Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: This is a serious observational study case, initially received from other health care-professional on 07-Nov-2018, concerns a 38-year-old, adult, pregnant subject enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV  seasonal quadrivalent vaccine, during pregnancy. It was reported that the subject's body weight as 164 lbs, 65.5 inches and body mass index (BMI) as 26.9. The subject had no previous pregnancies. The subject had no family history of offspring and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol and illicit drugs during pregnancy. The subject's risk factor included advanced maternal age (AMA). The subject's last menstrual period date (LMP) was 10-Apr-2018. It was reported that the at an age of 38 years the subject had pregnancy which was considered as advanced maternal age. On 25-Jun-2018, prenatal birth weight (PNBW) test was performed, on 10-Jul-2018, the non-invasive prenatal testing (NIPT) was performed, and on 10-Sep-2018, anatomical scan was performed, it was reported that no congenital malformations were noted. On 18-Oct-2018, 1-hour Glucola test (as reported) was performed which showed elevated. On 23-Oct-2018, at gestational age of 28-weeks (third trimester of pregnancy) the subject was administered Influenza vaccine, dose: 0.5 ml, batch number: YF41708, route of administration, anatomical location, and expiry date: not reported for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On the same day, 3-hour Glucola test (as reported) was performed and no congenital malformation was noted. On 21-Dec-2018, subject underwent GBS culture test and the it was negative, and no congenital malformations were noted. The subject had singleton pregnancy and the estimated delivery date (EDD) was reported as 15-Jan-2019. On 2 months and 19 days after vaccination, the subject delivered a full-term male neonate at 39.4 weeks gestation. Pregnancy complications were reported as Meconium in amniotic fluid and fetal intolerance to labor. The baby was delivered with the help of forceps. During suctioning of infant moderate thick secretion was noted. 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 and foetal complications were noted from meconium. This case was cross-linked to the Case: 201901229 (baby case). Follow up received from the other health professional on 31-Jan-2019. The classification special case with no adverse event was added in the general tab. The GBS culture test was added as relevant tests in the patient tab. It was reported that 2 months and 19 days after vaccination, the subject delivered a full-term female neonate at 39.4 weeks gestation. At the time of delivery pregnancy complications were reported as Meconium (coded a meconium in amniotic fluid) and fetal intolerance to labor and so the delivery was done with the help of 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. Narrative was amended accordingly. Follow-up received from other health professional on 23-Apr-2019: The classification "Special case with no AE" was removed from the general tab. Event 'meconium in amniotic fluid' was added in the event tab. This case was upgraded as serious. Pregnancy complications were reported as Meconium in amniotic fluid and fetal intolerance to labor. The baby was delivered with the help of forceps. During suctioning of infant moderate thick secretion was noted. There was no major congenital malformation and foetal complications were noted from meconium. The narrative was amended accordingly.; Reporter's Comments: A 38-year-old pregnant subject, experienced meconium in amniotic fluid (pregnancy complication), 2 months 19 days after receipt of Flu Vaccine Egg Split QIV vaccine (considered as vaccine exposure during pregnancy) at 28 weeks of gestation. Time to onset of the event meconium in amniotic fluid is considered implausible and also the event can be alternately explained by associated foetal distress, rather than the study vaccine. Hence, company assessed the causality of the event meconium in amniotic fluid as not related. The event vaccine exposure during pregnancy assessed as not related to the study vaccine, considering the intended use of the vaccine. The company assessed the event 'meconium in amniotic fluid' as serious (medically significant).