Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy
Clinical narrative: Edema around fetal head and abdomen; fetal exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 07-Aug-2019, concerning a neonate, female subject whose mother was enrolled in enrolled in a prospective observational safety study.  The mother was 33- year old. The mother's current condition included nasopharyngitis and environmental allergies. Concomitant medications included prenatal vitamins, Zyrtec (cetirizine hydrochloride) and terconazole. The mother's obstetrical history included two previous pregnancies with one live birth, and one stillbirth. The mother had no maternal or paternal history with major congenital malformations. The mother's last menstrual period date was on 06-Oct-2019.The mother's estimated delivery date (EDD) was 13-Jul-2019 and corrected estimated date of delivery (CEDD) was 20-Jul-2019.  The type of pregnancy was singleton. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  On 02-Jan-2019 subject's mother underwent following prenatal tests: spinal muscular atrophy screen, haemoglobin electrophoresis, cystic fibrosis mutation and no malformations were noted.  At approximately 23 weeks gestation, on 06-Feb-2019, the mother received Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for unknown indication. On the same day mother had ultrasound, that showed normal result. On 13-Mar-2019, mother underwent prenatal ultrasound that showed oedema around foetal head. On the same day QNatal test was performed and no congenital malformations were noted.  On 18-Mar-2019, the subject's mother developed candidiasis. On 12-Apr-2019 additional ultrasound was performed and showed that the event of edema around foetal head and abdomen was recovered. On 29-May-2019, the mother developed gestation diabetes. The mother vaginally delivered a female neonate at 38 weeks gestation. The infant's birth weight was 3460 g, her length 50.2 cm, and head circumference 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  This case is linked to ID: 201904366, the corresponding maternal pregnancy report.  Company comment: The patient experienced localized edema (reported as edema around foetal head and abdomen), one month after maternal receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Reportedly, additional ultrasound was performed one month later and showed that the event of edema around foetal head and abdomen was recovered. Mother's medical history of previous stillbirth and concomitant drugs (cetirizine hydrochloride and terconazole) may have contributed to development of the event. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related to the event of localized oedema. The event foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine.; Reporter's Comments: The patient experienced localized edema (reported as edema around foetal head and abdomen), one month after maternal receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Reportedly, additional ultrasound was performed one month later and showed that the event of edema around foetal head and abdomen was recovered. Mother's medical history of previous stillbirth and concomitant drugs (cetirizine hydrochloride and terconazole) may have contributed to development of the event. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related to the event of localized oedema. The event foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine.