Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Fetal exposure during pregnancy; Apgar score 3 at one minute; This is an observational study case from, initially received from other health professional on 09-Jun-2020, concerning a female, neonate whose mother was 33-year-old, female subject (Race:, Ethnicity: not reported) of body weight: 194 lbs, height: 63 inches and body mass index (BMI): 34.4, enrolled in, a prospective observational safety study.   The medical history of neonate's mother included high BMI and chronic hypertension.  The neonate's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. The neonate's mother's obstetrical history included no previous pregnancies. The neonate's mother had no history of offspring with major congenital malformation (MCM). The neonate's mother had no maternal or paternal history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The neonate's mother last menstrual period (LMP) date was 29-Jun-2019. The estimated delivery date (EDD) was reported as 04-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 13-Apr-2020. The type of pregnancy was singleton. The neonate's father was 36 years old.  On 27-Aug-2019, the neonate's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy and no MCM was noted.  On 24-Sep-2019, the neonate's mother underwent ultrasound scan and no MCM was noted.  On 30-Oct-2019, the neonate's mother underwent ultrasound scan and panorama test and no MCM was noted.  On 13-Nov-2019, at approximately 19 weeks of gestation (calculated per LMP), the neonate's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, batch number: 261218, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.   On 04-Jan-2020, the neonate's mother underwent ultrasound scan and no MCM was noted.  On 29-Jan-2019, the neonate's mother developed anaemia and started treatment with ferrous sulfate at a dose of 325 mg, twice a day, administered via oral route.  On the same day, the neonate's mother underwent ultrasound scan and no MCM was noted.  On 06-Feb-2020, the neonate's mother developed gestational diabetes.  On 13-Feb-2020, 19-Feb-2020, 04-Mar-2020, 11-Mar-2020 and 25-Mar-2020, the neonate's mother underwent ultrasound scan and no MCM was noted.  On 08-Apr-2020, at 39.3 weeks of gestation (as reported), the neonate's mother delivered a live female neonate by caesarean method. The neonate's birth weight was 3140 grams, head circumference was 34.3 cm and body length 48.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 3 at one minute, 8 at five minutes and 8 at ten minutes. There was no MCM identified at birth.  On the same day, the outcome for the event of 'APGAR score low' was resolved. The neonate's mother recovered from anaemia and finished treatment with ferrous sulphate.  The event of 'APGAR score low' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to 202003798 (corresponding mother case).  Company Comment: A female neonate experienced Apgar score low, 4 months and 26 days after foetal exposure to the suspect product Flucelvax QIV. The neonate's mother was administered vaccine at approximately 19 weeks of gestation. No MCM was noted after vaccine administration. Causal role of the suspect product is assessed as not related, due to biological implausibility and unsuggestive chronology. The subject's medical history of high BMI, chronic hypertension and gestational diabetes may provide more plausible aetiology. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: Company Comment: A female neonate experienced Apgar score low, 4 months and 26 days after foetal exposure to the suspect product Flucelvax QIV. The neonate's mother was administered vaccine at approximately 19 weeks of gestation. No MCM was noted after vaccine administration. Causal role of the suspect product is assessed as not related, due to biological implausibility and unsuggestive chronology. The subject's medical history of high BMI, chronic hypertension and gestational diabetes may provide more plausible aetiology. Foetal exposure during pregnancy is assessed as not related per company conventions.