Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Gestational diabetes, Pre-eclampsia, Prenatal screening test
Clinical narrative: Pre-eclampsia; Gestational diabetes; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 18-Sep-2019, concerning a 37-year-old, pregnant, female subject, of body weight: 191 lbs, height: 65 inches and body mass index (BMI): 31,8, enrolled a prospective observational safety study.  The subject's obstetrical history noted that the subject had three previous pregnancies which included one full-term live birth, one pre-term live birth and one spontaneous abortion. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco or alcohol during pregnancy. The subject's current conditions included nausea, vomiting and use of marijuana. The subject's concomitant medication included Prenatal vitamins (mineral NOS, vitamin NOS) for pregnancy.  The subject's last menstrual period (LMP) date was 29-Sep-2018. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 06-Jul-2019. The type of pregnancy was singleton.  On 12-Nov-2018, at gestational age of 6 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 252664, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   On 26-Nov-2018, the subject underwent ultrasound and no major congenital malformation was noted.   On 24-Dec-2018, the subject underwent Qnatal test and no major congenital malformation was noted.   On 24-Jan-2019, the subject underwent ultrasound and no major congenital malformation was noted.   On 31-Jan-2019, the subject underwent MSAFP / serum markers test and no major congenital malformation was noted.   On 04-Mar-2019, approximately three months after vaccination, the subject developed gestational diabetes. No further details were provided.   On an unspecified date, unknown amount of time after vaccination, at gestational age of 29 weeks, the subject developed pre-eclampsia.  At the time of initial reporting, the outcome of the events was not reported.  Company comment: The patient was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) at approximately 6 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  The patient experienced gestational diabetes approximately three months after vaccination and pre-eclampsia after the unknown amount of time after vaccination. Chronology seems unsuggestive.  Causality was confounded by patient's use of marijuana. The event of vaccine exposure during pregnancy is assessed as not related based on company's conventions. Causal relationship between the suspect product and events of gestational diabetes and pre-eclampsia is assessed as related.; Reporter's Comments: The patient was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) at approximately 6 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  The patient experienced gestational diabetes approximately three months after vaccination and pre-eclampsia after the unknown amount of time after vaccination. Chronology seems unsuggestive.  Causality was confounded by patient's use of marijuana. The event of vaccine exposure during pregnancy is assessed as not related based on company's conventions. Causal relationship between the suspect product and events of gestational diabetes and pre-eclampsia is assessed as related.