chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Urinary tract infection, White blood cell disorder
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anaemia, Anorexia, Brain oedema, Coombs positive haemolytic anaemia, Disseminated intravascular coagulation
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Enzyme abnormality, Haemolysis, Hypoxia, Leukocytosis, Pyrexia
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Somnolence, Stupor, Subarachnoid haemorrhage, Thrombocythaemia
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anaemia, Anorexia, Blood lactate dehydrogenase increased, Brain oedema, Disseminated intravascular coagulation
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Haemolysis, Haemolytic anaemia, Leukocytosis, Pyrexia, Somnolence
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Stupor, Subarachnoid haemorrhage, Thrombocytopenia, Urinary tract infection, Urine analysis abnormal
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anaemia, Anorexia, Brain oedema, Disseminated intravascular coagulation, Haemolysis
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Leukocytosis, Pyrexia, Somnolence, Stupor, Subarachnoid haemorrhage
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Urinary tract infection
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Irritability, Otitis media
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Angioneurotic oedema, Injection site erythema, Injection site swelling
Clinical narrative: Two hours post vax parent noticed hives on pt's neck and trunk. Instructed by MD to give Benadryl and symptoms resolved over several days. Symptoms returned 2 wks later and have not abated. Pt gets hives daily and also swelling of eyes, face, hands, feet and ankles. Pt also had purpuric rash on trunk.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Eye swelling, Oedema peripheral, Purpura, Swelling face, Urticaria
Clinical narrative: Two hours post vax parent noticed hives on pt's neck and trunk. Instructed by MD to give Benadryl and symptoms resolved over several days. Symptoms returned 2 wks later and have not abated. Pt gets hives daily and also swelling of eyes, face, hands, feet and ankles. Pt also had purpuric rash on trunk.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Urticaria
Clinical narrative: Two hours post vax parent noticed hives on pt's neck and trunk. Instructed by MD to give Benadryl and symptoms resolved over several days. Symptoms returned 2 wks later and have not abated. Pt gets hives daily and also swelling of eyes, face, hands, feet and ankles. Pt also had purpuric rash on trunk.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, IPV, MMR
Symptoms: Rash erythematous
Clinical narrative: This child had a rash on his torso, arms, legs, neck, and face. Raised area of various sizes to 1 1/2 cm diameter.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, IPV, MMR
Symptoms: Rash, Rash maculo-papular
Clinical narrative: This child had a rash on his torso, arms, legs, neck, and face. Raised area of various sizes to 1 1/2 cm diameter.
Sex: F
Vaccine: IPV, MMR, IPV, MMR
Symptoms: Erythema, Injection site inflammation
Clinical narrative: On 08/23/01 this patient had elevated pink area on the back of her left arm at the site of the MMR (diameter 1 1/2 inch).
Sex: F
Vaccine: IPV, MMR, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 08/23/01 this patient had elevated pink area on the back of her left arm at the site of the MMR (diameter 1 1/2 inch).
Age: 63.0
Sex: F
Vaccine: YF, YF
Symptoms: Rash
Clinical narrative: This patient had yellow fever vaccine administered on 08/14/01, 1-2 days later she developed diffuse rash. She was seen by physician in the office on 08/21/01. Diffuse erythematous maculopapular eruption; spread face and mucus membranes.
Age: 63.0
Sex: F
Vaccine: YF, YF
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: This patient had yellow fever vaccine administered on 08/14/01, 1-2 days later she developed diffuse rash. She was seen by physician in the office on 08/21/01. Diffuse erythematous maculopapular eruption; spread face and mucus membranes.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Brain oedema, Headache, Hernia, Lethargy, Pyrexia
Clinical narrative: On 08/12, headache complaints, On 08/14, headache and a fever. On 08/15, lethargic. On 08/17, herniation. On 08/18, life support removed.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Viral infection
Clinical narrative: On 08/12, headache complaints, On 08/14, headache and a fever. On 08/15, lethargic. On 08/17, herniation. On 08/18, life support removed.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Headache, Hernia, Lethargy, Pyrexia
Clinical narrative: On 08/12, headache complaints, On 08/14, headache and a fever. On 08/15, lethargic. On 08/17, herniation. On 08/18, life support removed.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Unevaluable event
Clinical narrative: On 08/12, headache complaints, On 08/14, headache and a fever. On 08/15, lethargic. On 08/17, herniation. On 08/18, life support removed.
