Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Polyhydramnios, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; Anemia; Polyhydramnios; This is a spontaneous case, reported by other health professional and initially received on 02-Jul-2019, concerning a 25-year-old, adult, female pregnant patient of body weight: 205 pounds, height: 66 inches and body mass index (BMI): 33.1.  The patient's obstetrical history included two previous pregnancies which includes one full term live birth and one spontaneous abortion. No birth defects were reported. 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 did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.  The patient's current condition included asthma. The patient's concomitant medications included Prenatal vitamins [minerals NOS, vitamins NOS] for pregnancy.  The patient's last menstrual period (LMP) date was 16-Aug-2018 and the type of pregnancy was singleton.  On an unspecified date, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, 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 09-Oct-2018, 20-Dec-2018 and 06-Mar-2019, the patient underwent ultrasound scan and no major congenital malformations were noted.  On an unspecified date in Apr-2019, the gestational age 33 weeks, the patient was noted to have polyhydramnios.  On 10-Apr-2019, 26-Apr-2019 and 17-May-2019, the patient underwent ultrasound scan and no major congenital malformations were noted.   On 24-May-2019, after vaccination, the patient experienced anemia and was treated with ferrous sulphate (dose: 1 tablet, twice daily via oral route).  At gestational age of 40.6 weeks, the patient delivered a female neonate by vaginal method. The characteristics of neonate included birth weight: 3827 grams, head circumference: 35.6 cm and body length: 50.8 cm and appearance, pulse, grimace, activity, respiration (APGAR) scores were 9 at one minute, 9 at five minutes and no data for ten minutes. There was no major congenital malformation identified at birth.   The outcome of the event polyhydramnios was not reported, and outcome of the event anaemia was not recovered.  The patient's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) was reported as 23-May-2019.; Reporter's Comments: A 25-year-old pregnant patient with history of spontaneous abortion and current condition of asthma, experienced polyhydramnios and anaemia, unspecified period after receipt of Flucelvax QIVc. These events can be explained with pregnancy state rather than suspect vaccine. Hence, assessed as not related to suspect vaccine. 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).