Sex: M
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy
Clinical narrative: This is a spontaneous case initially received from other health professional on 31-Jan-2019, concerning a male neonate. The patient's mother was 38-year-old female, who had no previous pregnancies. The mother had no family history of offspring and no relevant maternal and paternal medical history. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 10-Apr-2018. The type of pregnancy was singleton. It was reported that the at an age of 38 years the mother had pregnancy which considered as advanced maternal age. The patient's mother underwent prenatal birth weight (PNBW) test (on 25-Jun-2018), non-invasive prenatal (NIPT) testing (on 10-Jul-2018), and anatomical scan (on 10-Sep-2018) which showed no congenital malformations. On 18-Oct-2018, 1-hour glucola test (as reported) was performed which showed elevated. On 23-Oct-2018, at gestation age of 28 weeks, the fetus was exposed to AFLURIA QUADRIVALENT [influenza vaccine, batch number: YF41708, route of administration: transplacental, dose, anatomical location, and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, 3-hour glucola test (as reported) was performed and no congenital malformation was noted. On 21-Dec-2018, patient underwent Group B streptococcus (GBS) culture test which was negative, and no congenital malformations were noted. 2 months and 19 days after vaccination, the mother delivered a full-term female neonate at 39.4 weeks gestation. Pregnancy complications were reported as meconium and fetal intolerance of labor. The delivery method was reported as forceps. The neonate's birth weight was 3858 grams, head circumference was 34.5 cm and body length was 53.3 cm. The APGAR scores were 7 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation was noted. The outcome of the events was not reported. The mother's estimated delivery date (EDD) was reported as 15-Jan-2019. This case is linked to 201805302, the corresponding maternal pregnancy report.; Reporter's Comments: A male neonate patient was born with fetal intolerance of labor (fetal distress) and meconium in amniotic fluid, more than 2 months after maternal receipt of AFLURIA QUADRIVALENT vaccine at 28 weeks of gestation (considered as fetal exposure during pregnancy). Considering implausible temporal relationship and biological implausibility, the event fetal distress during labor assessed as not related. The event meconium in amniotic cavity can be alternatively explained by fetal distress rather than suspect vaccine. Hence, causality assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event fetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the events 'fetal intolerance of labor and meconium in amniotic fluid' as serious (medically significant).