chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: Initial report received on 02 February 2010 from a consumer, who is the patient.  A 63 year old female patient, with no medical history and no illness at the time of vaccination, received a first left deltoid intramuscular injection of ADACEL (lot number C351AA) on 11 December 2009.  On 12 December 2009, the patient developed continuous aching left arm pain from the shoulder to the elbow.  It was accompanied by extreme episode of pain lasting up to 30 minutes.  She also had episodes of electrical shock type pain shooting up the arm.  "Pain scale 2-3 Episode 7-8".  On 05 January 2010, the patient had not recovered.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Initial report received on 02 February 2010 from a consumer, who is the patient.  A 63 year old female patient, with no medical history and no illness at the time of vaccination, received a first left deltoid intramuscular injection of ADACEL (lot number C351AA) on 11 December 2009.  On 12 December 2009, the patient developed continuous aching left arm pain from the shoulder to the elbow.  It was accompanied by extreme episode of pain lasting up to 30 minutes.  She also had episodes of electrical shock type pain shooting up the arm.  "Pain scale 2-3 Episode 7-8".  On 05 January 2010, the patient had not recovered.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test, Computerised tomogram, Dizziness, Dizziness postural, Electrocardiogram
Clinical narrative: Initial report received on 05 February 2010 from a consumer, who is the patient. A 35 year old female, with food allergies to soy and cinnamon, received a left deltoid intramuscular injection of ADACEL (lot number nor reported) on 04 February 2010. She had no other medical history, no concomitant medications, and had received no other vaccinations within the four previous weeks. She had an unspecified adverse event following prior vaccination as a child (vaccine not specified). At the time of vaccination, the patient was being seen in the ER for an infected ingrown toe nail. She also had a sore throat and sniffles. Within five to ten minutes of receiving ADACEL, the patient developed ringing in her ears and dizziness. That evening, she also had fever. At the time of the report, the patient had no recovered. Of note, the patient stated that she had refused and protested to getting the vaccine because "it was not indicated" but they administered it anyway.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site haematoma, Injection site pain, Pyrexia, Tinnitus
Clinical narrative: Initial report received on 05 February 2010 from a consumer, who is the patient. A 35 year old female, with food allergies to soy and cinnamon, received a left deltoid intramuscular injection of ADACEL (lot number nor reported) on 04 February 2010. She had no other medical history, no concomitant medications, and had received no other vaccinations within the four previous weeks. She had an unspecified adverse event following prior vaccination as a child (vaccine not specified). At the time of vaccination, the patient was being seen in the ER for an infected ingrown toe nail. She also had a sore throat and sniffles. Within five to ten minutes of receiving ADACEL, the patient developed ringing in her ears and dizziness. That evening, she also had fever. At the time of the report, the patient had no recovered. Of note, the patient stated that she had refused and protested to getting the vaccine because "it was not indicated" but they administered it anyway.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Pyrexia, Tinnitus
Clinical narrative: Initial report received on 05 February 2010 from a consumer, who is the patient. A 35 year old female, with food allergies to soy and cinnamon, received a left deltoid intramuscular injection of ADACEL (lot number nor reported) on 04 February 2010. She had no other medical history, no concomitant medications, and had received no other vaccinations within the four previous weeks. She had an unspecified adverse event following prior vaccination as a child (vaccine not specified). At the time of vaccination, the patient was being seen in the ER for an infected ingrown toe nail. She also had a sore throat and sniffles. Within five to ten minutes of receiving ADACEL, the patient developed ringing in her ears and dizziness. That evening, she also had fever. At the time of the report, the patient had no recovered. Of note, the patient stated that she had refused and protested to getting the vaccine because "it was not indicated" but they administered it anyway.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal, Premature labour
