chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Hepatitis, Hepatitis viral test, Hepatomegaly, Jaundice, Pharyngitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Splenomegaly, Urine analysis abnormal, Urine bilirubin increased, Urobilin urine present
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Biopsy bone marrow, Biopsy liver abnormal, Blood bilirubin increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Diarrhoea, Epstein-Barr virus antibody positive, Fatigue, Gallbladder disorder, Hepatic failure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Hepatitis acute, Hepatomegaly, International normalised ratio increased, Jaundice, Liver function test abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Needle biopsy site unspecified abnormal, Pharyngitis, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Splenomegaly, Transaminases increased, Ultrasound scan abnormal, Urine analysis abnormal, Urine bilirubin increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Urobilin urine present, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Abasia, Arthralgia, Back pain, Juvenile arthritis, Musculoskeletal pain
Clinical narrative: Initial report received on 26 May 2009 from another manufacturer, report # WAES0905USA01139. The initial reporter to the manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a nurse practitioner concerning her 18 year old daughter who on 29-AUG-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included MENACTRA. On approximately 05-SEP-2007 the patient experienced lower back, butt, pelvis, and hip pain. The patient was hospitalized from 28-DEC-2008 to 31-DEC-2008 because she could not walk. She had since been diagnosed with juvenile rheumatoid arthritis. The reporter considered the events to be disabling. Follow up information was received from this nurse practitioner. She reported that her daughter on 29-AUG-2007 was vaccinated with GARDASIL (Lot # 658222/0927U). Secondary suspect therapy included MENACTRA (U2381BA). Within a week of the two vaccinations the patient complained of pain in the jaw, lower back, pelvis, hips and buttocks. The symptoms became more severe in about 3.5 months. By December of 2007, the patient had two episodes of difficulty walking and needed help to walk. The patient had an MRI which revealed inflammation with no confirmed diagnosis. The patient was hospitalized in December 2007. In January of 2008 the patient was seen by an Orthopedic Specialist. The patient received joint injections and had a bone marrow biopsy. The patient was also seen by an Oral surgeon and received jaw injections, IM and methotrexate injections, SC. In March of 2008, the patient was seen by a Pediatric Rheumatologist. The nurse stated that she thought that the Rheumatologist reported the case about her daughter to the CDC. The patient was started on HUMIRA injections, IM and methotrexate injections, SC. In June of 2008, the patient was started on REMICADE by infusion every 4 weeks. Laboratory evaluation were performed every 4 weeks. The patient did not have another episode where she could not walk but the patient was never pain free. Additional information is not expected."
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Pelvic pain
Clinical narrative: Initial report received on 26 May 2009 from another manufacturer, report # WAES0905USA01139. The initial reporter to the manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a nurse practitioner concerning her 18 year old daughter who on 29-AUG-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included MENACTRA. On approximately 05-SEP-2007 the patient experienced lower back, butt, pelvis, and hip pain. The patient was hospitalized from 28-DEC-2008 to 31-DEC-2008 because she could not walk. She had since been diagnosed with juvenile rheumatoid arthritis. The reporter considered the events to be disabling. Follow up information was received from this nurse practitioner. She reported that her daughter on 29-AUG-2007 was vaccinated with GARDASIL (Lot # 658222/0927U). Secondary suspect therapy included MENACTRA (U2381BA). Within a week of the two vaccinations the patient complained of pain in the jaw, lower back, pelvis, hips and buttocks. The symptoms became more severe in about 3.5 months. By December of 2007, the patient had two episodes of difficulty walking and needed help to walk. The patient had an MRI which revealed inflammation with no confirmed diagnosis. The patient was hospitalized in December 2007. In January of 2008 the patient was seen by an Orthopedic Specialist. The patient received joint injections and had a bone marrow biopsy. The patient was also seen by an Oral surgeon and received jaw injections, IM and methotrexate injections, SC. In March of 2008, the patient was seen by a Pediatric Rheumatologist. The nurse stated that she thought that the Rheumatologist reported the case about her daughter to the CDC. The patient was started on HUMIRA injections, IM and methotrexate injections, SC. In June of 2008, the patient was started on REMICADE by infusion every 4 weeks. Laboratory evaluation were performed every 4 weeks. The patient did not have another episode where she could not walk but the patient was never pain free. Additional information is not expected."
