Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Cervical dysplasia, Exposure during pregnancy, Gene mutation identification test negative, Prenatal screening test
Clinical narrative: Group B streptococcus; Group B streptococcus positive; Anxiety; LSIL Pap noted; Vaccine exposure during pregnancy; LSIL; This is a serious observational study case initially received on 07-Jun-2019, concerning a 25-year-old adult female, pregnant subject of body weight 122 lbs, height 63 inches and body mass index (BMI) 21.6, 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 two previous pregnancies that included full term live birth and there were no major congenital/ birth defects noted. 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 use tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included nausea. The subject's concomitant medications included Prenatal Vitamins (minerals nos, vitamins nos) for pregnancy and promethazine for nausea.  The subject's last menstrual period (LMP) date was 06-Aug-2018. The type of pregnancy was singleton. On an unknown date, the pregnancy status of the subject was collected, and no major congenital malformations were noted.  On 04-Oct-2018, at approximately 8 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 the same day, after vaccination, the subject underwent PAP smear test which detected low-grade squamous intraepithelial lesion (LSIL) (Pap smear abnormal). The subject also underwent prenatal screening test which included spinal muscular atrophy test and cystic fibrosis mutation analysis with no major congenital malformations noted.  On 11-Oct-2018 and 29-Nov-2018, the subject underwent ultrasound scan, with no major congenital malformations noted.  On 03-Jan-2019, 2 months and 30 days after vaccination, the subject developed anxiety and started treatment with Zoloft (sertraline hydrochloride) (dose: one unit, frequency: one at night, route: oral, stop date: ongoing).  On 28-Feb-2019, the subject underwent ultrasound scan, with no major congenital malformations noted.  On 22-Apr-2019, 6 months and 18 days after vaccination, the subject was tested positive for group B streptococcus.  On, at 39 gestational weeks, the subject gave live birth to a female neonate, by vaginal method. The neonate's birth weight was 3232 grams, body length was 50.2 cm and head circumference were 33 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 outcome of the events anxiety, low-grade squamous intraepithelial lesion (LSIL) and streptococcal infection was not recovered.  The subject's estimated date of delivery (EDD) was reported as 13-May-2019.; Reporter's Comments: A 25-year-old pregnant subject was diagnosed with cervical dysplasia [low-grade squamous intraepithelial lesion (LSIL)], on the same day after receipt of Flu Vaccine Cell Subunit QIV at approximately 8 weeks of gestation (considered as vaccine exposure during pregnancy). The subject also experienced anxiety, 2 months 30 days post vaccination and 6 months 18 days after vaccination, the subject was tested positive for group B streptococcus. Considering the implausible temporal relationship between vaccination and reported event cervical dysplasia which appears more likely as an incidental finding, rather than due to study vaccine, the causality assessed as not related. The event anxiety assessed as not related, considering implausible temporal relationship and the event positive for group B streptococcus is due to infection (bacterial), hence causality assessed as not related to 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).