chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Anorexia, Appendicectomy, Bowel movement irregularity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 12 week male patient with Gastro esophageal reflux disease and a history of Respiratory syncytial virus bronchiolitis was vaccinated with the second dose of ROTATEQ (lot 661054/0966x) orally on 29-DEC-2008. Concomitant vaccine included the second dose of PREVNAR (Lot #C99098) intramuscularly into the right leg, the second dose of PEDIARIX (Lot #AC21B198BA), intramuscularly into the right leg and the second dose of ACTHIB (Lot # UF520AA) intramuscularly into the left leg. About 2 weeks post vaccination, child had intussusception. The patient was admitted to the hospital for intussusception on 15-JAN-2009. Final diagnostic: intussusception after laparotomy with reduction of ileal segment and appendectomy. Records revealed patient experienced anorexia, diet refusal, increased irritability, occasional emesis for 3 days, no bowel movement for 2 days and abdominal pain for one day. The patient had bloody stool in emergency room. Surgery consult was done. Enema did not reduce ileal segment and the patient was taken to operation room. Progressed well, diet advanced and discharged to home with surgery follow-up. The patient returned to emergency room on 22-JAN-2009 due to vomiting, diarrhea, irritability and apparent abdominal pain. Final diagnostic: gastroenteritis. Surgery consult done. Labs diagnostics performed included: abdominal x-ray negative and abdominal ultrasound positive ileal segment. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 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 government and was released. The original reporting source was not provided. The VAERS ID # is 341802. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Enema administration, Gastroenteritis, Haematochezia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 12 week male patient with Gastro esophageal reflux disease and a history of Respiratory syncytial virus bronchiolitis was vaccinated with the second dose of ROTATEQ (lot 661054/0966x) orally on 29-DEC-2008. Concomitant vaccine included the second dose of PREVNAR (Lot #C99098) intramuscularly into the right leg, the second dose of PEDIARIX (Lot #AC21B198BA), intramuscularly into the right leg and the second dose of ACTHIB (Lot # UF520AA) intramuscularly into the left leg. About 2 weeks post vaccination, child had intussusception. The patient was admitted to the hospital for intussusception on 15-JAN-2009. Final diagnostic: intussusception after laparotomy with reduction of ileal segment and appendectomy. Records revealed patient experienced anorexia, diet refusal, increased irritability, occasional emesis for 3 days, no bowel movement for 2 days and abdominal pain for one day. The patient had bloody stool in emergency room. Surgery consult was done. Enema did not reduce ileal segment and the patient was taken to operation room. Progressed well, diet advanced and discharged to home with surgery follow-up. The patient returned to emergency room on 22-JAN-2009 due to vomiting, diarrhea, irritability and apparent abdominal pain. Final diagnostic: gastroenteritis. Surgery consult done. Labs diagnostics performed included: abdominal x-ray negative and abdominal ultrasound positive ileal segment. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 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 government and was released. The original reporting source was not provided. The VAERS ID # is 341802. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Laparotomy, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 12 week male patient with Gastro esophageal reflux disease and a history of Respiratory syncytial virus bronchiolitis was vaccinated with the second dose of ROTATEQ (lot 661054/0966x) orally on 29-DEC-2008. Concomitant vaccine included the second dose of PREVNAR (Lot #C99098) intramuscularly into the right leg, the second dose of PEDIARIX (Lot #AC21B198BA), intramuscularly into the right leg and the second dose of ACTHIB (Lot # UF520AA) intramuscularly into the left leg. About 2 weeks post vaccination, child had intussusception. The patient was admitted to the hospital for intussusception on 15-JAN-2009. Final diagnostic: intussusception after laparotomy with reduction of ileal segment and appendectomy. Records revealed patient experienced anorexia, diet refusal, increased irritability, occasional emesis for 3 days, no bowel movement for 2 days and abdominal pain for one day. The patient had bloody stool in emergency room. Surgery consult was done. Enema did not reduce ileal segment and the patient was taken to operation room. Progressed well, diet advanced and discharged to home with surgery follow-up. The patient returned to emergency room on 22-JAN-2009 due to vomiting, diarrhea, irritability and apparent abdominal pain. Final diagnostic: gastroenteritis. Surgery consult done. Labs diagnostics performed included: abdominal x-ray negative and abdominal ultrasound positive ileal segment. