Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Delivery, Exposure during pregnancy, Nausea, Placental disorder
Clinical narrative: Dysmature placenta; Nausea and vomiting; Nausea and vomiting; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 09-Jun-2020, concerning a 22-year-old, female pregnant subject (Race:; Ethnicity: not reported) of body weight: 185 lbs, height: 64 inches and body mass index (BMI): 31.8, enrolled in, a prospective observational safety study.  The subject's medical history included anaemia, migraine history and BMI high.  The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's obstetrical history included no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal and paternal medical history with MCM, but it was also noted that the subject was adopted. The subject did not use tobacco, alcohol or illicit drug during pregnancy.  The subject's last menstrual period (LMP) date was 20-Jul-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 25-Apr-2020.  On 22-Oct-2019, the subject underwent ultrasound and no MCM was noted.  On 05-Nov-2019, approximately at 15 weeks of gestation (calculated per LMP), the subject was administered Flucelvax (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.  On the same day, the subject underwent ultrasound and no MCM was noted.  On 16-Nov-2019, the subject underwent panorama and no MCM was noted.  On 18-Nov-2019, the subject underwent ultrasound and no MCM was noted.  On 16-Dec-2019, 1 month 11 days after vaccination, the subject experienced nausea and vomiting and started treatment with Phenergan (promethazine) 0.25 mg, every six hours, orally.  On 13-Jan-2020 and 04-Feb-2020, the subject underwent ultrasound and no MCM was noted.  On 02-Mar-2020, 3 months 26 days after vaccination, pregnancy was complicated with dysmature placenta.  On the same day, the subject underwent ultrasound and no MCM was noted.  On 23-Mar-2020, the subject underwent ultrasound and no MCM was note  On 24-Apr-2020, at 39,9 weeks of gestation (as reported), the subject delivered a female neonate by vaginal method of delivery. The neonate's birth weight was 3430 grams, body length: 54.6 cm, head circumference: 35.6 cm and the appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute: 8, five minutes: 9 and ten minutes: not reported. There was no MCM identified at birth.   On the same day, the outcome of the event dysmature placenta, nausea and vomiting was resolved. The subject finished treatment with Phenergan.  The event of placental disorder' was assessed as serious due to criteria of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: A pregnant subject experienced nausea and vomiting one month and 11 days after receiving Flucelvax QIV. Reportedly, 3 months 26 days after vaccination, pregnancy was complicated with dysmature placenta. The events of nausea and vomiting are frequent during pregnancy. Causal role of the suspect vaccine is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced nausea and vomiting one month and 11 days after receiving Flucelvax QIV. Reportedly, 3 months 26 days after vaccination, pregnancy was complicated with dysmature placenta. The events of nausea and vomiting are frequent during pregnancy. Causal role of the suspect vaccine is assessed as not related for all events, due to biological implausibility and unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.