Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Neonatal disorder, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: Neonate's birth weight was 4791 grams; Anemia; Constipation; Vaccine exposure during pregnancy; This is a serious spontaneous case, initially received on 31-May-2019, concerning a 24-year-old, adult, female pregnant patient, body weight: 180 lbs, height: 66 inches and body mass index (BMI): 29.0.   The patient had no previous pregnancy. The patient had no maternal or paternal history with major congenital malformations. The patient had no history of offspring with major congenital malformations. The patient did not have any concurrent medical conditions during this pregnancy. The concomitant medications of the patient included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy.   The patient's last menstrual period (LMP) date was 18-May-2018. The type of pregnancy was singleton. The patient did not use tobacco, alcohol or illicit drugs during pregnancy. On an unknown date, the pregnancy status of the patient was collected, and no major congenital malformations were noted.  On an unspecified date, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured 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 27-Jun-2018, the patient underwent hemoglobinopathy evaluation (reported as eval), spinal muscular atrophy test and cystic fibrosis test and no major congenital malformations were noted. On 09-Jul-2018 and 31-Aug-2018, the patient underwent ultrasound scan and no major congenital malformations were noted. On 28-Sep-2018, the patient underwent ultrasound scan and quad screening test and no major congenital malformations were noted. On an unspecified date after vaccination, the patient experienced anemia and constipation. The patient was treated with ferrous sulphate [dosage: 325 mg, twice daily (bid), orally, from 29-Jan-2018 and 16-Feb-2019] for anemia and Colace (docusate sodium) [dosage: 1 capsule (1 dosage form), bid, as needed (prn), orally, from 16-Feb-2019 and ongoing] as a stool softner. There were no pregnancy complications noted during pregnancy.  at 39.1 gestational weeks, the patient gave live birth to a male neonate, by caesarean method. The neonate's birth weight was 4791 grams (explicitly coded as large for gestational age), body length was 55.9 cm and head circumference was 36.2 cm. The reported appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 minute, 5 minutes were 8 and 8 respectively and at 10 minutes no data was provided. There was no major congenital malformation identified at birth.  The outcome of the event anemia and constipation were not reported.    This case is linked to case number 201903687 (baby case).; Reporter's Comments: A 24-year-old female pregnant patient experienced anemia and constipation, at unspecified time after administration of Flucelvax QIV vaccine (considered as exposure during pregnancy). At 39.1 gestational weeks, the patient gave live birth to a male neonate, by caesarean method. The neonate's birth weight was 4791 grams (explicitly coded as large for gestational age). The events (anemia, constipation and large for gestational age) were assessed as not related as there is no evidence of a biological mechanism that could cause the events and underlying pregnancy which appears to be a more likely explanation rather than 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 this case as serious (medically significant).