Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal growth restriction, Neonatal gastrointestinal disorder, Splenic calcification
Clinical narrative: Fetal spleen calcifications; Intrauterine growth restriction; Echogenic bowel; Hyperechoic areas splenic capsule / stable echogenic areas at the spleen; Foetal exposure during pregnancy; This is spontaneous case, initially received from other health professional on 20-Feb-2020, concerning a neonate male patient.  The patient's mother medical history included high risk pregnancy.  The patient's mother's concomitant medications included Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Prometrium (progesterone) for high risk pregnancy.  The patient's mother's obstetrical history noted that the mother had six previous pregnancies with two full term live births and four spontaneous abortions. The patient's mother had no history of offspring with major congenital malformation (MCM). The patient's mother had no relevant maternal and paternal medical history. The patient's mother did not use tobacco, illicit drug or alcohol during pregnancy.  The patient's mother's last menstrual period (LMP) date was 19-Jun-2018, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 26-Mar-2019. The type of pregnancy was singleton.   On 07-Aug-2018, the patient's mother underwent initial ultrasound and no MCM was noted.  On 13-Sep-2018, at gestational age of 12 weeks, the patient's mother was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 252226; dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an unknown indication.   On 31-Oct-2018, the patient's mother underwent quad screen and no MCM was noted. Additionally, the mother underwent ultrasound scan and echogenic bowel was noted.  On 03-Dec-2018, the patient's mother underwent ultrasound scan and hyperechoic areas splenic capsule were noted.  On 29-Jan-2019, the patient's mother underwent ultrasound scan and stable echogenic areas at the spleen were noted.  At gestational age of 39.1 weeks, the patient's mother vaginally delivered live male neonate. The neonate's birth weight was 2693 g. No data was reported for head circumference and length. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). No data was reported for APGAR score at ten minutes. Pregnancy complication noted during pregnancy was intrauterine growth restriction (IUGR). MCM identified on birth was foetal spleen calcification.  At the time of initial reporting, the outcome of all events was not reported.  The event of 'foetal spleen calcification' was assessed as serious due criteria of congenital anomaly, while the events of 'foetal growth restriction', 'foetal gastrointestinal tract imaging abnormal' and 'spleen scan abnormal' were assessed as serious due to criteria of medically significance, per company.  The reporter did not provide causality assessment.  This case is linked to case 202001888, the corresponding mother case.  Company comment: A male neonate experienced splenic calcification, foetal growth restriction, foetal gastrointestinal tract imaging abnormal and spleen scan abnormal after maternal receipt of Flucelvax QIV vaccine at approximately 12 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible.  Mother's medical history of four spontaneous abortions and high-risk pregnancy may provide alternative aetiology for the events. Causality is also confounded with non-company vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events splenic calcification, foetal growth restriction, foetal gastrointestinal tract imaging abnormal and spleen scan abnormal is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: A male neonate experienced splenic calcification, foetal growth restriction, foetal gastrointestinal tract imaging abnormal and spleen scan abnormal after maternal receipt of Flucelvax QIV vaccine at approximately 12 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible.  Mother's medical history of four spontaneous abortions and high-risk pregnancy may provide alternative aetiology for the events. Causality is also confounded with non-company vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events splenic calcification, foetal growth restriction, foetal gastrointestinal tract imaging abnormal and spleen scan abnormal is assessed as unlikely related (defaults to related for reporting purposes).