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5 ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. On 22 August 2009, 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. Follow-up information was received 19 April and 20 April 2010 from a health care professional. Maternal vaccination consisted of a left deltoid intramuscular injection of ADACEL, lot number UF460BA (sanofi pasteur Ltd. lot number C3066). According to the reporter, prenatal testing had not been performed (previously reported results with normal findings). Fetal demise had been known prior to birth, and the etiology for both pre-term labor and fetal death was reported as "premature rupture membranes". The onset of pre-term labor was 22 August 2009. According to the reporter, an autopsy had not been performed. The reporter for this case is the same for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5 ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. On 22 August 2009, 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. Follow-up information was received 19 April and 20 April 2010 from a health care professional. Maternal vaccination consisted of a left deltoid intramuscular injection of ADACEL, lot number UF460BA (sanofi pasteur Ltd. lot number C3066). According to the reporter, prenatal testing had not been performed (previously reported results with normal findings). Fetal demise had been known prior to birth, and the etiology for both pre-term labor and fetal death was reported as "premature rupture membranes". The onset of pre-term labor was 22 August 2009. According to the reporter, an autopsy had not been performed. The reporter for this case is the same for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature baby
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5 ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. On 22 August 2009, 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. Follow-up information was received 19 April and 20 April 2010 from a health care professional. Maternal vaccination consisted of a left deltoid intramuscular injection of ADACEL, lot number UF460BA (sanofi pasteur Ltd. lot number C3066). According to the reporter, prenatal testing had not been performed (previously reported results with normal findings). Fetal demise had been known prior to birth, and the etiology for both pre-term labor and fetal death was reported as "premature rupture membranes". The onset of pre-term labor was 22 August 2009. According to the reporter, an autopsy had not been performed. The reporter for this case is the same for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Sex: M
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature labour, Premature rupture of membranes
Clinical narrative: Initial report was received 19 February 2010 from a health care professional. A male patient had received a 0.5 ml transplacental dose of ADACEL (lot number not reported) on 07 July 2009 at 10 weeks gestation. Maternal history reported the patient's mother had been in good health and her last menstrual period was 26 April 2009. The patient's estimated date of delivery was 31 January 2010. On 22 August 2009, 46 days post vaccination, the patient was born vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was fetal demise. Prior to the event, prenatal testing had been normal (specific tests were not reported). According to the reporter, there had been no complications during labor and delivery, and there were no maternal problems until delivery at 22 weeks. A cause of death was not reported, and it was not reported if an autopsy had been performed. Follow-up information was received 19 April and 20 April 2010 from a health care professional. Maternal vaccination consisted of a left deltoid intramuscular injection of ADACEL, lot number UF460BA (sanofi pasteur Ltd. lot number C3066). According to the reporter, prenatal testing had not been performed (previously reported results with normal findings). Fetal demise had been known prior to birth, and the etiology for both pre-term labor and fetal death was reported as "premature rupture membranes". The onset of pre-term labor was 22 August 2009. According to the reporter, an autopsy had not been performed. The reporter for this case is the same for the mother case (delivery at 22 weeks) which has been captured in 2009-03014. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal, Premature labour
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred  26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighting 296 grams (0.296 kilograms) with no congenital anomalies. Apgar score were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complication s during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 18 march 2010. The patient had received the ADACEL (lot number UF460BA, Sanofi Pasteur SA lot number C3066) intramuscular in the left deltoid. Follow-up information was received on 19 April and 20 April 2010 from a health care professional. According to the reporter, prenatal testing had not been performed (previously reported with results of normal findings). Fetal demise had been known prior to birth and an autopsy had not been performed. The onset of preterm labor was 22 August 2009. Per the reporter, the etiology for both preterm labor and early fetal death was reported as premature rupture of membranes. According to the reporter, the patient recovered on 22 August 2009. