Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Born at 36.7 weeks of gestation; Birth weight 2495 g; This is an observational study case from, initially received from other health professional on 06-May-2020, concerning a female, neonate subject whose mother was 25-years-old female subject (Race:; Ethnicity:) (subject ID:) of body weight: 102.6 lbs, height: 62 inches and body mass index (BMI) 18.8, enrolled in, a prospective observational safety study.  The subject's mother's medical history and concomitant medications were not provided.  The subject's mother's obstetrical history included one previous pregnancies with one full term live birth. The subject's mother did not have a history of offspring with major congenital malformation (MCM). The subject's mother had no maternal or paternal history with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 07-Jun-2019, the estimated delivery date (EDD) was reported as 13-Mar-2020, while the corrected estimated date of delivery (CEDD) was reported as 11-Mar-2020. The type of pregnancy was singleton. The subject's father was 28-years-old.  On 07-Aug-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 04-Sep-2019, the subject's mother underwent first trimester screen and no MCM was noted.   On 17-Oct-2019, at approximately 18 weeks of gestation (calculated per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number reported as 100108765 (Seqirus Batch number: P100108765), dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 07-Nov-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On an unspecified date, subject's mother developed pre-eclampsia.  On, at 36.7 weeks of gestation (as reported), the mother delivered live premature female neonate, vaginally. The neonate's birth weight was 2495 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   At the time of this report, the outcome of events premature birth' and low birth weight baby' was not reported.   The events of premature birth' and low birth weight baby' were assessed as serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked to 202003310 (the corresponding mother's case).  Company comment: A female neonate subject, whose mother was 25-years-old female subject, developed premature baby and low birth weight baby after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, at 36.7 weeks of gestation the mother delivered live premature female neonate, vaginally. Chronology seems compatible. The subject's mother's medical history and concomitant medications were not provided. The subject's mother's obstetrical history included one previous pregnancies with one full term live birth. The subject's mother did not have a history of offspring with major congenital malformation (MCM). With information presented, causality is assessed as unassessable for both events. Clarification regarding medical history and concomitant medications is needed in order to establish a proper causal relationship. Temporality does not seems suggestive. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A female neonate subject, whose mother was 25-years-old female subject, developed premature baby and low birth weight baby after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, at 36.7 weeks of gestation the mother delivered live premature female neonate, vaginally. Chronology seems compatible. The subject's mother's medical history and concomitant medications were not provided. The subject's mother's obstetrical history included one previous pregnancies with one full term live birth. The subject's mother did not have a history of offspring with major congenital malformation (MCM). With information presented, causality is assessed as unassessable for both events. Clarification regarding medical history and concomitant medications is needed in order to establish a proper causal relationship. Temporality does not seems suggestive. Foetal exposure during pregnancy is assessed as unrelated per company conventions.