Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Gonorrhoea, Labia enlarged, Neisseria test positive, Premature delivery, Rash pustular
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 21 year old female patient with no drug/allergies and unconfirmed lupus which she had in July 2013. The patient presented to the nurse's facility on 29-APR-2014 for sexual transmitted disease (STD) testing and treatment, reporting that she was pregnant. During the patient's physical exam, her blood pressure was 76/53 on two attempts. The patient reported feeling "dizzy and faint" and she was instructed to go to her primary care physician for examination and to consult an obstetrician for management of her pregnancy. On 22-MAY-2014, the patient returned to the facility reporting that she was required to receive VARIVAX (Merck) and Tdap for an employment requirement. On the same date, the patient denied being pregnant, and she received a dose of VARIVAX (Merck), 0.5 ml, subcutaneous in the right arm (lot # was not reported). It was not reported if the patient received Tdap. Concomitant medication included "prenatal vitamins". On 29-MAY-2014, the patient returned to facility reporting that she was pregnant. The patient became pregnant on an unknown date. The last menstrual period (LMP) and expected date of delivery (EDD) were unknown. The patient stated that she was having discomfort in her abdominal region (onset date was not specified, approximately in May 2014). Patient was examined, and the nurse reported that the patient had copious vaginal discharge and multiple macerated lesions in the genital area. The nurse could not determine from the exam if the lesions were vesicular or pustular, due to the amount of discharge that the patient was experiencing. The nurse did not confirm pregnancy during the examination. The outcome of the events was reported as not recovered. The pregnancy outcome was pending. Causality assessment was not reported. Follow up has been received from the registered nurse concerning the 21 year old female patient who non smoker and non drug/alcohol use. The patient had no known drug allergies (NKDA). The patient's obstetrics (OB) history was unknown. The patient stated in July 2013 she had unconfirmed/non documented lupus and took medication daily. On 22-MAY-2014, the patient denied having lupus and taking medication. On 22-MAY-2014 at 15:00, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous in the right arm, lot# J012376, expiry date: 03-OCT-2015. None illness was reported at time of vaccination. The patient was not tested for varicella antibodies before vaccination with Varicella Zoster Virus (VZV) containing vaccine. The patient denied her being pregnant at time of vaccination. On 24-MAY-2014, the patient had pustule filled lesions on and around vaginal area, enlarged labia and green thick vaginal discharge. On 29-MAY-2014 the patient was tested for gonorrhea and the test was positive. The patient was treated for gonorrhea at primary care physician (PCP). The patient stated that she was pregnant on 29-MAY-2014 when she went for STD testing. The last menstrual period (LMP) was on 15-MAY-2014 and expected date of delivery (EDD) was on 19-FEB-2015. No maternity care or records on file as the patient sought prenatal care at another medical clinic. The outcome of the events was unknown. Follow up received on 12-FEB-2015 from the reporting registered nurse for VARIVAX (Merck), a Pregnancy Registry product. It was unknown whether the following tests were performed: pregnancy test, antibodies (ABO) or Rh factor (RH), glucose, toxoplasmosis, Maternal Serum Alpha Fetoprotein (MSAFP), Group B Streptococcus (B-Strep), amniocentesis and ultrasound scan. Pregnancy was reported as single. The patient's LMP was reported as 15-JAN-2014 (previously reported as 15-MAY-2014), the estimated date of conception was reported as 29-JAN-2014 and the EDD as 22-OCT-2014 (previously reported as 19-FEB-2015). It was reported that the patient had a preterm delivery through a cesarean section, during which she had elevated blood pressure and went to the emergency section due to this complication. The pregnancy outcome was live birth - premature. There was no hospitalization due to complications after delivery. The gestational age at pregnancy outcome was 30 weeks from LMP. The patient delivered a female baby, with 2 lbs. and 2 oz. of weight and 15 in of length. Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score and head circumference measures were unknown. The infant was born normal and there were no congenital anomalies. The prenatal care information was limited as the patient was not followed at the facility. The outcome of elevated blood pressure and preterm delivery was unknown. This is one of two reports from the same source (parent-child link MARRS #1502USA005785). Additional information is not expected for this report due to all follow ups requested to complete the case were received.