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165. Document held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred  26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighting 296 grams (0.296 kilograms) with no congenital anomalies. Apgar score were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complication s during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 18 march 2010. The patient had received the ADACEL (lot number UF460BA, Sanofi Pasteur SA lot number C3066) intramuscular in the left deltoid. Follow-up information was received on 19 April and 20 April 2010 from a health care professional. According to the reporter, prenatal testing had not been performed (previously reported with results of normal findings). Fetal demise had been known prior to birth and an autopsy had not been performed. The onset of preterm labor was 22 August 2009. Per the reporter, the etiology for both preterm labor and early fetal death was reported as premature rupture of membranes. According to the reporter, the patient recovered on 22 August 2009. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165. Document held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature baby
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred  26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighting 296 grams (0.296 kilograms) with no congenital anomalies. Apgar score were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complication s during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 18 march 2010. The patient had received the ADACEL (lot number UF460BA, Sanofi Pasteur SA lot number C3066) intramuscular in the left deltoid. Follow-up information was received on 19 April and 20 April 2010 from a health care professional. According to the reporter, prenatal testing had not been performed (previously reported with results of normal findings). Fetal demise had been known prior to birth and an autopsy had not been performed. The onset of preterm labor was 22 August 2009. Per the reporter, the etiology for both preterm labor and early fetal death was reported as premature rupture of membranes. According to the reporter, the patient recovered on 22 August 2009. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165. Document held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Premature labour, Premature rupture of membranes
Clinical narrative: Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred  26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighting 296 grams (0.296 kilograms) with no congenital anomalies. Apgar score were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complication s during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 18 march 2010. The patient had received the ADACEL (lot number UF460BA, Sanofi Pasteur SA lot number C3066) intramuscular in the left deltoid. Follow-up information was received on 19 April and 20 April 2010 from a health care professional. According to the reporter, prenatal testing had not been performed (previously reported with results of normal findings). Fetal demise had been known prior to birth and an autopsy had not been performed. The onset of preterm labor was 22 August 2009. Per the reporter, the etiology for both preterm labor and early fetal death was reported as premature rupture of membranes. According to the reporter, the patient recovered on 22 August 2009. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165. Document held by sender: None.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discharge, Injection site nodule, Injection site pain, Wound complication
Clinical narrative: Initial case was received on 01 March 2010 from a healthcare professional.  A 22 year old female patient received a left deltoid intramuscular injection of ADACEL (Sanofi Pasteur Inc. lot number U2969BA, Sanofi Pasteur Ltd. lot number C3171) at 9:30 A.M. on 25 February 2010.  Beginning at 12:00 P.M. on 26 February 2010, the patient experienced a nodule at the injection site, described as the size of a "fingernail."  She returned to the physician on 01 March 2010 with complaint of an "oily" excretion from the nodule that smelled like "motor oil" and was the size of a quarter on her shirt.  The patient had no illness at the time of the vaccination.  She had no reported pre-existing medical conditions, no concomitant medications and no known allergies.  As of this report the event had not resolved.  Document held by sender:  None.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Application site odour, Injection site discharge, Injection site nodule
Clinical narrative: Initial case was received on 01 March 2010 from a healthcare professional.  A 22 year old female patient received a left deltoid intramuscular injection of ADACEL (Sanofi Pasteur Inc. lot number U2969BA, Sanofi Pasteur Ltd. lot number C3171) at 9:30 A.M. on 25 February 2010.  Beginning at 12:00 P.M. on 26 February 2010, the patient experienced a nodule at the injection site, described as the size of a "fingernail."  She returned to the physician on 01 March 2010 with complaint of an "oily" excretion from the nodule that smelled like "motor oil" and was the size of a quarter on her shirt.  The patient had no illness at the time of the vaccination.  She had no reported pre-existing medical conditions, no concomitant medications and no known allergies.  As of this report the event had not resolved.  Document held by sender:  None.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), TDAP, FLU(H1N1), TDAP
