Sex: M
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Stillbirth
Clinical narrative: Foetal exposure during pregnancy; Stillbirth; Low birth weight; Premature birth; This is an observational study case, initially received from other health professional on 16-Dec-2019 with an additional information received on 18-Dec-2019 (being processed together), concerning a male, neonatal subject. The subject's mother was 33-year-old  pregnant female of body weight: 246 Ibs, height: 67 in and body mass index (BMI) 38.5 enrolled in a prospective observational safety study.  The subject's mother current medical condition included history of venous thromboembolism, gestational hypertension (GHTN), anxiety, nausea, vomiting, history of deep vein thrombosis (DVT) and obesity.   The subject's mother concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Lexapro (escitalopram oxalate) for anxiety, promethazine for nausea and vomiting and Lovenox (enoxaparin sodium) for history of venous thromboembolism.  The subject's 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 last menstrual period (LMP) date was 24-Jun-2019. Estimated delivery date (EDD) was reported as 30-Mar-2020 and corrected estimated delivery date (CEDD) was not reported.   The type of pregnancy was singleton.    On 18-Sep-2019, the subject's mother underwent first sequential and nuchal translucency. No MCMs were noted.  On 16-Oct-2019, at approximately 16 weeks of gestation, the subject's mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100112488, dose, 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, the subject's mother underwent second sequential and no MCMs were noted.  On 30-Oct-2019, the subject's mother underwent early glucose tolerance test and per reporter, it failed.  On 04-Nov-2019, the subject's mother underwent three-hour glucose tolerance test and no MCMs were noted.  At approximately 22 weeks of gestation, mother vaginally delivered a stillbirth male neonate, (explicitly coded as 'Premature birth'). The pregnancy outcome was stillbirth. The characteristics of the neonate included weight: 417 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. No MCMs were identified at the time of birth. On the same day, the subject's mother was diagnosed with HELLP syndrome (characterised with hemolysis, elevated liver enzymes, and a low platelet count). It was reported that the factors that may had impact on fetal loss included mother's HELLP syndrome and history of DVT. It was unknown whether the autopsy was performed.  The event of stillbirth is considered as serious due to fatal outcome, while the events of low birth weight baby and premature birth are considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Afluria QIV.  This case is linked to case 201907406 (corresponding mother case).  Company comment: The patient experienced preterm birth and low birth weight, one months and 14 days after maternal receipt of Afluria QIV. The pregnancy outcome was stillbirth. The subject's mother was administered vaccine at approximately 16 weeks of gestation. Chronology is plausible. Mother's medical history of venous thromboembolism, gestational hypertension and concomitant drugs used during pregnancy may have contributed to development of the events. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: The patient experienced preterm birth and low birth weight, one months and 14 days after maternal receipt of Afluria QIV. The pregnancy outcome was stillbirth. The subject's mother was administered vaccine at approximately 16 weeks of gestation. Chronology is plausible. Mother's medical history of venous thromboembolism, gestational hypertension and concomitant drugs used during pregnancy may have contributed to development of the events. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Reported Cause(s) of Death: Unknown cause of death