Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Foetal exposure during pregnancy, Vacuum extractor delivery
Clinical narrative: Fetal exposure during pregnancy; Apgar score at one minute 2; This is an observational study case, initially received from other health professional on 29-Apr-2020, concerning a neonate, male subject whose mother was a 33-year-old, female pregnant subject of body weight: 173 lbs, height: 61.5 inches and body mass index (BMI): 32.2, enrolled in a prospective observational safety study.  The subject's mother current medical conditions included body mass index high (BMI 32.2) and anxiety.   The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The mother's obstetrical history included three previous pregnancies with two full-term live births and one spontaneous abortion. The mother had no history of offspring with major congenital malformations (MCMs) and no relevant maternal or paternal medical history. The mother did not use alcohol or illicit drugs during pregnancy. The mother smoked cigarettes during pregnancy (8 to 10 cigarettes per day).   The subject's mother last menstrual period (LMP) date was 09-Jul-2019. The subject's mother estimated delivery date (EDD) was reported as 14-Apr-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 01-Oct-2019, the mother underwent dating ultrasound and no MCM was noted.  On 07-Oct-2019, at gestational age of 12 weeks (calculated per LMP), the subject's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100118559, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Fetal exposure during pregnancy') for influenza immunisation.  On 23-Oct-2019, the mother underwent chlamydia and gonorrhoea culture test and no MCM was noted.  On 26-Nov-2019, the mother underwent anatomic scan and no MCM was noted.  On 24-Jan-2020, the mother underwent one-hour glucose tolerance test and no MCM was noted.  On 04-Feb-2020, the mother underwent prenatal bloodwork and no MCM was noted.  On 05-Feb-2020, it was noted that the subject's mother continued to smoke cigarettes.  On an unspecified date, pregnancy status of the subject's mother was collected, and gestational hypertension was noted as pregnancy complication.  At gestational age of 40.9 weeks (as reported), the mother delivered live birth male neonate via vaginal method of delivery (vacuum assisted). The neonate's birth weight was 3460 grams, head circumference 35.5 cm and body length 51 cm. The APGAR (appearance, pulse, grimace, activity and respiration) scores were at one minute 2, at five minutes 6 and 8 at ten minutes. There were no major MCM identified at birth.  On the same date, the subject recovered from the event of APGAR score low'.   Per company, the event of APGAR score low' was assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment.  This case is linked to 202003282, the corresponding mother case.  Company Comment: A neonate subject experienced Apgar score low, 6 months 13 days after foetal exposure to the suspect product Afluria QIV. Chronology is unsuggestive. The mother's obstetrical history included three previous pregnancies with two full-term live births and one spontaneous abortion. The subject's mother current medical conditions included body mass index high (BMI 32.2) and anxiety. Causality was confounded by cigarettes smoking during pregnancy (8 to 10 cigarettes per day). Causal role of the suspect product is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A neonate subject experienced Apgar score low, 6 months 13 days after foetal exposure to the suspect product Afluria QIV. Chronology is unsuggestive. The mother's obstetrical history included three previous pregnancies with two full-term live births and one spontaneous abortion. The subject's mother current medical conditions included body mass index high (BMI 32.2) and anxiety. Causality was confounded by cigarettes smoking during pregnancy (8 to 10 cigarettes per day). Causal role of the suspect product is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.