Symptoms: Caesarean section, Drug exposure during pregnancy, Premature labour, Ultrasound scan normal
Clinical narrative: Initial report received on 24 November 2009 via telephone conversation with health care professional. A pregnant 22-year-old female patient was vaccinated via intramuscular injection with ADACEL (Sanofi Pasteur, lot number UF500BA) and H1N1 (Sanofi Pasteur, lot number UP012AA) on 29 October 2009. The patient's medical history includes asthma, migraines and depression. Concomitant medications include PROZAC 20 mg and prenatal vitamins. Past obstetric history included one prior pregnancy with full term delivery (cesarean section for possible fetal distress). The patient's current pregnancy includes an unremarkable ultrasound from 27 August 2009. The patient's estimated due date for delivery is 01 January 2010 (corrected). The patient has not experienced any adverse events since being vaccinated. Follow-up information was received from the reporter on 29 March 2010. Based upon this new information, it was determined that the event met serious criteria, and has been upgraded to serious. The patient's last menstrual period was 05 April 2009, with an estimated delivery date of 10 January 2010. On 16 December 2009, at 36.2 weeks gestation, the patient experienced pre-term labor (reported as "repeat"). She was treated with Terbutaline, and delivered an infant weighing 6 pounds 2 ounces via C-section. Apgars scores were 8. No additional information was reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Laparotomy, Pregnancy test urine positive, Ruptured ectopic pregnancy
Clinical narrative: Initial report was received 09 June 2009 from a health care professional. A 33-year-old pregnant female with a history of asthma and no prior pregnancies had received a 0.5 mL intramuscular injection of ADACEL, lot number C3029AA on 03 June 2009. She had also been taking SINGULAIR 10mg and an unspecified inhaler concomitantly for her pre-existing condition of asthma. The patient's last menstrual period occurred on 12 May 2009 and she had been approximately three weeks pregnant at the time of vaccination. It was further noted that the patient had received ADACEL because she was a health care worker. On 8 June 2009, the patient had urine and blood serum pregnancy tests performed; results for both tests were provided on 09 June 2009 which confirmed a positive pregnancy. The patient's expected date of confinement was unknown at the time of the report. According to the reporter, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient had a tubal ectopic pregnancy on an unspecified date and was treated with methotrexate. Subsequently, an emergency laparotomy was performed for a ruptured ectopic on an unspecified date. No further information was provided. Follow-up information was received from the healthcare professional on 29 April 2010. The reporter had no additional information to report at this time. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Laparotomy, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: Initial report was received 09 June 2009 from a health care professional. A 33-year-old pregnant female with a history of asthma and no prior pregnancies had received a 0.5 mL intramuscular injection of ADACEL, lot number C3029AA on 03 June 2009. She had also been taking SINGULAIR 10mg and an unspecified inhaler concomitantly for her pre-existing condition of asthma. The patient's last menstrual period occurred on 12 May 2009 and she had been approximately three weeks pregnant at the time of vaccination. It was further noted that the patient had received ADACEL because she was a health care worker. On 8 June 2009, the patient had urine and blood serum pregnancy tests performed; results for both tests were provided on 09 June 2009 which confirmed a positive pregnancy. The patient's expected date of confinement was unknown at the time of the report. According to the reporter, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient had a tubal ectopic pregnancy on an unspecified date and was treated with methotrexate. Subsequently, an emergency laparotomy was performed for a ruptured ectopic on an unspecified date. No further information was provided. Follow-up information was received from the healthcare professional on 29 April 2010. The reporter had no additional information to report at this time. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ruptured ectopic pregnancy