Age: 0.4
Sex: M
Vaccine: HEP, PNC
Symptoms: Crying, Purpura, Sepsis
Clinical narrative: A consumer reported that her 5 month old son received his 2nd dose of Prevnar and Hep-B vaccines on 7/23/01. Two days later, the child was hospitalized with sepsis and purpura. No further information was available at the time of this report. F/U info was rec'd on 9/18/01 the hepatitis B vaccine rec'd by the pt was Engerix B. An additional adverse event was reported high pitched crying. The pt was hospitalized for 8 days in an intensive care unit. He subsequently recovered.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: On 6/25/01, the pt had a fever and a seizure X 1. Exam was normal except for fever. Dx'd with viral induced fever versus fever from MMR and febrile seizure. On 7/21/01, had non-febrile seizure.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Analgesic effect, Balance disorder, Facial palsy, Headache, Muscular weakness
Clinical narrative: Pt reported that soon after receiving the TD vaccine, she developed dysequilibrium, visual blurring, facial discomfort, severe pain of the right upper extremity and right trapezius area and right upper extremity analgesia. She was later noted with a facial droop and right medial pectus weakness.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Vision blurred
Clinical narrative: Pt reported that soon after receiving the TD vaccine, she developed dysequilibrium, visual blurring, facial discomfort, severe pain of the right upper extremity and right trapezius area and right upper extremity analgesia. She was later noted with a facial droop and right medial pectus weakness.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Convulsion, Loss of consciousness, Pallor
Clinical narrative: Post vax, child became pale and white and unconscious for about 1 1/2 minutes, non-responsive to sound or touch. It took 45 minutes to regain normal behavior. Went to ER and admitted. Continued to have episodes that have been dx'd as seizures and he is now on phenobarbital.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abnormal behaviour, Apathy, Crying, Mood swings, Pyrexia
Clinical narrative: Ran fever of 102F and screamed with shot. For the next couple of months, he started not have eye contact, lack of facial expression, starring spells and bizarre mood swings. Per doc 199569, patient ran fever day of injection, crying. The annual follow up states still autistic like behaviors, no eye contact, speech delay.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Speech disorder, Staring
Clinical narrative: Ran fever of 102F and screamed with shot. For the next couple of months, he started not have eye contact, lack of facial expression, starring spells and bizarre mood swings. Per doc 199569, patient ran fever day of injection, crying. The annual follow up states still autistic like behaviors, no eye contact, speech delay.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: CSF test abnormal, Dizziness, Headache, Hyperventilation, Pyrexia
Clinical narrative: The pt experienced a fever on 7/13/01 which continued until 7/16/01. On 7/18/01 developed a severe debilitating headache. Pain was on "top" of head. Pain was so bad it caused the pt to hyperventilate and become very dizzy.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Joint swelling, Rheumatoid arthritis
Clinical narrative: The pt experienced joint pain and swelling. Went to a physician. Lab test were done and the child was diagnosed with juvenile rheumatoid arthritis. Went to a hospital and diagnosis was confirmed. Parents were told that it might be due to the Varicella Vaccine. The annual follow up states child's diagnosis is rheumatoid arthritis. Child is refusing care. Takes medication.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Hypotonia, Lethargy, Pyrexia, Staring
Clinical narrative: The pt received vaccines on 8/25/01. On 8/26/01 became febrile to 102, experienced and episode of atonia, unresponsive with forward staring. The pt regained consciousness with lethargy. The pt was taken to ER and given 1 dose of Tylenol and became afebrile thereafter.
