Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion induced, Cellulitis staphylococcal, Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via licensee and described the occurrence of induced abortion in a 19-year-old female patient who received MENVEO (batch number 10135, expiry date unknown). The patient's past medical history included vomiting (pregnancy antepartum, associated with pregnancy). Concurrent medical conditions included obesity (BMI 30 to 39.9, not associated with pregnancy), abdominal mass (not associated with pregnancy), tobacco user (not associated with pregnancy) and nausea (pregnancy antepartum, associated with pregnancy). Concomitant products included folic acid, BACTRIM, MOTRIN, Prenatal Vitamin, ZOFRAN ODT and TYLENOL. On 1st May 2012, the patient received MENVEO .5 ml. The patient's last menstrual period was on 2nd April 2012 and estimated date of delivery was 16th February 2013. The patient received MENVEO at week 4 of the pregnancy and during the first trimester of pregnancy. On 30th August 2012, 121 days after receiving MENVEO and 1 day after starting MOTRIN, the patient experienced induced abortion. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the induced abortion and vaccine exposure during pregnancy were unknown. The pregnancy was electively terminated, and a congenital anomaly was present. It was unknown if the reporter considered the induced abortion to be related to MENVEO. Additional details were reported as follows: The patient's last menstrual period was on 2nd April 2012. The patient was enrolled in pregnancy registry for MENVEO. Number of previous pregnancies were 0. There were no relevant family history of birth defects. The patient had no history of alcohol usage. The has history of tobacco and illicit drug use with Marijuana prior to conception and 1st trimester as well. On 1st May 2012, the patient received BACTRIM and SEPTRA DS 800 orally for skin or subcutaneous tissue abscess, MRSA cellulitis. The patient received the MENVEO at doctor's office, at 4 weeks of gestation (1st trimester). On 28th June 2012, the patient received ZOFRAN ODT (dissolve one tablet in mouth every 6 hours as required) 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, 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) and abdominal wall defect in the fetus. It was also reported that, the development of these defects and timing of the drug contact cannot rule out a possible association. The cofounding factors identified for cystic hygroma was tobacco usage and for abdominal wall defect were tobacco usage and illicit drug usage. 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 patient received TYLNEOL 300-30 for pain 1 to 2 every 4 hours as required. Patient also received MOTRIN 400 mg, 1 to 2 every 4 hours as required. On 30th August 2012, the patient had induced abortion at the gestational age of 15 weeks. The gender of the fetus (singleton) was female. The patient's estimated date of delivery was on 16th February 2013. This case was linked to US2017GSK173228 (baby case).