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 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 government and was released. The original reporting source was not provided. The VAERS ID # is 341802. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: X-ray normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 12 week male patient with Gastro esophageal reflux disease and a history of Respiratory syncytial virus bronchiolitis was vaccinated with the second dose of ROTATEQ (lot 661054/0966x) orally on 29-DEC-2008. Concomitant vaccine included the second dose of PREVNAR (Lot #C99098) intramuscularly into the right leg, the second dose of PEDIARIX (Lot #AC21B198BA), intramuscularly into the right leg and the second dose of ACTHIB (Lot # UF520AA) intramuscularly into the left leg. About 2 weeks post vaccination, child had intussusception. The patient was admitted to the hospital for intussusception on 15-JAN-2009. Final diagnostic: intussusception after laparotomy with reduction of ileal segment and appendectomy. Records revealed patient experienced anorexia, diet refusal, increased irritability, occasional emesis for 3 days, no bowel movement for 2 days and abdominal pain for one day. The patient had bloody stool in emergency room. Surgery consult was done. Enema did not reduce ileal segment and the patient was taken to operation room. Progressed well, diet advanced and discharged to home with surgery follow-up. The patient returned to emergency room on 22-JAN-2009 due to vomiting, diarrhea, irritability and apparent abdominal pain. Final diagnostic: gastroenteritis. Surgery consult done. Labs diagnostics performed included: abdominal x-ray negative and abdominal ultrasound positive ileal segment. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 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 government and was released. The original reporting source was not provided. The VAERS ID # is 341802. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: PL received the Zostavax vaccine on 4/3/2009.  About 2 days after the injection she noticed a big, red, and swollen area on her upper arm.  She reported it being about 5 inches in size.  She also noted that there was a hard spot and it looked similar to a bee sting.  She stated she experienced minimal itching and it was not painful.  It lasted for about a week before it disappeared, and during this time she did not do anything to treat this.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus
Clinical narrative: PL received the Zostavax vaccine on 4/3/2009.  About 2 days after the injection she noticed a big, red, and swollen area on her upper arm.  She reported it being about 5 inches in size.  She also noted that there was a hard spot and it looked similar to a bee sting.  She stated she experienced minimal itching and it was not painful.  It lasted for about a week before it disappeared, and during this time she did not do anything to treat this.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: NB received the ZOSTAVAX vaccine on 4/10/2009.  After administration of the vaccine, she reported a dollar sized red wheel around the injection site.  It was not raised or bumpy.  She did not experience any pain or itching.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Alanine aminotransferase increased, Albumin globulin ratio abnormal, Alpha 1 globulin increased, Alpha 2 globulin increased, Anti-SS-A antibody positive
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Antineutrophil cytoplasmic antibody positive, Antinuclear antibody positive, Arthralgia, Arthritis, Aspartate aminotransferase increased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune hepatitis, Biopsy liver abnormal, Biopsy skin abnormal, Blood albumin decreased, Blood alkaline phosphatase increased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Blood calcium normal, Blood chloride decreased, Blood cholesterol increased, Blood creatinine normal, Blood glucose increased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Blood immunoglobulin G increased, Blood sodium decreased, Blood sodium increased, Blood triglycerides increased, Blood urea increased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray abnormal, Colonoscopy abnormal, Computerised tomogram abnormal
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram thorax abnormal, DNA antibody positive, Double stranded DNA antibody, Electrophoresis protein abnormal, Eosinophil percentage increased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Gamma-glutamyltransferase increased, Haematocrit decreased, Haemoglobin decreased, Hepatic cirrhosis, High density lipoprotein decreased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Hypertension, Immunoglobulins increased, Liver function test normal, Low density lipoprotein decreased, Lymphocyte count decreased
