Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Bacterial vaginosis, Blood glucose normal, Delivery, Exposure during pregnancy, Premature delivery
Clinical narrative: Premature delivery at 36.3 weeks of gestation; Bacterial vaginosis; Vomiting; Vaccine exposure during pregnancy; This is an observational study case, initially received on 02-Jan-2020  concerning a 28-year-old female, pregnant subject of body weight: 130 lbs, height: 62 inches and body mass index (BMI): 23.8, enrolled in in a prospective observational safety study.  The subject's relevant medical history was not reported.   The subject's concomitant medications included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and OB complete one (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, sodium fluoride, taurine, thiamine mononitrate, tocopheryl acetate, zinc sulfate monohydrate), both for healthy pregnancy.  The subject's obstetrical history noted that the subject had three previous pregnancies which included one full term live birth and two elective abortions. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) was on 21-May-2019. The subject's estimated date of delivery (EDD) was reported as 25-Feb-2020, while corrected estimated date of delivery (CEDD) was not reported. Type of pregnancy was singleton.  On 14-Aug-2019, the subject underwent first trimester screen and no MCM was noted.   On 11-Sep-2019, at approximately 16 weeks of gestation (calculated per LMP), the subject was administered Afluria Quadrivalent (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100110950, dose, 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 second trimester screen and no MCM was noted.   On 24-Sep-2019, the subject experienced bacterial vaginosis and vomiting. The subject started treatment with medications Zofran (ondansetron) at a dose of 8 mg, consumed three times daily and oral vitamin B6 tablets, at a dose of 25 mg, once daily, both indicated for vomiting.   On 26-Sep-2019, the subject started treatment with Metrogel (metronidazole) at the dose of 0.75 %, consumed once daily and vaginally for bacterial vaginosis.  On 30-Sep-2019, the outcome for the event bacterial vaginosis was resolved and the subject stopped treatment with Metrogel.  On 24-Oct-2019, the outcome for the event vomiting was resolved and the subject stopped treatment with Zofran and Vitamin B6.  On 13-Nov-2019, the subject underwent one-hour glucose challenges test and no MCM was noted.  At approximately 36.3 weeks of gestation, the subject vaginally delivered a female neonate. The neonate's birth weight was 1990 grams, length was 41.9 cm and head circumference was 30 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. The APGAR score for ten minutes was not reported. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of 'premature delivery' was not reported.  The event of premature delivery' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202002791 (the corresponding baby case).  Follow-up received from other health professional on 21-Jan-2020: Start and stop date added for the events of bacterial vaginosis and vomiting, and outcome was changed from Not reported' to Resolved'. The narrative was amended accordingly.  Follow-up received from other health professional on 09-Apr-2020: Pregnancy outcome was provided. The event of premature delivery' was added and the case was upgraded from non-serious to serious. Stop date was added for the event of vaccine exposure during pregnancy' date and outcome was changed from not reported to resolved. The narrative was amended accordingly.  Company comment: The pregnant patient developed bacterial vaginosis and vomiting after receiving suspect product Flu Vaccine Egg Split QIV CSL. The patient experienced premature delivery 4 months and 19 days after vaccination. Vomiting is common during pregnancy. More information regarding medical history is needed. Bacterial vaginosis may have contributed to development of the premature delivery. Causality is assessed as not related for all events. Vaccine exposure during pregnancy is not related per company conventions.; Sender's Comments: The pregnant patient developed bacterial vaginosis and vomiting after receiving suspect product Flu Vaccine Egg Split QIV CSL. The patient experienced premature delivery 4 months and 19 days after vaccination. Vomiting is common during pregnancy. More information regarding medical history is needed. Bacterial vaginosis may have contributed to development of the premature delivery. Causality is assessed as not related for all events. Vaccine exposure during pregnancy is not related per company conventions.