Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Premature birth; This is an observational study case, initially received from other health professional on 27-Nov-2019, concerning a male neonate subject, whose mother was a 21-year-old female, of body weight 189.5 lbs, height 69.5 inches and body mass index (BMI) 27.6, enrolled in, A prospective observational safety study. The subject's father was 21-year-old.  The mother's medical history included anemia and BMI increased.  Subject's mother concomitant medications included Prenatal vitamin (unspecified minerals, unspecified vitamins) for pregnancy and ferrous sulfate for anemia.   The subject's mother had no obstetrical history and no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 15-Mar-2019 and type of pregnancy was singleton and the pregnancy were complicated with preterm labor not resulting in birth. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother were reported as 20-Dec-2019.   On 15-Apr-2019, the subject's mother underwent Horizon 4 (fragile X carrier, cystic fibrosis mutation analysis (CF), duchenne muscular dystrophy (D/B MS), and spinal muscular atrophy (SMA) and no MCM was noted.   On 16-May-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 28-May-2019, the subject's mother underwent Panorama test and no MCM was noted.   On 18-Jul-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 07-Sep-2019, the subject's mother underwent ultrasound scan and non-stress test and no MCM was noted.   On 24-Oct-2019, at approximately 35 weeks of gestation, the mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization.  On the same day and 03-Nov-2019, the subject's mother underwent ultrasound scan and no MCM noted.   On 03-Nov-2019, 06-Nov-2019 and 14-Nov-2019, the subject's mother underwent non-stress test and no MCM was noted.  On 17-Nov-2019, at gestational age of 35.3 weeks, the subject's mother vaginally delivered a normal, male neonate of body weight 3620 grams, head circumference 33.7 cm and body length 54.6 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no MCM identified at birth.  The reporter did not provide causality assessment to Afluria QIV.  The event of 'premature birth' was considered serious due to the criterion of medical significance, per company.  This case was linked to the case 201907047 (the corresponding mother case).  Company comment: A male neonate patient experienced preterm birth, 24 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 35 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible and causal role of the suspect vaccine cannot be totally excluded, it is assessed as related. The event foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A male neonate patient experienced preterm birth, 24 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 35 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible and causal role of the suspect vaccine cannot be totally excluded, it is assessed as related. The event foetal exposure during pregnancy is assessed as unrelated per company's conventions.