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Mean cell haemoglobin concentration decreased, Mean platelet volume decreased, Myalgia, Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Osteoarthritis, Pain, Platelet count normal, Protein total increased, Pulmonary function test abnormal
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width increased, Rheumatoid factor positive, Smooth muscle antibody positive
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Transferrin saturation decreased, Urobilin urine present, White blood cell count decreased, Whole body scan, X-ray abnormal
Clinical narrative: Subject received BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. He was diagnosed with autoimmune hepatitis and inflammatory arthritis. He is also being treated for high blood pressure. 4/16/09 Medical Records received from Dr.'s office. See case for details. Summary of Medical Records: Subject was initially evaluated in the Rheumatology Clinic on April 4, 2008. This individual has received multiple immunizations in the past related to his military service. Subject has experienced diffuse pain, including myalgias and arthralgias, in the past 1 year with a workup revealing several positive auto-antibodies including positive ANA, homogenous pattern with titer of 1:2560, borderline elevated rheumatoid factor, positive anti-SSA/anti-RO antibody, positive anti-SmRNP antibody, positive liver smooth muscle antibody, positive P-NCA of greater than 1:320, and elevated sed rate and CRP. Laboratory tests reveal negative anti-dsDNA, negative anti-SSB/LA, negative anti-SM, negative anti-RNP, negative anti-Jo-1, negative anti-SCL70. X-rays of all affected areas showed changes consistent with inflammatory arthritis. A whole body bone scan revealed no evidence of inflammatory arthritis, however there were multiple areas of degenerative arthritis. A liver biopsy on July 22, 2008 confirmed the diagnosis of autoimmune hepatitis. A wedge resection of the liver on October 22, 2008 revealed auto-immune hepatitis-related cirrhosis. He is receiving treatment with IMURAN. The Subject's medical record also includes a history of: AAA repair, bilateral inguinal hernia repair, smoking/COPD, lung granuloma, GERD, diverticulosis, and eczematous rash vs. primary eczema.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Osteomyelitis, Swelling
Clinical narrative: Information has been received from a health care professional concerning an 11 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient called the next day after receiving GARDASIL with complaints of swelling. It was reported that this adverse event occurred four to five months ago (approximately in December 2008). It was reported that two weeks later the patient was at the office and was referred to the Emergency Room and was provided antibiotics. The patient was identified with osteomyelitis and was hospitalized for three to four days. It was reported that the patient had recovered at the time of the report. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her now 5 year old son with OMNICEF allergy and a history of bronchiolitis at 5 weeks of age who was vaccinated with a dose of MMR II at around 1 year of age (in approximately October 2004). Concomitant therapy included vitamins (unspecified). The patient was later diagnosed with autism at around 2 years of age (in approximately October 2005). At time of reporting, the patient did not recover. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Paralysis
Clinical narrative: Information has been received from a female patient, with iodine allergy and "severe food allergies", who on approximately 09-MAY-1977, at the age of 18 months old, was vaccinated with MMR II. There was no concomitant medication. The patient reported that when she was 18 months old, she received the MMR II and immediately after receiving the vaccine she became paralyzed for several days. The consumer reported that she was not hospitalized but was under the care of a physician and she recovered about a week after MMR II. Upon internal review paralysis was determined to be an other important medical event. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her friends' boys who on an unspecified dates were vaccinated with MMRII. "One week later", the children were diagnosed as being autistic. No further information was provided at this time. It was unknown if the patients sought medical attention or not. Upon internal review, autism was considered to be other important medical event. No further information is available.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram abnormal, Fat necrosis
Clinical narrative: This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of the peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008, and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Infarction, Lymphoid hyperplasia of appendix, Nausea
Clinical narrative: This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of the peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008, and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.