Clinical narrative: Initial report was received 09 June 2009 from a health care professional. A 33-year-old pregnant female with a history of asthma and no prior pregnancies had received a 0.5 mL intramuscular injection of ADACEL, lot number C3029AA on 03 June 2009. She had also been taking SINGULAIR 10mg and an unspecified inhaler concomitantly for her pre-existing condition of asthma. The patient's last menstrual period occurred on 12 May 2009 and she had been approximately three weeks pregnant at the time of vaccination. It was further noted that the patient had received ADACEL because she was a health care worker. On 8 June 2009, the patient had urine and blood serum pregnancy tests performed; results for both tests were provided on 09 June 2009 which confirmed a positive pregnancy. The patient's expected date of confinement was unknown at the time of the report. According to the reporter, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient had a tubal ectopic pregnancy on an unspecified date and was treated with methotrexate. Subsequently, an emergency laparotomy was performed for a ruptured ectopic on an unspecified date. No further information was provided. Follow-up information was received from the healthcare professional on 29 April 2010. The reporter had no additional information to report at this time. Documents held by sender: None.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old male patient who experienced death. At 9 weeks of age, the patient received the first dose on 07-Apr-2010. The patient also received the first dose of ACT-HIB (Aventis) and the first dose of PEDIARIX (GlaxoSmithKline) on 07-Apr-2010. Additional suspect medication included ZANTAC. The patient was vaccinated with PREVNAR, ACT-HIB and PEDIARIX on 07-Apr-2010; ENGERIX B was given at birth on 01-Feb-2010. Antipyretics were not given at the time of vaccination. On 08-Apr-2010 the patient was found dead by chance sleeping alone in his crib. His last meal had been formula given before bed. He had been placed face down as found this way. Emergency medical personnel administered cardiopulmonary resuscitation and epinephrine in attempts to revive the child. An autopsy was performed but results were not available. The reporter noted that the patient's death could have been associated with his being found in the prone position. It was unknown whether the child experienced crying, fever, convulsions, other neurological events, allergic reaction or other adverse events following the vaccinations. Reportedly, within two weeks prior to vaccinations, the subject had not "attended the emergency room and not been exposed to contagious disease, had no history of infection, fever, excessive sweating during sleep, loud breathing or snoring during sleep, appetite change, diarrhea or stool change, dyspnea, abnormal crying, lethargy or other illness." The time interval between vaccination and death was reported as less than 24 hours. No additional information was available at the time of this report.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Resuscitation
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old male patient who experienced death. At 9 weeks of age, the patient received the first dose on 07-Apr-2010. The patient also received the first dose of ACT-HIB (Aventis) and the first dose of PEDIARIX (GlaxoSmithKline) on 07-Apr-2010. Additional suspect medication included ZANTAC. The patient was vaccinated with PREVNAR, ACT-HIB and PEDIARIX on 07-Apr-2010; ENGERIX B was given at birth on 01-Feb-2010. Antipyretics were not given at the time of vaccination. On 08-Apr-2010 the patient was found dead by chance sleeping alone in his crib. His last meal had been formula given before bed. He had been placed face down as found this way. Emergency medical personnel administered cardiopulmonary resuscitation and epinephrine in attempts to revive the child. An autopsy was performed but results were not available. The reporter noted that the patient's death could have been associated with his being found in the prone position. It was unknown whether the child experienced crying, fever, convulsions, other neurological events, allergic reaction or other adverse events following the vaccinations. Reportedly, within two weeks prior to vaccinations, the subject had not "attended the emergency room and not been exposed to contagious disease, had no history of infection, fever, excessive sweating during sleep, loud breathing or snoring during sleep, appetite change, diarrhea or stool change, dyspnea, abnormal crying, lethargy or other illness." The time interval between vaccination and death was reported as less than 24 hours. No additional information was available at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Initial report received on 10 May 2010 from a health care professional, who is also the patient.  A 45 year old female patient, with no allergies, no medical history, and no concomitant medications, received a left arm injection of ADACEL (lot number C3475AA) on 07 May 2010.  She had no illness at the time of vaccination and had received no other vaccinations within the four previous weeks.  Later, on the day of vaccination, the patient developed a sore left arm.  At approximately 2:00 A.M., the patient started to experience severe shaking, severe diffuse body pain, severe headache, severe chest wall pain on the left side, low grade fever, and loss of appetite.  The patient took Ibuprofen, but did not obtain any relief.  She took TYLENLOL with codeine and relief was provided until the dose wore off.  No laboratory or diagnostic tests were performed.  At the time of the report, 10 May 2010, the patient continued to have all symptoms.  Of note, three years prior to this event, the patient received MENACTRA (lot number not reported) and on the night of vaccination developed severe body ache, severe headache, severe shivering, and severe fever which lasted two to three hours.  These events are captured in case 2010-02676.
