Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Premature delivery, Ultrasound antenatal screen abnormal
Clinical narrative: Gestational diabetes; Candidiasis; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 07-Aug-2019, concerning a 33-year-old, pregnant female subject of body weight 120 lbs, height: 62 inches and body mass index (BMI) 21.9, enrolled in a prospective observational safety study.  The subject's obstetrical history noted that the subject had 2 previous pregnancies which included 1 full term, live births and 1 stillbirth. No birth defects were reported. Also, the subject had no maternal or 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 medical history included environmental allergy and nasopharyngitis. The subject's concomitant medications included Prenatal Vitamins (mineral NOS, vitamin NOS) as a supplement and Zyrtec (cetirizine hydrochloride) for environmental allergy.  The subject's last menstrual period (LMP) date was 06-Oct-2018, estimated delivery date (EDD) was 13-Jul-2019 and corrected estimated date of delivery (CEDD) was 20-Jul-2019. The type of pregnancy was singleton.   On 06-Feb-2019, at gestation age of 17 weeks, the subject received Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, batch number: 252664, expiration date, route of administration and anatomical location: not reported] (explicitly coded as vaccine exposure during pregnancy) for influenza immunisation.  On 13-Mar-2019, the subject underwent ultrasound scan, and edema around fetal head and abdomen was noted.  On 18-Mar-2019, approximately one month after vaccination, the subject developed candidiasis. The subject received 0.8 % terconazole, administered via vaginal route, as a corrective treatment.   On 19-Mar-2019, the subject recovered from the event of candidiasis'.  On 12-Apr-2019, the subject underwent ultrasound scan, and it was noted that the edema around fetal head and abdomen were resolved.   On 29-May-2019, approximately four months after vaccination, the subject developed gestational diabetes. It was not reported whether the subject received any corrective treatment for the event.  At gestational age of 28.4 weeks, the subject vaginally delivered live birth, female neonate. The neonate's birth weight was 3460 g, head circumference 33.7 cm and length 50.2 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). No major congenital malformation was identified at birth. There were no pregnancy complications noted.  On the same day, the subject recovered from the event of gestational diabetes'.  This case is linked to case 201904367, the corresponding child report.  Company comment: The patient experienced gestational diabetes 3 months 23 days after vaccination with Flu Vaccine Cell Subunit QIV NVD. The patient also developed candida infection 1 month 12 days after vaccination with the suspect product, administered at 17 weeks of gestation. Chronology is plausible. Considering patient's medical history of stillbirth and treatment with concomitant drug (cetirizine hydrochloride), causality was confounded. However, causal role of the suspect vaccine cannot be totally excluded and was assessed as related to the events of gestational diabetes and candida infection. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine due to intended use of the vaccine.; Reporter's Comments: The patient experienced gestational diabetes 3 months 23 days after vaccination with Flu Vaccine Cell Subunit QIV NVD. The patient also developed candida infection 1 month 12 days after vaccination with the suspect product, administered at 17 weeks of gestation. Chronology is plausible. Considering patient's medical history of stillbirth and treatment with concomitant drug (cetirizine hydrochloride), causality was confounded. However, causal role of the suspect vaccine cannot be totally excluded and was assessed as related to the events of gestational diabetes and candida infection. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine due to intended use of the vaccine.