Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Neonatal aspiration, Perineal laceration, Suture insertion, Ultrasound antenatal screen normal, Urethral disorder
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with drug reaction/allergy to VAGISTAT, who on 07-OCT-2009 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 664355/0655Y), because the patient was an IVF (in vitro fertilization) candidate and had negative titer. The patient was discovered to be pregnant on a serum pregnancy test on 21-OCT-2009 (LMP: 06-OCT-2009). At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information was received from a physician who reported that on 16-MAR-2009 the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck), which was negative. In follow-up information the physician reported that the patient had not history of previous pregnancies; concomitant therapy included prenatal vitamins. On 11-MAR-2009 (also reported as 16-MAR-2009) the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck), which was negative. On 21-OCT-2009 an ultrasound was performed and showed viable IVP 5 weeks and 54 days. There were local reactions at vaccination site, no varicella (chickenpox) symptoms post-vaccination and there were not herpes (zoster) symptoms post-vaccination. On 21-JUN-2010 the patient delivered a healthy female baby weighing 8 pounds 7 ounces. There were not congenital anomalies, no complications during the pregnancy, the patient experienced meconium during the labor/delivery. There were no diagnostic test during the pregnancy. There were not infections or illness during pregnancy, and not concurrent medical conditions. Follow up information has been received from a physician and an obstetrics registered nurse via medical records who indicated that the patient was a 29 year old female gravida 1 who presented to labor and delivery on 21-JUN-2010, with complaints of regular uterine contractions since 14:00 on 20-JUN-2010. The patient had 40 weeks and 3 days. The patient was examined in triage and noted to be contracting regularly with cervix of about 3 cm dilated. She was admitted at 02:20. The patient requested epidural anesthesia and received it at 03:21. The patient was 15 cm at the time. Her contractions spaced over time and PITOCIN was added at 06:30. The patient's first stage of labor progressed without incident and she had artificial rupture of membranes at 08:30 for clear fluid. At 10:14, the patient complained of rectal pressure, was examined and rated to be completely dilated and completely effaced with the vortex at +2. Thick particulate meconium was noted at that point. Subsequently, the patient entered her second stage and at approximately 11:28, the patient had a normal spontaneous vaginal delivery of a female infant weighing 8 pounds 7 ounces. APGAR score was pending at the time of dictation but the initial APGAR was quoted as 8. The placenta followed spontaneously and complete at 11:32. Inspection of perineum, vagina and cervix revealed a midline second-degree perineal laceration, a right labial laceration of second degree and a left periurethral laceration of the second-degree. Because of the brisk bleeding, the right labial laceration was repaired in routine fashion with a 3-0 vicryl suture. Then the left periurethral laceration was repaired with a 4-0 chromic in routine fashion. Then the perineal laceration was repaired in routine fashion using a 2-0 and 3-0 vicryl suture. Estimated blood loss was 350 cc. Good hemostasis was contained. A vaginal sweep was performed and an empty uterus was noted. Approximately 100 cc of clot was evacuated from the lower uterine segment and the fundus was firm. Sponge and needle counts were correct x2. The patient entered to recovery without incident. The pediatric team was called because of the patient's baby particulate meconium aspiration, the baby was hospitalized for 4 days due to meconium aspiration, (WAES # 0910USA02803B1). On 24-JUN-2010, the patient was discharged from the hospital with prescription of LOESTRIN 1 tablet oral daily, phenergan via rectrum TID PRN, ZOFRAN BID PRN for nausea. The patient was immunized with influenza virus split virion 3v vaccine inactivated (manufacturer unspecified) and intranasal H1N1. On 28-JUL-2010, the patient had her last menstrual period prior to the visit performed on 02-AUG-2010, when the patient was seen for a post-partum care and examination and a surveillance of the previously prescribed contraceptive pill. The patient's blood pressure was 100/70 mmHg, her weight was 177 lb 8 oz, and height 5 feet 8 inches. The patient's physical and gynecological exams were within normal limits. The exam was considered as normal postpartum exam. No problems were reported for the patient's baby. The patient would return to the reporting hospital on 02-DEC-2010. Additional informatino has been requested by RN.