Sex: M
Vaccine: FLUX
Symptoms: Apgar score, Caesarean section, Exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Preterm birth at 36 weeks of gestation; Low birth weight, 2450 grams; Birth length 43.8 cm; This observational study case was received from other health professional on 27-Apr-2021 and concerned a male neonate, whose mother was a 29-year-old, pregnant, female subject of body weight 151 lbs, height 65 inches and body mass index (BMI) 25.1, enrolled in a prospective observational safety study on pregnancy outcome in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  Maternal concurrent conditions included high BMI, body itch and drug allergies. Maternal concomitant medication included OB complete (multivitamin, multimineral) for healthy pregnancy.  Maternal obstetrical history included no previous pregnancies. The neonate's mother had no offspring with major congenital malformations (MCMs). The neonate's mother had no maternal or paternal history with MCMs. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   Maternal last menstrual period (LMP) date was 01-Aug-2020, the estimated delivery date (EDD) was reported as 08-May-2021 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The neonate's father's age was not reported.  On 09-Sep-2020, at approximately five weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and  route of administration: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number was P100239705.  On 15-Oct-2020, the cystic fibrosis mutation analysis revealed no MCMs.  On 23-Oct-2020, the first trimester screen revealed no MCMs.  On 14-Dec-2020, the second sequential screen revealed no MCMs.  On 25-Dec-2020, three months and 16 days after receiving Afluria QIV, the neonate's mother developed group B streptococcus infection and was treated with clindamycin at a dose of 300 mg, three times a day, orally, from 21-Jan-2021 to 27-Jan-2021.  At 36 weeks of gestation (as reported), the mother delivered live preterm male neonate via caesarean method of delivery. The neonate's birth weight was 2450 grams, body length: 43.8 centimetres, while head circumference was not reported. APGAR (appearance, pulse, grimace, activity and respiration) scores at one minute was nine, at five minutes was nine and at ten minutes was not reported. No MCM and no pregnancy complications were identified at delivery.  The outcome of the events of 'premature baby', 'low birth weight baby' and 'small for gestational age' was not reported.  The reporter did not provide a causality assessment.  The events of 'premature baby', 'low birth weight baby' and 'small for gestational age' were considered to be medically significant by a Physician.  This case is linked to cases 202101521 (the corresponding mother case).  Company Comment: A male neonate was exposed in utero to the suspect product Afluria QIV. The neonate's mother was administered Afluria QIV at approximately five weeks of gestation. At 36 weeks of gestation (as reported), the mother delivered live preterm male neonate via caesarean method of delivery. The neonate's birth weight was 2450 grams, body length was 43.8 centimetres. Causal role of the suspect product is assessed as not related for all events. Maternal medical history of high BMI and group B streptococcus infection may have contributed to development of the events. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A male neonate was exposed in utero to the suspect product Afluria QIV. The neonate's mother was administered Afluria QIV at approximately five weeks of gestation. At 36 weeks of gestation (as reported), the mother delivered live preterm male neonate via caesarean method of delivery. The neonate's birth weight was 2450 grams, body length was 43.8 centimetres. Causal role of the suspect product is assessed as not related for all events. Maternal medical history of high BMI and group B streptococcus infection may have contributed to development of the events. Foetal exposure during pregnancy is assessed as not related per company conventions.