chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Asthenia, Death, Frequent bowel movements, Hypophagia, Hypothermia
Clinical narrative: Pt developed decreased PO intake and increased frequency of stools with mucus on the night of 12/29/08 < 12 hours after immunizations. Next day continued to have poor intake and increased stool and became weak/lethargic. Pt came to evening clinic and was in state of shock and hypothermia. He died at about 10pm.  2/13/09 Autopsy report received with COD Dilated and hypertrophic cardiomyopathy.  DX:  Left ventricular myocardial hypertrophy and dilitation, marked.  Fatty alteration of the liver, moderate to marked.  Bilateral hydroceles, R>L. Pt seen 12/27/08 with c/o spitting up blood and sneezing. Dx with thrush and tx with Diflucan.  Returned to PCP 12/29/08, impetigo noted and vax given. Returned 12/30/08 with c/o poor feeding, multiple watery, stringy stools, weakness and pallor. PE notable for grunting, poor color and decreased activity. Transported via EMS to hospital with concern for sepsis. T=96.8'F. HR=170's. Severly dehydrated on arrival. Infant coded and expired.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lethargy, Mucous stools, Shock
Clinical narrative: Pt developed decreased PO intake and increased frequency of stools with mucus on the night of 12/29/08 < 12 hours after immunizations. Next day continued to have poor intake and increased stool and became weak/lethargic. Pt came to evening clinic and was in state of shock and hypothermia. He died at about 10pm.  2/13/09 Autopsy report received with COD Dilated and hypertrophic cardiomyopathy.  DX:  Left ventricular myocardial hypertrophy and dilitation, marked.  Fatty alteration of the liver, moderate to marked.  Bilateral hydroceles, R>L. Pt seen 12/27/08 with c/o spitting up blood and sneezing. Dx with thrush and tx with Diflucan.  Returned to PCP 12/29/08, impetigo noted and vax given. Returned 12/30/08 with c/o poor feeding, multiple watery, stringy stools, weakness and pallor. PE notable for grunting, poor color and decreased activity. Transported via EMS to hospital with concern for sepsis. T=96.8'F. HR=170's. Severly dehydrated on arrival. Infant coded and expired.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Autoimmune disorder, Pain, Pyrexia, Vaccination complication
Clinical narrative: Began with left elbow pain, progressed to right elbow, then to other joints. Peaked, with all over, achy body and high fever. Patient has been slowly getting better, according to patient on 12/23/2008.
Age: 1.4
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: As part of flu clinic  17 mo was given FLUMIST approved for equal to or greater than 2 year olds.  No reactions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Woke up on the 11th with a horrendous headache.  Lasted about 3 hrs.  Woke up on the 12th with a bad headache and dizziness.  Headache went away after 2-3 hrs, but dizziness lasted until the afternoon of Dec. 14th
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test negative, Biopsy chorionic villous, Cholelithiasis, Condition aggravated, Drug exposure during pregnancy
Clinical narrative: This serious case was received from a health professional on 27 December 2008. The patient was enrolled in a study for which Sanofi Pasteur was not the sponsor. A 38-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2456AA) on 03 May 2006. The patient was pregnant at the time of injection, and date of last menstrual period was 30 December 2005. Past medical history included asthma, obesity (BMI 40), varicose veins, occasional migraines, and a herniated disc at age 25 (since resolved). Obstetric history included two previous pregnancies, resulting in one live birth and one spontaneous abortion prior to 20 weeks gestation. She had a history of superficial thrombophlebitis in a previous pregnancy. Concomitant medications included COMBIVENT, PULMICORT, and prenatal vitamins. Prenatal testing was all normal, including chorionic villi sampling, serologies, fetal stress test, ultrasound, and genetic screening. During pregnancy, the patient developed superficial thrombophlebitis and symptomatic gall stones. On 12 October 2006, at 41.2 weeks gestation, the patient delivered a 3345g female infant via normal vaginal delivery. Apgar scores were 8/10 at one minute and 9/10 at five minutes. Due to the precipitous nature of the second stage of labor, one dose of ampicillin was given for GBS prophylaxis. A nuchal cord X 2 was easily reduced. The health professional who reported this case also reported 15 other serious and non-serious events. These events are captured in case numbers 2008-04101, -04103, -04104, -04105, -04106, -04107, -04108, -04109, -04110, -04111, -04112, -04113, -04114, and -04115. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: HIV test negative, Hepatitis B surface antigen negative, Rubella antibody positive, Streptococcal identification test positive, Syphilis test negative
