Sex: M
Vaccine: UNK
Symptoms: Amniotic cavity infection, Apgar score normal, Foetal exposure during pregnancy
Clinical narrative: Chorioamnionitis; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 31-Jan-2020, concerning a neonate male subject, whose mother was a 24-year-old female of body weight 158 lbs, height 64.5 inches and body mass index (BMI) 26.7, enrolled in a prospective observational safety study.  The mother's medical history included anxiety, depression, nausea and body mass index high. The mother was RhD negative.   The subject's mother concomitant medications included Unisom (doxylamine succinate) and vitamin B6 for nausea, Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.    The mother's obstetrical history included no previous pregnancies. 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 date (LMP) was 14-Mar-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) was 19-Dec-2019 and corrected estimated date of delivery (CEDD) was reported as 12-Jan-2020. The subject's father was 28 years old.   On 07-Jun-2019, the subject's mother underwent dating scan and no MCM was noted.    On 11-Sep-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; dose: 0.5 ml, batch number: 216200, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   On the same date the subject's mother underwent anatomy ultrasound and no MCM was noted.   On an unspecified date, an unknown amount of time after vaccination, the pregnancy was complicated by chorioamnionitis.  At 41.3 weeks of gestation, the subject's mother gave a live birth to a normal male neonate, delivered by vaginal method. The neonate's birth weight was 3430 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 major congenital malformation identified at birth.   At the time of this report, the outcome of the event chorioamnionitis was not reported.   Per company, the event of chorioamnionitis was 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 202001618 (the corresponding mother case).  Company comment: A neonate male subject developed amniotic cavity infection after his mother was vaccinated with the suspect product Flu Vaccine Cell Subunit QIV NVD for influenza immunization at approximately 25 weeks of gestation. Reportedly, on an unspecified date, an unknown amount of time after vaccination, the subject/subject's mother developed event. Chronology needs more clarification. The mother's medical history included anxiety, depression, nausea and body mass index high. The mother was RhD negative. The subject's mother concomitant medications included Unisom (doxylamine succinate) and vitamin B6 for nausea, Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine. With information presented, causality is assessed as not related to the product since in majority of cases chorioamnionitis is a bacterial infection that occurs before or during labour. Foetal exposure during pregnancy is considered not related per company conventions.; Sender's Comments: A neonate male subject developed amniotic cavity infection after his mother was vaccinated with the suspect product Flu Vaccine Cell Subunit QIV NVD for influenza immunization at approximately 25 weeks of gestation. Reportedly, on an unspecified date, an unknown amount of time after vaccination, the subject/subject's mother developed event. Chronology needs more clarification. The mother's medical history included anxiety, depression, nausea and body mass index high. The mother was RhD negative. The subject's mother concomitant medications included Unisom (doxylamine succinate) and vitamin B6 for nausea, Rhophylac (anti-d immunoglobulin) for RhD negative and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine. With information presented, causality is assessed as not related to the product since in majority of cases chorioamnionitis is a bacterial infection that occurs before or during labour. Foetal exposure during pregnancy is considered not related per company conventions.