Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: Intrauterine growth restriction; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 26-Mar-2020 concerning a female foetal subject. The subject's mother was 23-year-old pregnant, female subject (Ethnicity: not reported), of body weight: 112 Ibs, height: 64 in and body mass index (BMI) 19.22  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 relevant medical history was not reported.  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 no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). 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 15-May-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 19-Feb-2020. The type of pregnancy was singleton. The subject's father was 25-year-old.  On 26-Jun-2019, the subject's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy test. No MCMs were noted.  On 29-Jun-2019, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 24-Jul-2019, the subject's mother underwent panorama test and ultrasound scan. No MCMs were noted.  On 06-Sep-2019, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 01-Nov-2019, at approximately 24 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: 262218, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 20-Dec-2019, the subject's mother's pregnancy status was collected, and intrauterine growth restriction was noted.   On the same day, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 17-Jan-2020, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 21-Jan-2020, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 31-Jan-2020, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 02-Feb-2020, the subject's mother developed anaemia and started treatment with ferrous sulphate at the dose of 365 mg, administered two times per day via oral route.  At approximately 39 weeks of gestation (as reported), the mother vaginally delivered a live female neonate. The neonate's birth weight was 3168 g, body length was 50.3 cm and head circumference was 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and no data was provided for APGAR score at 10 minutes. No MCMs were identified at the time of the birth.   On the same day, the subject recovered from the event of intrauterine growth restriction, while the subject's mother recovered from the event of anaemia.  The event of foetal growth restriction' was considered as serious due to criteria of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202002638 (the corresponding mother case).  Company comment: A female foetal subject developed foetal growth restriction after her mother was vaccinated with the suspect product Flucelvax QIVc  for influenza immunisation. Reportedly, one and a half month later the event was detected. Chronology seems plausible. The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother's relevant medical history was not reported. The subject's mother's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as possibly related. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A female foetal subject developed foetal growth restriction after her mother was vaccinated with the suspect product Flucelvax QIVc  for influenza immunisation. Reportedly, one and a half month later the event was detected. Chronology seems plausible. The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother's relevant medical history was not reported. The subject's mother's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as possibly related. Foetal exposure during pregnancy is assessed as unrelated per company conventions.