Clinical narrative: This serious case was received from a health professional on 27 December 2008. The patient was enrolled in a study for which Sanofi Pasteur was not the sponsor. A 38-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2456AA) on 03 May 2006. The patient was pregnant at the time of injection, and date of last menstrual period was 30 December 2005. Past medical history included asthma, obesity (BMI 40), varicose veins, occasional migraines, and a herniated disc at age 25 (since resolved). Obstetric history included two previous pregnancies, resulting in one live birth and one spontaneous abortion prior to 20 weeks gestation. She had a history of superficial thrombophlebitis in a previous pregnancy. Concomitant medications included COMBIVENT, PULMICORT, and prenatal vitamins. Prenatal testing was all normal, including chorionic villi sampling, serologies, fetal stress test, ultrasound, and genetic screening. During pregnancy, the patient developed superficial thrombophlebitis and symptomatic gall stones. On 12 October 2006, at 41.2 weeks gestation, the patient delivered a 3345g female infant via normal vaginal delivery. Apgar scores were 8/10 at one minute and 9/10 at five minutes. Due to the precipitous nature of the second stage of labor, one dose of ampicillin was given for GBS prophylaxis. A nuchal cord X 2 was easily reduced. The health professional who reported this case also reported 15 other serious and non-serious events. These events are captured in case numbers 2008-04101, -04103, -04104, -04105, -04106, -04107, -04108, -04109, -04110, -04111, -04112, -04113, -04114, and -04115. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Thrombophlebitis superficial, Ultrasound antenatal screen normal
Clinical narrative: This serious case was received from a health professional on 27 December 2008. The patient was enrolled in a study for which Sanofi Pasteur was not the sponsor. A 38-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2456AA) on 03 May 2006. The patient was pregnant at the time of injection, and date of last menstrual period was 30 December 2005. Past medical history included asthma, obesity (BMI 40), varicose veins, occasional migraines, and a herniated disc at age 25 (since resolved). Obstetric history included two previous pregnancies, resulting in one live birth and one spontaneous abortion prior to 20 weeks gestation. She had a history of superficial thrombophlebitis in a previous pregnancy. Concomitant medications included COMBIVENT, PULMICORT, and prenatal vitamins. Prenatal testing was all normal, including chorionic villi sampling, serologies, fetal stress test, ultrasound, and genetic screening. During pregnancy, the patient developed superficial thrombophlebitis and symptomatic gall stones. On 12 October 2006, at 41.2 weeks gestation, the patient delivered a 3345g female infant via normal vaginal delivery. Apgar scores were 8/10 at one minute and 9/10 at five minutes. Due to the precipitous nature of the second stage of labor, one dose of ampicillin was given for GBS prophylaxis. A nuchal cord X 2 was easily reduced. The health professional who reported this case also reported 15 other serious and non-serious events. These events are captured in case numbers 2008-04101, -04103, -04104, -04105, -04106, -04107, -04108, -04109, -04110, -04111, -04112, -04113, -04114, and -04115. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Antibody test negative, Chlamydia identification test negative, Chorioamnionitis, Complication of delivery
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 32 year old female patient with no history of tobacco or drug use. BMI- 23.7, 2 ETOH drinks per week prior to pregnancy, no ETOH after conception received an intramuscular initial dose of ADACEL (lot number C2456A) in the left deltoid. The patient had the following diagnostics performed: 03 November 2005 and 02 May 2006: B+, antibody negative, HBsAg - Negative, HIV-negative, Rubella Immune, Syphilis IgG-negative, Gc/Chlamydia-negative. 03 April 2006, 08 May 2006: normal-ultrasound, single IUP. 08 May 2006: normal genetic screening, first trimester screen was negative. 13 June 2006. 28 June 2008: normal ultrasound, normal anatomy. 30 May 2006: alpha feto protein: normal. The patient's last menstrual period was 08 February 2006. Her estimated date of delivery was 15 November 2006. The patient received PITOCIN for augmentation of labor. The patient had intermediate moderate variables and intermediate late decelerations and mild fetal tachycardia. The patient was diagnosed with chorioamnionitis with a fever > 38.0 in second stage labor with prolonged second stage. She received ampicillin and gentamycin during labor. She had a deep sulcus tear and a second degree laceration. She had a post partum hemorrhage and was given misoprostol and Methergine. She was moved to the operating room and underwent dilation and curettage (D and C), evaluation of a vaginal hematoma, and a repair of sulcal tear under general anesthesia. She received a blood transfusion of two units of packed red blood cells. She delivered a baby boy vaginally on 22 November 2006 at 41 weeks gestation. The baby did not have any congenital anomalies. APGAR score was 8 at one minute and 9 at five minutes. List of Documents held by Sender: None. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04115.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy, Foetal disorder, HIV test negative, Hepatitis B surface antigen negative, Postpartum haemorrhage
