Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: This is a spontaneous case, initially received from other health professional on 14-May-2019, concerning a female neonate patient. The patient's family history included Down syndrome (father of baby-maternal uncle with Down syndrome). The patient's mother was a 34-year-old who had 2 previous pregnancies reported with one previous spontaneous abortion and one previous full-term live birth. The patient's maternal history included no congenital malformation and paternal history included Down syndrome. The current condition of patient's mother included hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus. The concomitant medication of the patient's mother included sertraline for hypertension, RHOPHYLAC (anti-D immunoglobulin) for Rh-negative, HUMULIN for diabetes mellitus and metformin for chronic hypertension. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 20-Aug-2018. On 06-Nov-2018, the patient's mother had undergone ultrasound scan and no major congenital malformations were noted. On 09-Nov-2018, at the gestational age of 11 weeks, the patient's mother received FLUCELVAX QIVc [route of administration: transplacental, batch number: 252226, dose, frequency, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route for an unknown indication. On 16-Nov-2018, the patient's mother had undergone prenatal test (first trimester screening) and no major congenital malformations were noted. On 12-Dec-2018, the patient's mother had had undergone prenatal test (second trimester screening) and no major congenital malformations were noted. On the same day, the patient's mother underwent Maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum markers test and no major congenital malformations were noted. On 09-Jan-2019, the patient's mother underwent prenatal test (anatomy ultrasound) and no major congenital malformations were noted. The patient's mother gave a live birth to a female neonate at the gestational age of 37.1 weeks via vaginal method of delivery. The characteristics of the neonate included birth weight: 2806 grams, head circumference, length and appearance, pulse, grimace, activity, and respiration (APGAR) scores were not provided. No major congenital malformations (MCMs) were identified at birth. Six months after vaccination, the neonate died (reported as deceased). The mother's estimated delivery date (EDD) was reported as 27-May-2019. The reporter assessed the case as serious (death). This case (201903453) is linked to 201903452 (mother case). Reporter's Comments: A female neonate patient died (2 days post delivery), 6 months after maternal receipt of FLUCELVAX vaccine at 11 weeks of gestational age (considered as foetal exposure during pregnancy). The autopsy result is awaited. Considering the time frame of event, lack of detection of congenital anomalies in prenatal tests and post delivery, the event death assessed as not related to suspect vaccine. The maternal concurrent medical conditions hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus and concomitant medications are considered as risk factors. The case will be further assessed upon receipt of follow up information. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. Reported Cause(s) of Death: Unknown cause of death.