Sex: F
Vaccine: FLUC4
Symptoms: Premature delivery, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: Premature delivery; Yeast; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 18-Sep-2019, concerning a 29-year-old, adult female pregnant subject of body weight: 144 lbs, height: 64 inches and body mass index (BMI): 24.7 [ethnicity: not reported] enrolled in a study.  The subject's obstetrical history included seven previous pregnancies (five full term live births, one preterm live birth and one spontaneous abortion). The subject did not have history of offspring with major congenital malformation (MCM) and did not have maternal and paternal history with MCM. The subject did not consume tobacco, alcohol and illicit-drugs.  The subject's historical condition included bacterial vaginosis. The subject's historical medication included Metrogel (metronidazole). The subject's concomitant medications included Prenatal vitamin (unspecified vitamins).   The subject's last menstrual period (LMP) date was 25-Jun-2018. The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were 01-Apr-2019. The type of pregnancy was singleton.  On 01-Aug-2018, the subject performed cystic fibrosis mutation analysis and spinal muscular atrophy (mother+carrier) and no MCM was noted.  On 07-Aug-2018 and 13-Aug-2018, the subject underwent ultrasound and no MCM was noted.  On 15-Oct-2018, approximately at gestational age of 16 weeks, the subject was administered Flu Vaccine Egg Split QIV NVD (Flucelvax QIVc) (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose: 0.5 ml, route of administration, anatomical location and expiration: not reported) (explicitly coded as Vaccine exposure during pregnancy) for Influenza immunisation.  On 15-Oct-2018, the subject performed Quad screen and ultrasound and no MCM was noted.  On 12-Dec-2018, 1 month and 27 days after vaccination, the subject developed anemia. The subject started corrective treatment with ferrous sulfate, at dose of one tablet, twice a day, orally.  On 22-Dec-2018, the subject recovered from anemia.  On 09-Jan-2019 and 31-Jan-2019, the subject underwent ultrasound and no MCM was noted.  On 14-Feb-2019, 3 months and 30 days after vaccination, the subject developed yeast. The subject started corrective corrective treatment with Metrogel (metronidazole), 0.75% gel, twice a day, vaginally.   On 21-Feb-2019, the subject underwent ultrasound and no MCM was noted.  On 24-Feb-2019, the subject recovered from yeast.  On 09-Mar-2019, at gestational age of 36.7 weeks, the subject vaginally delivered male neonate. No pregnancy complications were noted. The neonate's birth weight was 2977 g, head circumference was 33 cm and length was 52.1 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  This case is linked to 201904705, the corresponding child case.  Company comment:The patient was administered Flu Vaccine Egg Split QIV NVD (Flucelvax QIVc) at approximately 16 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  The patient experienced anaemia and fungal infection, approximately two and four months after vaccination, respectively. Chronology seems plausible. At 36.7-week gestational age, the subject gave birth to a male infant (reported as preterm delivery). 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 vaccine exposure during pregnancy is assessed as not related considering the intended use of the vaccine. Causal relationship between the suspect product and events of anaemia, fungal infection and preterm delivery is assessed as related.; Reporter's Comments: The patient was administered Flu Vaccine Egg Split QIV NVD (Flucelvax QIVc) at approximately 16 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  The patient experienced anaemia and fungal infection, approximately two and four months after vaccination, respectively. Chronology seems plausible. At 36.7-week gestational age, the subject gave birth to a male infant (reported as preterm delivery). 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 vaccine exposure during pregnancy is assessed as not related considering the intended use of the vaccine. Causal relationship between the suspect product and events of anaemia, fungal infection and preterm delivery is assessed as related.