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 32 year old female patient with no history of tobacco or drug use. BMI- 23.7, 2 ETOH drinks per week prior to pregnancy, no ETOH after conception received an intramuscular initial dose of ADACEL (lot number C2456A) in the left deltoid. The patient had the following diagnostics performed: 03 November 2005 and 02 May 2006: B+, antibody negative, HBsAg - Negative, HIV-negative, Rubella Immune, Syphilis IgG-negative, Gc/Chlamydia-negative. 03 April 2006, 08 May 2006: normal-ultrasound, single IUP. 08 May 2006: normal genetic screening, first trimester screen was negative. 13 June 2006. 28 June 2008: normal ultrasound, normal anatomy. 30 May 2006: alpha feto protein: normal. The patient's last menstrual period was 08 February 2006. Her estimated date of delivery was 15 November 2006. The patient received PITOCIN for augmentation of labor. The patient had intermediate moderate variables and intermediate late decelerations and mild fetal tachycardia. The patient was diagnosed with chorioamnionitis with a fever > 38.0 in second stage labor with prolonged second stage. She received ampicillin and gentamycin during labor. She had a deep sulcus tear and a second degree laceration. She had a post partum hemorrhage and was given misoprostol and Methergine. She was moved to the operating room and underwent dilation and curettage (D and C), evaluation of a vaginal hematoma, and a repair of sulcal tear under general anesthesia. She received a blood transfusion of two units of packed red blood cells. She delivered a baby boy vaginally on 22 November 2006 at 41 weeks gestation. The baby did not have any congenital anomalies. APGAR score was 8 at one minute and 9 at five minutes. List of Documents held by Sender: None. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04115.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Prolonged labour, Pyrexia, Rubella antibody positive, Surgery, Syphilis test negative
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 32 year old female patient with no history of tobacco or drug use. BMI- 23.7, 2 ETOH drinks per week prior to pregnancy, no ETOH after conception received an intramuscular initial dose of ADACEL (lot number C2456A) in the left deltoid. The patient had the following diagnostics performed: 03 November 2005 and 02 May 2006: B+, antibody negative, HBsAg - Negative, HIV-negative, Rubella Immune, Syphilis IgG-negative, Gc/Chlamydia-negative. 03 April 2006, 08 May 2006: normal-ultrasound, single IUP. 08 May 2006: normal genetic screening, first trimester screen was negative. 13 June 2006. 28 June 2008: normal ultrasound, normal anatomy. 30 May 2006: alpha feto protein: normal. The patient's last menstrual period was 08 February 2006. Her estimated date of delivery was 15 November 2006. The patient received PITOCIN for augmentation of labor. The patient had intermediate moderate variables and intermediate late decelerations and mild fetal tachycardia. The patient was diagnosed with chorioamnionitis with a fever > 38.0 in second stage labor with prolonged second stage. She received ampicillin and gentamycin during labor. She had a deep sulcus tear and a second degree laceration. She had a post partum hemorrhage and was given misoprostol and Methergine. She was moved to the operating room and underwent dilation and curettage (D and C), evaluation of a vaginal hematoma, and a repair of sulcal tear under general anesthesia. She received a blood transfusion of two units of packed red blood cells. She delivered a baby boy vaginally on 22 November 2006 at 41 weeks gestation. The baby did not have any congenital anomalies. APGAR score was 8 at one minute and 9 at five minutes. List of Documents held by Sender: None. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04115.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Transfusion, Ultrasound scan normal
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 32 year old female patient with no history of tobacco or drug use. BMI- 23.7, 2 ETOH drinks per week prior to pregnancy, no ETOH after conception received an intramuscular initial dose of ADACEL (lot number C2456A) in the left deltoid. The patient had the following diagnostics performed: 03 November 2005 and 02 May 2006: B+, antibody negative, HBsAg - Negative, HIV-negative, Rubella Immune, Syphilis IgG-negative, Gc/Chlamydia-negative. 03 April 2006, 08 May 2006: normal-ultrasound, single IUP. 08 May 2006: normal genetic screening, first trimester screen was negative. 13 June 2006. 28 June 2008: normal ultrasound, normal anatomy. 30 May 2006: alpha feto protein: normal. The patient's last menstrual period was 08 February 2006. Her estimated date of delivery was 15 November 2006. The patient received PITOCIN for augmentation of labor. The patient had intermediate moderate variables and intermediate late decelerations and mild fetal tachycardia. The patient was diagnosed with chorioamnionitis with a fever > 38.0 in second stage labor with prolonged second stage. She received ampicillin and gentamycin during labor. She had a deep sulcus tear and a second degree laceration. She had a post partum hemorrhage and was given misoprostol and Methergine. She was moved to the operating room and underwent dilation and curettage (D and C), evaluation of a vaginal hematoma, and a repair of sulcal tear under general anesthesia. She received a blood transfusion of two units of packed red blood cells. She delivered a baby boy vaginally on 22 November 2006 at 41 weeks gestation. The baby did not have any congenital anomalies. APGAR score was 8 at one minute and 9 at five minutes. List of Documents held by Sender: None. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04115.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Amniotic fluid index abnormal, Antibody test negative, Chlamydia identification test negative, Drug exposure during pregnancy
