Sex: M
Vaccine: FLU4
Symptoms: Premature baby, Ultrasound foetal
Clinical narrative: Vaccine fetal exposure during pregnancy; Preterm birth at gestational age of 32.7; Low birth weight of 2231 g; APGAR score 5 at one minute and APGAR score 6 at five minutes; This is an observational study case, received on 26-Mar-2021 from other health professional and concerned a male neonate whose mother was a 32-year-old pregnant, female subject of body weight 272.5 lbs, height 67 inches and body mass index (BMI) 42.7, a prospective observational safety study.  The maternal concurrent conditions included obesity, uterine fibroids and asthma. The maternal concomitant medications included Prenatal plus DHA (unspecified vitamins and minerals and docosahexaenoic acid) for pregnancy.  The maternal obstetrical history included one previous pregnancy with full-term live birth. The neonate's mother had no history of offspring with major congenital malformation (MCM). Also, the neonate's mother had no maternal or paternal history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The neonate's father's age was 32 years.  The maternal  last menstrual period (LMP) date was reported as 20-Jun-2020, estimated delivery date (EDD) was reported as 27-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 07-Apr-2021. The type of pregnancy was singleton. The obesity complicating childbirth was marked as pregnancy complication.   On 18-Aug-2020, the ultrasound revealed no MCM.  On 11-Sep-2020, at approximately 11 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine, route of administration, anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.  On the same day, the ultrasound revealed no MCM.  On 25-Nov-2020, the ultrasound revealed no MCM.   At gestational age of 32.7 weeks (as reported), the mother delivered a male neonate via caesarean method. The neonate's birth weight was 2231 grams, head circumference: 30.5 cm and body length: 47 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 6 (five minutes) and 8 (ten minutes). No pregnancy complication was noted. No MCM was identified at birth.  On the same day, the neonate recovered from the event of 'APGAR score low'.  The outcome of 'premature baby' and 'low birth weight baby' was not reported.   The reporter did not provide a causality assessment.  The events of 'premature baby', 'low birth weight baby' and 'APGAR score low' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department  This case is linked to case 202007695 (the corresponding mother case).  Company comment: A male neonate whose mother was a 32-year-old pregnant, female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at gestational age of 11 weeks. Five months after vaccination, at gestational age of 32.7 weeks, the mother delivered a male neonate via caesarean method. The neonate's birth weight was 2231 grams. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 6 (five minutes) and 8 (ten minutes). The maternal concurrent conditions included obesity, uterine fibroids and asthma. The maternal obstetrical history included one previous pregnancy with full-term live birth. Chronology is unsuggestive. For the event of premature birth, causality was confounded by medical history (uterine fibroids). The events of low birth weight and Apgar score low are expected for premature birth. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: A male neonate whose mother was a 32-year-old pregnant, female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at gestational age of 11 weeks. Five months after vaccination, at gestational age of 32.7 weeks, the mother delivered a male neonate via caesarean method. The neonate's birth weight was 2231 grams. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 6 (five minutes) and 8 (ten minutes). The maternal concurrent conditions included obesity, uterine fibroids and asthma. The maternal obstetrical history included one previous pregnancy with full-term live birth. Chronology is unsuggestive. For the event of premature birth, causality was confounded by medical history (uterine fibroids). The events of low birth weight and Apgar score low are expected for premature birth. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.