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Abasia, Arthralgia, Back pain, Gait disturbance, Inflammation
Clinical narrative: Initial report received on 26 May 2009 from another manufacturer, report # WAES0905USA01139. The initial reporter to the manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a nurse practitioner concerning her 18 year old daughter who on 29-AUG-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included MENACTRA. On approximately 05-SEP-2007 the patient experienced lower back, butt, pelvis, and hip pain. The patient was hospitalized from 28-DEC-2008 to 31-DEC-2008 because she could not walk. She had since been diagnosed with juvenile rheumatoid arthritis. The reporter considered the events to be disabling. Follow up information was received from this nurse practitioner. She reported that her daughter on 29-AUG-2007 was vaccinated with GARDASIL (Lot # 658222/0927U). Secondary suspect therapy included MENACTRA (U2381BA). Within a week of the two vaccinations the patient complained of pain in the jaw, lower back, pelvis, hips and buttocks. The symptoms became more severe in about 3.5 months. By December of 2007, the patient had two episodes of difficulty walking and needed help to walk. The patient had an MRI which revealed inflammation with no confirmed diagnosis. The patient was hospitalized in December 2007. In January of 2008 the patient was seen by an Orthopedic Specialist. The patient received joint injections and had a bone marrow biopsy. The patient was also seen by an Oral surgeon and received jaw injections, IM and methotrexate injections, SC. In March of 2008, the patient was seen by a Pediatric Rheumatologist. The nurse stated that she thought that the Rheumatologist reported the case about her daughter to the CDC. The patient was started on HUMIRA injections, IM and methotrexate injections, SC. In June of 2008, the patient was started on REMICADE by infusion every 4 weeks. Laboratory evaluation were performed every 4 weeks. The patient did not have another episode where she could not walk but the patient was never pain free. Additional information is not expected."
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Juvenile arthritis, Laboratory test, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in jaw
Clinical narrative: Initial report received on 26 May 2009 from another manufacturer, report # WAES0905USA01139. The initial reporter to the manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a nurse practitioner concerning her 18 year old daughter who on 29-AUG-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included MENACTRA. On approximately 05-SEP-2007 the patient experienced lower back, butt, pelvis, and hip pain. The patient was hospitalized from 28-DEC-2008 to 31-DEC-2008 because she could not walk. She had since been diagnosed with juvenile rheumatoid arthritis. The reporter considered the events to be disabling. Follow up information was received from this nurse practitioner. She reported that her daughter on 29-AUG-2007 was vaccinated with GARDASIL (Lot # 658222/0927U). Secondary suspect therapy included MENACTRA (U2381BA). Within a week of the two vaccinations the patient complained of pain in the jaw, lower back, pelvis, hips and buttocks. The symptoms became more severe in about 3.5 months. By December of 2007, the patient had two episodes of difficulty walking and needed help to walk. The patient had an MRI which revealed inflammation with no confirmed diagnosis. The patient was hospitalized in December 2007. In January of 2008 the patient was seen by an Orthopedic Specialist. The patient received joint injections and had a bone marrow biopsy. The patient was also seen by an Oral surgeon and received jaw injections, IM and methotrexate injections, SC. In March of 2008, the patient was seen by a Pediatric Rheumatologist. The nurse stated that she thought that the Rheumatologist reported the case about her daughter to the CDC. The patient was started on HUMIRA injections, IM and methotrexate injections, SC. In June of 2008, the patient was started on REMICADE by infusion every 4 weeks. Laboratory evaluation were performed every 4 weeks. The patient did not have another episode where she could not walk but the patient was never pain free. Additional information is not expected."
