Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Apgar score low; This is a observational study case initially received from other health professional on 20-Dec-2019, concerning a male neonate whose mother was a 20-year-old female subject, of body weight 140.2 lbs, height 64 in and body mass index (BMI) 24.1, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's mother relevant medical history included migraines, asthma and anaemia.   The subject's mother concomitant medications included: Butalbital and acetaminophen (butalbital, paracetamol) for migraines, ferrous sulfate for anemia, Albuterol (salbutamol) for asthma and Prenatal gummy (unspecified vitamins and minerals) as supplement.   The subject's mother did not have previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM) and paternal history with MCM, but maternal history with MCM included heart murmur of subject's brother. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The paternal age was 20-year-old.  The subject's mother last menstrual period (LMP) date was 02-Feb-2019, estimated date of delivery (EDD) was reported as 09-Nov-2019 and corrected EDD (CEDD) was reported as 04-Nov-2019. The type of pregnancy was singleton.  On 08-Apr-2019, the subject's mother underwent ultrasound scan and no MCM was noted.  On 08-May-2019, the subject's mother underwent ultrasound scan and maternal serum alphafetoprotein (MSAFP)/ serum markers and no MCM was noted.   On 20-Jun-2019, the subject's mother underwent ultrasound and no MCM was noted.   On 27-Sep-2019, at approximately 34 weeks of gestation, the subject's mother was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100118566, dose, expiration date, route of administration, anatomical location: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunization.  On an unknown date in Oct-2019, the subject's mother experienced gastroesophageal reflux disease and was treated with Prilosec OTC (omeprazole) at dose of 20 mg, orally, every day from 07-Oct-2019 to 18-Oct-2019.   On 18-Oct-2019, the subject's mother started therapy with Nexium 24 hour (esomeprazole magnesium) at dose of 20 mg, every day, orally.   On the same day, the subject's mother underwent ultrasound scan and no MCM was noted.   at 38.9 weeks of gestation, the subject's mother delivered vaginally live, male neonate. The neonate's body weight was 3090 grams, head circumference and length were not reported.  The appearance, pulse, grimace, activity, and respiration (APGAR) score one minute: 8, five minutes: 1 (explicitly coded as Apgar score low') and ten minutes: not reported. There was no major congenital malformation identified at birth.   At the time of initial reporting the outcome of 'apgar score low' was not reported.  The causality assessment was not provided.  The case was linked with 201907465 (corresponding mother case).  Company comment: The subject experienced Apgar score low (Apgar score in five minutes: 1) after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 34 weeks of gestation. Chronology is plausible. Reportedly, Apgar score in first minute was 8. There is no evidence for a biological mechanism that could cause the event due to vaccination. Apgar score low and foetal exposure during pregnancy are assessed as not related to the suspect vaccine.; Sender's Comments: The subject experienced Apgar score low (Apgar score in five minutes: 1) after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 34 weeks of gestation. Chronology is plausible. Reportedly, Apgar score in first minute was 8. There is no evidence for a biological mechanism that could cause the event due to vaccination. Apgar score low and foetal exposure during pregnancy are assessed as not related to the suspect vaccine.