Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Haemorrhage, Haemorrhage urinary tract, Headache, Hypoglycaemia, Hypokalaemia
Clinical narrative: Information has been received from a licensed practical nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on approximately 16-SEP-2010 "about 1 week ago," was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported).  Concomitant therapy included MENACTRA.  The vaccination with VARIVAX (Merck) occurred at a mass vaccination program at her school.  A urine pregnancy test was performed at physician's office, the result was positive.  At the time of the report, the pregnancy was normal.  Date of Last Menstrual Period (LMP): 19-JUN-2010.  Estimated Date of Delivery (EDD): 26-MAR-2011.  The patient sought medical attention.  Follow-up information was received from a physician who reported that the 17 year old female patient with no history of previous pregnancies, on approximately 16-SEP-2010, was vaccinated by a health nurse with a dose of VARIVAX (Merck) (Lot# not reported).  Concomitant vaccination included MENACTRA.  The physician reported that the patient was not tested for varicella antibodies before vaccination.  The patient's last menstrual period was on 19-JUN-2010 and her estimated delivery date on 26-MAR-2011.  On 29-SEP-2010, the patient had an ultrasound because of the given vaccines, and the results were normal.  The physician reported that the patient did not experience any local reaction at vaccination site and did not have varicella or herpes zoster symptoms post vaccination.  Follow-up information was received from medical records concerning the 17 year old G1P0 female non-smoker, non-drinker, negative family history of birth defects, with eczema and a history of premenstrual dysphoric disorder and left wrist fracture (2000).  On 25-SEP-2010, the patient was seen with amenorrhea and several positive home pregnancy tests.  She had been immunized at school with VARIVAX and MENACTRA.  Assessment: pregnancy confirmed, vaccination complication.  On 29-SEP-2010, an ultrasound revealed a single intrauterine pregnancy with estimated gestational age of 12 weeks 3 days plus/minus 1 week for an estimated date of confinement of 10-APR-2011.  The pregnancy was complicated by early 1st trimester inadvertent vaccination with VARIVAX (Merck) and MENACTRA.  It was noted the patient had recently developed gestational diabetes mellitus, diet controlled.  The pregnancy had been significant by being Rhesus negative.  Medications included CROMOLYN opthalmic solution and prenatal vitamins.  On 05-NOV-2010, the patient was noted to be experiencing headaches and was taking TYLENOL which was reported to have helped.  On 22-NOV-2010, an ultrasound revealed a single fetus in breech presentation.  No fetal abnormalities were identified, and a good fetal heart motion was observed with real-time and documented to be 147 beats per minute with Doppler.  No evidence of hydronephrosis was seen.  The gestational age was reported as being approximately 21 weeks 1 day with an estimated date of delivery of 03-APR-2011.  On 29-NOV-2010, it was noted the patient was having occasional aches and pains for which she took APAP.  On 05-DEC-2010, the patient was diagnosed with a urinary tract infection after noticing blood-tinged fluid upon wiping at school.  It was reported that she passed a blood clot and had been cramping.  On 19-JAN-2011, patient was found to have mild anemia with hemoglobin of 10.7.  On 20-JAN-2011, the patient was seen for initial visit for gestational diabetes-insulin.  Her blood glucose was measured at 238 after glucola.  It was noted (20-JAN-2011) that the patient experienced heartburn for which she took TUMS.  On 27-JAN-2011, pt developed an upper respiratory illness.  On 30-JAN-2011 at 2300 hours, the patient developed some contractions.  She was admitted to the hospital on 31-JAN-2011 with pre-term labor at 31.5 weeks.  On initial laboratory assessment, the patient had hypokalemia (2.9).  She was given terbutaline subcutaneously with some improvement in contraction frequency, but they did not resolve completely and the patient was given PROCARDIA 10 mg PO.  It was suggested that treatment proceed with IV magnesium and try to resolve the contractions.  It was also reported the patient was to start with betamethasone prior to delivery.  Ampicillin was added for possible pre-term labor.  Magnesium was watched closely for any toxicity by monitoring intake and output and frequent toxicity checks.  Patient's A1C was measured at 5.0 on 01-FEB-2011.  A limited pregnancy ultrasound on 02-FEB-2011 showed menstrual age at 30 weeks 1 day and an estimated delivery date of 12-APR-2011; the head was very low in the pelvis and unable to be measured, limiting the reliability of the menstrual age.  On 03-FEB-2011, the patient delivered vaginally a 3.42 lb, 41 cm male.  Apgars: 8, 9.  The baby was admitted to the NICU for observation based on indications of prematurity and respiratory distress.  Assessment: gestational age 30 + 4 wks, respiratory distress-initially infant in room air with saturations 100%; air exchange was not as good on admission with minimal retractions noted; sepsis-GBS unknown, rupture of membranes x 5 hrs, Mom treated with ampicillin; infant of diabetic mother (IDDM) on admission to hospital uncontrolled hyperglycemia; hypovolemia, poor perfusion with capillary refill approx 5 seconds after delivery VBG with -3 base deficit, normal saline bolus 10 mL/kg x1.  She also needed globulin, immune (RHOGAM).  Labor complications: premature labor and magnesium toxicity.  Upon internal review, pre-term labor was determined to be an Other Important Medical Event.  All available medical records will be provided upon request.  Additional information has been requested.