Clinical narrative: Initial report received on 27 December 2008 from a physician. A 31-year-old pregnant female experienced oligohydramnios approximately 193 days after she received a first left deltoid intramuscular injection of ADACEL (lot number C2457AA) on 04 May 2006. At that time, the patient had medical history of moderate mitral regurgitation on echocardiogram in 2002, history of pregnancy induced hypertension (PIH), chronic hypertension the was well controlled with LISINOPRIL that was stopped prior to the current pregnancy, and exercise induced asthma. The patient had no drug use, alcohol use (ETOH) or use of tobacco. Regarding the current pregnancy, the date of patient's last menstrual period was on 15 February 2006 and her expected date of delivery was on 22 November 2006. The patient had a normal alpha feto protein test on 7 June 2006 and normal serology testing on 3 May 2006 with B+; antibody-neg, HIV-NR; Rub Immune; Syph IgG-NR; Gc/chlam, neg-neg; HBsAg-NR. Ultrasounds on 03 May 2006 revealed a single intrauterine pregnancy (IUP); on 23 June 2006 an ultrasound revealed normal anatomy; on 02 October 2006 an ultrasound revealed abnormal amniotic fluid index (AFI), at 6.4; normal growth; an ultrasound on 09 October 2006 revealed abnormal amniotic fluid index (AFI) at 7.8; an ultrasound on 16 October 2008 revealed abnormal amniotic fluid index (AFI) at 7.6; an ultrasound on 24 October 2006 normal AFI at 10.4; an ultrasound on 30 October 2006 revealed normal AFI at 9.4 and an ultrasound on 6 November 2006 revealed normal AFI; normal growth. An ultrasound on 13 November 2006 revealed an abnormal AFI on 2.1 and oligohydramnics. The following day the patient was treated with induction of labor and she delivered vaginally a single healthy female baby whose Apgar scores were eight at one minute, and nine at five minute. The baby was delivered at 38 plus six days/7 weeks and weighed 3 kilogram (3180g). The baby did not experience any congenital anomalies. The oligohydramnios was considered to be recovered at delivery. Documents held by sender: none. The reporter for this case is the same as in case numbers: 2008-04101, 2008-04102,2008-04103, 2008-04104, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115, 2008-04116, 2008-00011.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: HIV test negative, Hepatitis B surface antigen negative, Labour induction, Oligohydramnios, Rubella antibody test
Clinical narrative: Initial report received on 27 December 2008 from a physician. A 31-year-old pregnant female experienced oligohydramnios approximately 193 days after she received a first left deltoid intramuscular injection of ADACEL (lot number C2457AA) on 04 May 2006. At that time, the patient had medical history of moderate mitral regurgitation on echocardiogram in 2002, history of pregnancy induced hypertension (PIH), chronic hypertension the was well controlled with LISINOPRIL that was stopped prior to the current pregnancy, and exercise induced asthma. The patient had no drug use, alcohol use (ETOH) or use of tobacco. Regarding the current pregnancy, the date of patient's last menstrual period was on 15 February 2006 and her expected date of delivery was on 22 November 2006. The patient had a normal alpha feto protein test on 7 June 2006 and normal serology testing on 3 May 2006 with B+; antibody-neg, HIV-NR; Rub Immune; Syph IgG-NR; Gc/chlam, neg-neg; HBsAg-NR. Ultrasounds on 03 May 2006 revealed a single intrauterine pregnancy (IUP); on 23 June 2006 an ultrasound revealed normal anatomy; on 02 October 2006 an ultrasound revealed abnormal amniotic fluid index (AFI), at 6.4; normal growth; an ultrasound on 09 October 2006 revealed abnormal amniotic fluid index (AFI) at 7.8; an ultrasound on 16 October 2008 revealed abnormal amniotic fluid index (AFI) at 7.6; an ultrasound on 24 October 2006 normal AFI at 10.4; an ultrasound on 30 October 2006 revealed normal AFI at 9.4 and an ultrasound on 6 November 2006 revealed normal AFI; normal growth. An ultrasound on 13 November 2006 revealed an abnormal AFI on 2.1 and oligohydramnics. The following day the patient was treated with induction of labor and she delivered vaginally a single healthy female baby whose Apgar scores were eight at one minute, and nine at five minute. The baby was delivered at 38 plus six days/7 weeks and weighed 3 kilogram (3180g). The baby did not experience any congenital anomalies. The oligohydramnios was considered to be recovered at delivery. Documents held by sender: none. The reporter for this case is the same as in case numbers: 2008-04101, 2008-04102,2008-04103, 2008-04104, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115, 2008-04116, 2008-00011.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Serology test, Syphilis test negative, Ultrasound scan abnormal
