Sex: M
Vaccine: FLU4
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Apgar score at one minute was 4 and at 5 minutes was 6; Fetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 18-Jun-2019, concerning a male neonate patient.  The patient's mother was a 40-year-old adult female with weight 153.2 pounds, height 63 inches and body mass index (BMI) 27.1.  The patient's mother had 2 previous pregnancies in which one was pre-term live birth and the other was a spontaneous abortion. No birth defects were noted in the previous pregnancies. The subject had no history of offspring with major congenital malformations. Also, the subject had no maternal or paternal history with major congenital malformations. The current conditions of the patient's mother included depression, anxiety, post-traumatic stress disorder, genital herpes simplex, anemia and acid reflux. The concomitant medications included Prenatal Vitamins (minerals nos;vitamins nos), ferrous sulfate, pantoprazole, hydoxyprogesterone caproate (17p), iron and sertraline.  The last menstrual period (LMP) date of the patient's mother was 13-Sep-2018. The type of pregnancy was singleton. The patient's mother had not used tobacco, alcohol or illicit drugs during current pregnancy. On an unknown date, pregnancy status was collected and there was no pregnancy complication noted.  At approximately 12 weeks in gestation, on 10-Dec-2018, the patient's mother received Afluria Quadrivalent [influenza vaccine, batch number: YF42609, expiry date, dose, anatomical location and route of administration: not reported] for an unknown indication and the fetus was exposed to Afluria Quadrivalent via transplacental route (explicitly coded as fetal exposure during pregnancy).  On 31-Oct-2019, patient's mother underwent ultrasound scan and there was no major congenital malformation identified.  On 06-Dec-2018, patient's mother underwent informaseq test and there was no major congenital malformation identified.  On 07-Jan-2019, patient's mother underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and there was no major congenital malformation identified.  On 04-Mar-2019, patient's mother underwent fetal echo and there was no major congenital malformation identified.  5 months and 20 days after vaccination, the patient's mother gave live birth to a male neonate at 37 weeks of gestation by caesarean method. The neonate (patient) weighed 3175 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 minute was 4, at 5 minutes was 6 (explicitly coded as Apgar score low) and at 10 minutes was 8. There were no pregnancy complications noted. There was no major congenital malformation identified at birth.  The outcome of the event Apgar score low was recovered.  The mother's corrected estimated date of delivery (CEDD) was reported as 20-Jun-2019 and estimated date of delivery (EDD) was reported as 21-Jun-2019.  This case is linked to 201903637 (the corresponding mother case).; Reporter's Comments: A male neonate had low APGAR score at one minute and five minutes after birth. The foetus had exposure to Afluria QUAD vaccine at 12 weeks of gestation. Considering the risk factors of progressed maternal age (40 Years), prior maternal history of preterm birth and spontaneous abortion, the causal role of suspect vaccine seems not related. Also, there are no known biological mechanism to explain causal role of suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).