Sex: M
Vaccine: FLU4
Symptoms: Apgar score low, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 21-May-2019, concerning a male neonate patient. The patient's mother was a 28-year-old whose menstrual onset was at her 15 years of age and had history of 1 spontaneous abortion (on an unspecified date in Jul-2018), but no history of offspring with major congenital malformation. Also, the patient's mother had no maternal or paternal history with major congenital malformations and didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's mother also had no family history of fibroids. The medical history of patient's mother included obesity with body mass index greater than 30.1 on 29-Sep-2018. The historical drug of patient's mother included unspecified oral contraceptives (from 13-Dec-2014 to 01-Aug-2018) and current condition constituted depression and anxiety.  The concomitant medications of patient's mother included Zoloft (sertraline hydrochloride) for depression and Prenatal vitamins (minerals nos, vitamins nos) (started prior to pregnancy) for pregnancy. The details of patient's mother related to vitamin D deficiency and diet high in red meat were unknown.   The mother's last menstrual period (LMP) date was 09-Sep-2018. On 25-Oct-2018, mother's ultrasound was performed, and no major congenital malformation was noted. On 06-Nov-2018, at gestation age of 8 weeks, the patient was exposed to Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41708, dose, route of administration: transplacental, anatomical location and expiry date: not reported) (explicitly coded as fetal exposure during pregnancy) via mother for an unknown indication.  On 30-Nov-2018, 24 days after vaccination, the patient's mother underwent ultrasound first trimester screening and leiomyoma was noted (reported leiomyoma x 3; ultrasound antenatal screen). On 10-Jan-2019, the mother underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformation was noted. On 25-Jan-2019, the mother underwent anatomical ultrasound scan and no major congenital malformation was noted. On 20-Mar-2019, the patient's mother underwent growth ultrasound scan which revealed fibroids of 73.3 mm x 63 mm and of 22.1 mm x 20.8 mm. On an unspecified date in May-2019, the patient's mother underwent WBC count for which result was inconclusive (10.3), 24 hr urine analysis which was increased (501) (urine volume 24 hour increased), urine protein which was increased (29) (protein urine positive) and urine creatinine (181) which was normal. On an unspecified date, the patient's mother developed gardnerella infection and the blood pressure was increased. The mother was treated with Flagyl [metronidazole, dose: 500 mg, start date: 18-May-2019 and frequency: twice a day (bid)] for gardnerella infection, nifedipine [dose: 30 mg, start date: 19-May-2019 and frequency: once a day (qd)] for increased blood pressure and Phenergan [promethazine, dose: 25 mg, route of administration: intramuscular, start date and stop date: 18-May-2019 and frequency: od (reported as once)] for an unknown indication. The mother's pregnancy complications included mild pre-eclampsia and prodromal labour which started on 17-May-2019. On 18-May-2019, the patient's mother was admitted to the hospital for monitoring of preterm labour. At gestational age of 36.7 weeks, the mother gave live birth to a male neonate vaginally (preterm delivery). The characteristics of the neonate included birth weight: 3345 grams and APGAR (appearance, pulse, grimace, activity, and respiration) scores were 6 at one minute and 8 at five minutes). No major congenital malformations (MCMs) were identified at birth.  The estimated delivery date (EDD) of patient's mother was reported as 12-Jun-2019. The outcome of the event (premature birth) was unknown. This case is linked to 201805306 (mother case).; Reporter's Comments: A male neonate was delivered at 36.7 weeks gestation (premature birth), 6 months and 14 days after administration of AFLURIA QIV (foetal exposure during pregnancy). Considering there is no evidence for a biological mechanism that could cause the event, the event was assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. This company assessed this case as serious (medically significant).