Sex: F
Vaccine: UNK
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Fetal exposure during pregnancy; Apgar score 3 at one minute; This is an observational study case, initially received from other health professional on 27-Feb-2020, concerning a female, fetal subject, whose mother was a 20-year-old, pregnant female subject of body weight 117 lbs, height 64 inches and body mass index (BMI) 20.1, enrolled in a prospective observational safety study.  The subject's mother's medical history included anemia, anxiety and migraines.   The subject's mother's concomitant medications included Flintstone gummy (unspecified vitamins) for pregnancy, Lexapro (escitalopram oxalate) for anxiety and ferrous sulfate for anemia.    The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) was on 08-Apr-2019, the estimated delivery date (EDD) was reported as 23-Jan-2020, while corrected estimated date of delivery (CEDD) was not reported. Type of pregnancy was singleton. The subject's father's age was not reported.   On 15-Jul-2019, the subject's mother underwent first sequential and nuchal translucency ultrasound and no MCM was noted.   On 11-Sep-2019, the subject's mother underwent targeted ultrasound and no MCM was noted.   On 09-Oct-2019, at approximately 24 weeks of gestation, the mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   At 39.9 weeks of gestation (as reported), the subject's mother vaginally delivered a normal, female neonate. The neonate's birth weight was 2800 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 3 (one minute) and 7 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   On the same day, the subject recovered from the event of 'APGAR score low'.   The event of APGAR score low' was considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to 201905911 (the corresponding mother's case).  Company comment: Apgar score low was reported in neonate subject, after foetal exposure Afluria QIV. Subject's mother was administered vaccine at approximately 24 weeks of gestation. Chronology is unsuggestive. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) since no alternative aetiology was provided. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.; Sender's Comments: Apgar score low was reported in neonate subject, after foetal exposure Afluria QIV. Subject's mother was administered vaccine at approximately 24 weeks of gestation. Chronology is unsuggestive. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) since no alternative aetiology was provided. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.