Sex: F
Vaccine: MNQ
Symptoms: Abdominal wall disorder, Cardiac malposition, Cystic lymphangioma, Exomphalos, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via licensee and described the occurrence of cystic hygroma in a female neonate exposed to MENVEO (batch number 10135, expiry date unknown) in utero. The mother received the product. The parent's medical history included abdominal mass (not associated with pregnancy), nausea (pregnancy antepartum, associated with pregnancy), obesity (BMI 30 to 39.9, not associated with pregnancy), tobacco user (not associated with pregnancy) and vomiting (pregnancy antepartum, associated with pregnancy). On an unknown date, the 19-year-old mother received MENVEO. The mother's last menstrual period was on 2nd April 2012 and estimated date of delivery was 16th February 2013. The neonate was exposed to MENVEO at week 4 of gestation and during the first trimester of pregnancy. The neonate was diagnosed with omphalocele (serious criteria GSK medically significant and congenital anomaly), cardiac malposition (serious criteria GSK medically significant and congenital anomaly) and spinal disorder (serious criteria congenital anomaly). On 16th August 2012, the neonate experienced cystic hygroma (serious criteria GSK medically significant and congenital anomaly) and abdominal wall disorder (serious criteria congenital anomaly). On an unknown date, the neonate experienced fetal exposure during pregnancy. On an unknown date, the outcome of the cystic hygroma, abdominal wall disorder, omphalocele, cardiac malposition, spinal disorder and fetal exposure during pregnancy were unknown. The reporter considered the cystic hygroma, abdominal wall disorder and omphalocele to be possibly related to MENVEO. It was unknown if the reporter considered the cardiac malposition and spinal disorder to be related to MENVEO. See case US2017GSK175422 for details regarding the mother case. Additional details were reported as follows: The age at vaccination was not applicable for this report. The mother was enrolled in protocol pregnancy registry for MENVEO. The date of 1st contact was 21st August 2017. Number of previous pregnancies for mother was 0. There were no relevant family history of birth defects. The mother had no history of alcohol usage. The mother had history of tobacco and illicit drug use with Marijuana prior to conception and 1st trimester as well. The mother received Folic acid and prenatal vitamin orally for supplement. The mother's concurrent conditions included obesity (BMI: 30 to 39.9) and abdominal mass prior to conception. On 1st May 2012, the mother received BACTRIM and SEPTRA DS 800 orally for skin or subcutaneous tissue abscess, MRSA cellulitis. The mother received MENVEO 0.5 mL at doctor's office, at 4 weeks gestational age. On 28th June 2012, the mother received ZOFRAN ODT for nausea and vomiting of pregnancy antepartum. On 10th August 2012, an ultrasound abdominal of Gravid Uterus at less than 14 weeks of fetus was performed which revealed probable omphalocele displaced heart, splayed L-spine, probable hygroma. On 16th August 2012, for mother, chorionic villus sampling was performed. An ultrasound revealed cystic hygroma (large anterior wall defect was noted that appeared to include the chest wall resulting in the heart and liver being external to the body cavity) with tobacco as cofounding factors for cystic hygroma and tobacco, illicit drug usage as cofounding factors for abdominal wall defect. It was also reported that, the development of these defects and timing of the drug contact cannot rule out a possible association. On 28th August 2012, normal II chorionic villus sampling (growth scan cystic hygroma) was performed with body wall complex defect. On 29th August 2012, the mother received TYLENOL 300-30 for pain 1 to 2 every 4 hours as required. The mother also received MOTRIN 400mg, 1 to 2 every 4 hours as required. On 30th August 2017, the mother had induced abortion at the gestational age of 15. The gender of the fetus (singleton) was female. The mother's estimated delivery date was on 16th February 2013. This case was linked to case US2017GSK175422 (mother case).