Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Breech presentation, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Breech presentation; Foetal exposure during pregnancy; This is an observational study case, initially reported by other health professional on 01-Jun-2020, concerning a female, neonate subject whose mother was 27-year-old, female of body weight 220 lbs, height 67 inches and body mass index (BMI) 34.5, enrolled in a prospective observational safety study.  The subject's mother's medical history included Rhesus (RH) negative and previous caesarean section.  The subject's mother's concomitant medication included prenatal vitamins (unspecified minerals and vitamins) for pregnancy.  The subject's mother's obstetrical history noted that the mother had three previous pregnancies, one of which was full term live birth, while two were spontaneous abortions. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was on 05-Jun-2019. The mother's estimated delivery date (EDD) was reported as 11-Mar-2020, while corrected estimated date of delivery (CEDD) was reported as 23-Mar-2020. The type of pregnancy was singleton.   On 09-Sep-2019, the subject's mother underwent nuchal translucency and first sequential. No MCMs were noted.  On 07-Oct-2019, at approximately 17 weeks of gestation (calculated per LMP), 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] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject's mother underwent second sequential and no MCMs were noted.  On an unspecified date, unknown amount of time after vaccination, the subject was in breech position in uterus.  At 37.9 weeks of gestation (as reported), the mother delivered a live female neonate via caesarean method. The neonate's birth weight was 3475 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was provided at ten minutes. No MCMs were identified at the time of birth.   At the time of initial reporting, the outcome for the event of 'breech presentation' was not reported.  The event of 'breech presentation' was considered as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked to the case 202003724, the corresponding mother case.  Company comment: Reportedly, breech presentation was associated with Afluria QIV. Subject's mother was administered vaccine at approximately 17 weeks of gestation. On an unspecified date, unknown amount of time after vaccination, the subject was in breech position in uterus. 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 17 weeks of gestation. On an unspecified date, unknown amount of time after vaccination, the subject was in breech position in uterus. 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.