Sex: M
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Premature baby; This is an observational study case, initially received from other health professional on 06-Aug-2019, concerning a neonate, male subject, whose mother was a 32-year-old, pregnant, female subject of body weight 199 lbs, height 60 inches and body mass index (BMI): 38.9, enrolled in a prospective observational safety study.  The mother's medical history included history of deep vein thrombosis (DVT), candidiasis and urinary tract infection. Concomitant medications included Prenatal vitamins (mineral NOS, vitamin NOS), terconazole, Macrobid (nitrofurantoin) and Lovenox (enoxaparin sodium).  The subject's mother obstetrical history noted that the mother had 5 previous pregnancies which included four full term, live births and one spontaneous abortion. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother did not have a prior history of use of cigarettes, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 27-Aug-2018 and the pregnancy was singleton. The estimated delivery date (EDD) was 03-Jun-2019 and the corrected estimated date of delivery (CEDD) were 23-Jun-2019.  On 29-Oct-2018, gestation age of nine weeks, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, batch number: 252664, expiry date, anatomical location and route of administration: not reported] (explicitly coded as Fetal exposure during pregnancy') for influenza immunization.  At gestational age of 36.3 weeks, the mother vaginally delivered live birth, male neonate [explicitly coded as Premature baby']. The neonate's birth weight was 3090 g, his head circumference was 34.3 and body length was 48.3. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. There was no major congenital malformation identified at birth.  This case is linked to case 201904358, corresponding mother case.  Company comment: The patient experienced preterm birth, 6 months 29 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Mother's medical history of deep vein thrombosis (DVT), candidiasis, urinary tract infection and concomitant drugs used during pregnancy may have contributed to development of the event. However, causal role of the suspect vaccine cannot be totally excluded and was assessed as related for the event of preterm birth. The event foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine.; Reporter's Comments: The patient experienced preterm birth, 6 months 29 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Mother's medical history of deep vein thrombosis (DVT), candidiasis, urinary tract infection and concomitant drugs used during pregnancy may have contributed to development of the event. However, causal role of the suspect vaccine cannot be totally excluded and was assessed as related for the event of preterm birth. The event foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine.