Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Ultrasound antenatal screen normal
Clinical narrative: Severe pre-eclampsia; Vaccine exposure during pregnancy; This is a serious, observational study case, initially received from other health professional on 26-Aug-2019, concerning a 24-years-old, adult, female, pregnant subject of body weight 241 lbs, height 66 inches and body mass index (BMI) 38.9, enrolled in a prospective observational safety study.   The subject's obstetrical history included no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's historical conditions included chlamydia, bacterial vaginosis and yeast. The subject's concurrent conditions included nausea and vomiting.  The subject's past medications included Zithromax (azithromycin) for chlamydia, Flagyl (metronidazole) for bacterial vaginosis, Terazol 7 (terconazole) and Metrogel (metronidazole) both for yeast. The subject's concomitant medications included prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy and Zofran (ondansetron) for nausea and vomiting.  The subject's last menstrual period (LMP) date was 25-Mar-2018. The subject's estimated date of delivery (EDD) was reported as 01-Jan-2019. The type of pregnancy was singleton.  On 16-May-2018, the subject underwent spinal muscular atrophy test and no major congenital malformations were noted. On the same day, the subject, also underwent cystic fibrosis mutation analysis and no major congenital malformations were noted.  On 21-May-2018 and 06-Jun-2018, the subject underwent ultrasound and no major congenital malformations were noted.  On 06-Jun-2018, the subject underwent ultrasound and no major congenital malformations were noted.  On 05-Jul-2018, the subject underwent ultrasound and no major congenital malformations were noted.  On 19-Jul-2018, the subject underwent quadscreen and no major congenital malformations were noted. On the same day, the subject, also underwent ultrasound and no major congenital malformations were noted.  On 11-Oct-2018, the subject was administered Flu vaccine cell subunit QIV NVD [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 the same day, the subject underwent ultrasound and no major congenital malformations were noted.  On 09-Nov-2018, the subject underwent ultrasound and no major congenital malformations were noted.  On an unspecified date, the subject developed severe pre-eclampsia  At gestational age 40.1 weeks, the subject delivered a normal live male infant via a caesarean method. The infant's birth weight was 2807 grams, head circumference was 33 cm and body length was 52.1 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). It was reported that there were no major congenital malformations (MCM) identified at birth.   The outcome for the events was not reported.  The causality of the events was not reported.  Company Comment: The subject experienced pre-eclampsia on unknown date after vaccination with the suspect product Flu vaccine cell subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy.  Chronology is plausible. Causality was confounded by therapy with concomitant medications Zofran (ondansetron). Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event pre-eclampsia.; Reporter's Comments: The subject experienced pre-eclampsia on unknown date after vaccination with the suspect product Flu vaccine cell subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy.  Chronology is plausible. Causality was confounded by therapy with concomitant medications Zofran (ondansetron). Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event pre-eclampsia.