Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Complication of delivery, Delivery, Exposure during pregnancy, Face presentation, Streptococcus test negative
Clinical narrative: Face up delivery; Vaccine exposure during pregnancy; This is an observational  study case from, initially received from other health professional on 11-Aug-2020, concerning a 19-year-old, female, pregnant subject of body weight: 131 lbs, height: 64 inches and body mass index (BMI): 22.5, enrolled in, a prospective observational study.  The subject's current medical conditions included anemia and unspecified allergies.   The subject's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) for pregnancy, iron for anemia and Zyrtec (cetirizine hydrochloride) for allergies.   The subject's obstetrical history included no previous pregnancies. The subject had no history of offspring with major congenital malformations (MCMs). Also, the subject had no maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 19-Jan-2019. The estimated delivery date (EDD) was reported as 26-Oct-2019, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 22-Jul-2019, the subject underwent one hour glucose tolerance test, but results were not provided and no MCM was noted.   On 25-Sep-2019, the subject 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 subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On 22-Oct-2019, 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.   On the same day, the subject recovered from the event of complication of delivery'.   On 11-Aug-2020, the subject completed the study and the registry was closed.   The event of complication of delivery' was assessed as serious, due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Afluria QIV.  This case is linked to 202004097 (the corresponding baby case).  Company comment: Face up delivery (coded as Complication of 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. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Face up delivery (coded as Complication of 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. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.