Sex: F
Vaccine: FLUX
Symptoms: Face presentation, Foetal exposure during pregnancy
Clinical narrative: Face up delivery; Vaccine foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-Aug-2020, concerning a female foetus, whose mother was 19-year-old, pregnant, female subject of body weight: 131 lbs, height: 64 inches and body mass index (BMI): 22.5 enrolled in a prospective observational safety study.  The foetus' mother's current medical conditions included unspecified allergies and anemia.  The foetus' mother's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) for pregnancy, iron for anemia and Zyrtec (cetirizine hydrochloride) for allergies.  The foetus' mother's obstetrical history included no previous pregnancies. The foetus' mother had no maternal or paternal history with major congenital malformation (MCM). The foetus' mother had no history of offspring with MCMs.  The foetus' mother did not consume tobacco, alcohol and illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) date was 19-Jan-2019, estimated date of delivery (EDD) was reported as 26-Oct-2019 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 22-Jul-2019, the foetus' mother underwent one-hour glucose tolerance test, but results were not provided and no MCM was noted.  On 25-Sep-2019, the foetus' mother underwent group B streptococcus (group B strep) test, but results were not provided and no MCM was noted.  On 09-Oct-2019, at gestational age of 37 weeks (calculated per LMP), the foetus' mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization.  At 39.4 weeks of gestation (as reported), the subject gave a live birth to a female neonate via vaginal method of delivery. The delivery complication included face up delivery. The neonate's birth weight was 3374 grams, body length was 54.6 cm, while head circumference was not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores at one, five and ten minutes were not reported. There was no MCM identified at birth.    The outcome of the event of face presentation' was resolved on the same day.  On 11-Aug-2020, the subject completed the study and the registry was closed.   The event of face presentation' was considered serious due to the criterion of medical significance, per company.   The reporter did not provide the causality assessment to Afluria QIV.  This case is linked to case 202004096 (the corresponding mother's case).  Company comment: Face up delivery was reported in pregnant subject vaccinated with Afluria QIV. The subject gave a live birth to a female neonate via vaginal method of delivery. Face presentations account for less than 1% of presentations at term. Causative factors associated with a face presentation are similar to those leading to general malpresentation. For the event Face presentation, causal role of the suspect vaccine is assessed as not related due to biological implausibility. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Face up delivery was reported in pregnant subject vaccinated with Afluria QIV. The subject gave a live birth to a female neonate via vaginal method of delivery. Face presentations account for less than 1% of presentations at term. Causative factors associated with a face presentation are similar to those leading to general malpresentation. For the event Face presentation, causal role of the suspect vaccine is assessed as not related due to biological implausibility. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.