Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Perineal laceration
Clinical narrative: Information has been received from a Registered Nurse (R.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 23 year old female patient who was vaccinated with the first and second dose of VARIVAX (Merck) (doses, route and lot#s not reported), on 02-MAR-2011 and 07-APR-2011, respectively. Secondary suspect included MMR II (doses, routes and lot#s not reported), the first and second on 12-MAR-2010 and the second dose on 07-APR-2011. The nurse reported the patient received her second doses of VARIVAX (Merck) and MMR on 07-APR-2011 and was subsequently found to be pregnant. The nurse did not know the patient's gestation or the date of the patient's last menstrual period. The nurse stated the patient's the estimated delivery date was 01-DEC-2011. No adverse symptoms reported. There was no treatment given for AE. The patient came to the office to seek medical attention. Follow up information has been received from a physician via medical record with who reported that the 25 year old married patient with no allergies and no pertinent medical history and risks reported weight of 53 Kg "patient was not sure about weight said she was 53 kilos she did not think lost any weight" and risk of obesity (>/= 35 BMI) Stage II- First trimester 1 hr GTT w rpt at 26-28 weeks, kick counts starting at 36 weeks and growth U/S at approximately 36-37 weeks". Concomitant therapy included: famotidine (MSD) The patient had no previous pregnancies. The patient experienced a third degree perineal laceration. On 28-APR-20111, blood pressure measurement: 96 Systolic, 60 Diastolic. On 13-MAY-2012 the following test examinations were performed: body weight measurement:116, diagnostic laboratory test (HEENT): Normal, Lean Tissue Mass (LTM) occluded, L side occluded, physical examination: Teeth: Normal, diagnostic laboratory tests:Skin: Normal Vulva: Normal no lesions, Breasts: No masses or discharge, Normal skin/nipples Heart: (RRR) no murmur, gynecological examination, Vagina: Mucosa, normal discharge Adnexa: Normal, Preceptor initials (LMH), Resident initials: (AA), Uterus size: Consistent with dates: Abdomen: + BS, soft, NT/ND, Lungs: Clear to auscultation bilateral, Thyroid: Normal size on Masses, Lymph Nodes: No Leukocyte Adhesion Deficiency (LAD), physical examination Extremities: No edema, Normal/=Pulses and body weight measurement previous pregnancy: patient was not sure about weight said she was 53 kilos and blood pressure measurement: 98 Systolic, 66 Diastolic. On 09-JUN-2011, blood pressure measurement: 100 Systolic, 40 Diastolic. On 13-JUL-2011, blood pressure measurement: 90 Systolic, 60 Diastolic. On 11-AUG-2011, blood pressure measurement: 88 Systolic, 50 Diastolic. On 30-AUG-2011, blood pressure measurement: 90 Systolic, 50 Diastolic. On 20-SEP-2011, blood pressure measurement: 110 Systolic, 60 Diastolic. On 05-OCT-2011, blood pressure measurement: 98 Systolic, 50 Diastolic. It was reported that on 04-DEC-2011, the patient delivered a male baby by normal spontaneous vaginal delivery with no neonatal resuscitation needed who weighted 6 lbs 4 oz, length 20 inches, Apgar score 8, 9 and experienced a congenital defects (WAES # 1107USA01431B1). At the time of reporting, the patient's outcome from third degree perineal laceration was unknown. Additional information has been requested.