Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Alpha 1 foetoprotein normal, Gestational diabetes, Human chorionic gonadotropin normal, Inhibin B, Maternal exposure during pregnancy
Clinical narrative: This is a retrospective pregnancy case. This 17-year-old female subject was enrolled in an open label study. The subject received MENVEO .5 ml on 23rd March 2012. Concurrent medical conditions included sebaceous cyst (not associated with pregnancy). Concomitant products included folic acid, FLUARIX, Flu Seasonal TIV Dresden, Prenatal Vitamins, GARDASIL, ZOFRAN ODT, BENADRYL and SUBLIMAZE. The subject's last menstrual period was on 13th February 2012 and estimated date of delivery was 19th November 2012. The subject received MENVEO at week 5 of the pregnancy and during the first trimester of pregnancy. On 13th September 2012, 174 days after receiving MENVEO, the subject developed gestational diabetes mellitus. Serious criteria included GSK medically significant. Additional event(s) included live birth and vaccine exposure during pregnancy. The outcome of gestational diabetes mellitus was unknown. The outcome(s) of the additional event(s) included live birth (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy resulted in a live neonate with a congenital anomaly. The neonate weighed 3260 grams (7lbs 3oz) at birth. It was unknown if the investigator considered the gestational diabetes mellitus to be related to MENVEO. Relevant Tests: On 4th June 2012, unconjugated estriol test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound (at less than 14 weeks of gestation) showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. Diagnostic results (unless otherwise stated, normal values were not provided): On 4th June 2012, Alpha 1 foetoprotein result was No congenital abnormality unknown, Human chorionic gonadotropin result was No congenital abnormality unknown and Inhibin B result was No congenital abnormality unknown. On 28th June 2012, Ultrasound abdomen result was see text unknown. See case US2017GSK173180 for details regarding the baby case. Additional details were provided as follows: The relevant family history of birth defects was none. The patient had not been exposed to tobacco, alcohol, and illicit drug use. The age at vaccination was not reported but the patient could be 16 or 17 years old. On 23rd March 2012, the patient received a dose of MENVEO (batch number 10135). On 4th June 2012, alpha 1 foetoprotein, human chorionic gonadotropin, unconjugated estriol and inhibin B test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. A singleton male live infant was born at gestational age of 40 weeks. The pregnancy resulted in a birth defect. The birth defect was shortened frenulum of tongue not noted prior to birth. The patient delivered a baby boy weighing 3.26 kg after 243 days of receiving MENVEO. The pregnancy did not result in fetal loss. The temporal relationship with the development of this defect and the timing of the exposure to vaccine could not be ruled out for a possible association. The reporter considered the gestational diabetes mellitus to be associated with pregnancy.