Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Gene mutation identification test negative, Influenza, Prenatal screening test, Streptococcus test positive, Ultrasound antenatal screen
Clinical narrative: Vaccination failure; Group B strep; Cough; Group B strep positive; Anemia; Influenza; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 18-Jun-2019, concerning a 34-year-old adult, female, pregnant subject of body weight 127 lbs, height 62.5 inches and body mass index (BMI) 22.9, enrolled in A prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's obstetrical history included three previous pregnancies which includes one full time live birth, one ectopic pregnancy and one spontaneous abortion. 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 pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's current condition included anxiety. The subject's concomitant medication included Prenatal vitamins (minerals NOS, vitamins NOS) as supplement and Zoloft (sertraline) for anxiety.  The subject's last menstrual period date was 28-Sep-2018 and type of pregnancy was singleton. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.  On 16-Nov-2018, the subject was administered Flu Vaccine Egg Split QIV CSL (Influenza vaccine, batch number: YF42609, dose, route of administration, anatomical location and expiry date: not reported) for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On the same day, the subject underwent ultrasound and no major congenital malformation was noted.  On 28-Dec-2018, the subject underwent inheritest core, informaseq prenatal test and nuchal translucency, no major congenital malformations were noted. On 25-Jan-2019, the subject underwent maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum markers and no major congenital malformation was noted.  On 27-Feb-2019, 3 months and 11 days after administration of vaccine, the subject experienced influenza (explicitly coded as vaccination failure) and was treated with Tamiflu [oseltamivir, dose: 75 milligrams, twice in a day (bid), oral, start date: 27-Feb-2019 and stop date: 04-Mar-2019] which was recovered on 26-Mar-2019.  On 13-May-2019, 5 months and 27 days after administration of vaccine, the subject experienced anaemia and was treated with iron [dose: 325 milligrams, daily (qd), oral, start date: 13-May-2019 and stop date: ongoing].  On 07-Jun-2019, 6 months and 22 days after administration of vaccine, the subject experienced cough. On the same day, strep test was performed which found to be positive for group B streptococcal infection. The subject was treated with Flovent [fluticasone propionate, dose: 110 micrograms/actuation), twice in a day (bid), respiratory route (inhalation), start date: 07-Jun-2019 and stop date: ongoing].  The outcome of the events anaemia, cough and bacterial infection due to streptococcus, group B was not recovered.  The subject's corrected estimated delivery date (CEDD) was reported as 05-Jul-2019 and estimated delivery date (EDD) was reported as 06-Jul-2019.; Reporter's Comments: A 34-year-old pregnant subject experienced influenza (considered as vaccination failure), 3 months and 11 days after receipt of Flu vaccine Egg Split QIV. Considering the plausible temporal relationship between vaccination to influenza onset (more than 2-3 weeks post vaccination), the causality for Influenza and vaccination failure was assessed as related to suspect vaccine. The events anaemia (onset latency more than 5 months) and group B streptococcal infection (onset latency more than 6 months), were assessed as not related to suspect vaccine due to implausible temporal and biological relationship. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant)