Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound antenatal screen abnormal, Vaginal infection
Clinical narrative: Candidiasis; Vaccine exposure during pregnancy; Two small subchorionic hematomas; Vaginitis; This is an observational study case, initially received from other health professional on 12-Aug-2019, concerning a 31-year-old, pregnant, female subject of body weight 114 lbs, height 60 inches and body mass index (BMI): 22.3, enrolled in a prospective observational safety study.   The subject's obstetrical history noted that the subject had 3 previous pregnancies which included 2 full term, live births and one ectopic pregnancy. 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 streptococcus infection positive to group B, urinary tract infection and nausea. Then subject's concomitant medications included Prenatal vitamins (mineral NOS, vitamin NOS), promethazine and Macrobid (nitrofurantoin).   The subject's last menstrual period was 01-Aug-2018, estimated delivery date (EDD) was 08-May-2019 and corrected estimated date of delivery (CEDD) was 14-May-2019. The type of pregnancy was singleton.   On 29-Oct-2018, the patient was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, batch number: 252664, route of administration, anatomical location, expiration date: not reported] (explicitly coded as vaccine exposure during pregnancy) for unknown indication.   On the same day, the subject underwent ultrasound scan and two small subchorionic hematomas were noted. The subject also experienced vaginitis and received 0.75 % Metrogel (metronidazole) administered via vaginal route two times per day as a corrective treatment.   On 01-Nov-2018, three days after vaccination, the subject experienced candidiasis and was treated with 0.4 % terconazole administered via vaginal route once daily.  On the same day, the subject recovered from the event of candidiasis'.  On 05-Nov-2018, the subject recovered from the event of vaginal infection'.  On an unreported date, the subject underwent spinal muscular atrophy screen and cystic fibrosis mutation analyses, and no congenital malformation was noted.  On 29-Nov-2018, the subject underwent ultrasound scan and no congenital malformation was noted.    On 22-Feb-2019, the subject underwent ultrasound scan and no congenital malformation was noted.    On 25-Mar-2019, the subject underwent ultrasound scan and no congenital malformation was noted.    On 16-Apr-2019, the subject underwent ultrasound scan and no congenital malformation was noted.    At gestation age of 39 weeks, the subject vaginally delivered a live birth, female neonate. The neonate's birth weight was 3289 g, her head circumference was 34.9 cm and body length was 50.8 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 10 (five minutes). There was no major congenital malformation identified at birth.  At the time of initial reporting, the outcome of the event subchorionic hematoma' was not reported.  Company Comment: The subject experienced subchorionic haematoma, vaginal infection and candida infection after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy. Temporal relationship is implausible for the events subchorionic haematoma and vaginal infection because the events occurred on the day of vaccination. Medical history of streptococcus infection positive to group B and urinary tract infection may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, promethazine and Macrobid (nitrofurantoin). Considering all the above mentioned, causal relationship between the suspect product and subchorionic haematoma, vaginal infection and exposure during pregnancy is assessed as not related and as related for candida infection.; Reporter's Comments: The subject experienced subchorionic haematoma, vaginal infection and candida infection after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy. Temporal relationship is implausible for the events subchorionic haematoma and vaginal infection because the events occurred on the day of vaccination. Medical history of streptococcus infection positive to group B and urinary tract infection may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, promethazine and Macrobid (nitrofurantoin). Considering all the above mentioned, causal relationship between the suspect product and subchorionic haematoma, vaginal infection and exposure during pregnancy is assessed as not related and as related for candida infection.