Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Complication of pregnancy, Condition aggravated, Exposure during pregnancy, Foetal non-stress test normal
Clinical narrative: Dysmature placenta; Chronic hypertension; Anxiety; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 08-Oct-2019, concerning a 30-year-old, pregnant, female subject of body weight: 230 lbs, height: 65 inches and body mass index (BMI): 38.3, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's obstetrical history noted that the subject had four previous pregnancies including one full-term live birth pregnancy and three spontaneous abortions. No birth defects were reported. Also, the subject had no maternal or paternal history with major congenital malformations (MCM). The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's medical history included hypertension, bacterial vaginosis, herpes simplex virus II and high body mass index (38.3). The subject's past medications included Metrogel (metronidazole) for bacterial vaginosis and Prenatal Vitamins (minerals nos, vitamins nos) for pregnancy.  The subject's last menstrual period (LMP) date was 13-Apr-2018, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) was 18-Jan-2019. The type of pregnancy was singleton.   On 27-Jun-2018, the subject underwent ultrasound and non-stress test and no MCMs was noted.  On 08-Aug-2018, the subject underwent ultrasound and no MCM was noted.  On 10-Aug-2018, the subject underwent quad screen and no MCM was noted.  On 03-Oct-2018, at 24 weeks of gestation, the subject was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 252664, route of administration, expiry date and anatomical location: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On the same day, the subject experienced anxiety and was treated with Celexa (celecoxib) at a dose of one tablet administered once per day via oral route.   On an unspecified date after vaccination, the subject experienced dysmature placenta and chronic hypertension, reported as pregnancy complications.  On 31-Oct-2018 and 27-Nov-2018 the subject underwent ultrasound and no MCM was noted.  On 13-Dec-2018, the subject underwent non-stress test and no MCM was noted.  On 03-Jan-2019, at gestation age of 37.9 weeks, the subject vaginally delivered a live birth, female neonate. The neonate's birth weight was 3090 g, length was 51.1 cm and head circumference was 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). It was reported that there were no MCM identified at birth.  At the time of initial reporting, the subject had not recovered from the event of 'anxiety', while the outcome of the events 'dysmature placenta' and 'chronic hypertension' were not reported.   The case was assessed as serious.   The reporter did not provide causality assessment.; Sender's Comments: A pregnant subject developed placental disorder and hypertension on an unspecified date after vaccination with Flucelvax QIVc. Chronology needs more clarification. Vaccine was administered at gestational age of 24 weeks and on the same day, the subject experienced anxiety. Causality was highly confounded my medical history of three spontaneous abortions, hypertension and high body mass index. However, causal role of the suspect product cannot be excluded and it is assessed as unlikely related for all three events. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.