Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Bacterial vulvovaginitis, Caesarean section, Exposure during pregnancy, Placental insufficiency, Premature delivery
Clinical narrative: Suspected placental insufficeincy in third trimester; Bacterial vag; Urinary tract infection; Gestational aget at outcome 35.6 weeks/preterm delivery; Vaccine exposure during pregnancy; This is a non-serious observational study case, initially received from other health professional on 31-May-2019, concerning a 31-year-old adult, female pregnant subject of body weight: 150 lbs, height: 66 inches and body mass index (BMI): 24.2, enrolled 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 one previous pregnancy with full term live birth. The subject had no history of offspring with major congenital malformation. The subject had no maternal and paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's historical drug included Aspirin (acetylsalicylic acid), as subject had history of pre-eclampsia. The subject's current condition included addiction (unspecified). The subject's concomitant medications included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy and Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) for addiction.  The subject's last menstrual period (LMP) date was 07-Jul-2018. The type of pregnancy was singleton.  On 13-Nov-2018, at gestational age of approximately 18 weeks, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 19-Nov-2018, the subject underwent ultrasound scan, and no major congenital malformation was noted.  On 18-Jan-2019, the subject underwent ultrasound scan, and no major congenital malformation was noted.  On 24-Jan-2019, the subject underwent ultrasound scan, and no major congenital malformation was noted.  On 31-Jan-2019, the subject underwent ultrasound scan, and no major congenital malformation was noted.  On an unspecified date (in third trimester of pregnancy), after vaccination. the patient developed placental insufficiency (pregnancy complication). On an unspecified date, the patient developed bacterial vaginitis and was treated with Metrogel gel (metronidazole, dose: 0.75 percent, route: vaginal, frequency: bid, from 19-Nov-2018 to 26-Nov-2018). On an unspecified date, the patient developed urinary tract infection and was treated with Macrobid (clarithromycin, dose: 1 DF, route: oral, frequency: bid, from 04-Jan-2019 to 11-Jan-2019).  On 07-Feb-2019, the subject underwent ultrasound scan, and no major congenital malformation was noted.   At gestational age of 35.6 weeks, the subject gave birth to a female infant (reported as preterm delivery) by caesarean method of delivery. The characteristics of the neonate included birth weight: 3147 grams, head circumference: 34.3 cm, body length: 47.6 cm, appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute: 8, five minutes: 9 and ten minutes: no data was provided. There were no major congenital malformations identified at birth.  The outcome of the events placental insufficiency, bacterial vaginitis and urinary tract infection was not reported.  This case was linked to case 201903676 (baby case).; Reporter's Comments: A 31-year-old pregnant subject experienced suspected placental insufficiency, an unspecified date (in third trimester of pregnancy) after administration of study vaccine, during 18 weeks of gestation (coded to Exposure during pregnancy). Considering the unlikely temporal relationship between vaccination and reported event (suspected placental insufficiency), no evidence for a biological mechanism that could cause the events and risk factors (history of pre-eclampsia, unspecified addiction treated with suboxone, bacterial vulvovaginitis and urinary tract infection), the event was assessed as not related to the vaccination. Considering the time frame of event (premature delivery), no evidence for a biological mechanism that could cause the events and risk factors (history of pre-eclampsia, unspecified addiction treated with suboxone, suspected placental insufficiency, bacterial vulvovaginitis and urinary tract infection), the event was assessed as not related to the study vaccine. Considering the inactivated nature of the study vaccine and infectious aetiology of the reported event (suspected bacterial) the causal role of suspect vaccine was assessed as not related for events (bacterial vulvovaginitis and urinary tract infection). 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 case as serious (medically significant).