Clinical narrative: Initial report received on 27 December 2008 from a physician. A 31-year-old pregnant female experienced oligohydramnios approximately 193 days after she received a first left deltoid intramuscular injection of ADACEL (lot number C2457AA) on 04 May 2006. At that time, the patient had medical history of moderate mitral regurgitation on echocardiogram in 2002, history of pregnancy induced hypertension (PIH), chronic hypertension the was well controlled with LISINOPRIL that was stopped prior to the current pregnancy, and exercise induced asthma. The patient had no drug use, alcohol use (ETOH) or use of tobacco. Regarding the current pregnancy, the date of patient's last menstrual period was on 15 February 2006 and her expected date of delivery was on 22 November 2006. The patient had a normal alpha feto protein test on 7 June 2006 and normal serology testing on 3 May 2006 with B+; antibody-neg, HIV-NR; Rub Immune; Syph IgG-NR; Gc/chlam, neg-neg; HBsAg-NR. Ultrasounds on 03 May 2006 revealed a single intrauterine pregnancy (IUP); on 23 June 2006 an ultrasound revealed normal anatomy; on 02 October 2006 an ultrasound revealed abnormal amniotic fluid index (AFI), at 6.4; normal growth; an ultrasound on 09 October 2006 revealed abnormal amniotic fluid index (AFI) at 7.8; an ultrasound on 16 October 2008 revealed abnormal amniotic fluid index (AFI) at 7.6; an ultrasound on 24 October 2006 normal AFI at 10.4; an ultrasound on 30 October 2006 revealed normal AFI at 9.4 and an ultrasound on 6 November 2006 revealed normal AFI; normal growth. An ultrasound on 13 November 2006 revealed an abnormal AFI on 2.1 and oligohydramnics. The following day the patient was treated with induction of labor and she delivered vaginally a single healthy female baby whose Apgar scores were eight at one minute, and nine at five minute. The baby was delivered at 38 plus six days/7 weeks and weighed 3 kilogram (3180g). The baby did not experience any congenital anomalies. The oligohydramnios was considered to be recovered at delivery. Documents held by sender: none. The reporter for this case is the same as in case numbers: 2008-04101, 2008-04102,2008-04103, 2008-04104, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115, 2008-04116, 2008-00011.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Amniotic fluid index abnormal, Antibody test negative, Chlamydia identification test negative, Complication of delivery
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor.  A 28-year-old pregnant female with a history of body mass index (BMI) 24, Asthma, Anemia, and Mitral valve prolapse was found to have oligohydramnios 234 days after she had received a first dose of intramuscular left deltoid injection of ADACEL, lot number C455AA on 01 May 2006. She had no history of prior pregnancies, and no history of tobacco, alcohol (ETOH) or drugs. Concomitant medications included Augmentin (indicated for otitis), Albuterol, Flovent and prenatal vitamins. On 21 December 2006, an ultrasound revealed normal growth and a low amniotic fluid index (AFI). Pregnancy, labor and delivery complications occurred and the patient was diagnosed with Oligohydramnios at 40 (3/7) weeks; AFI - 6.6. The patient was induced with misoprostol, augmentation with Pitocin and artificial rupture of membranes (AROM). Fetal heart tones (FHT) decelerations to 100's occurred with return to baseline after one minute throughout the active labor phase. During the second stage of labor, decelerations to 100's occurred with no slow return to baseline, however delivery was imminent, so labor continued. The patient delivered a single live female infant vaginally on 22 December 2006 at 40 (4/7) weeks gestation weighing 3070 grams. A tight nuchal cord was reduced. The infant was handed to nursing, ICN was called due to no respiratory effort. Apgar readings were 2/5 at one and five minutes respectively. The infant was intubated briefly, then extubated. The infant had no congenital anomalies. The patient experienced a second degree laceration and urinary retention post-partum day zero. Her Foley was replaced, and then removed 24 hours later without further problems. The patient's recovery status was not reported. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Complication of pregnancy, Foetal disorder, HIV test negative, Labour complication, Oligohydramnios
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor.  A 28-year-old pregnant female with a history of body mass index (BMI) 24, Asthma, Anemia, and Mitral valve prolapse was found to have oligohydramnios 234 days after she had received a first dose of intramuscular left deltoid injection of ADACEL, lot number C455AA on 01 May 2006. She had no history of prior pregnancies, and no history of tobacco, alcohol (ETOH) or drugs. Concomitant medications included Augmentin (indicated for otitis), Albuterol, Flovent and prenatal vitamins. On 21 December 2006, an ultrasound revealed normal growth and a low amniotic fluid index (AFI). Pregnancy, labor and delivery complications occurred and the patient was diagnosed with Oligohydramnios at 40 (3/7) weeks; AFI - 6.6. The patient was induced with misoprostol, augmentation with Pitocin and artificial rupture of membranes (AROM). Fetal heart tones (FHT) decelerations to 100's occurred with return to baseline after one minute throughout the active labor phase. During the second stage of labor, decelerations to 100's occurred with no slow return to baseline, however delivery was imminent, so labor continued. The patient delivered a single live female infant vaginally on 22 December 2006 at 40 (4/7) weeks gestation weighing 3070 grams. A tight nuchal cord was reduced. The infant was handed to nursing, ICN was called due to no respiratory effort. Apgar readings were 2/5 at one and five minutes respectively. The infant was intubated briefly, then extubated. The infant had no congenital anomalies. The patient experienced a second degree laceration and urinary retention post-partum day zero. Her Foley was replaced, and then removed 24 hours later without further problems. The patient's recovery status was not reported. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Rubella immunity confirmed, Syphilis test negative, Ultrasound scan normal