Age: 45.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chest pain, Decreased appetite, Headache, Injection site pain, Pain
Clinical narrative: Initial report received on 10 May 2010 from a health care professional, who is also the patient.  A 45 year old female patient, with no allergies, no medical history, and no concomitant medications, received a left arm injection of ADACEL (lot number C3475AA) on 07 May 2010.  She had no illness at the time of vaccination and had received no other vaccinations within the four previous weeks.  Later, on the day of vaccination, the patient developed a sore left arm.  At approximately 2:00 A.M., the patient started to experience severe shaking, severe diffuse body pain, severe headache, severe chest wall pain on the left side, low grade fever, and loss of appetite.  The patient took Ibuprofen, but did not obtain any relief.  She took TYLENLOL with codeine and relief was provided until the dose wore off.  No laboratory or diagnostic tests were performed.  At the time of the report, 10 May 2010, the patient continued to have all symptoms.  Of note, three years prior to this event, the patient received MENACTRA (lot number not reported) and on the night of vaccination developed severe body ache, severe headache, severe shivering, and severe fever which lasted two to three hours.  These events are captured in case 2010-02676.
Age: 45.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Initial report received on 10 May 2010 from a health care professional, who is also the patient.  A 45 year old female patient, with no allergies, no medical history, and no concomitant medications, received a left arm injection of ADACEL (lot number C3475AA) on 07 May 2010.  She had no illness at the time of vaccination and had received no other vaccinations within the four previous weeks.  Later, on the day of vaccination, the patient developed a sore left arm.  At approximately 2:00 A.M., the patient started to experience severe shaking, severe diffuse body pain, severe headache, severe chest wall pain on the left side, low grade fever, and loss of appetite.  The patient took Ibuprofen, but did not obtain any relief.  She took TYLENLOL with codeine and relief was provided until the dose wore off.  No laboratory or diagnostic tests were performed.  At the time of the report, 10 May 2010, the patient continued to have all symptoms.  Of note, three years prior to this event, the patient received MENACTRA (lot number not reported) and on the night of vaccination developed severe body ache, severe headache, severe shivering, and severe fever which lasted two to three hours.  These events are captured in case 2010-02676.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician and described the occurrence of skin discoloration in a 4-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline).  On 5 April 2010 at 09:30 the subject received 4th dose of KINRIX (unknown route, right thigh).  On 5 April 2010, immediately after vaccination with KINRIX, the subject experienced skin discoloration and skin hyperpigmentation.  At the time of reporting the outcome of the events was unspecified.  The physician considered the events were possibly related to vaccination with KINRIX.  The subject's mother brought the subject to the reporting physician on 29 April 2010 to allow them to look at the discoloration of her skin, described as hyperpigmentation.  The physician reported that she thinks that the mother noticed the discoloration immediately after the vaccination, but was not certain of that fact.  The physician had not seen the subject since 29 April 2010, so was unsure whether there had been any change in appearance.  The physician had also reported this case to a GSK sales representative, with the additional events of rash and possible vaccination site scar.  The onset date of these events was not specified.  The representative reported that the physician considered the events of hyperpigmentation, rash and vaccination site scar probably related to vaccination with KINRIX.  Follow-up information received from physician on 18 June 2010:  The start date of all events was 05 April 2010.  Biopsy was not performed.  At the time of reporting, the events were improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Immediate post-injection reaction, Rash, Skin discolouration, Skin hyperpigmentation, Vaccination site scar
Clinical narrative: This case was reported by a physician and described the occurrence of skin discoloration in a 4-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline).  On 5 April 2010 at 09:30 the subject received 4th dose of KINRIX (unknown route, right thigh).  On 5 April 2010, immediately after vaccination with KINRIX, the subject experienced skin discoloration and skin hyperpigmentation.  At the time of reporting the outcome of the events was unspecified.  The physician considered the events were possibly related to vaccination with KINRIX.  The subject's mother brought the subject to the reporting physician on 29 April 2010 to allow them to look at the discoloration of her skin, described as hyperpigmentation.  The physician reported that she thinks that the mother noticed the discoloration immediately after the vaccination, but was not certain of that fact.  The physician had not seen the subject since 29 April 2010, so was unsure whether there had been any change in appearance.  The physician had also reported this case to a GSK sales representative, with the additional events of rash and possible vaccination site scar.  The onset date of these events was not specified.  The representative reported that the physician considered the events of hyperpigmentation, rash and vaccination site scar probably related to vaccination with KINRIX.  Follow-up information received from physician on 18 June 2010:  The start date of all events was 05 April 2010.  Biopsy was not performed.  At the time of reporting, the events were improved.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Approximately 24hrs after vaccine administered - noted to have swollen & red area around injection site. Presented on 07/11/2010 and diagnosed with cellulitis.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Electroencephalogram
Clinical narrative: Head jerking started 5days after vaccination.
