Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Vaginal haemorrhage
Clinical narrative: Initial report received from a physician on 17 November 2010. A 22-year-old pregnancy female patient, who was 5 weeks gestation, had received a first intramuscular booster dose of ADACEL (lot number U3110BA, sanofi pasteur lot number C3349) on 12 November 2010. The date of the patient's last menstrual period was unknown. The expected date of delivery was unknown. The patient has not experienced any adverse events after receiving the ADACEL vaccination. Follow-up information received from a health care professional on 20 December 2010. OBGYN contact information was provided. Per the reporter, please contact the OBGY for follow-up. Follow-up information received from a physician on 01 March 2011. Copies of infant and prenatal records were provided that included results of 1 obstetrical ultrasound, and 1 fetal anatomy survey scan reports. A pregnancy reporting form was returned that was not completed. The following is from medical records. Date of patient's last menstrual period was on 09 October 2010 with expected date of delivery 16 July 2011. Current pregnancy was noted to be high risk due to current medical history of hypertension. Obstetrical history includes: Gravida 4 Para 1 Abortion 2. Patient experienced spontaneous abortion at 7 weeks gestation in 2005, and at 9 weeks gestation in 2007 with D&C. In March 2009, patient experienced preterm delivery secondary to pre-eclampsia and delivered one live infant via cesarean section at 34 weeks 3 days gestation that weighed 4.8 pounds. Medical history included: onset of menses at age 12 years; positive PPD test at age 12 for which she received 12 months treatment with INH; latex allergy; hypertension that is currently being treated with Labetalol (it was noted patient was taking Lisinopril at time of positive pregnancy test, but later switched to Labetalol); asthma; recurrent urinary tract infections (last infection date not reported); and chickenpox as a child. Her family history includes: hypertension in mother, father, and maternal grandmother; diabetes in father; cancer (type not identified) in 2 maternal aunts, a maternal great aunt, and a maternal great uncle. His family medical history includes father with history of hypertension, heart disease and diabetes. The patient's initial obstetrical interview was on 16 December 2010 where she reported taking Labetalol 100 mg once a day instead of twice a day due to feeling dizzy (onset date not reported) and was feeling much better that day. She received a flu vaccination that day; however trade name, manufacturer name, lot number route and site were not reported. Labs performed that day included urinalysis with culture and sensitivity, and HIV screening. The patient was seen for initial obstetrical visit on 22 December 2010. At the time she was 6 weeks 4 days gestation and was taking prenatal vitamins. Blood pressure was 126/82 mmHg. Patient reported taking Labetalol once a day "sometimes" secondary to nausea (onset date not reported). Urine protein was 1+ with no sign of sugar in the urine. A baseline 24-hour urine test was ordered to rule out proteinemia. Plan was to check "PEP" (protein electrophoresis) at next blood draw. Doppler ultrasound revealed positive fetal heart rate. Patient was to follow-up in 3-4 weeks. On 05 January 2011 patient was prescribed Amox for an upper respiratory infection. At that time she complained of spotting times one with voiding but without cramping. Doctor notation was "negative for IC." Patient was again seen on 11 January 2011. Gestation age was 13 weeks 3 days. Blood pressure was 130/80 mmHg. Urine check showed urine protein ++ with no sugar. Doctor notation was "24 hour urine 590 mg, C of 0.9". No diagnosis was written in doctor notes. On 25 January 2011 patient was re-evaluated and stated she experienced "1+" small amount of red spotting with decreased abdominal cramping. No bleeding was noted on examination. She denied dysuria, fever or chills. An obstetrical ultrasound was completed for complaint of spotting that revealed a first trimester single viable intrauterine pregnancy. Size was consistent with dates. Cervix was long and closed. Both ovaries were seen and appeared normal. Placenta was anterior with no evidence of bleed sites. CRL (crown to rump length) was 94.0 mm, and was at the 47 percentile. Gestation was 15 week 3 days. The expected date of delivery was confirmed to be 16 July 2011. On 10 February 2011 patient was re-evaluated and reported she had come off Labetalol times 1.5 weeks but had increased blood pressure and headache, so she resumed the Labetalol at 100 mg bid. Patient's blood pressure that day was 124/82 mmHg. Urine was negative for protein and sugar. Patient was to start having serial ultrasounds after 24 weeks gestation. Patient reported positive fetal movements. Fetal anatomy survey scan was completed that day that revealed a single 17 week 5 days gestation. BPD was 38.3mm, HC 139.2mm, AC 120.7mm, Fl 25.5mm, OFD 48.4mm, TCD 17.9mm, CM 2.9mm Nuchal fold 2.92mm, HC/AC ratio 1.153, 24th %, FL/AC ration 0.211, 65th%, and BPD/FL ratio 1.502, 8th%. Fetal heart rate was 153 beats/minute, amniotic fluid was normal, 3 vessel cords was visible, and placenta was anterior. Documents held by sender: Infant and prenatal records, results of 1 obstetrical ultrasound and 1 fetal anatomy survey scan.