Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Pre-term birth; This is a serious retrospective pregnancy study case, initially received from other health professional on 10-Sep-2019, concerning a neonate, female subject, whose mother was a 25-year-old, pregnant, female subject of body weight 179 lbs, height 64 inches and body mass index (BMI) 30.7, 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 mother's medical history included depression. Concomitant medications included Prenatal vitamins (mineral NOS, vitamins NOS), clonazepam and Effexor XR (venlafaxine hydrochloride).  The mother's obstetrical history noted that mother had two previous pregnancies with two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformation and no relevant maternal and paternal medical history. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was 23-Apr-2018. Estimated delivery date (EDD) and corrected delivery date (CEDD) were 28-Jan-2019. The pregnancy was singleton.  On 07-Jun-2018, the mother underwent ultrasound and no major congenital malformations were noted.   On 16-Aug-2018, the mother underwent Quad screen and ultrasound and no major congenital malformations were noted.   On 17-Sep-2018, the mother underwent ultrasound and no major congenital malformations were noted.   On 08-Oct-2018, at gestational age at 24 weeks, the subject's mother was administered with Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose: 0.5ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as fetal exposure during pregnancy) for immunization to Influenza virus.  On 06-Dec-2018, the mother underwent ultrasound and no major congenital malformations were noted.   at gestational age of 36.9 weeks, the mother vaginally delivered premature live birth, female neonate. The neonate's birth weight was 3459 g, head circumference 33 cm and length 50.8 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). No data was provided for Apgar score in 10 minutes. There was no major congenital malformation identified at birth.   The outcome of event premature birth' was not reported.   The case is linked to 201904582, corresponding mother case.  Company comment: A female neonate patient experienced preterm birth, 3 months after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 24 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible. Maternal medical history of two spontaneous abortions and concomitant use of clonazepam and Effexor XR confound causality. However, causal role of the suspect vaccine cannot be totally excluded and it is assessed as related. The event foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Reporter's Comments: A female neonate patient experienced preterm birth, 3 months after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 24 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible. Maternal medical history of two spontaneous abortions and concomitant use of clonazepam and Effexor XR confound causality. However, causal role of the suspect vaccine cannot be totally excluded and it is assessed as related. The event foetal exposure during pregnancy is assessed as unrelated per company's conventions.