Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Premature delivery, Prenatal screening test, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Delivered neonate at 36.3 week of gestation; Candidiasis; Urinary tract infection; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Aug-2019, concerning a 32-year-old, pregnant, female subject of body weight: 199 lbs, height: 60 inches and body mass index (BMI): 38.9, enrolled in a prospective observational safety study.  The subject's obstetrical history noted that the subject had 5 previous pregnancies which included 4 full term, live births and 1 spontaneous abortion. 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 history of deep vein thrombosis. The subject's concomitant medications included Prenatal Vitamins (mineral NOS, vitamin NOS) as a supplement and Lovenox (enoxaparin sodium) for deep vein thrombosis.  The subject's last menstrual period (LMP) date was 27-Aug-2018, estimated delivery date (EDD) was 03-Jun-2019 and corrected estimated date of delivery (CEDD) was 23-Jun-2019. The type of pregnancy was singleton.  On 29-Oct-2018, at gestation age of 9 weeks, the subject was administered 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 07-Nov-2018, the subject developed urinary tract infection (UTI) and candidiasis. The subject received 0.4% terconazole, administered via vaginal route, as a corrective treatment for candidiasis, and Macrobid (nitrofurantoin) at a dose of 100mg, administered via oral route, two times per day, as a corrective treatment for UTI.   On 08-Nov-2018, the subject recovered from the event of candidiasis', and treatment with terconazole was discontinued.  On 14-Nov-2018, the subject recovered from the event of urinary tract infection', and the treatment with Macrobid was discontinued.  On 28-May-2019, at gestational age of 36.3 weeks, the subject vaginally delivered male neonate (explicitly coded as Premature delivery'). The neonate's birth weight was 3090 g, head circumference was 34.3 cm and length was 48.3 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7 and at five minutes was 5.  APGAR score was not reported for 10 minutes. No major congenital malformation was identified at birth. There were no pregnancy complications noted.  The case is linked to 201904408, the corresponding child case.  Follow up received by other health care professional on 17-Sep-2019: The information on ongoing use of Lovenox and APGAR score at one minute and at five minutes were provided. Action taken for Lovenox was updated. The narrative was amended accordingly.  Company comment: A 32-year-old female pregnant subject experienced candidiasis, urinary tract infection and premature delivery after receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology seems plausible for the events of candidiasis and urinary tract infection while for premature delivery remains unsuggestive. UTIs are common during pregnancy, because the growing uterus makes pressure on the bladder and urinary tract. Candida infections are also frequent during pregnancy. According to one study, about 20 percent of women have Candida yeast in their vagina normally. That number goes up to 30 percent during pregnancy. Although causality was highly confounded, causal role of the suspect vaccine cannot be totally excluded and is assessed as related for all 3 events. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.; Reporter's Comments: A 32-year-old female pregnant subject experienced candidiasis, urinary tract infection and premature delivery after receipt of Flu Vaccine Cell Subunit QIV NVD. Chronology seems plausible for the events of candidiasis and urinary tract infection while for premature delivery remains unsuggestive. UTIs are common during pregnancy, because the growing uterus makes pressure on the bladder and urinary tract. Candida infections are also frequent during pregnancy. According to one study, about 20 percent of women have Candida yeast in their vagina normally. That number goes up to 30 percent during pregnancy. Although causality was highly confounded, causal role of the suspect vaccine cannot be totally excluded and is assessed as related for all 3 events. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.