Sex: F
Vaccine: UNK
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 32.7 weeks of gestational age; This is an observational study case, initially received from other health professional on 12-Feb-2020, concerning a female neonate subject, whose mother was 38-year-old, female subject of body weight 263 lbs, height 67 inches and body mass index (BMI) 41.2 enrolled in a prospective observational safety study.  The mother's current conditions included increased BMI, hypertension, pain and pregnancy with advanced maternal age and superimposed pre-eclampsia.  The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Tylenol (paracetamol) for pain, labetalol and Procardia (nifedipine) both for hypertension.  The subject's mother had one previous preterm live birth pregnancy. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was 30-May-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 06-Mar-2020. The type of pregnancy was singleton. The subject's father was 59-year-old.  On 12-Aug-2019, the subject's mother had an ultrasound scan and no MCMs were noted.  On 24-Sep-2019, at approximately 16 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [Influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  At approximately 32.7 weeks of gestation, the subject's mother delivered a live birth male neonate via caesarean method. The neonate's birth weight was 2693 g, length was 48.3 cm and head circumference was 32.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 6 (five minutes) and 9 (ten minutes). No MCM was identified at birth.   At the time of this report, the outcome of the event 'premature birth' was not reported.  The event of 'premature birth' was considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202001708 (the corresponding mother case).  Company Comment: A female neonate subject was delivered as premature baby after maternal receipt of Afluria Quadrivalent vaccine at approximately 16 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is incompatible due to very long onset latency over three months. Mother's current conditions of obesity (body mass index 41.2), hypertension, advanced maternal age and superimposed pre-eclampsia may provide more plausible alternative aetiology. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event premature baby is assessed as not related.; Sender's Comments: A female neonate subject was delivered as premature baby after maternal receipt of Afluria Quadrivalent vaccine at approximately 16 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is incompatible due to very long onset latency over three months. Mother's current conditions of obesity (body mass index 41.2), hypertension, advanced maternal age and superimposed pre-eclampsia may provide more plausible alternative aetiology. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event premature baby is assessed as not related.