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor.  A 28-year-old pregnant female with a history of body mass index (BMI) 24, Asthma, Anemia, and Mitral valve prolapse was found to have oligohydramnios 234 days after she had received a first dose of intramuscular left deltoid injection of ADACEL, lot number C455AA on 01 May 2006. She had no history of prior pregnancies, and no history of tobacco, alcohol (ETOH) or drugs. Concomitant medications included Augmentin (indicated for otitis), Albuterol, Flovent and prenatal vitamins. On 21 December 2006, an ultrasound revealed normal growth and a low amniotic fluid index (AFI). Pregnancy, labor and delivery complications occurred and the patient was diagnosed with Oligohydramnios at 40 (3/7) weeks; AFI - 6.6. The patient was induced with misoprostol, augmentation with Pitocin and artificial rupture of membranes (AROM). Fetal heart tones (FHT) decelerations to 100's occurred with return to baseline after one minute throughout the active labor phase. During the second stage of labor, decelerations to 100's occurred with no slow return to baseline, however delivery was imminent, so labor continued. The patient delivered a single live female infant vaginally on 22 December 2006 at 40 (4/7) weeks gestation weighing 3070 grams. A tight nuchal cord was reduced. The infant was handed to nursing, ICN was called due to no respiratory effort. Apgar readings were 2/5 at one and five minutes respectively. The infant was intubated briefly, then extubated. The infant had no congenital anomalies. The patient experienced a second degree laceration and urinary retention post-partum day zero. Her Foley was replaced, and then removed 24 hours later without further problems. The patient's recovery status was not reported. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test negative, Chlamydia identification test negative, Drug exposure during pregnancy, Foetal disorder, HIV test negative
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 28-year-old pregnant female patient with a history of thalassemia minor trait experienced pre-term labor at 29 weeks gestation after she had received a first dose intramuscular injection of ADACEL, lot number C2456AA on 03 May 2006. The patient had two previous pregnancies; both had been live births with no congenital anomalies. Concomitant medications included prenatal vitamins throughout pregnancy. On 03 January 2006, serology test results indicated she was AB positive, antibody - negative; Rub - immune; HBsAg - nonreactive; HIV - nonreactive; Syph IgG - negative; Gc/Chlam - negative/negative and genetic screening indicated the patient was negative for cystic fibrosis (CF) gene mutation. On 02 March 2006, the patient had a negative quad screen, and an abnormal ultrasound which revealed a bilateral choroid plexus cyst and echogenic focus. At 29 weeks gestation, the patient experienced an episode of pre-term labor which resolved with subcutaneous terbutaline. The patient subsequently delivered a live female infant vaginally at 39 weeks gestation on 23 July 2006. The infant weighed 2360 grams and had no congenital anomalies. Apgar scores had been 8/9 at one and five minutes respectfully. There had been no complications experienced during labor and delivery. No additional information was provided. The reporter for this case is the same as in case numbers 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hepatitis B surface antigen negative, Premature labour, Rubella immunity confirmed, Syphilis test negative, Ultrasound scan abnormal
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 28-year-old pregnant female patient with a history of thalassemia minor trait experienced pre-term labor at 29 weeks gestation after she had received a first dose intramuscular injection of ADACEL, lot number C2456AA on 03 May 2006. The patient had two previous pregnancies; both had been live births with no congenital anomalies. Concomitant medications included prenatal vitamins throughout pregnancy. On 03 January 2006, serology test results indicated she was AB positive, antibody - negative; Rub - immune; HBsAg - nonreactive; HIV - nonreactive; Syph IgG - negative; Gc/Chlam - negative/negative and genetic screening indicated the patient was negative for cystic fibrosis (CF) gene mutation. On 02 March 2006, the patient had a negative quad screen, and an abnormal ultrasound which revealed a bilateral choroid plexus cyst and echogenic focus. At 29 weeks gestation, the patient experienced an episode of pre-term labor which resolved with subcutaneous terbutaline. The patient subsequently delivered a live female infant vaginally at 39 weeks gestation on 23 July 2006. The infant weighed 2360 grams and had no congenital anomalies. Apgar scores had been 8/9 at one