Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Breech presentation, Foetal exposure during pregnancy
Clinical narrative: Breech; Foetal vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 27-Feb-2020, concerning a female foetal subject, whose mother was 26-year-old, pregnant, female subject of body weight: 141 lbs, height: 68.5 inches and body mass index (BMI): 21.1 enrolled in, a prospective observational safety study.  The mother's medical history included Chiari malformation and she was Rh negative.  The mother's concomitant medications included ferrous sulfate for anemia.  The mother did not have any previous pregnancies, nor maternal and paternal history with major congenital malformation (MCM). The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The mother's last menstrual period (LMP) date was 07-Apr-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) was 12-Jan-2020 and corrected estimated delivery date (CEDD) was not provided. The subject's mother did not consume alcohol, tobacco and illicit drugs during pregnancy. The father's age was not provided.  On 28-Jun-2019, the subject's mother underwent first sequential and nuchal translucency.  No MCM was noted.  On 26-Jul-2019, the subject's mother underwent second sequential and no MCM was noted.  On 03-Sep-2019, the subject's mother underwent targeted ultrasound and no MCM was noted.  On 21-Oct-2019, at gestational age of 28 weeks, the subject's 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] for influenza immunisation (explicitly coded as 'Foetal exposure during pregnancy').  On 19-Nov-2019, 29 days after vaccination, the subject's mother developed anemia.  On an unknown date, the pregnancy was complicated with breech presentation of foetus in uterus.   At gestational age of 39.1 weeks, the subject's mother vaginally delivered a live female neonate. The neonate birth weight was 3130 grams. No data was reported for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 6 and at five minutes was 8. No data was reported for APGAR score at ten minutes. No MCM was identified at birth.  At the time of this report, the outcome of breech presentation' was not reported.  The event of 'breech presentation' was considered serious due to the criterion of medical significance.  The reporter did not provide the causality assessment to Afluria QIV.  This case is linked to case 201907400 (the corresponding mother case).  Company comment: Reportedly, breech presentation was associated with Afluria QIV. Subject's mother was administered vaccine at approximately 28 weeks of gestation and the event was noted on an unknown date. Chronology needs more clarification. Most breech presentations seem to be chance occurrences. However, 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, breech presentation was associated with Afluria QIV. Subject's mother was administered vaccine at approximately 28 weeks of gestation and the event was noted on an unknown date. Chronology needs more clarification. Most breech presentations seem to be chance occurrences. However, 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.