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, VARCEL
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Information has been received from an office manager concerning a 12 year old female who on 19-MAY-2009 was vaccinated with a dose of VARIVAX (lot#663819/0336Y) and the patient had a "severe reaction of swelling at the injection site that continued to get larger".  It was reported that the patient also had numbness and tingling and complained of having difficulty breathing.  The patient sought medical attention and visiting the physician's office.  The patient was taken to the emergency room and was admitted for 24 hours.  On an unspecified date the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, VARCEL
Symptoms: Dyspnoea, Hypoaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Information has been received from an office manager concerning a 12 year old female who on 19-MAY-2009 was vaccinated with a dose of VARIVAX (lot#663819/0336Y) and the patient had a "severe reaction of swelling at the injection site that continued to get larger".  It was reported that the patient also had numbness and tingling and complained of having difficulty breathing.  The patient sought medical attention and visiting the physician's office.  The patient was taken to the emergency room and was admitted for 24 hours.  On an unspecified date the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Pallor, Urinary incontinence
Clinical narrative: Pt had vaccines administered at Health Department on 6/1/09, within 5 minutes pt had syncope and seizure, lasted under 1 minute then pt had additional seizure.  Pt transported to ER. CT normal.  EEG pending.  I saw pt on 6/2/09 (day after vaccines), she was not feeling steady, no fever. She was seen again in ER that night for headache vomiting and 100.3 fever per moms call.  CT and Spinal tap done and reported as negative.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Balance disorder, Computerised tomogram, Convulsion, Electroencephalogram, Headache
Clinical narrative: Pt had vaccines administered at Health Department on 6/1/09, within 5 minutes pt had syncope and seizure, lasted under 1 minute then pt had additional seizure.  Pt transported to ER. CT normal.  EEG pending.  I saw pt on 6/2/09 (day after vaccines), she was not feeling steady, no fever. She was seen again in ER that night for headache vomiting and 100.3 fever per moms call.  CT and Spinal tap done and reported as negative.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Lumbar puncture, Pyrexia, Syncope, Vomiting
Clinical narrative: Pt had vaccines administered at Health Department on 6/1/09, within 5 minutes pt had syncope and seizure, lasted under 1 minute then pt had additional seizure.  Pt transported to ER. CT normal.  EEG pending.  I saw pt on 6/2/09 (day after vaccines), she was not feeling steady, no fever. She was seen again in ER that night for headache vomiting and 100.3 fever per moms call.  CT and Spinal tap done and reported as negative.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Pericarditis
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 82 year old female patient with Behcet's syndrome, colitis, morphine allergy, DARVOCET allergy and MOTRIN allergy and a history of cardiac failure congestive who on 29-APR-2009 was vaccinated with a dose of ZOSTAVAX (Lot # 663202/1730X) 0.65ml, subcutaneously. Concomitant therapy included ASACOL, LOPERAMID, oxazepam, sucralfate, TOPROL XL TABLETS, colchicine, lisinopril, furosemide, "cholestryramine", ezetimibe (+) simvastatin (MSD), CELEBREX and TYLENOL WITH CODEINE. On 30-APR-2009 after she received the vaccine, the patient experienced pericarditis, congestive heart failure and pleural effusion. On 30-APR-2009 to 12-MAY-2009 the patient was hospitalized. At the time of the report on 01-JUN-2009 the patient had been recovering. On unspecified date echocardiogram, chest x-ray and other unspecified studies and laboratories were performed results not reported. Pericarditis, congestive heart failure, and pleural effusion were reported as disabling and life-threatening. A priority lot check has been requested. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Chest X-ray, Condition aggravated, Echocardiogram, Laboratory test
