Sex: M
Vaccine: FLUC4
Symptoms: Apgar score low, Foetal exposure during pregnancy, Intensive care, Premature baby
Clinical narrative: APGAR score at one minute 2, at five minutes 4; Chorioamnionitis; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jul-2020, concerning a male foetus, whose mother was a 29-year-old, pregnant female subject of body weight 173 lbs, height 64 inches and body mass index (BMI) 29.7, enrolled in, a prospective observational safety study.   The foetus' mother's medical history included high BMI.  The mother's concomitant medication included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The mother had no previous pregnancies. The mother had no history of offspring with major congenital malformations (MCMs). Also, the foetus' mother had no maternal or paternal history with MCMs. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The foetus' mother's last menstrual period (LMP) date was 01-Aug-2019. The estimated delivery date (EDD) was reported as 07-May-2020 and corrected estimated date of delivery (CEDD) was reported as 22-May-2020. The foetus' father was 29-year-old.   On 25-Oct-2019, at approximately 12 weeks of gestation (calculated per LMP), the foetus' mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On 27-Dec-2019, the foetus' mother underwent anatomy ultrasound and no MCM was noted.  On 13-Apr-2020, five months and 19 days after vaccination, the foetus' mother developed pregnancy induced hypertension.  On 16-Apr-2020, the foetus' mother underwent growth ultrasound and no MCM was noted.  On unspecified dates in 2020, chorioamnionitis and spontaneous rupture of membrane 24 hours prior to admission (as reported), were noted as pregnancy complications.  At 37.4 weeks of gestation (as reported), the mother delivered a male neonate via vaginal method of delivery. The neonate's birth weight was 3544 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 2, at five minutes was 4 and ten minutes was 7. The event of APGAR score low' was resolved on the same day, but the neonate was transported to neonatal intensive care unit (NICU) due to low APGAR scores at birth.  At the time of initial reporting, the outcome of the event chorioamnionitis was not reported. It was unknown if the neonate was discharged from NICU.  The events of APGAR score low' was assessed as serious due to criteria of hospitalisation and medical significance, while the event of chorioamnionitis was assessed as serious due to criteria of medical significance.  The reporter did not provide causality assessment.  This case is linked to the case 202003889 (the corresponding mother's case).  Company comment: A 29-year-old pregnant subject was administered Flucelvax QIVc at approximately 12 weeks of gestation. The subject delivered a male neonate, six months later. The neonate experienced Apgar score low (at one minute 2, at five minutes 4). Along with subject, the neonate also experienced the event of amniotic cavity infection on unspecified dates in 2020 (reported as 24 hours prior to admission, suggesting that it was approximately six months after vaccination). The subject's current medical conditions included high body mass index and the event of gestational hypertension, which may have contributed to development of Apgar score low. Causal role of the suspect product is assessed as not related for both events, due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy was assessed as unrelated per company's conventions.; Sender's Comments: A 29-year-old pregnant subject was administered Flucelvax QIVc at approximately 12 weeks of gestation. The subject delivered a male neonate, six months later. The neonate experienced Apgar score low (at one minute 2, at five minutes 4). Along with subject, the neonate also experienced the event of amniotic cavity infection on unspecified dates in 2020 (reported as 24 hours prior to admission, suggesting that it was approximately six months after vaccination). The subject's current medical conditions included high body mass index and the event of gestational hypertension, which may have contributed to development of Apgar score low. Causal role of the suspect product is assessed as not related for both events, due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy was assessed as unrelated per company's conventions.