Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal malpresentation; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-Feb-2020, concerning a female neonate subject, whose mother was a 30-year-old, female, body weight 170.4 lbs, height 60 inches and body mass index (BMI) 33.3, enrolled in a prospective observational safety study.  The subject's mother current conditions included obesity, anxiety depression, nausea, vomiting, gastroesophageal reflux disease (GERD) and human papilloma virus infection (HPV + Pap). The subject's mother was varicella non-immune.  The subject's mother concomitant medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and Zofran (ondansetron), both for nausea, Prenatal vitamins (minerals not otherwise specified (nos); vitamins nos) for obstetrical (OB) care, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Pepcid (famotidine) for GERD.  The subject mother's obstetrical history noted that mother had two previous pregnancies with one full term live birth and one spontaneous abortion. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject mother's last menstrual period (LMP) date was 03-Apr-2019. Estimated delivery date (EDD) and corrected delivery date (CEDD) were 08-Jan-2020. The pregnancy was singleton. The subject's father age was 25-year-old.  On 28-Jun-2019, the subject's mother underwent nuchal translucency and first trimester screen tests and no MCM was noted.  On 26-Jul-2019, the subject's mother underwent second trimester screen test and no MCM was noted.  On 23-Aug-2019, the subject's mother underwent ultrasound and no MCM was noted.  On an unspecified date in 2019, the subject underwent Papanicolaou (Pap) test and the result was HPV positive.  On 18-Oct-2019, at gestational age of 28 weeks, the subject's mother was administered  Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy) for influenza immunisation.  On an unspecified date in 2019, an unknown amount of time after vaccination, the foetal malpresentation was noted.  At gestational age of 38 weeks, the subject's mother delivered live birth, female neonate by widelock caesarean delivery. Arrest of descent and uterine artery laceration on left side were noted as pregnancy complications. The subject's mother also underwent cystoscopy. The neonate's birth weight was 3118 g, her head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (one minute) and 9 (five minutes). There was no MCM identified at birth.   At the time of initial reporting, the outcome of the event foetal malpresentation was not reported.   The event of foetal malpresentation was assessed as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  The case is linked to case 201905842, the corresponding mother case.  Company comment: Reportedly, foetal malpresentation was associated with Flucelvax QIVc. The subject's mother was administered vaccine at approximately 28 weeks of gestation and the event was noted on an unspecified date in 2019. Chronology needs more clarification. Most foetal malpresentations seem to be chance occurrences. However, 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, foetal malpresentation was associated with Flucelvax QIVc. The subject's mother was administered vaccine at approximately 28 weeks of gestation and the event was noted on an unspecified date in 2019. Chronology needs more clarification. Most foetal malpresentations seem to be chance occurrences. However, 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.