Sex: F
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Intensive care, Neonatal respiratory distress, Premature baby
Clinical narrative: Baby to NICU for respiratory distress; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Feb-2020, concerning a female, neonate subject, whose mother was a 31-year-old female of body weight 142 lbs, height 69 inches and body mass index (BMI) 21, enrolled in a prospective observational safety study.  The mother's medical history included anxiety and human papilloma virus (HPV)+ Pap.   The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as OB care and escitalopram for anxiety.  The mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 05-May-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 09-Feb-2020 and corrected estimated date of delivery (CEDD) of subject's mother was reported as 03-Mar-2020. The subject's father was a 32-year-old.  On 19-Aug-2019, the subject's mother underwent first trimester screen and nuchal translucency ultrasound and no MCM was noted.   On 16-Sep-2019, at approximately 19 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On the same day, the subject's mother underwent second trimester alpha-fetoprotein (AFP) screen and no MCM was noted.   On 14-Oct-2019, the subject's mother underwent anatomy ultrasound scan and no MCM was noted.   At 37 weeks of gestation, the subject's mother vaginally delivered a live, female neonate of birth weight 3544 grams. The neonate's head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. The subject was sent to Neonatal intensive care unit (NICU) for respiratory distress.  At the time of initial reporting, the outcome of the event respiratory distress was not reported.  The event of respiratory distress was considered serious due to the criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked to 202001883 (the corresponding mother case).  Company comment: A female neonate subject experienced respiratory distress after maternal receipt of Flucelvax QIVcvaccine at approximately 19 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is implausible due to very long onset latency (more than 5 months). Mother's medical history of human papilloma virus and concomitant medication escitalopram may have contributed to development of the the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event respiratory distress is assessed as not related.; Sender's Comments: A female neonate subject experienced respiratory distress after maternal receipt of Flucelvax QIVcvaccine at approximately 19 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is implausible due to very long onset latency (more than 5 months). Mother's medical history of human papilloma virus and concomitant medication escitalopram may have contributed to development of the the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event respiratory distress is assessed as not related.