Sex: M
Vaccine: FLUC4
Symptoms: Abnormal labour affecting foetus, Apgar score normal, Caesarean section, Congenital megacolon, Foetal distress syndrome
Clinical narrative: Hirschsprung's disease; Fetal intolerance; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a male fetal subject whose mother was 34-year-old, pregnant female subject, of body weight: 185 lbs, height: 63.6 inches and body mass index (BMI): 32.2, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's mother's medical history included obesity with BMI of 32.2. It was noted that the subject's mother was in advanced maternal age.   The subject's mother's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy and Tdap (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid) as vaccine.   The subject's mother obstetrical history noted that the mother had one previous full-term live birth pregnancy, with shoulder dystocia as complication at delivery. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 07-Jun-2019. The subject's mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 13-Mar-2020. The type of pregnancy was singleton. The subject's father was a 35-year-old.  On 08-Aug-2019, the subject's mother underwent ultrasound scan, and no MCM was noted.  On 22-Aug-2019, the subject's mother underwent Maternit 21 test, and no MCM was noted.  On 03-Oct-2019, the subject's mother underwent second trimester screen and mother's serum alpha fetoprotein (MSAFP) / serum markers test, and no MCM was noted.  On 24-Oct-2019, at approximately 19 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261223, dose: 0.5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject's mother underwent anatomy ultrasound scan and no MCM was noted.  On 19-Nov-2019, 26 days after vaccination, the subject's mother developed upper respiratory infection. The subject's mother started treatment with Zithromax z-pack (azithromycin), at a dose of 250 mg (one tablet), orally, two times during the first day and one tablet for next four days and Tessalon perle (benzonatate), at a dose of 100 mg, orally, three times daily (tid) per need (prn) from the same day.   On 02-Dec-2019, one month and eight days after vaccination, the subject's mother experienced cough and was treated with Albuterol hfa (salbutamol), at a dose of two puffs every four hours.   On 16-Jan-2020, the outcome of the event 'upper respiratory infection' was resolved.  On 20-Feb-2020, three months and 27 days after vaccination, Group B Strep (GBBS) infection was noted.    On the same day, the subject's mother underwent ultrasound follow-up scan, and no MCM was noted.   On 12-Mar-2020, at gestational age of 39.9 weeks (as reported), the subject's mother gave birth to a live male neonate via caesarean method of delivery. The neonate's birth weight was 3549 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 at one minute, 9 at five minutes. APGAR score for ten minutes was not reported. Complications during delivery included fetal intolerance with failure to progress in second stage and arrest of descent. MCM identified at birth included Hirschsprung's disease.  At the time of initial reporting, the outcome for the events 'Hirschsprung's disease' and abnormal labor affecting fetus' was not reported.  The events of 'Hirschsprung's disease' and abnormal labor affecting fetus' were assessed as serious due to criteria of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 201907067 the corresponding mother case.  Company comment: A male fetal subject, whose mother was 34-year-old pregnant female subject, developed congenital megacolon and abnormal labour affecting foetus after his mother was vaccinated with the suspect product Flucelvax QIV  for influenza immunisation. The events were established after birth. Chronology seems compatible. The subject's mother obstetrical history noted that the mother had one previous full-term live birth pregnancy, with shoulder dystocia as complication at delivery. The subject's mother's medical history included obesity with BMI of 32.2. It was noted that the subject's mother was in advanced maternal age. The subject's mother's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy and Tdap (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid) as vaccine. With information presented, causality is assessed as unlikely related for both events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A male fetal subject, whose mother was 34-year-old pregnant female subject, developed congenital megacolon and abnormal labour affecting foetus after his mother was vaccinated with the suspect product Flucelvax QIV  for influenza immunisation. The events were established after birth. Chronology seems compatible. The subject's mother obstetrical history noted that the mother had one previous full-term live birth pregnancy, with shoulder dystocia as complication at delivery. The subject's mother's medical history included obesity with BMI of 32.2. It was noted that the subject's mother was in advanced maternal age. The subject's mother's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy and Tdap (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid) as vaccine. With information presented, causality is assessed as unlikely related for both events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)