Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 25-Mar-2019, concerning a male neonate patient. The patient's mother was a 23-year-old female of height 65.5 cm and body weight 185 lbs. The patient mother had no previous pregnancies. The patient's mother had no history of offspring with major congenital malformation. Also, the patient's mother had no maternal history with major congenital malformations. The family history of major congenital malformation included sickle cell disease (reported as father of baby's cousin). The patient's mother last menstrual period (LMP) date was 21-Jun-2018. The type of pregnancy was singleton. The pregnancy status of the patient was collected, and her pregnancy complication 'eclampsia' was noted. On 14-Sep-2018, the mother had undergone nuchal ultrasound and no major congenital malformations were noted. The patient had not used tobacco or alcohol or illicit drugs during her current pregnancy. The mother's current conditions included anaemia, high body mass index, asthma, gestational diabetes mellitus and nausea. The mother's concomitant medication included CITRANATAL BLOOM for obstetrician's care (reported as OB care), DICLEGIS and promethazine for nausea and Metformin for gestational diabetes mellitus. On 12-Oct-2018, at the gestational age of 16 weeks, the patient's mother received FLUCELVAX QIVc (batch number: 252226, dose, route of administration, anatomical location, expiry date: not reported) for an unknown indication. The patient was exposed to the vaccine via transplacental route. On the same day (12-Oct-2018), the patient's mother had undergone maternal serum alpha-fetoprotein (MSAFP/ serum markers) and second trimester screen and no major congenital malformations were noted. On 25-Oct-2018, the patient's mother had undergone anatomy ultrasound and no major congenital malformations were noted. On 28-Dec-2018, at her gestational age of 27.1 weeks, the mother was administered a non-company suspect vaccine Tdap (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) as vaccination. On 18-Feb-2019, 4 month and 6 days after vaccination, the patient's mother experienced pre-eclampsia. 4 months and 10 days after vaccination with FLUCELVAX QIVc, the patient's mother gave live birth to a male neonate vaginally of body weight 2920 grams at gestational age of 35.1 weeks (reported as pre-term delivery), body length 53.3 cm and head circumference 30.5 cm. The APGAR (appearance, pulse, grimace, activity, and respiration) scores were 8 (one minute) and 9 (five minutes). No major congenital malformations (MCMs) were identified at birth. The mother's estimated delivery date (EDD) was reported as 28-Mar-2019. This case is linked to 201902081 (mother-baby case). Reporter's Comments: A male neonate patient was delivered prematurely (35.1 week of gestation), 4 months 10 days after maternal receipt of FLUCELVAX QIVc at 16 weeks of gestation (considered as foetal exposure during pregnancy). The maternal medical conditions (BMI 30 plus, anaemia, gestational diabetes mellitus, pre-eclampsia and eclampsia) provide more plausible explanation for the event premature baby rather than suspect vaccine. Hence, causality assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The Tdap vaccine is considered as co-suspect. The company assessed the case as serious (medically significant).