Age: 0.62
Sex: F
Vaccine: HEP, PNC
Symptoms: Febrile convulsion, Urinary tract infection
Clinical narrative: Pt started having febrile seizures on 6/19/01, lasting over 1 hour, originally. Dx'd as a Urinary Tract Infection. Original urine results were lost by hospital. All subsequent tests, including urine cultures-neg. The hospital believes seizures are from Prevnar.
Age: 72.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Bone pain, Ear pain, Headache, Muscle spasms
Clinical narrative: Progressive pain and disability in the following: knee to knee to hip, fingers to shoulders, to elbows, to feet with earaches, failing eye sight and tingling on skin surfaces. Also has finger numbness, muscle pain, head and neck pain. The annual follow-up states "all bones, joints, front teeth very painful. Large muscle cramp and painful disabling at an ever increasing pace disease."
Age: 72.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Neck pain, Paraesthesia, Visual acuity reduced
Clinical narrative: Progressive pain and disability in the following: knee to knee to hip, fingers to shoulders, to elbows, to feet with earaches, failing eye sight and tingling on skin surfaces. Also has finger numbness, muscle pain, head and neck pain. The annual follow-up states "all bones, joints, front teeth very painful. Large muscle cramp and painful disabling at an ever increasing pace disease."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: The pt experienced a fever and was hospitalized on 8/22/01 to 8/24/01.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: On 7/28/01 pt's upper left arm became hot and swollen. She had no fever. On 7/30/01 pt was taken to the ER since her condition did not improve. She was told she had an allergic reaction. She was put on antibiotics and steroids.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blister, Injection site induration, Rash papular, Skin nodule, Skin ulcer
Clinical narrative: Pt developed initial induration at site of DTAP and polio vax which measured about 4 cm when seen at 24 hrs. Pt was treated symptomatically. She developed vesicles with crusts which resolved. 5 days post vax pt has since developed a similar area of induration on calf with denuded 1 cm ulcerative base of vesicle. Pt also has another smaller papule with about 1 cm of induration on right forearm.
Age: 0.75
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: After receiving vax pt started screaming and crying uncontrollably. This lasted for 5 days. He also ran a temperature of 100-102. Tylenol was given.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Dermatitis bullous, Injection site induration, Injection site vesicles
Clinical narrative: Pt developed local induration at injection site with 10-15 blisters, varicella appearance.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Leukopenia
Clinical narrative: Pt developed fever with convulsion on the sixth day post vax.
Age: 0.3
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: The evening of receiving vax pt had a temp of 103.8 and was cranky. On 8/25/01 his temp was 103. The duration of the temp was 1.5 days.
Age: 1.9
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Dyspnoea, Injection site swelling, Urticaria
Clinical narrative: Pt developed swelling at injection site and hives over entire body day of vax. Pt was taken to ER on 8/16/01 because of difficulty breathing.
Age: 14.0
Sex: M
Vaccine: PNC
Symptoms: Grand mal convulsion, Injection site erythema
Clinical narrative: Pt awoke around 6:30 AM on 8/22/01 with grand mal seizure lasting about 2 minutes requiring Diastat to stop. Pt also noted to have an approximately 7" red area at injection site. The redness resolved over 24 hours. Pt had no other reaction. He was well on 8/23/01.
