Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Placenta praevia, Ultrasound scan normal
Clinical narrative: Initial report received on 02 November 2007 from a health care professional.  A 38-year-old female patient, who was pregnant at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 30 October 2007.  Two days post-vaccination, the patient experienced a sore throat, and it was uncomfortable to swallow.  The event did not require medical examination.  The patient experienced no fever or chills and slept well.  Last menstrual period and estimated date of delivery were not provided.  Other medications included prenatal vitamins.  The patient recovered from the event.  Follow-up information received on 26 November 2007 from the patient.  The patient's primary care provider, OBGYN, and Maternal Fetal Medicine Center contact information was provided.  The patient has no known allergies but could possibly have a history of environmental allergies.  The patient experienced symptoms of coughing and headache two days post-vaccination (02/Nov/2007), in addition to the previously reported adverse events of sore throat, and "it was uncomfortable to swallow."  The date of the patient's last menstrual period was reported as "unknown"; but the expected date of delivery was reported as 13 March 2008.  Prenatal testing so far includes: ultrasound (routine), completed on 08 August 2007 (within normal limits); ultrasound for high risk age, completed on 30 August 2007 (results not reported); and ultrasound for high risk age, completed on 31 October 2007 (results not reported).  The patient is scheduled to see her OBGYN on 03 December 2007, and her next ultrasound is scheduled for 04 January 2007.  The recovery status of the coughing and headache was not reported.  At the time of this report, the recovery status was amended to "not recovered."  Follow-up information received on 24 June 2008 from a health care professional.  Per the reporter, the patient's obstetrical history included two previous pregnancies that resulted in one live birth and one spontaneous abortion prior to 20 weeks of gestation.  The patient did not use alcohol, tobacco or recreational drugs during her current pregnancy.  Ultrasound completed on 08 August 2007 confirmed the patient's pregnancy at eight weeks six days gestation.  Another ultrasound completed on 31 October 2007 showed a normal appearing fetus at 20 weeks four days gestation.  An Alpha feto protein test (date not reported) showed an increased level of "hcg").  The patient did not see the physician for any complaints regarding her pregnancy following her FLUZONE vaccination on 30 October 2007.  However, the patient did have complication of pregnancy identified as complete placenta previa requiring primary cesarean section on 21 February 2008.  The patient did not experience any complications of labor and/or delivery.  She did not experience any post operation or post partum sequelae.  The patient delivered one, live male child who's Apgar scores were eight at one minute, and nine at five minutes.  The baby weighed six pounds one ounce (3 kilogram), and he had no congenital anomalies.  Due to this new information, the case was upgraded to serious.