Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Neonatal disorder
Clinical narrative: Neonate's birth weight was 4130 grams/large for gestational age; Leg cramps; Yeast infection; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case initially received on 06-Jun-2019, concerning a 32-year-old adult female, pregnant subject, of body weight 128 lbs, height 63.4 inches and body mass index (BMI) 22.4, 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 previous pregnancy. The subject had no maternal or paternal history with major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject did not have any concurrent medical conditions during this pregnancy. The subject's last menstrual period (LMP) date was 21-May-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On an unknown date, the pregnancy status of the subject was collected, and no major congenital malformations were noted. On 10-Aug-2018, the subject underwent first trimester screening and cystic fibrosis mutation analysis, with no major congenital malformations noted. On 08-Sep-2018, the subject underwent second trimester screen and there were no major congenital malformations noted. On 13-Oct-2018, at approximately 20 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, 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 10-Nov-2018, 28 days after vaccination, the subject developed anemia. The subject was treated with Ferrousul (ferrous sulfate) [dose: 325 mg, frequency: daily (qd), route: oral, start date: 23-Nov-2018 and it was ongoing]. On 23-Nov-2018, one month and 10 days after vaccination, the subject experienced leg cramps and was treated with Caltrate 600 Plus-D (calcium carbonate, colecalciferol, dose: 600 mg, frequency: qd, route: oral, from 23-Nov-2018 and it was ongoing). On the same day, the subject also developed yeast infection and was treated with terconazole cream (dose: 0.4 percent, frequency: qd, route: topical, from 23-Nov-2018 and it was ongoing). The outcome of the events anemia, leg cramps and yeast infection were recovered on 15-Dec-2018. at 38.1 gestational weeks, the subject gave live birth to a male neonate, by caesarean method. The neonate's birth weight was 4130 grams (explicitly coded as large for gestational age), body length was 50.8 cm and head circumference were 35 cm. The reported appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute was 8, five minutes was 9 and at 10 minutes no data was provided. There was no major congenital malformation identified at birth. The subject's estimated date of delivery (EDD) was reported as 25-Feb-2019. This case is linked to case number 201903692 (baby case).; Reporter's Comments: A 32-year-old female pregnant subject was diagnosed with anaemia, 28 days after receipt of Flu Vaccine Cell Subunit QIV (considered as vaccine exposure during pregnancy). The subject was also diagnosed with leg cramps and yeast infection, 1 month 10 days post vaccination. The subject delivered large for gestational age (LGA) baby at 38.1 weeks of gestation which was diagnosed at birth. The known aetiologies for LGA includes genetic, increased maternal weight gain during pregnancy and maternal gestational diabetes. Considering the lack of biological evidence associated with study vaccine, the event large for gestational age, causality assessed as not related. Considering the implausible temporal relationship between vaccination and reported event leg cramp, causality assessed as not related. The event yeast infection is due to infectious (fungal) aetiology, hence causality assessed as not related to inactivated study vaccine. Despite the plausible temporal relationship for the event anemia, causality assessed as not related considering pregnancy state of the subject which provide more plausible explanation rather than study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).