and five minutes respectfully. There had been no complications experienced during labor and delivery. No additional information was provided. The reporter for this case is the same as in case numbers 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion threatened, Antepartum haemorrhage, Antibody test negative, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor. A 30 year old female patient with a history of chronic hypertension (controlled with LABETALOL), asthma, occasional UTI's, depression, anxiety in college and no drugs, tobacco or alcohol use. The patient received an initial intramuscular left deltoid injection of ADACEL (lot number C2456AA) on 08 May 2006. The patient's last menstrual period was on 22 November 2005 and estimated date of delivery was 29 August 2006. The patient had the following labs and diagnostics completed: On 16 March 2006: all normal serology testing showed: Parvovirus IgG 5.7, Parvovirus IgM negative, A+, Rubella Imm., NBsAg-NR, HIV-NR, Antibody negative. On 04 August 2006, 08 August 2006, 14 August 2006 and 17 August 2006 normal fetal stress test. On 12 Jan 2006, 04 July 2006, 20 June 2006, 05 July 2006 and 10 August 2006 were all normal ultrasounds. On 02 August 2006 was an abnormal ultrasound which revealed AFI-8.5, bilateral hydroceles. On 16 March 2006 genetic screening was normal and on 27 April 2006 GBS (group B strep) was positive. The patient had first trimester bleeding-threatened abortion and oligohydramnios at term with AFI (amniotic fluid)- 7.3. On 20 August 2006 she delivered a male baby vaginally at 38 5/7 weeks gestation with no congenital anomalies. APGAR testing revealed a score of 9 at one minute and a score of 9 at five minutes. List of Documents held by Sender: None. Another case was created for the baby which is captured in case number 2009-00011. The reporter of this case is same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113 and 2008-04115.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: HIV test negative, Hepatitis B surface antigen negative, Oligohydramnios, Parvovirus B19 serology negative, Rubella immunity confirmed
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor. A 30 year old female patient with a history of chronic hypertension (controlled with LABETALOL), asthma, occasional UTI's, depression, anxiety in college and no drugs, tobacco or alcohol use. The patient received an initial intramuscular left deltoid injection of ADACEL (lot number C2456AA) on 08 May 2006. The patient's last menstrual period was on 22 November 2005 and estimated date of delivery was 29 August 2006. The patient had the following labs and diagnostics completed: On 16 March 2006: all normal serology testing showed: Parvovirus IgG 5.7, Parvovirus IgM negative, A+, Rubella Imm., NBsAg-NR, HIV-NR, Antibody negative. On 04 August 2006, 08 August 2006, 14 August 2006 and 17 August 2006 normal fetal stress test. On 12 Jan 2006, 04 July 2006, 20 June 2006, 05 July 2006 and 10 August 2006 were all normal ultrasounds. On 02 August 2006 was an abnormal ultrasound which revealed AFI-8.5, bilateral hydroceles. On 16 March 2006 genetic screening was normal and on 27 April 2006 GBS (group B strep) was positive. The patient had first trimester bleeding-threatened abortion and oligohydramnios at term with AFI (amniotic fluid)- 7.3. On 20 August 2006 she delivered a male baby vaginally at 38 5/7 weeks gestation with no congenital anomalies. APGAR testing revealed a score of 9 at one minute and a score of 9 at five minutes. List of Documents held by Sender: None. Another case was created for the baby which is captured in case number 2009-00011. The reporter of this case is same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113 and 2008-04115.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcal identification test positive, Ultrasound scan abnormal
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor. A 30 year old female patient with a history of chronic hypertension (controlled with LABETALOL), asthma, occasional UTI's, depression, anxiety in college and no drugs, tobacco or alcohol use. The patient received an initial intramuscular left deltoid injection of ADACEL (lot number C2456AA) on 08 May 2006. The patient's last menstrual period was on 22 November 2005 and estimated date of delivery was 29 August 2006. The patient had the following labs and diagnostics completed: On 16 March 2006: all normal serology testing showed: Parvovirus IgG 5.7, Parvovirus IgM negative, A+, Rubella Imm., NBsAg-NR, HIV-NR, Antibody negative. On 04 August 2006, 08 August 2006, 14 August 2006 and 17 August 2006 normal fetal stress test. On 12 Jan 2006, 04 July 2006, 20 June 2006, 05 July 2006 and 10 August 2006 were all normal ultrasounds. On 02 August 2006 was an abnormal ultrasound which revealed AFI-8.5, bilateral hydroceles. On 16 March 2006 genetic screening was normal and on 27 April 2006 GBS (group B strep) was positive. The patient had first trimester bleeding-threatened abortion and oligohydramnios at term with AFI (amniotic fluid)- 7.3. On 20 August 2006 she delivered a male baby vaginally at 38 5/7 weeks gestation with no congenital anomalies. APGAR testing revealed a score of 9 at one minute and a score of 9 at five minutes. List of Documents held by Sender: None. Another case was created for the baby which is captured in case number 2009-00011. The reporter of this case is same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113 and 2008-04115.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Antepartum haemorrhage, Antibody test negative, Bed rest, Blood immunoglobulin G normal, Body mass index
