Sex: U
Vaccine: UNK
Symptoms: Breech presentation, Exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Breech presentation; This is an observational study case, initially received from other health professional on 23-Dec-2019, concerning a foetus subject, whose mother was a 31-year-old subject of body weight: 174 lbs, height: 68 inches and body mass index (BMI): 26.5, enrolled in a prospective observational safety study.   The subject's mother current conditions included body mass index (BMI) high and history of chronic hypertension.   The subject's mother concomitant medications included Prenatal vitamin (minerals not specific (nos), vitamins (nos)) for pregnancy.  The subject's mother had two previous pregnancies with two full term live births. The subject's mother did not have any history of offspring with major congenital malformation (MCM) and no paternal or maternal history with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The paternal age was not reported.  The subject's mother last menstrual period (LMP) date was on 21-Feb-2019, The type of pregnancy was singleton. The subject's mother estimated delivery date (EDD) was 28-Nov-2019 and corrected estimated date of delivery (CEDD) was not reported.   On 23-Apr-2019, ultrasound was performed, no major MCMs was noted.  On 23-May-2019, sequential one and nuchal translucency were performed, no major MCMs was noted.  On 19-Jun-2019, sequential two was performed, no major MCMs was noted.  On 23-Jul-2019, maternal foetal medicine anatomy scan was performed, no major MCMs was noted.  On 23-Sep-2019, at approximately 35 weeks of gestation, the subject's mother received Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100112488, dose, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for an unknown indication.  On unspecified date in 2019, the pregnancy status was collected and it was noted breech presentation.  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 the criterion of medical significance.  The reporter did not provide causality assessment.  This case is linked with case 201907452 corresponding mother case.  Company comment: Reportedly, breech presentation was associated with Afluria QIV. The subject's mother was administered vaccine at approximately 35 weeks of gestation and the event was noted on an unspecified date in 2019. 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 (such as multiparity, in presented case). 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. The subject's mother was administered vaccine at approximately 35 weeks of gestation and the event was noted on an unspecified date in 2019. 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 (such as multiparity, in presented case). Therefore, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.