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 82 year old female patient with Behcet's syndrome, colitis, morphine allergy, DARVOCET allergy and MOTRIN allergy and a history of cardiac failure congestive who on 29-APR-2009 was vaccinated with a dose of ZOSTAVAX (Lot # 663202/1730X) 0.65ml, subcutaneously. Concomitant therapy included ASACOL, LOPERAMID, oxazepam, sucralfate, TOPROL XL TABLETS, colchicine, lisinopril, furosemide, "cholestryramine", ezetimibe (+) simvastatin (MSD), CELEBREX and TYLENOL WITH CODEINE. On 30-APR-2009 after she received the vaccine, the patient experienced pericarditis, congestive heart failure and pleural effusion. On 30-APR-2009 to 12-MAY-2009 the patient was hospitalized. At the time of the report on 01-JUN-2009 the patient had been recovering. On unspecified date echocardiogram, chest x-ray and other unspecified studies and laboratories were performed results not reported. Pericarditis, congestive heart failure, and pleural effusion were reported as disabling and life-threatening. A priority lot check has been requested. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pericarditis, Pleural effusion
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 82 year old female patient with Behcet's syndrome, colitis, morphine allergy, DARVOCET allergy and MOTRIN allergy and a history of cardiac failure congestive who on 29-APR-2009 was vaccinated with a dose of ZOSTAVAX (Lot # 663202/1730X) 0.65ml, subcutaneously. Concomitant therapy included ASACOL, LOPERAMID, oxazepam, sucralfate, TOPROL XL TABLETS, colchicine, lisinopril, furosemide, "cholestryramine", ezetimibe (+) simvastatin (MSD), CELEBREX and TYLENOL WITH CODEINE. On 30-APR-2009 after she received the vaccine, the patient experienced pericarditis, congestive heart failure and pleural effusion. On 30-APR-2009 to 12-MAY-2009 the patient was hospitalized. At the time of the report on 01-JUN-2009 the patient had been recovering. On unspecified date echocardiogram, chest x-ray and other unspecified studies and laboratories were performed results not reported. Pericarditis, congestive heart failure, and pleural effusion were reported as disabling and life-threatening. A priority lot check has been requested. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Dysarthria, Fall, Hiccups, Hypoaesthesia
Clinical narrative: Two weeks after the vaccination, I'm getting weaker and weaker. Have cold symptom like. Went to dinner. After 10 minutes, experience hiccup. My cousin offered me a bottle of water. I open it and drank it. When I'm about to close it my (R) hand drop the bottle cover. Pick it up again and drop it again. Then I fainted, drop on the ground, slurred speech. All left side is numb with tingling sensation. Until now still experiencing numbness and tingling sensation on (L) Hand and (L) foot.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Nasopharyngitis, Paraesthesia, Syncope
Clinical narrative: Two weeks after the vaccination, I'm getting weaker and weaker. Have cold symptom like. Went to dinner. After 10 minutes, experience hiccup. My cousin offered me a bottle of water. I open it and drank it. When I'm about to close it my (R) hand drop the bottle cover. Pick it up again and drop it again. Then I fainted, drop on the ground, slurred speech. All left side is numb with tingling sensation. Until now still experiencing numbness and tingling sensation on (L) Hand and (L) foot.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: It looked like a huge hive 2 x 3 1/2 inches. It was red and hot and lasted 5 days. (It was on the injection site).
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reddness, swelling and warmth to site where varivax was administered.
Age: 57.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Chills, Confusional state, Coordination abnormal, Depression, Erythema
Clinical narrative: After each rabies vaccine, had progressively worse headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, uncoordinated, confusion, dry heaves, worse sleep disorder.  Still with headache, sleeping problem, muscle weakness, fatigue, depression.  Had to stay in ER for several hrs after each vaccine.
Age: 57.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Fatigue, Headache, Hyperhidrosis, Muscle fatigue, Retching
Clinical narrative: After each rabies vaccine, had progressively worse headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, uncoordinated, confusion, dry heaves, worse sleep disorder.  Still with headache, sleeping problem, muscle weakness, fatigue, depression.  Had to stay in ER for several hrs after each vaccine.
