Initial case was received on 23 September 2010 from a healthcare professional. A 17 year old female patient received an intramuscular injection of MENACTRA on an unspecified date. The patient was pregnant at the time of the vaccination. Her last menstrual period was 19 June 2010. The estimated date of delivery was not yet established, but the patient was scheduled for an ultrasound on Monday 27 September 2010 "for dating". The patient experienced no adverse event as of this report. Follow-up information was received on 18 October 2010 from a healthcare professional. The reporter provided the MENACTRA lot number of "43088AA" (invalid lot number). On the same unspecified date as the MENACTRA was administered, the patient also received a subcutaneous injection of Varicella (lot number 1411Y, manufacturer Merck). No further information was provided. Follow-up information was received from a health care professional on 02 December 2010. The lot number of the MENACTRA was corrected to U3088AA (previously reported as 43088AA). The patient received on 17 September 2010 a left arm injection of MENACTRA and a left arm injection of Varicella vaccine. The patient had refused getting the vaccines in the right arm. The patient experienced no adverse event as of this report. The outcome remained not reported. Follow-up information was received from a health care professional on 06 December 2010. The patient's last menstrual period was reported as 19 June 2010 and the estimated date of delivery was reported as 04 March 2011. The patient had no past obstetrical history. The Obstetrician reported the date given of the MENACTRA and Varicella vaccine as August 2010 which was administered by a nurse for the health department (previously reported by the health department as 17 September 2010). The outcome was reported as unknown. Follow-up information was received from a health care professional on 19 January 2011 confirmed the date of administration of the MENACTRA was 17 September 2010. No further information available. Follow-up information and medical records were received 11 February 2011 from health care professional. From new information received, it was determined this case now meets seriousness criteria and this case has been upgraded from non-serious to serious. According to the reporter, the patient experienced complications of gestational diabetes, a teen-age pregnancy and pre-term labor during pregnancy. She also experienced complications of pre-term labor and magnesium toxicity during labor and delivery. On 03 February 2011, the patient delivered a premature male infant vaginally at 30 + 4 weeks gestation weighing 1560 grams, length 43 cm, birth head circumference of 27.25 cms with no congenial anomalies; apgar scores were 8 and 9 at one and five minutes respectively. Post delivery, the infant was admitted to NICU for prematurity and respiratory distress (captured in case number 2011-00602). Concomitant medication during pregnancy consisted of Cromolyn Sodium and Prenatal vitamins beginning 21 September 2010. On 24 September 2010, prenatal testing was normal. The patient was found to be Rh negative and Rhogam was recommended as soon as possible. On 05 November 2010 triple screen results were normal. On 29 September and 22 November 2010, the patient had normal ultrasound findings. During her November 2010 prenatal visits, she reported she had experienced headaches and unspecified aches/pains (dates of onset not reported) which were helped by TYLENOL. Urine strip test results during November and December 2010 revealed Alb (trace), leuk (trace to 1+) and blood (trace to 2+) and urine was submitted for culture. During her 02 December 2010 prenatal visit, the patient stated she had some blood-tinged fluid upon wiping while at school that day. She had been cramping and passed a blood clot. Speculum examination was normal with no blood in the vault or in the os. Assessment was a UTI with antibiotics prescribed as corrective treatment. On 18 January 2011, the patient had a one hour blood glucose level of 238 and there was concern about possible Type 1 diabetes. Additional laboratory test results included Hgb 10.7 gm/dL (reference 12.0-15.0); Syphilis <.2 non-reactive and an abnormal urinalysis which revealed the presence of Leukocyte (100), Glucose (1000), and Blood (250). In addition to prenatal vitamins, the patient received oral ferrous sulfate 35 mg daily to treat mild anemia. Urine strip test results in January 2011 revealed Alb (trace), Ket (positive), Glu (4+), Leuk (1+), blood (2+ to 3+). On 20 January 2011, she presented for her initial consult visit for gestational diabetes (insulin required). During this visit, she was noted to have experienced hypoglycemia (corrective treatment of food) and she complained of heartburn for which she took TUMS. She remained at her baseline state of health until four day prior to 31 January 2011, when she developed an upper respiratory illness with symptoms of sore throat, cough and phlegm production. Then, at 23:00 hours on 30 January 2011, she developed pre-term labor with some cramping sensations and contractions which increased in frequency and intensity. She reported to labor and delivery for further evaluation the following morning on 31 January 2011 and was found to have contractions approximately every four minutes. IV Fluid bolus followed by IV fluid maintenance (sodium chloride 0.9%, dextrose 5% lactated ringers) were ordered. Magnesium Sulfate and subcutaneous Terbutaline were ordered for preterm contractions. Contractions did not completely resolve and PROCARDIA 10 mg was administered orally. That same day she was found to have hypokalemia (2.9) of uncertain etiology although possibilities included glycemic fluctuations and side effects from terbutaline. Potassium riders were administered as corrective treatment. Contractions continue, and the patient reported a brown vaginal discharge. A review of systems noted cervical dilation at 1.5cm, 70% effaced, -1 station, bag of water intact, cephalic presenting part noted. She had trace ankle edema and low back pain; however the remainder of physical examination findings were normal. Good fetal movement was present. Fetal heart rates were 140s-150s baseline with good long-term variability with some mild variable decelerations, and positive accelerations with an overall reassuring characteristic to the tracing. Tocometry varied, but averaged every four to five minutes. Contractions occurred every two to five minutes lasting about 45 seconds to a minute. On 01 February 2011, the patient had +1 spotting, cervix 2.5/100, stable on magnesium and hypokalemia. On 02 February 2011, ultrasound revealed a live intrauterine pregnancy of approximately 30 weeks with normal amniotic fluid index and normal systolic to diastolic ratio. The patient's C-peptide was 2 suggesting reasonable insulin secretion. She was administered another dose of LEVEMIR and continued with nine dose of sliding scale insulin. Additional medications received included Promethazine 12.5 mg IV push q6h (2 doses). OB/GYN progress note from 02 February 2011 noted the patient was 5cm with no rupture of membranes. Additional labor medications consisted of insulin, COLACE, betamethasone, ampicillin, Pitocin and epidural anaesthesia. On 03 February 2011, the patient delivered a premature male infant who was alert, active, pale pink, HR >100 with minimal retractions. He received blowby for five minutes. He was subsequently admitted to NICU for prematurity and respiratory distress. On 03 February 2011, the patient was scheduled to receive a 0.5 mL injection of ADACEL unless previously vaccinated with ADACEL or BOOSTRIX. The patient's outcome for the events of gestational diabetes, magnesium toxicity, upper respiratory illness, hypokalemia, anemia, headache, aches and pains and heartburn were not reported. The baby case has been captured in case number 2011-00602. Documents held by sender: Hospital records.