Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Shoulder dystocia
Clinical narrative: Foetal exposure during pregnancy; Shoulder dystocia labor complication; This is an observational study case, initially received from other health professional on 10-Dec-2019, concerning a neonate, female subject, whose mother was a 31-year-old female, of body weight 133 lbs, height 66 inches and body mass index (BMI) 21.5, 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 father was 32-year-old.  The mother's medical history included hypothyroidism. Concomitant medications included Prenatal (unspecified vitamins and minerals), magnesium citrate and Synthroid (levothyroxine sodium) for hypothyroidism.   The mother's obstetrical history included three previous pregnancies: two spontaneous abortions and one full term live birth. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 18-Feb-2019 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother were reported as 25-Nov-2020.  On 15-Apr-2019 and 03-Jul-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 18-Sep-2019, at approximately 30 weeks of gestation, the mother was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100118562, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.  On 04-Oct-2019 and 01-Nov-2019, the subject's mother underwent ultrasound scan and no MCM was noted.  At gestational age of 40.1 weeks, the mother vaginally delivered live female neonate. The characteristics of neonate included birth weight: 4270 grams, head circumference: 35 cm and length: 55.9 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 7 and at five minutes was 9. APGAR score at 10 minutes was not reported. The neonate experienced labour complication - shoulder dystocia.   At the time of initial reporting, the outcome of the event was not reported.  Per company, the event of shoulder dystocia was considered serious due to the criterion of medical significance.   The reporter did not provide causality assessment to Afluria QIV.  This case is linked to the case 201907228 (the corresponding mother case).  The female neonate subject experienced shoulder dystocia (labour complication) after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 30 weeks of gestation. Chronology is plausible. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the shoulder dystocia is assessed as not related due to biological implausibility.; Sender's Comments: The female neonate subject experienced shoulder dystocia (labour complication) after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 30 weeks of gestation. Chronology is plausible. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the shoulder dystocia is assessed as not related due to biological implausibility.