Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Shoulder dystocia
Clinical narrative: Chorioamnionitis; Shoulder dystocia; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Jul-2020, concerning a male foetus, whose mother was 24-year-old, female pregnant subject of body weight: 112 lbs, height: 66 inches and body mass index (BMI): 18.1, enrolled in, a prospective observational safety study on pregnancy outcomes in woman immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The foetus' mother's medical history included body mass index low, anxiety and depressin. The foetus' mother's wasa RhD negative.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin, escitalopram for anxiety, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Rhogram (anti-D immunoglobulin) for RhD negative.  The foetus' mother had no obstetrical history. The  foetus' mother had no history of offspring with major congenital malformation (MCM). The foetus' mother had no maternal and paternal medical history with MCM. The foetus' mother did not use tobacco, illicit drug or alcohol during pregnancy.  The foetus' mother's last menstrual period (LMP) date was reported as 06-Sep-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) both were reported as 12-Jun-2020.   On 12-Nov-2019, at approximately 9 weeks of gestation (calculated per LMP), the foetus' mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261223, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.   On an unspecified date, unknown amount of time after vaccination, the pregnancy was complicated with chorioamnionitis.  On 03-Dec-2019, the foetus' mother underwent maternit 21 test and nuchal translucency test, no MCM was noted.  On 17-Dec-2020, the foetus' mother underwent ultrasoun scan, no MCM was noted.  On 02-Jan-2020, the foetus' mother underwent maternal serum alpha-fetoprotein (MSAFP/serum markers), no MCM was noted.  On 21-Jan-2020, the foetus' mother underwent anatomy ultrasound, no MCM was noted.  At gestational age of 39.4 weeks (as reported), the mother vaginally delivered live birth, male neonate. The neonate's birth weight was 3856 grams, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score was at one minute: 8, at five minutes: 9 and at ten minutes: not reported. No MCM was identified at birth. The delivery was complicated with shoulder dystocia.  At the time of this report, the outcome of the event chorioamnionitis and shoulder dystocia were not reported.  The events of chorioamnionitis and shoulder dystocia were assessed as serious due to criterion of medical significance, per the company.  The reporter did not provide causality assessment to Flucelvax QIVc.  The case is linked to case 202003892 (the corresponding mother case).  Company Comment: A pregnant subject was administered the suspect product Flucelvax QIVc at approximately 9 weeks of gestation. The foetus as well as mother experienced amniotic cavity infection on unspecified date in 2020, unknown amount of time after vaccination. Chronology needs more clarification. The foetus also experienced shoulder dystocia six months after vaccination, as complication during delivery. For the event shoulder dystocia, causality is assessed as not related due to biological implausibility and unsuggestive chronology. Due to lack of information regarding onset date, diagnostic findings and isolated infection agent, causal role of the suspect vaccine is unassessable for amniotic cavity infection. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A pregnant subject was administered the suspect product Flucelvax QIVc at approximately 9 weeks of gestation. The foetus as well as mother experienced amniotic cavity infection on unspecified date in 2020, unknown amount of time after vaccination. Chronology needs more clarification. The foetus also experienced shoulder dystocia six months after vaccination, as complication during delivery. For the event shoulder dystocia, causality is assessed as not related due to biological implausibility and unsuggestive chronology. Due to lack of information regarding onset date, diagnostic findings and isolated infection agent, causal role of the suspect vaccine is unassessable for amniotic cavity infection. Foetal exposure during pregnancy is assessed as not related per company conventions.