Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Seasonal allergy, Vaginal infection
Clinical narrative: This is a serious observational study case initially received from other health professional on 26-Nov-2018, concerning a 29-year-old, adult, pregnant female, subject body weight: 109 lbs, height: 63 inches of body mass index (BMI): 19.3, 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 had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's obstetrical history included 3 previous pregnancies with 1 full-term live birth and 2 elective abortions. No birth defects were reported. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included OB complete one (as reported) for healthy pregnancy. The subject's last menstrual period (LMP) date was 17-Aug-2018. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no pregnancy complications were noted. On 09-Oct-2018, at gestation age of 7 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252232, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On an unspecified date in 2018, the subject developed vaginitis. The subject was treated with Metrogel (metronidazole) (dose: 0.75 percent, qd, vaginal, from 09-Oct-2018 to 27-Nov-2018) and terconazole (reported as teraconazole) (dose: 0.4 percent, qd, topical, from 29-Oct-2018 to 27-Nov-2018) for vaginitis. On 09-Nov-2018, the subject underwent first trimester screening and no congenital malformation was noted. On an unspecified date in 2018, the subject developed Group B streptococcus infection and was treated with amoxicillin (dose: 500 mg, prn, oral, from 20-Nov-2018 to 27-Nov-2018). On 04-Dec-2018, the subject underwent a second trimester screening and no congenital malformation was noted. On 01-Feb-2019, 3 months and 23 days after vaccination, the subject's platelet's count was low. On 29-Mar-2019, 5 months and 20 days after vaccination, the subject experienced seasonal allergies; watery eyes. The subject was treated with Patanol (olopatadine hydrochloride) (dose: 0.1 percent, bid, intraocular, from 30-Mar-2019 and was ongoing) for allergy. The subject's estimated delivery date (EDD) was reported as 24-May-2019. The outcome of the events Bacterial infection due to streptococcus, group B and vaginitis was not reported. The outcome of the events low platelet, seasonal allergy and watery eyes was not recovered. Follow-up received from other health professional on 12-Dec-2018: Stop date (27-Nov-2018) of the treatment medications Metrogel and terconazole was added and new treatment drug amoxicillin for 'Group B streptococcus' was added in product tab. The new event 'Group B streptococcus' was added in the event tab. The narrative was amended accordingly. Follow-up received from other health professional on 03-Apr-2019: It was reported that, the subject underwent a second trimester screening and no congenital malformation was noted. New events seasonal allergy, watery eyes and low platelet were added in event tab. The subject's treatment medication Patanol (olopatadine hydrochloride) was added in the product tab. The narrative was amended accordingly.; Reporter's Comments: A 29-year-old, pregnant female subject was administered Flu Vaccine Cell Subunit QIV at 7 weeks of gestation (considered as vaccine exposure during pregnancy) and developed vaginitis on the same day after vaccination with Flu Vaccine Cell Subunit QIV NVD. The subject also developed Group B streptococcus infection, unspecified period after vaccination. The company assessed the causality of the event vaccine exposure during pregnancy as not related to the study vaccine considering the intended use of vaccine. The events vaginitis and Group B streptococcus infection assessed as not related to the  inactivated study vaccine due to the infectious origin of the events. The subject experienced platelet count decreased, 3 months 23 days post vaccination and seasonal allergies, 5 months 20 days post vaccination. Considering the implausible temporal relationship between vaccination and these reported events, causality assessed as not related to study vaccine. The company assessed the case as serious (medically significant).