Sex: F
Vaccine: FLUC4
Symptoms: Alpha 1 foetoprotein amniotic fluid increased, Bacterial vaginosis, Caesarean section, Exposure during pregnancy, Foetal non-stress test normal
Clinical narrative: Uterine dehiscence; Premature delivery; Hypertension; Trichomonas; Bacterial vaginosis; Nausea; Vomiting; Elevated AFP; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 27-Sep-2019, concerning a 25-year-old, female pregnant subject of body weight: 193 lbs, height: 66 inches and body mass index (BMI): 31.1 (Ethnicity: not reported) enrolled in, a prospective observational safety study.  The subject's past medical history included bacterial vaginosis and the subject's historical drug included Metrogel (metronidazole) for bacterial vaginosis. The subject's current condition included Herpes simplex virus II and anemia. The subject's concomitant medications included: Prenatal vitamins (mineral nos, vitamins nos) for pregnancy and Venofer (saccharated iron oxide) for anemia.  The subject's obstetrical history included six previous pregnancies with five full-term live births and one preterm live births. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 29-Jun-2018. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 05-Apr-2019. The type of pregnancy was singleton.  On 22-Aug-2018, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCMs were noted.  On 05-Sep-2018 and 20-Sep-2018, the subject underwent ultrasound and no MCMs were noted.  On 03-Oct-2018, at gestational age at 13 weeks, the subject was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose: 0,5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation. On the same day, the subject underwent ultrasound and no MCM was noted.  On 22-Oct-2018, 19 days after vaccination, the subject underwent maternal serum alpha fetoprotein (MSAFP)/Serum markers test and the result was 3.33 (no units were provided) and it was reported as elevated alpha 1 foetoprotein (AFP). On the same date, the subject underwent ultrasound and Qnatal test and no MCM was noted.  On 15-Nov-2018, 1 month and 12 days after vaccination, the subject experienced nausea and vomiting.   On 18-Dec-2018, 2 months and 15 days after vaccination, the subject developed bacterial vaginosis.  From 18-Dec-2018 to 28-Dec-2018, the subject was treated with Metrogel gel for bacterial vaginosis, dose reported as 0.75 %, two times a daily (BID), vaginally.   On 28-Dec-2018, the subject recovered from the event of bacterial vaginosis.  On 15-Jan-2019, the subject underwent Non-stress test and no MCM was noted.  On 28-Jan-2019, 3 months and 25 days after vaccination, the subject developed hypertension and trichomonas.  From 28-Jan-2019 to 08-Feb-2019, the subject was treated with Procardia capsule (prasugrel hydrochloride) for hypertension, at one dose, every six hours (Q6h), orally and with Flagyl (metronidazole) for trichomonas, at dose of 375 mg, BID, orally.  On 05-Feb-2019, the subject underwent ultrasound and no MCM was noted.  On 07-Feb-2019, the subject underwent Non-stress test and no MCM was noted.  On 08-Feb-2019, the subject underwent ultrasound and Non-stress test and no MCMs were noted. On the same date, the subject recovered from the event of trichomonas.  On 11-Feb-2019, the subject underwent Non-stress test and no MCM was noted.  On 14-Feb-2019, at gestational age of 32.9 weeks, the mother delivered live birth, male neonate by caesarean method of delivery. The neonate's birth weight was 2140 g, his head circumference and length: were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). At the time of delivery, pregnancy complication uterine dehiscence was noted, but details were not specified. There was no MCMs identified at birth. On the same date, the subject recovered from the event nausea and vomiting.  At the time of initial reporting, the outcome of the events uterine dehiscence, premature delivery and alpha 1 fetoprotein increased was not reported, while the event of hypertension was not resolved.  This case is linked to 201904856, the corresponding child case.  Company Comment: The subject experienced uterine dehiscence, premature delivery, alpha 1 fetoprotein increased, hypertension, trichomoniasis, bacterial vaginosis, nausea and vomiting after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy.   Chronology is plausible. Medical history of bacterial vaginosis, Herpes simplex virus II, anaemia and pregnant state may have contributed to development of the events. Considering all the above mentioned, causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The subject experienced uterine dehiscence, premature delivery, alpha 1 fetoprotein increased, hypertension, trichomoniasis, bacterial vaginosis, nausea and vomiting after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy.   Chronology is plausible. Medical history of bacterial vaginosis, Herpes simplex virus II, anaemia and pregnant state may have contributed to development of the events. Considering all the above mentioned, causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.