Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Delivery, Exposure during pregnancy, Placenta praevia haemorrhage
Clinical narrative: Low lying placenta with hemorrhage 2nd trimester; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 12-Aug-2019, concerning a 30-year-old, pregnant, female subject of body weight 178 lbs, height 63 inches and body mass index (BMI) 31.5, 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 of full term, live births. 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 alcohol or illicit drugs during pregnancy. The subject was a smoker (less than 1 pack per day). The subject's medical history included anemia, yeast infection and bacterial vaginosis. The subject's concomitant medications included Prenatal vitamins (mineral NOS, vitamin NOS), Flagyl (metronidazole) and Terazol (terconazole).   The subject's last menstrual period (LMP) date was 26-Sep-2018, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 03-Jul-2019. The type of pregnancy was not reported.  On 28-Nov-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, anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On an unreported date at second trimester, an unknown amount of time after vaccination, the subject's pregnancy status was collected, and it was noted that the subject had low lying placenta with haemorrhage.   At gestational age of 39 weeks, the subject vaginally delivered live birth, male neonate. The neonate's birth weight was 3657 g, his head circumference was 34.3 cm and length 51.4 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 9 (one minute) and 10 (five minutes). No major congenital malformation was identified at birth.  At the time of initial reporting, the outcome of the event placenta previa hemorrhage' was not reported.  Company comment:The patient developed placenta praevia haemorrhage after administrating the suspect product, Flu Vaccine Cell Subunit QIV NVD. Reportedly, the patient received vaccine at gestation age of 9 weeks (explicitly coded as Vaccine exposure during pregnancy').  Causality was confounded by medical history of 3 previous pregnancies and smoking. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related , while for placenta praevia haemorrhage is assessed as related.; Reporter's Comments: The patient developed placenta praevia haemorrhage after administrating the suspect product, Flu Vaccine Cell Subunit QIV NVD. Reportedly, the patient received vaccine at gestation age of 9 weeks (explicitly coded as Vaccine exposure during pregnancy').  Causality was confounded by medical history of 3 previous pregnancies and smoking. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related , while for placenta praevia haemorrhage is assessed as related.