Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight of 2410 g; This observational study case was received on 26-Feb-2021 from other health professional and concerned a male neonate, whose mother was 24-year-old, pregnant, female subject of body weight: 198 Ibs, height: 62.3 inches and body mass index (BMI) 35.9, enrolled in, a prospective observational safety study.   The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) used for pregnancy.  The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was reported as 15-May-2020, the estimated delivery date (EDD) was reported as 19-Feb-2021 and corrected estimated date of delivery (CEDD) was reported as 11-Feb-2021 (also reported as 19-Feb-2021). The type of pregnancy was singleton. The paternal age was not reported.  On 19-Aug-2020, the ultrasound revealed no MCMs.  On 10-Sep-2020, at approximately 16 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 an influenza immunisation. The batch number reported was P100230203.  On the same day, maternal serum alpha-fetoprotein (MSAFP)/serum markers revealed no MCMs.  On 09-Oct-2020, the ultrasound revealed no MCMs.  At gestational age of 38.4 weeks (as reported), the mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g, the head circumference was 30.5 cm and length was 48.3 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 at one minute, 9 at five minutes. APGAR score for ten minutes was not reported. No pregnancy complications and MCMs were noted at delivery.   The outcome of the event 'low birth weight' was not reported.  The reporter did not provide a causality assessment.  The event 'low birth weight' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The case is linked with the case 202101590 (the corresponding mother case).  Company comment: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. The neonate's mother was administered Afluria QIV at approximately 16 weeks of gestational age. The mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g. The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. With information available, causal role of the suspect vaccine is assessed as not related for both events, due to unsuggestive chronology (five months after vaccination). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A male neonate experienced foetal exposure to the suspect vaccine Afluria QIV. The neonate's mother was administered Afluria QIV at approximately 16 weeks of gestational age. The mother delivered live birth, male neonate via vaginal delivery method. The neonate's birth weight was 2410 g. The mother's concurrent conditions included increased BMI and the mother was group B streptococcus carrier. The maternal obstetrical history included two previous pregnancies which included one full-term live birth and one spontaneous abortion. With information available, causal role of the suspect vaccine is assessed as not related for both events, due to unsuggestive chronology (five months after vaccination). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.