Age: 0.6
Sex: M
Vaccine: IPV, PNC
Symptoms: Irritability
Clinical narrative: Within 1 hour after receiving vax mother noticed a marked increase in irritability which lasted for 24 hours. Mother stated pt did not have a noticeable fever, but it was not checked. Pt was fine the next day without treatment.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Drooling, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Pt started turning head side to side, stiffening, drooling, body taut, making gurgling sounds and shrill, shrieking noises and her skin was sweaty. After 45 mins of attempts to bring her out of what was happening, 911 was called. Paramedic assessed pt as all right at that time.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Torticollis
Clinical narrative: Pt started turning head side to side, stiffening, drooling, body taut, making gurgling sounds and shrill, shrieking noises and her skin was sweaty. After 45 mins of attempts to bring her out of what was happening, 911 was called. Paramedic assessed pt as all right at that time.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pharyngitis, Rhinorrhoea
Clinical narrative: Varicella vaccine was being administered to pt's child when child struggled, and pt was accidentally scratched by clean needle. A clean needle was replaced on the syringe and child was given injection. On 8/22/01 pt complained of runny nose, cough and cold symptoms due to scratch.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Hyperglycaemia, Muscular weakness
Clinical narrative: Mother reported that pt "can't hold his head up." She stated she was taking him to ER because pediatrician told her to. See ER record and nurse's notes. (ER visit unremarkable. Advised mother to "keep an eye on the child.") Pt never had a fever.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt started with fever of 101 at 17:30 which was controlled until 22:15. Temperature then went up to 101.8, and at 23:30 it was 104 even with prior cooling measures and Tylenol.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Ear disorder, Infection, Irritability, Listless, Oral intake reduced
Clinical narrative: Pt had a fever for 3 days post vax. There was no local reaction to the vax. Pt was quite irritable and somewhat listless at times. During this same time frame, the pt was placed on Augmentin for serous otitis. As of 8/22/01 the pt had been off the Augmentin for several days. The pt was eating, but not great, and sleeping a little longer. As of 8/22/01 pt seemed to be gradually getting better.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt had a fever for 3 days post vax. There was no local reaction to the vax. Pt was quite irritable and somewhat listless at times. During this same time frame, the pt was placed on Augmentin for serous otitis. As of 8/22/01 the pt had been off the Augmentin for several days. The pt was eating, but not great, and sleeping a little longer. As of 8/22/01 pt seemed to be gradually getting better.
Age: 0.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Decreased appetite, Irritability, Rash
Clinical narrative: Pt developed irritability, rash and a decreased appetite.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Blister, Discomfort, Erythema
Clinical narrative: Office visit on 8/27/01 revealed on back of right hand and scattered on lateral arm from tip to shoulder vesicular clusters and isolates with significant erythema and discomfort with palpation. Pt was placed on Acyclovir.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed fever to 101.3 which lasted 36 hrs and a rash from head to toe, even on face, soles of feet and palms of hands. Rash had small, raised bumps, and it was still bad on his back and bottom 1 week later. No scratching was noted. The rash is slowly improving and the pt is acting well.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue, Hypokinesia, Laboratory test abnormal
Clinical narrative: Pt developed arthritic problems in knees, back and neck with swelling. Pt developed fatigue. Pt developed severe joint pain to several joints. The pain travels and pt experiences loss of use of limb until the pain leaves or goes to another joint. Pt could not write or work or lift leg, etc.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Pain, Swelling
Clinical narrative: Pt developed arthritic problems in knees, back and neck with swelling. Pt developed fatigue. Pt developed severe joint pain to several joints. The pain travels and pt experiences loss of use of limb until the pain leaves or goes to another joint. Pt could not write or work or lift leg, etc.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: About an hour post vax pt broke out with hives all over, in mouth also. Mother took pt to private MD where she was treated with oral Benadryl. Mother was advised to give Benadryl q6h. Pt also had an increased temperature to 103. Pt was fine the next AM. Private MD felt it was "probably vaccine related."
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed a quarter sized red, hot, tender spot that was sore to the touch. The site was swollen the first 24 hrs post vaccine and then red spot was flush to skin at 48 hours post vax.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed a 7 x 9.5 cm area of erythema, induration, warmth and swelling on 8/29/01.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Pt developed redness to left shoulder 5 mins after IPV given. Benadryl 6ml given PO as ordered. Within 20 mins all of the redness had disappeared. There were no respiratory problems and no distress was noted at discharge.
Age: 27.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed an 8 cm diameter local area of redness and swelling.