Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure during pregnancy, Nitrite urine absent, Pre-eclampsia, Premature delivery, Protein urine present
Clinical narrative: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning an 18 year old female patient with no pertinent medical history and no drug reactions/allergies who on 13-OCT-2011, was vaccinated subcutaneously with a dose of VARIVAX (Merck) (Lot # not reported). There was no concomitant medication. The physician reported that during the patient's first obstetrics appointment (OB) on 19-DEC-2011, the patient was determined to be 22 weeks pregnant, which would have made her 10 weeks pregnant at the time of immunization. The patient was vaccinated with VARIVAX (Merck) while in college. A pregnancy test was not performed prior to immunization. There were no adverse events. There was no treatment given. The patient did not seek medical attention. At the time of the report, the patient outcome was unknown. The last menstrual period was on approximately 18-JUL-2011. Estimated delivery date would be 23-APR-2012. Follow up information has been received from Licensed Practical Nurse concerning an 19 year old female patient with acne and a history of 1 previous pregnancy who on 13-OCT-2011, was vaccinated with a dose of VARIVAX (Merck) (Lot # 0814AA during validation process). Concomitant therapy included metronidazole and "PNV-DHA" (prenatal vitamins and docosahexaenoic acid). On an unknown date the patient experienced complications during pregnancy: preeclampsia and gestational hypertension; complications during delivery: several preeclampsia and failed indication to labor and fetal intolerance to labor. On 23-FEB-2012, the patient delivered preterm, in 32 weeks from LMP, live child (gender not reported). (weight 3 lbs 11 oc). The infant was reported to be normal. The patient underwent clinical tests: on 21-FEB-2012 uric acid was of 6.3. On 23-FEB-2012 urine creatinine was 86.3; creatinine clearance was of 154.82; 24 hr urine creatinine was of 1338; estimated glomerular filtration rate was of 128.35; estimated glomerular filtration rate was of 155.56. On 27-FEB-2012 estimated glomerular filtration rate was of 128.33; estimated glomerular rate was of 155.54; uric acid was 8.2, urine 6.0; urine protein, random (dipstick) was of >=300; urine glucose, ketones, bilirubin and nitrite were negative; urine blood was trace-lysed; urine urobilinogen was 0.2 and urine leukocytes was trace. On 28-FEB-2012 the patient underwent ultrasound test. Follow up information has been received from the Licensed Practical Nurse concerning an 19 year old female patient with a history of nephrolithiasis, unassigned family history of cancer, coronary artery disease, skin cancer and stroke syndrome, acne and no known drug allergies, who was vaccinated with a dose of VARIVAX (Merck). On an unknown date the patient experienced severe preeclampsia, failed induction, fetal intolerance to labor and headache. On 29-FEB-2012, the patient underwent lower uterine transverse cesarean section. The patient delivered viable infant, 3 pounds 11 ounces, Apgars of 5 and 9, with no visualized abnormalities. Special care present at delivery. The patient had normal tubes, uterus and ovaries. The patient had not experienced any complications during procedure. On 27-MAR-2012 during postpartum evaluation she was doing well - she also continues to improve with significant decreased in headache, rarely had to take LORTAB for discomfort, better each week, no toxemia signs or symptoms, overall doing well without any complaints. The patient had no systems' symptoms. The patient also underwent medical investigations - systolic was of 120; diastolic 80; BMI 36.44; BSA 1.9. On 28-APR-2012 patient temperature was 98.3; heart rate 68 and respiration 20. The physical examine was within normal limits. Upon internal review, the event of lower uterine transverse cesarean section (because requires an in-patient hospitalization) and several preeclampsia were considered to be other important medical events. The baby's experience was captured in WAES # 1201USA00759B1. No further information is available. All available medical records will be provided upon request.