Sex: F
Vaccine: FLUX
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; APGAR score 4 at one minute; This observational study case, initially received on 22-Jan-2021 from other health professional, concerning female neonate, whose mother was 33-year-old pregnant, female subject of body weight 227 lbs, height 70 inches and body mass index (BMI) 32.6,  enrolled in, a prospective observational safety study.  The neonate's mother's concurrent conditions included increased BMI, allergy to Darvocet N (dextropropoxyphene napsilate, paracetamol), anxiety, morning sickness and depression. The subject was rhesus (Rh) negative.  The neonate's mother's past medical condition included urinary tract infection. The neonate's mother's concomitant medications included omeprazole, Zofran (ondansetron), metoclopramide HCL (metoclopramide hydrochloride), all used for morning sickness, duloxetine and clonazepam used for anxiety and depression, and Rhophylac (anti-d immunoglobulin) used for Rh negative. The neonate's mother's past medications included Keflex (cefalexin monohydrate) used for urinary tract infection, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) used for morning sickness and Prenatal (unspecified vitamins and minerals) plus docosahexaenoic acid (DHA) used for pregnancy.  The neonate's mother's obstetrical history included no previous pregnancies. The neonate's mother had no history of offspring with major congenital malformation (MCM). Also, the neonate's mother had no maternal or paternal history with MCM. The neonate's mother did not use tobacco or alcohol during pregnancy, but she used marijuana vape during pregnancy at unknown amount.  The neonate's mother's last menstrual period (LMP) date was reported as 04-Apr-2020. The neonate's mother's estimated delivery date (EDD) was reported as 09-Jan-2021 and corrected estimated date of delivery (CEDD) was reported as 22-Jan-2021. The type of pregnancy was singleton. The neonate's father was 34 years old.  On 15-Jun-2020 and 23-Jun-2020, the ultrasound revealed no MCM.  On 06-Jul-2020, the counsyl fundamental panel with fragile X (three conditions) and counsyl chromosomes 13, 18, 21 + sex chromosome analysis revealed no MCM.  On 17-Aug-2020, the maternal serum alpha fetoprotein screening (MSAFP/serum markers) revealed no MCM.   On 08-Sep-2020, at approximately 22 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100230203.  On the same day, 05-Oct-2020 and 02-Nov-2020, the ultrasound scans revealed no MCM.   At 38.6 weeks of gestation (as reported), the mother delivered a live birth female neonate, by vaginal method of delivery. The neonate's birth weight was 2900 grams, head circumference 33.0 cm, length 49.5 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 4 at one minute, 8 at five minutes and not reported for ten minutes. There was no MCM identified at birth. No pregnancy complications were noted on delivery.  On the same day, the neonate recovered from event 'apgar score low'.  The reporter did not provide a causality assessment.   The event of 'apgar score low' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The case is linked to the case 202006389 (the corresponding mother case).  Company comment: A neonate's mother was vaccinated with Afluria QIV at approximately 22 weeks of gestation. At 38.6 weeks of gestation (four months after vaccination), the mother delivered a live birth female neonate, by vaginal method of delivery. Apgar scores were 4 at one minute, 8 at five minutes and not reported for ten minutes. There was no MCM identified at birth. Apgar score low is assessed as not related due to biological and chronologic implausibility. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A neonate's mother was vaccinated with Afluria QIV at approximately 22 weeks of gestation. At 38.6 weeks of gestation (four months after vaccination), the mother delivered a live birth female neonate, by vaginal method of delivery. Apgar scores were 4 at one minute, 8 at five minutes and not reported for ten minutes. There was no MCM identified at birth. Apgar score low is assessed as not related due to biological and chronologic implausibility. Foetal exposure during pregnancy assessed as not related per company's conventions.