Sex: F
Vaccine: FLU4
Symptoms: Apgar score normal, Breech presentation, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Breech; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jun-2020, concerning a foetal subject whose mother was a 25-year-old pregnant, female subject of body weight 165 lbs, height 68 inches and body mass index (BMI) 25.1,  enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The paternal age was not reported.  The foetus' mother's current medical condition included increased BMI and right ovarian dermoid.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The foetus' mother's obstetrical history included one previous spontaneous abortion with no birth defects. The foetus' mother had no history of offspring with major congenital malformation (MCM). Also, the foetus' mother had no maternal or paternal history with MCM. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The foetus' mother's last menstrual period (LMP) date was 09-Jul-2019. The foetus' mother's estimated delivery date (EDD) was reported as 14-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 01-Oct-2019, the foetus' mother underwent first sequential and nuchal translucency. There was no MCM noted.  On 28-Oct-2019, at approximately 15 weeks of gestation (calculated per LMP), the foetus' mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the foetus' mother underwent second sequential. There was no MCM noted.  On an unspecified date, unknown amount of time after vaccination, the subject was in breech position in uterus (reported as pregnancy complication). Also, the foetus' mother developed herpes simplex.  At gestation age of 39 weeks (as reported), the mother delivered a live, female neonate via caesarean method. The neonate's birth weight was 3345 g, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was unknown for 10 minutes. No MCM was identified at birth.  At the time of this report, the outcome of the event 'breech presentation' was not reported.  The event of 'breech presentation' was considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  This case is linked to case number 202003810, corresponding mother case.  Company comment: Reportedly, foetus' mother was administered Afluria QIV vaccine at approximately 15 weeks of gestation. On an unspecified date, unknown amount of time after vaccination was noted that foetus is in breech position in uterus. Chronology needs more clarification. However, most breech presentations seem to be chance occurrences. In up to 15% of cases, it may be due to foetal or uterine causes. Therefore, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, foetus' mother was administered Afluria QIV vaccine at approximately 15 weeks of gestation. On an unspecified date, unknown amount of time after vaccination was noted that foetus is in breech position in uterus. Chronology needs more clarification. However, most breech presentations seem to be chance occurrences. In up to 15% of cases, it may be due to foetal or uterine causes. Therefore, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.