Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Complication of pregnancy, Exposure during pregnancy, Nausea
Clinical narrative: Nausea; Vaccine exposure during pregnancy; Unspecified pregnancy complications; This is an observational study case, initially received from other health professional on 28-Oct-2019, concerning a 32-year-old, pregnant, female subject of body weight: 125 lbs, height: 66 inches and body mass index (BMI): 20.2, enrolled in a prospective observational safety study.  The subject's obstetrical history included one previous full-term live birth. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's relevant medical history included anemia. The concomitant medications of the subject included folic acid as vitamin and OB Complete (as reported) for vitamin obstetrics (OB) care and anemia.   The subject's last menstrual period (LMP) date was 24-Jun-2019, the estimated date of delivery (EDD) was reported as 30-Mar-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 12-Sep-2019, approximately at 11 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On the same day, after vaccination, the subject experienced nausea and started therapy with Bonjesta (doxylamine succinate and pyridoxine hydrochloride) one tablet administered two times per day via oral route.   On an unknown date, after vaccination, the subject's pregnancy status was collected, and unspecified pregnancy complication was noted. No further details were provided.  At the time of initial reporting, the patient had not recovered from nausea, while the outcome of unspecified pregnancy complication was not reported.   The case was assessed as serious.  The reporter did not provide causality assessment.  Company comment: The subject experienced nausea and complication of pregnancy after vaccination with the suspect product Flucelvax QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of anaemia and pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.; Sender's Comments: The subject experienced nausea and complication of pregnancy after vaccination with the suspect product Flucelvax QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of anaemia and pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.