Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal growth restriction, Ultrasound antenatal screen abnormal
Clinical narrative: Intrauterine growth restriction; Small for gestational age; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Nov-2019, concerning a foetal subject of an unspecified gender. The subject's mother was 22-year-old, female pregnant subject of body weight 133 lbs, height 61.5 inches and body mass index (BMI) 24.7 enrolled in a prospective observational safety study.  The mother's current conditions included nausea, gastroesophageal reflux disease (GERD) and irritable bowel syndrome.   The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, lansoprazole for GERD and ondansetron for nausea.  The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was 31-Jan-2019. The mother's estimated date of delivery (EDD) was reported as 07-Nov-2019 while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 10-Oct-2019, at approximately 36 weeks of gestation, the subject's mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100123038, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 18-Oct-2019, the subject's mother underwent ultrasound and it was noted that the foetal weight was less than fifth percentile while head and abdominal measurements were less than fourth percentile. No MCMs were noted.  On 04-Nov-2019, 25 days after vaccination, the subject's mother underwent ultrasound and subject was small for gestation age (SGA) and intrauterine growth restriction (IUGR) was noted. Amniotic fluid volume was normal. No MCMs were noted.  At the time of the initial reporting, the outcome for the events of SGA and IUGR was not reported.  This case is linked with case 201905985 (the corresponding mother case).  The case was assessed as serious and the reporter did not provide causality assessment to Afluria QIV.  Company comment: Reportedly, foetal growth restriction and small for dates baby were noted in female subject of an unspecified gender. The subject's mother was administered Afluria QIV at approximately 36 weeks of gestation. The mentioned events were noted 25 days after vaccination. Chronology is plausible. Foetal exposure during pregnancy is assessed as unrelated per company's conventions. For other events, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: Reportedly, foetal growth restriction and small for dates baby were noted in female subject of an unspecified gender. The subject's mother was administered Afluria QIV at approximately 36 weeks of gestation. The mentioned events were noted 25 days after vaccination. Chronology is plausible. Foetal exposure during pregnancy is assessed as unrelated per company's conventions. For other events, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.