Age: 33.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Placental disorder, Ultrasound antenatal screen abnormal, Vaginal discharge
Clinical narrative: This is a serious observational study case, initially received from other health professional on 18-Mar-2019, concerning a 33-year-old, adult female pregnant subject of body weight: 173 lbs, height: 62 inches and body mass index (BMI): 31.6 enrolled in prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had no previous pregnancies. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's historical condition included human papilloma virus infection (HPV). The subject's current conditions included anxiety, hypothyroidism and seasonal allergies. The subject's concomitant medications included Prenatal Vitamins (minerals nos, vitamins nos) for pregnancy (reported as OB care), levothyroxine for hypothyroidism, and Zyrtec (cetirizine hydrochloride) for allergies. The subject's last menstrual period (LMP) date was 16-Jun-2018. The type of pregnancy was singleton. On 06-Aug-2018, the subject had undergone ultrasound scanning and no major congenital malformations were noted. On 10-Sep-2018, the subject had undergone ultrasound/nuchal translucency and no major congenital malformations were noted. On 17-Sep-2018, at gestational age of 13 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252226, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 18-Sep-2018, the subject had undergone first trimester screening and no major congenital malformations were noted. On 08-Oct-2018, the subject had undergone maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformations were noted. On 29-Oct-2018, the subject had undergone anatomy ultrasound and no major congenital malformations were noted. On 27-Dec-2018, at the gestational age of 27 weeks, the subject received a non-company suspect vaccine TDAP [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 (unspecified unit), frequency: reported as once, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] for vaccination. On the same day (27-Dec-2018), 3 months and 10 days after vaccination with Flu Vaccine Cell Subunit QIV NVD, the subject had undergone ultrasound scanning and succenturiate posterior lobe (anomaly of placenta) was noted. On 29-Jan-2019, 4 months and 12 days after vaccination with Flu Vaccine Cell Subunit QIV NVD, at the gestational age of 32.4 weeks, the subject experienced vaginal discharge. The subject was treated with Terconazole [reported as tercanozole, dose: 0.4 percent, frequency: once a day (qd), route of administration: vaginal, from 29-Jan-2019 to 04-Feb-2019] for vaginal discharge.  The subject's estimated delivery date (EDD) was reported as 23-Mar-2019. The outcome of the event vaginal discharge was recovered on 04-Feb-2019 and the outcome of the event placental disorder' was not reported.; Reporter's Comments: A 33-year-old pregnant subject with medical history/current conditions (anxiety, hypothyroidism, human papilloma virus infection (HPV) and seasonal allergies) experienced placental disorder, 3 months and 10 days after administration of study vaccine at gestational age of 13 weeks (coded to Exposure during pregnancy). The subject also experienced vaginal discharge treated with Terconazole, 4 months and 12 days after study vaccination. Considering the implausible temporal relationship between vaccination and reported events and no evidence of a biological mechanism that could cause the events, the events were assessed as not related to the study vaccine. However, TDAP vaccine was considered as noncompany suspect in this case. The medical history/current conditions and co-administered drugs (Levothyroxine and Zyrtec) further confound this case. 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 the event 'placental disorder' as serious (medically significant).