Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature delivery, Urinary tract infection
Clinical narrative: Pre-eclampsia; Delivered neonate at 29.1 weeks of gestation; Vaccine exposure during pregnancy; Urinary tract infection; This is an observational study case, initially received from other health professional on 06-Aug-2019, concerning a 27-year-old, pregnant, female subject of body weight: 337 lbs, height: 72 inches and body mass index (BMI): 45.7, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's obstetrical history noted that the subject had 3 previous pregnancies which included 3 full term live births. No birth defects were reported. The subject had no history of offspring with major congenital malformation. 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 yeast infection, vaginitis and headaches. The subject's concomitant medications included Prenatal vitamins (mineral NOS, vitamin NOS) as a supplement and Metrogel (metronidazole) for vaginitis. The subject's historical dug included Diflucan (fluconazole) for yeast infection.  The subject's last menstrual period (LMP) date was 21-May-2018, estimated delivery date (EDD) was 25-Feb-2019 and corrected estimated date of delivery (CEDD) was 11-Mar-2019. The type of pregnancy was singleton.  On 01-Oct-2018, at gestation age of 15 weeks, the subject was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, the batch number used was 252664, expiration date, route of administration and anatomical location: not reported] for influenza immunisation.  On the same day, the subject developed urinary tract infection. The subject received Macrobid (nitrofurantoin) at a dose of 100mg, two times per day, administered via oral route, as a corrective treatment.   On 15-Oct-2018, the subject recovered from the event of urinary tract infection' and treatment with Macrobid was discontinued.  On an unspecified date in 2018, an unknown amount of time after vaccination, the subject experienced pre-eclampsia. No further details were provided.  On 21-Dec-2018, the subject was transferred to care unit due to high risk, but the details were not specified.  On 25-Dec-2018, at gestational age of 29.1 weeks, the subject delivered live birth, female neonate [explicitly coded as Premature delivery'] by caesarean delivery. The neonate's birth weight was 1260 g, head circumference and length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) score were 8 (one minute) and 9 (five minutes). No major congenital malformation was identified at birth.  At the time of initial reporting, the outcome of the event of pre-eclampsia' was not reported.  This case is linked to 201904354, the corresponding child report.  Company comment: Patient developed urinary tract infection the same day Flucelvax QIV was administered. The occurrence of this adverse event could be incidental, however causal role is not excluded based on the available information. The event of urinary tract infection is therefore assessed as related. Pre-eclampsia developed upon introduction of suspect vaccine, however latency interval is unknown. The event of pre-eclampsia is also assessed as related. Premature delivery was recorded upon vaccination. Causal involvement of suspect product is not excluded, therefore the event of premature delivery is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Reporter's Comments: Patient developed urinary tract infection the same day Flucelvax QIV was administered. The occurrence of this adverse event could be incidental, however causal role is not excluded based on the available information. The event of urinary tract infection is therefore assessed as related. Pre-eclampsia developed upon introduction of suspect vaccine, however latency interval is unknown. The event of pre-eclampsia is also assessed as related. Premature delivery was recorded upon vaccination. Causal involvement of suspect product is not excluded, therefore the event of premature delivery is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.