Age: 32.0
Sex: F
Vaccine: FLU3, FLUX, TDAP
Symptoms: Caesarean section, Complication of pregnancy, Drug exposure during pregnancy, Hypertension, Normal newborn
Clinical narrative: Initial report received from the patient's spouse on 02 November 2010. A pregnant female patient (date of birth not reported) had received a first dose of ADACEL (lot number not reported) on 23 October 2010. The patient's estimated date of delivery is 09 December 2010. At the time of this report, the patient had not experienced any adverse events since being vaccinated with ADACEL. Follow-up information received from the patient's spouse in on 14 and 18 February 2011. Upon receipt of this information, it was determined this case meets seriousness criteria and has been upgraded to serious. The patient was reported as being 34 years of age; however by calculation from the patient's date of birth the patient was 32 years of age at the time of vaccination. Confirmation of the patient's date of birth has been requested. The patient had received the ADACEL vaccination at "11:00 pm" on 23 October 2010. She had also received a flu shot in October 2010 of which the trade name, manufacturer name, lot number, route and site of administration were not reported. The patient had no reported medical history, no maternal drug use, and no infertility treatments. Obstetrical history included no prior pregnancies. The date of the patient's last menstrual period was 01 March 2010 with expected date of delivery 04 December 2010. Current pregnancy history included high blood pressure (reading not provided) and swelling of face and legs with no dates of onset. Per the spouse, the patient was followed by a mid-wife and experienced pregnancy complication on 04 December 2010 when she presented with "placenta rupture and detachment" that resulted in emergency cesarean section and delivery of a single 6 pound healthy male baby. It was reported that the baby is healthy and fine and the baby had no congenital anomalies. Hospitalization was not mentioned. No other medical information was provided. At the time of this report, the patient had recovered. Follow-up information was received 29 April 2011 from the patient's spouse. The patient's date of birth was confirmed to be 27 January 1978. The time of ADACEL administration was confirmed as 11:00 PM (night). She had not received any other vaccines within four weeks of receiving ADACEL or Influenza and she had not been taking any concomitant medications. The patient had no family history of hypertension; however, the patient's mother had a still birth during her first pregnancy (reason unknown; undiagnosed). According to the reporter, the onset of high blood pressure and swelling of the face, hands and legs began on approximately 01 November 2010. The patient normally had readings in the range of "60/90", but her reading increased to "90/140". According to the reporter, the midwives were unsure if the patient had gestational hypertension as they felt swelling of the face and hands was   [Due to memory limitations, the remainder of this text could not be compared.]  ds was not that common or prevalent. The patient did not receive any corrective treatment for hypertension and she was not hospitalized. Outcome remained recovered. Documents held by sender: None.