chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 07 March 2008 from an other manufacturer, report # WAES 0803USA00147.  The other manufacturer received the original report from a physician.  Verbatim from the report.  "Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated PO with her first dose of Rotateq (lot # 656379/0505U).  Suspect vaccinations administered on that same day included the first dose of PEDIARIX (lot # AC21B124BA) in the right thigh, the first dose of ACTHIB in the left thigh, and the first dose of PREVNAR (lot #B47300B) in the left thigh.  On 08-NOV-2007 the patient experienced intussusception and was hospitalized (length of stay unknown).  On that same day an ultrasound was performed which revealed ileocolic intussusception.  Subsequently, the event resolved.  The reporter felt that ileocolic intussusception was possibly related to therapy with Rotateq, PEDIARIX, ACTHIB and PREVNAR.  Ileocolic intussusception was considered to be immediately life-threatening and clinically significant by the physician.  No further information is available."
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from an investigator concerning a 24 year old female with gastrooesophageal reflux, anxiety depression and who used contraception and was previously enrolled in a study; It was reported that the patient received 3 injections of placebo on 18-MAr-2003, 28-APR-2003 and in 03-SEP-2003. She completed the base study on 06-FEB-2006. She subsequently entered the study extension and was eligible to receive active vaccine via the market "Ex-Protocol Approach". On 23-OCT-2007 the patient was vaccinated with a first dose of GARDASIL stated. Concomitant therapy included PRILOSEC, WELLBUTRIN and "CYCLEN". She subsequently had a menstrual period in November and her first day of last menstrual period (LMP) was on 17-NOV-2007. The site contacted her on 26-DEC-2007, to come for the second vaccination and then the patient told them that she was pregnant. She had a positive home pregnancy test on 23-DEC-2007, and was estimated to be 6 weeks pregnant on 26-DEC-2007. Her estimated date of delivery is 23-AUG-2008. In follow up information it was reported that the patient had an elective termination of pregnancy on 16-JAN-2008. No complication reported. Upon internal review elective termination of pregnancy was determined to be an other important medical event. The reporting investigator had not indicated if the event was related to GARDASIL. No further information is available at this time.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from an 18 year old female consumer with Amoxicillin allergy who on 12-FEB-2008 was vaccinated with a first dose of Gardasil (route, site and lot # not reported).  There were no concomitant therapies.  Her last menstrual period was on 22-JAN-2008 and expected delivery date (EDC) being 28-OCT-2008.  She later found out that she had a miscarriage on 06-MAR-2008.  The consumer did not report if any laboratory tests were done.  No other information was available at this time.  Upon internal review "miscarriage" was determined to be an other important medical event.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Merck Pregnancy Registry Gardasil from a 26 year old female who in April 2007 and June 2007 was vaccinated with a first and second dose of Gardasil 0.5 mL injection.  The third dose of Gardasil was administered on 03-DEC-2007.  Subsequently the patient found out she is 4 weeks pregnant on 03-JAN-2008.  The patient's LMP date was 12-DEC-2007.  Unspecified medical attention was sought.  On 06-MAR-2008 the patient had a miscarriage.  At the time of reporting it was unknown if the patient had recovered.  No additional information was provided.  Upon internal review miscarriage was considered to be an other medical event.  Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angina pectoris, Angiogram, Angioplasty, Cardiac failure congestive, Cardiac pharmacologic stress test
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cardiomegaly, Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram ambulatory, Nuclear magnetic resonance imaging abnormal, Stent placement
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Amnesia, Angiogram, Angioplasty, Anoxia, Anoxic encephalopathy
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrioventricular block, Brain injury, Cardiac arrest, Cardiac disorder, Cardiac failure congestive
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac pacemaker insertion, Cardiac stress test, Cardiomegaly, Cardiomyopathy, Chest discomfort
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Computerised tomogram, Dementia, Disability, Dyspnoea
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Electrocardiogram ambulatory, Implantable defibrillator insertion
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Occupational therapy, Physiotherapy, Speech rehabilitation, Stent placement