Age: 89.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood immunoglobulin E increased, Eosinophil count increased, Pruritus, Rash
Clinical narrative: Initial literature report received on 05 Jul 2010: Authors described about adverse events after flu vaccination in two patients with Immune disorders. This polymedicated patient (first case) with medical history of eczema and allergic rhinitis was vaccinated with seasonal flu vaccine (manufacturer unknown) and pneumococcus vaccine (manufacturer vaccine) on 14 Nov 2009. The patient's eczema was in remission at the time of injection. One week later (date unspecified), the patient developed a skin rash that became progressively more severe, involving both upper limbs, both knees and right ankle. The patient's trunk was also itchy but no rash. The patient was on multiple other drugs also since several years without any side effect. When rash was most pronounced, there were two significant laboratory findings including an increase in eosinophil count from 3.8% in a previous test to 18.7% (reference value unspecified) and immunoglobulin E was 3435.1 ng/mL (reference level: 0.2-379.2 ng/mL). The patient was treated with topical steroids, oral anti-histamines, and suspension of other medications (unspecified) for a week resulted in improvement of condition. The author concluded that the both cases did not constitute irrefutable evidence of vaccine-related exacerbations of immune disorders, but such type of adverse events should be noted for future references and emphasized the recommendation of foreign medical regulators about contraindication of H1N1 flu vaccine in patients with serious autoimmune diseases.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling abnormal, Pallor, Tinnitus, Unresponsive to stimuli
Clinical narrative: Client became pale and stated he felt faint.  Client dazed and was unresponsive to voice X 2 for approx. 5 sec.  Client stated ears ringing.  911 called.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Excoriation, Presyncope, Syncope
Clinical narrative: Patient had a syncopal episode in parking lot about 10 - 15 minutes after receiving vaccine.  Mother assisted to ground.  Patient taken to acute area for evaluation immediately afterwards.  Patient treated for vasovagal syncope and abrasions to knees cleaned and dressing applied.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dyskinesia, Hypotonia, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Within 10 min. client became faint and became limp.  Client exhibited extreme pallor.  Client jerked 3 times, was unresponsive to voice.  Client became alert but became pale again and vomited X 1.  911 called.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Within 10 min. client became faint and became limp.  Client exhibited extreme pallor.  Client jerked 3 times, was unresponsive to voice.  Client became alert but became pale again and vomited X 1.  911 called.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Bradycardia, Electrocardiogram T wave inversion, Electrocardiogram poor R-wave progression, Haemoglobin normal, Hyperhidrosis
Clinical narrative: 1120 admin. TDAP IM (L) delt - pt then went to Lab for a Hgb. Patient returned to exam room at 1145 and sat in chair. At 1147 patient became pale, mildly diaphoretic with bradycardia at 43 BPM given orange juice and crackers when able to sit - sent to ER by private auto with father for cardiac enzymes. No ? noted.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: 1120 admin. TDAP IM (L) delt - pt then went to Lab for a Hgb. Patient returned to exam room at 1145 and sat in chair. At 1147 patient became pale, mildly diaphoretic with bradycardia at 43 BPM given orange juice and crackers when able to sit - sent to ER by private auto with father for cardiac enzymes. No ? noted.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives around vaccine site as well as all over body - recommended giving BENADRYL.