Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Birth at 34.7 weeks of gestation; This is an observational study case, initially received on 07-Dec-2020 from other health professional and concerned a male neonate whose mother was a 40-year-old, pregnant, female subject of body weight: 173.5 lbs, height: 65 inches and body mass index (BMI): 28.9, enrolled in, a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The neonate's mother's concurrent conditions included advanced maternal age, chronic neck pain, anxiety and body mass index high (BMI 28.9). The neonate's mother's concomitant medications included folic acid for pregnancy, Zoloft (sertraline hydrochloride) for anxiety, Prenatal vitamins (unspecified vitamins and mineral) for pregnancy, Flexeril (cyclobenzaprine hydrochloride) and gabapentin for chronic neck pain. The neonate's mother had a history of previous pre-eclampsia.    The neonate's mother's obstetrical history included three previous pregnancies, with two full term live births and one elective abortion. The neonate's mother did not have a history of offspring with major congenital malformations (MCMs). Also, the mother had no relevant maternal or paternal history with MCMs.  The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The neonate's mother's last menstrual period (LMP) date was 09-Mar-2020. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 14-Dec-2020. The type of pregnancy was singleton.   On 18-May-2020, the ultrasound revealed no MCMs.    On 20-May-2020, the first trimester screen revealed no MCM  On 16-Jul-2020, the maternal serum alpha-fetoprotein screening (MSAFP) / serum markers revealed no MCMs.   On 20-Jul-2020, the ultrasound revealed no MCMs.    On 10-Sep-2020, at approximately 26 weeks of gestation (calculated per LMP) the neonate's mother was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV) [influenza vaccine, dose, route of administration, anatomical location: not reported] (explicitly coded as 'Fetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.  At gestational age of 34.7 weeks (as reported), the mother delivered live birth, male neonate via caesarean method of delivery. The neonate's birth weight was 2807 g, the neonate's body length was 47.7 cm and head circumference 34.5 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 at one minute and 8 at five minutes. APGAR score was not reported for ten minutes. No MCM was identified at birth.   On 19-Nov-2020, the neonate's mother experienced post-partum pre-eclampsia.    The outcome of event 'premature baby 33 to 36 weeks' was not reported.   The reporter did not provide a causality assessment.   The event of 'premature baby 33 to 36 weeks' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked with the case 202007584 (the corresponding mother case).  Company comment:The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 34.7 weeks. Reportedly, the event occurred approximately two months post vaccination with the suspect product Afluria Quadrivalent. Chronology is unsuggestive. The mother's history of previous pre-eclampsia highly confounds causality. Underlying mother's conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the event. Causality between suspect product and the event of premature baby is assessed as not related due to biological implausibility, unsuggestive chronology and presented confounders. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 34.7 weeks. Reportedly, the event occurred approximately two months post vaccination with the suspect product Afluria Quadrivalent. Chronology is unsuggestive. The mother's history of previous pre-eclampsia highly confounds causality. Underlying mother's conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the event. Causality between suspect product and the event of premature baby is assessed as not related due to biological implausibility, unsuggestive chronology and presented confounders. Foetal exposure during pregnancy is assessed as not related per company's conventions.