Age: 57.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Sleep disorder
Clinical narrative: After each rabies vaccine, had progressively worse headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, uncoordinated, confusion, dry heaves, worse sleep disorder.  Still with headache, sleeping problem, muscle weakness, fatigue, depression.  Had to stay in ER for several hrs after each vaccine.
Age: 57.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Headache, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: After each rabies vaccine, had progressively worse headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, uncoordinated, confusion, dry heaves, worse sleep disorder.  Still with headache, sleeping problem, muscle weakness, fatigue, depression.  Had to stay in ER for several hrs after each vaccine.
Age: 57.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Protein total, Pulmonary function test, Urine analysis
Clinical narrative: After each rabies vaccine, had progressively worse headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, uncoordinated, confusion, dry heaves, worse sleep disorder.  Still with headache, sleeping problem, muscle weakness, fatigue, depression.  Had to stay in ER for several hrs after each vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Diet refusal, Injection site erythema, Injection site mass, Vomiting
Clinical narrative: Patient's mom, states she tried to feed her in the AM and she vomited. Vomiting x 3 from 7:30 Am - 12 N. Refuses to eat or drink. No fever or diarrhea or other symptoms. Injection site at arms ok. (L) leg ok (R) leg small red bump. No swelling of injection sites. Patient normal, playing. Advised to monitor temp and watch for other symptoms. Also advised to call pediatrician for consultation.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Has hard, red swollen area at one injection site (believes to be varicella) running fever.  (Right arm site of injection).
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Blister, Rash generalised
Clinical narrative: Received immunizations @ 9AM - broke out in rash starting @ 12 N 1 place under eye (looked like blister- went away- 2 under neck @ 1:30 they went away then @ 4PM started getting them all over arms, face legs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Fall, Gaze palsy, Immediate post-injection reaction
Clinical narrative: Immediately following administration of GARDASIL she was sitting on exam table, felt lightheaded and fainted. falling to floor.  Mother in room reported patients eyes rolled back - immediately was awake & alert to place - Right hip sore from fall.  Had normal vital signs.  Rested , drank fluids & went home within 30 minutes
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Immediately following administration of GARDASIL she was sitting on exam table, felt lightheaded and fainted. falling to floor.  Mother in room reported patients eyes rolled back - immediately was awake & alert to place - Right hip sore from fall.  Had normal vital signs.  Rested , drank fluids & went home within 30 minutes
Age: 1.5
Sex: F
Vaccine: DT, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Vaccines 2/20/09 ----> mom reports LA (left arm) injection sit on 03/03/09 became red, raised, warm to touch physician diagnosed as cellulitis. Parents applied warm packs to site x3 days. 03/07/09 to physician decreased no further Tx prescribed. 03/03/09 diagnosed with non specific generalized body rash - x1 day treated with BENEDRYL.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt had small area of urticaria @ flexor surface of (R) arm on day of vaccination, but four days later, she developed urticaria over entire upper body & face.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Immediate post-injection reaction, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female with a history of convulsions and under the care of an unspecified neurologist who was vaccinated with the first (lot # 0947X), the second (lot # 1423X) and the third (lot # 0294Y) dose of GARDASIL (IM, 0.5ml) on 28-NOV-2008, 28-JAN-2009 and 28-MAY-2009 respectively. Concomitant therapy included Yaz. On 28-MAY-2009 the patient "fainted and then went into convulsions" immediately after receiving her third dose of GARDASIL. The patient roused after 60 seconds and was fully recovered within 1 hour. The patient did not have lab diagnostics studies performed. The patient did not experience adverse symptoms after the first and second dose of GARDASIL. Follow-up information has been received from a medical assistant who stated that the patient did not receive any concomitant vaccines when she received the GARDASIL. The reporter stated that the patient was on the exam table when she fainted and went into convulsions. The nurse was able to lay the patient down on the exam table. The reporter stated that the patient's neurologist was not documented in the patient's chart. Upon internal review, convulsions was determined to be an other important medical event. Additional information has been requested.