Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Caesarean section, Cytogenetic analysis normal, Exposure during pregnancy, Foetal biophysical profile score abnormal
Clinical narrative: Premature delivery; Anxiety; Yeast; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 20-Sep-2019, concerning a 30-year-old, female pregnant subject of body weight: 197 lbs, height: 65 inches and body mass index (BMI): 32.8 enrolled in, a study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's medical history included migraine and herpes simplex virus type II (HSV2).  The subject's concomitant medication prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy.   Subject had five previous pregnancy reported with full-term live birth for two pregnancies, pre-term live birth for other two pregnancies and one elective abortion. No birth defects were reported. There was no history of maternal or paternal congenital malformation. The subject had used alcohol (2 drinks or less per day) during pregnancy.   The subject's last menstrual period (LMP) date was on 25-Jun-2018. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery were reported as 01-Apr-2019. The type of pregnancy was singleton.   On 21-Aug-2018, the subject underwent ultrasound and there was no major congenital malformation (MCM) noted.  On 04-Sep-2018, the subject underwent ultrasound and there was no MCM noted.  On 02-Oct-2018, the subject underwent ultrasound and there was no MCM noted.  On 16-Oct-2018, at 16-weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 252664, route of administration, anatomical location and expiration date: not reported) (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunisation.  On 18-Oct-2018, the subject underwent ultrasound and quad test and there was no MCM noted.   On 29-Nov-2018, one month and 13 days after vaccination, the subject experienced yeast and on the same day started treatment with terconazole, vaginally, every day at bedtime until 08-Dec-2018.  On 08-Dec-2018, the patient recovered from yeast.  On 09-Jan-2019, the subject underwent ultrasound and non-stress test and there were polycystic kidneys, oligohydramnios and anhydramnios identified.  On 22-Jan-2019, the subject underwent non-stress test and there were polycystic kidneys, oligohydramnios and anhydramnios identified.  On 23-Jan-2019, three months and 7 days after vaccination, the subject developed anxiety and was treated with Zoloft (sertraline hydrochloride) once daily, orally.  On the same day, the subject underwent ultrasound and there were polycystic kidneys, oligohydramnios and anhydramnios identified.  On 25-Jan-2019, the subject underwent non-stress test and there were polycystic kidneys, oligohydramnios and anhydramnios identified.  On 29-Jan-2019, the subject underwent ultrasound and there were polycystic kidneys, oligohydramnios and anhydramnios identified.  On 07-Feb-2019, the subject underwent ultrasound and there were polycystic kidneys, oligohydramnios and anhydramnios identified. On the same day, the patient underwent genetic testing and there was no MCM noted.   On 13-Feb-2019, the subject underwent non-stress test and there were polycystic kidneys, oligohydramnios and anhydramnios identified.   On 14-Feb-2019, 21-Feb-2019 and 01-Mar-2019, the subject underwent biophysical profile test and there were polycystic kidneys, oligohydramnios and anhydramnios identified.   On 06-Mar-2019, at 36.3 weeks of gestation (explicitly coded as Premature delivery'), the subject delivered a live female neonate through Caesarean section. The neonate had major congenital malformation at the time of birth which included polycystic kidneys, oligohydramnios and anhydramnios. The birth weight was 2780 grams. No data regarding head circumference and length were provided. The appearance, pulse, grimace, activity, and respiration (APGAR) score was 1 at minute 1, 3 at minute 5 and 5 at minute 10. It was reported that the neonate ''passed away 10 minutes shy of being alive for 24 hours''.  The outcome for the event Anxiety' was not recovered.    This case is linked to the case 201904742, corresponding child case.  Company Comment: The subject experienced premature delivery, fungal infection and anxiety after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of herpes simplex virus type II and alcohol use may have contributed to development of the events. Exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The subject experienced premature delivery, fungal infection and anxiety after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of herpes simplex virus type II and alcohol use may have contributed to development of the events. Exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.