Age: 59.0
Sex: F
Vaccine: DT
Symptoms: Dyspnoea, Emphysema, Wheezing
Clinical narrative: Initial report was received 28 January 2009 from a consumer, who is also the patient. A 59-year-old female patient with history of a recent black widow spider bite (reported as May 2007), had received a left arm injection of DECAVAC, lot number U1759AA on an unspecified date in May 2007. The patient had been bitten by a black widow spider that had been in her shoes. During the summer (also reported as July 2007), the patient developed wheezing and stated she has had breathing problems ever since receiving the vaccine and spider bite. The patient had no reported illness at the time of vaccination and her medical history was reported as unknown. The patient has been receiving treatment under the care of her physician with a diagnosis of emphysema. At the time of the report, the patient's recovery status was unknown. Follow-up information was received on 21 April 2009 from a health care professional who stated that the patient received DECAVAC and treatment for a spider bite in May 2007. Following both incidents, the patient complained of shortness of breath/dyspnea and wheezing. In December 2007 the patient was seen by the reporter. Albuterol, Amoxicillin, Prednisone, ADVAIR, and SPIRIVA were prescribed for her symptoms. The patient returned to the reporter every month for an evaluation. The patient has never smoked but had a history of wheezing. However, the wheezing became worse following the spider bite and vaccination. The patient believed the symptoms were a result of the vaccination or the spider bite. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Joint swelling, Urticaria
Clinical narrative: hives covering entire body, swelling of joints, benadryl, oral steroids
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Mood altered, Pain in extremity
Clinical narrative: Within 5 min. post injection patient had mood change, redness, swelling at injection site along with leg pain. We watched patient for a while and then he seemed okay. We sent home with instructions with parent to use benadryl and tylenol, cold compresses as needed. Mom agreed.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Pain in extremity, Pallor, Tremor
Clinical narrative: Client received Tdap without any symptoms of concern. Then, immediately after HPV vaccine was given, the client complained that her arm hurt. She turned her head away and when I checked on her(within seconds), her upper body stiffened and her head and arms started shaking. She was very pale. Shaking lasted 15-30 seconds, then her eyes were opened very wide and she seemed to be aware that something had just happened.  She did not complain of dizziness, nausea, discomfort other than her right arm, headache or any other symptoms.  Vitals lying down - 10:20 am: BP 118/70, pulse 88; 10:23 am BP 122/74, Pulse 64, Resp 14; 10:38 am BP 118/60, pulse 76; 10:46 am BP 108/68, resp. 20,pulse 80, temp 98.4. Vitals sitting upright - 10:53 am BP 110/70; pulse 76; 11:02 BP 118/40, Pulse 68, Resp. 16.  Client was given Tylenol, peanut butter crackers and orange juice and reported feeling much better.  Telephone messages left for parent.
Age: 62.0
Sex: F
Vaccine: DTP
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Reaction to Tdap, muscle aches, headaches, fatigue.  Worst was injection site allergic reaction to pertussus vaccine.  Arm was very red, swollen, very hot and had an large red area covering approximately 3-4 inches.  Called facility and was told to take ibuprofen, to take benadryl and use warm wet compresses.  I was told to watch for redness spreading and any lumps under the arm.  I took acetamenaphine, benadryl and used compresses and slept a lot for a few days.  Symptoms are diminishing but still present.
Age: 62.0
Sex: F
Vaccine: DTP
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Reaction to Tdap, muscle aches, headaches, fatigue.  Worst was injection site allergic reaction to pertussus vaccine.  Arm was very red, swollen, very hot and had an large red area covering approximately 3-4 inches.  Called facility and was told to take ibuprofen, to take benadryl and use warm wet compresses.  I was told to watch for redness spreading and any lumps under the arm.  I took acetamenaphine, benadryl and used compresses and slept a lot for a few days.  Symptoms are diminishing but still present.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Read area around the Shingles vaccine
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Hyperaesthesia, Nausea, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Member reports beginning to feel nauseous 6 hours after receiving vaccine. 18- 24 hours post vaccination member reports nausea and 2 incidents of vomiting. Exam shows a flat,red, lacy rash 15 x 6 cm across chest, and 20 x 5 cm in the center of her back.  The rash itches and is sensitive to the touch.  Will follow up in 24 hours.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Member reports beginning to feel nauseous 6 hours after receiving vaccine. 18- 24 hours post vaccination member reports nausea and 2 incidents of vomiting. Exam shows a flat,red, lacy rash 15 x 6 cm across chest, and 20 x 5 cm in the center of her back.  The rash itches and is sensitive to the touch.  Will follow up in 24 hours.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Full blood count, Pyrexia
Clinical narrative: HIGH FEVER WITH NORMAL CBC,PARENT REPORTED 106 DEGREE FEVER THE NIGHT VACCINE WERE GIVEN
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Pt received MMR and Varicella vaccines and immedicately developed redness and swelling at both injection sites and hives on abdomen. No respiratory distress noted. Given single dose of benadryl with resolution of sxs
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right deltoid- 2 days sfter vaccine administration, the injection site is hard, red, warm to touch and tender upon palpation.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: Herpes Zoster  C34 dermatoma    Greater than 20 vesicles