Sex: M
Vaccine: UNK
Symptoms: Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Pre-term birth; Low birth weight; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a neonate male subject, whose mother was a 28-year-old female of body weight 193 lbs, height 60 inches and body mass index (BMI) 37.7, enrolled in a prospective observational safety study. The mother's medical history included diabetes mellitus, obesity and hypertensive disorder. The mother was rubella non-immune.   The subject's mother concomitant medications included Novolog (insulin aspart) and Lantus (insulin glargine), both used for diabetes mellitus, nifedipine and labetalol, both used for hypertensive disorder, vitamins with iron as OB (obstetrical) supplement and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.    The mother's obstetrical history included one previous spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was 06-Apr-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) 11-Jan-2020 and corrected estimated date of delivery (CEDD) was reported as 17-Jan-2020. The subject's father was 28 years old. The pregnancy was complicated by pre-eclampsia.  On 07-Jun-2019, the subject's mother underwent initial ultrasound and no MCM was noted.   On 05-Jul-2019, the subject's mother underwent first trimester screen and no MCM was noted.    On 05-Aug-2019, the subject's mother underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and second trimester screen and no MCM was noted.  On 04-Sep-2019, the subject's mother underwent anatomy ultrasound and short arm/leg measurements were noted on anatomy scan.  On 01-Oct-2019, at approximately 25 weeks of gestation, the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 216200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   At 36 weeks of gestation, the subject's mother gave a live birth to a normal male neonate, delivered by caesarean method. The neonate's birth weight was 2200 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (at one minute) and 9 (at five minutes). APGAR score was not reported for 10 minutes. There was no MCMs identified at birth.   At the time of initial reporting, the outcome of the events preterm birth and low birth weight baby was not reported.   The events of preterm birth and low birth weight baby were assessed as serious, due to the criterion of medical significance.   The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202000493 (the corresponding mother case).   Company Comment: The male neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy, at gestation age of 25 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 37.7), diabetes mellitus, obesity, hypertensive disorder and pre-eclampsia may provide alternative aetiology for the events. Causality is also confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature baby and low birth weight baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The male neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy, at gestation age of 25 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 37.7), diabetes mellitus, obesity, hypertensive disorder and pre-eclampsia may provide alternative aetiology for the events. Causality is also confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature baby and low birth weight baby is assessed as unlikely related (defaults to related for reporting purposes).