Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight; Born at 34.4 weeks of gestation; This is an observational study case, initially received from other health professional on 03-Apr-2020, concerning a female neonate subject, whose mother was 30-year-old, female subject (Ethnicity: Not reported), of body weight 225 lbs, height 62 inches and body mass index (BMI) 41.1 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 subject's mother's current conditions included obesity with increased BMI, herpes simplex virus 2, renal disease and hypertension.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history noted that the mother had two previous pregnancies, one with full term live birth and one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 10-Aug-2019, the estimated delivery date (EDD) was reported as 17-May-2020 and corrected estimated date of delivery (CEDD) was reported as 05-May-2020. The type of pregnancy was singleton.   On 07-Oct-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy and no MCMs were noted.   On 14-Oct-2019, at approximately 9 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On the same day and 14-Oct-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 29-Oct-2019, the subject's mother underwent panorama and no MCMs were noted.   On 01-Nov-2019, 22-Nov-2019 and 19-Dec-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 31-Jan-2020, 3 months and 17 days after vaccination, the subject's mother developed anaemia and started treatment with oral ferrous sulfate at dose of 325 mg, administered via oral route three times a day.  On 03-Mar-2019, 10-Mar-2019, 15-Mar-2019, 19-Mar-2019 and 20-Mar-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On unknown date, the pregnancy status was collected, and pregnancy was complicated with chronic hypertension.  at gestational age of 34.4 weeks (as reported), the subject's mother delivered a preterm live birth, female neonate by caesarean method. The neonate's birth weight was 1955 grams. The neonate's head circumference were 31.1 cm and body length were 44.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score for 10 minutes was not reported. No MCMs were identified at the time of birth.  On the same day, the subject's mother finished treatment and the outcome of event anemia' was resolved.  At the time of this report, the outcome of event premature baby 33 to 36 weeks' and low birth weight baby' was not reported.  The events of premature baby 33 to 36 weeks' and low birth weight baby' were considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202002755 (the corresponding mother case).  Company Comment: A foetal subject experienced premature birth with low birth weight 5 months and 13 days after foetal exposure to the suspect product, Flucelvax QIVc. Chronology is unsuggestive. The subject's mother's current conditions included obesity with increased BMI, herpes simplex virus 2, renal disease and hypertension. Causality was highly confounded. Causal role of the suspect vaccine is assessed as not related for both events. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A foetal subject experienced premature birth with low birth weight 5 months and 13 days after foetal exposure to the suspect product, Flucelvax QIVc. Chronology is unsuggestive. The subject's mother's current conditions included obesity with increased BMI, herpes simplex virus 2, renal disease and hypertension. Causality was highly confounded. Causal role of the suspect vaccine is assessed as not related for both events. Foetal exposure during pregnancy is assessed as not related per company's conventions.