male neonate subject was delivered as premature baby after foetal exposure during pregnancy to the suspect product Afluria QIV. The vaccine was administered at 28 weeks of gestation. Chronology is plausible. 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 during pregnancy to the suspect product Afluria QIV. The vaccine was administered at 28 weeks of gestation. Chronology is plausible. 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.