Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Cytogenetic analysis normal, Delivery, Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen normal
Clinical narrative: Echogenic cardiac focus; Vaccine exposure during pregnancy; This is a serious spontaneous case, reported by other health professional and initially received on 12-Jul-2019, concerning a 19-year-old, adult female pregnant patient of height: 68 inches, weight: 134 pounds and body mass index: 20.4.  The patient's obstetrical history included one previous full-term live birth. The patient had no history of offspring with major congenital malformation. Also, the patient had no maternal or paternal history with major congenital malformations. The patient had no prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's current conditions included bacterial vaginosis and yeast infection (reported as start date: 25-Sep-2018 and stop date: 05-Sep-2018). The patient's historical drug included Metrogel (metronidazole) for bacterial vaginosis. The patient's concomitant medications included Prenatal vitamins [minerals NOS, vitamins NOS] for pregnancy and Terazol [terconazole] for yeast infection.   The patient's last menstrual period (LMP) date was 19-Apr-2018 and the type of pregnancy was singleton. On 10-Aug-2018, the patient underwent spinal muscular atrophy and cystic fibrosis, but no major congenital malformations were noted. On 25-Sep-2019, the patient underwent ultrasound, Qnatal and informaSeq prenatal test which showed no major congenital malformations.  On 19-Oct-2018, at gestational age of 26 weeks, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On 30-Nov-2018, the patient underwent ultrasound and no major congenital malformations were noted.  On an unspecified date after administration of vaccine, echogenic cardiac focus was observed.  On 06-Jan-2019, at gestational age of 37.4 weeks, the patient delivered a male infant by vaginal method. The characteristics of the neonate included birth weight: 2835 grams, head circumference: 32.4 centimetres, body length: 50.8 centimetres, appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. The subject had no major congenital malformations identified at birth.  The patient's estimated date of delivery (EDD) and corrected estimated date of delivery (EDD) was reported as 24-Jan-2019.; Reporter's Comments: A 19-year-old pregnant patient experienced echogenic cardiac focus, on an unspecified day after administration of Flucelvax QIV vaccine at 26weeks of gestation (coded to Exposure during pregnancy). Considering the timeframe of event with respect to vaccine administration, nature of the event, risk factors (terconazole for yeast infection), no evidence for a biological mechanism that could cause the event and underlying pregnancy, the event was assessed as not related to the vaccination. 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).