Clinical narrative: Initial report was received on 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not the sponsor. A 29 year old female patient with a history of humeral muscular dystrophy "autosomal dominant", hypothyroidism and no alcohol or drug use received ADACEL (lot number C2457AA) intramuscularly in the left deltoid on 05 May 2006. The patient's last menstrual period was on 20 October 2005 and estimated date of delivery was 27 July 2006. The patient had the following prenatal testing completed: On 13/Dec/2005: normal serologies, O+, antibody neg., HBsAg neg., Syph IgG neg., Gc/Chlam neg, HIV-NR. On 04/Jan/2006 and 06/Jun/2006 normal ultrasounds. On 10/Jan/2006: Ultrasounds: moderate sub-chorionic hemorrhage which was treated with bed rest. On 02/Mar/2006- ultrasound: 2VC. On 29 July 2006 the patient was induced with PITOCIN at 40 2/7 weeks. She had a vaginal delivery without complications or congenital anomalies. The patient delivered a baby girl and the APGAR score was 5 at one minute and 8 at five minutes. List of Documents held by Sender: none. The reporter of this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04116.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chlamydia identification test negative, Drug exposure during pregnancy, Hepatitis B surface antigen negative, Induced labour, Serology normal
Clinical narrative: Initial report was received on 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not the sponsor. A 29 year old female patient with a history of humeral muscular dystrophy "autosomal dominant", hypothyroidism and no alcohol or drug use received ADACEL (lot number C2457AA) intramuscularly in the left deltoid on 05 May 2006. The patient's last menstrual period was on 20 October 2005 and estimated date of delivery was 27 July 2006. The patient had the following prenatal testing completed: On 13/Dec/2005: normal serologies, O+, antibody neg., HBsAg neg., Syph IgG neg., Gc/Chlam neg, HIV-NR. On 04/Jan/2006 and 06/Jun/2006 normal ultrasounds. On 10/Jan/2006: Ultrasounds: moderate sub-chorionic hemorrhage which was treated with bed rest. On 02/Mar/2006- ultrasound: 2VC. On 29 July 2006 the patient was induced with PITOCIN at 40 2/7 weeks. She had a vaginal delivery without complications or congenital anomalies. The patient delivered a baby girl and the APGAR score was 5 at one minute and 8 at five minutes. List of Documents held by Sender: none. The reporter of this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04116.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Syphilis test negative, Ultrasound scan abnormal
Clinical narrative: Initial report was received on 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not the sponsor. A 29 year old female patient with a history of humeral muscular dystrophy "autosomal dominant", hypothyroidism and no alcohol or drug use received ADACEL (lot number C2457AA) intramuscularly in the left deltoid on 05 May 2006. The patient's last menstrual period was on 20 October 2005 and estimated date of delivery was 27 July 2006. The patient had the following prenatal testing completed: On 13/Dec/2005: normal serologies, O+, antibody neg., HBsAg neg., Syph IgG neg., Gc/Chlam neg, HIV-NR. On 04/Jan/2006 and 06/Jun/2006 normal ultrasounds. On 10/Jan/2006: Ultrasounds: moderate sub-chorionic hemorrhage which was treated with bed rest. On 02/Mar/2006- ultrasound: 2VC. On 29 July 2006 the patient was induced with PITOCIN at 40 2/7 weeks. She had a vaginal delivery without complications or congenital anomalies. The patient delivered a baby girl and the APGAR score was 5 at one minute and 8 at five minutes. List of Documents held by Sender: none. The reporter of this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04116.
Sex: M
Vaccine: TDAP
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M increased, Foetal non-stress test, HIV antibody negative, Hydrocele
Clinical narrative: Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor. A neonate male patient received an initial dose of ADACEL (lot number C2456AA) at approximately 24 weeks gestation placentally. The patient's mother was taking LABETALOL and prenatal vitamins concomitantly throughout the pregnancy. The patient's mother had the following prenatal testing completed: On 16/Mar/2006: parvovirus IgG 5.7, parvovirus IgM negative, Rubella- Imm, NBsAg-NR, HIV-NR, antibody negative. On 04/Aug/2006, 08/Aug/2006, 14/Aug/2006, 17/Aug/2006 normal reactive NST (non fetal stress test). On 12/Jan/2006, 04/Jul/2006, 20/Jun/2006, 05/Jul/2006, 10/Aug/2006 all normal ultrasounds. On 02/Aug/2006: bilateral hydroceles and oliohydramnios AF1-7.3. On 27/Apr/2006: the patient's mother was GBS (group B strep) positive. On 20/Aug/2006 the patient was born at 38 5/7 weeks gestation. The patient had an APGAR score of 9 at one minute and 9 at five minutes. The patient did not have any complications during delivery. List of Documents held by Sender: None. Another case was created for the baby's mother which captured in case number 2008-04114. The reporter of this case is same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114.