Sex: F
Vaccine: FLUX
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Breech; Foetal exposure during pregnancy; APGAR score in one minute: 2; Birth weight: 1219 grams; Birth at 30 weeks of gestation; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a female, neonate subject, whose mother was a 34-year-old female of body weight 127.8 lbs, height 63 inches and body mass index (BMI) 22.6, a prospective observational safety study.  The subject's mother medical history included nausea, history of human papillomavirus (HPV)+ PAP and uterine leiomyoma.  The subject's mother past drugs included progesterone intermuscular oil for in vitro fertilisation (IVF).   The subject's mother concomitant medications of included Prenatal vitamins (unspecified vitamins and minerals) as obstetric (OB) care vitamin supplementation, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation.   The mother's obstetrical history included one 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.   On unspecified date the subject's mother had an IVF.  The subject's mother last menstrual period (LMP) was on 12-Apr-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) of subject's mother were reported as 17-Jan-2020. The pregnancy was complicated with eclampsia in third trimester, hemolysis elevated liver enzymes and low platelet count (HELLP) and large fibroid. The subject's father was a 34-year-old.  On 02-Aug-2019, the subject's mother underwent second trimester screen and underwent maternal serum alpha-fetoprotein screening (MSAFP)/ serum markers and no MCM was noted.   On 23-Aug-2019, the subject's mother underwent anatomy ultrasound scan and no MCM was noted.    On 20-Sep-2019, at approximately 22 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On an unspecified date in 2019, after vaccination, breech fetal presentation was noted.   On 08-Nov-2019, at 30 weeks of gestation, the subject's mother delivered a preterm, live, female neonate of birth weight 1219 grams, via caesarean method. The characteristics of neonate, such as body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 2 at one minute and 7 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  The outcome of APGAR score low' and 'breech presentation' was resolved.  Outcome of the events very low birth weight' and premature birth' was not reported.   The events of 'premature birth', very low birth weight', APGAR score low' and breech presentation' were considered serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202000549 (the corresponding mother case).  Company Comment: The male neonate subject was delivered as low birth weight baby, premature baby with breech presentation and apgar score low after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of human papillomavirus (HPV)+ PAP and uterine leiomyoma may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events low birth weight baby and premature baby is assessed as unlikely related (defaults to related for reporting purposes) and for the events with breech presentation and apgar score low as not related due to biological implausibility.; Sender's Comments: The male neonate subject was delivered as low birth weight baby, premature baby with breech presentation and apgar score low after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of human papillomavirus (HPV)+ PAP and uterine leiomyoma may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events low birth weight baby and premature baby is assessed as unlikely related (defaults to related for reporting purposes) and for the events with breech presentation and apgar score low as not related due to biological implausibility.