Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Pre-term birth at 36.7 weeks of gestation; This observational study case was received on 25-Feb-2021 from other health professional and concerned a male neonate, whose mother was 30-year-old, pregnant female subject of body weight: 147 lbs, height: 64 inches and body mass index (BMI): 25.2, enrolled, a prospective observational safety study.   The maternal concurrent conditions included BMI high and nausea. The maternal concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for healthy pregnancy and Zofran (ondansetron) for nausea.  The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.   The maternal last menstrual period (LMP) date was 08-May-2020, the estimated delivery date (EDD) was reported as 21-Feb-2021, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 28-Aug-2020, maternal serum alpha 1 fetoprotein (MSAFT) revealed no MCM.  On 25-Sep-2020, at gestation age of 20 weeks (calculated per LMP), the neonate's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly considered as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705.  On an unspecified date in Jan-2021, an unknown amount of time after receiving Afluria QIV, the neonate's mother developed gastroesophageal reflux disease (GERD).   On 08-Jan-2021, the neonate's mother started treatment with Pepcid Ac (famotidine), at a dose of 20 mg administered three times per day, via oral route for GERD.  At gestational age of 36.7 weeks (as reported), the mother vaginally delivered premature, live male neonate. The birth weight of the neonate was 2727 g, head circumference 33.5 centimetres and length 50.2 centimetres. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and at ten minutes was not reported. No pregnancy complications were noted. No MCM was identified at birth. On the same day, treatment with Pepcid Ac (famotidine) was stopped.  The outcome of the event 'premature baby' was not reported.   The reporter did not provide a causality assessment.  The event of 'premature baby' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with the case 202101522, the corresponding mother case.  Company comment: A male neonate patient was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Afluria QIV. Vaccine was administered at gestation age of 20 weeks, while the neonate was delivered at gestational age of 36.7 weeks. The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions which may be a contributing factor. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Based on provided information, causality for the event premature baby is assessed as not related. Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).; Sender's Comments: A male neonate patient was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Afluria QIV. Vaccine was administered at gestation age of 20 weeks, while the neonate was delivered at gestational age of 36.7 weeks. The maternal obstetrical history included three previous pregnancy with one live birth and two elective abortions which may be a contributing factor. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Based on provided information, causality for the event premature baby is assessed as not related. Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).