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sudden death, Ventricular fibrillation
Clinical narrative: Information has been received from a consumer concerning her 71 year old husband with no known allergies and a history of aortic valve replacement (pig valve) in December 2003, a normal echocardiogram in December 2006 and a flu vaccine (dates and manufacturer not specified) who on 11-APR-2007 was vaccinated with ZOSTAVAX (#656859/0357U) in his left arm. Concomitant therapy included aspirin. The consumer reported that she and her husband "RV" and they were an active energetic couple that liked to hike. On 31-OCT-2007 the patient developed shortness of breath, angina, tightness and pressure in his chest. An EKG performed indicated that a blockage was developing. This blockage triggered an overall heart weakness. On 02-NOV-2007, a heart chemical stress test was done (no results reported) and on 03-DEC-2007, another echocardiogram was done (no results reported). On 12-DEC-2007, an angiogram was done (no results reported). On 22-JAN-2008, an MRI revealed the overall weakness of the patient's heart. On 22-JAN-2008 and 23-JAN-2008, the patient wore a Holter Monitor (no results reported). On 12-FEB-2008, the patient experienced chest pressure and was admitted to the hospital via ambulance. On 14-FEB-2008, a heart chemical stress test and angioplasty were done. Two stents were placed to the left anterior descending artery. The patient was placed on increasing doses of COREG in addition to LASIX, PLAVIX, aspirin, simvastatin and COUMADIN. The patient was told that a live virus caused the weakness in his heart. The patient was diagnosed with cardiomyopathy, cardiomegaly and congestive heart failure. He was discharged from the hospital on 16-FEB-2008. As of 06-MAR-2008, the patient had not recovered. There was discussion as to whether the patient would need a possible pacemaker or defibrillator. The consumer felt that her husband's heart problems may have been related to the ZOSTAVAX. She noted that the previous flu shot was ruled out in causing the weakness of his heart. Additional information is not expected. 5/19/08-records received from cardiologist. 10/31/07-presented with C/O chest discomfort with dull ache in left chest area for past 3 nights. Recently began exercising using a stationary bike and developed chest pain 10-15 minutes into exercises.1/16/08-seend for C/O chest pain lightheadedness, peripheral edema. Left ventricular dysfunction with totally occluded right coronary artery. Stenting of LAD. Ischemic and nonischemic cardiomyopathy. 06/9/08-records received-3/13/07-office visit continues to see neurologist regarding peripheral neuropathy which is status quo.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: Localised muscle weakness, muscle pain, injection site reaction.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Discomfort, Injected limb mobility decreased, Injection site reaction, Mobility decreased
Clinical narrative: Localised muscle weakness, muscle pain, injection site reaction.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Localised muscle weakness, muscle pain, injection site reaction.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Henoch-Schonlein purpura, Laboratory test, Oedema peripheral, Prothrombin time
Clinical narrative: Pt. developed swelling in legs with purple discoloration under skin the day after flu shot given.  Pt. has seen doctor other than Dr., is on oral steroid - tentative diagnosis - allergic purpura.  3/19/08 Reviewed hospital medical records of 12/9-12/13/2007 admission. FINAL DX: Henoch-Scholein purpura, resolving. Records reveal patient experienced swelling & purplish discolortion of legs x several days.  PCP vs of 11/29 dx w/purpura & tx w/steroids.  Cleared lesions but they recurred in addition to discoloration & swelling of scrotum.  Tx w/IV steroids & transfused w/PRBC.  Improved & d/c to home on tapering steroids. .
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Pt. developed swelling in legs with purple discoloration under skin the day after flu shot given.  Pt. has seen doctor other than Dr., is on oral steroid - tentative diagnosis - allergic purpura.  3/19/08 Reviewed hospital medical records of 12/9-12/13/2007 admission. FINAL DX: Henoch-Scholein purpura, resolving. Records reveal patient experienced swelling & purplish discolortion of legs x several days.  PCP vs of 11/29 dx w/purpura & tx w/steroids.  Cleared lesions but they recurred in addition to discoloration & swelling of scrotum.  Tx w/IV steroids & transfused w/PRBC.  Improved & d/c to home on tapering steroids. .
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Numerous attempts were made between 08/22 - 08/24/07 to reach mother, unsuccessful (pay-as-go phone not accepting calls). TC to clinic 08/24/07 for review - child was not admitted to hospital. He was treated in ER only (transferred to clinic from hospital with fever and seizure). No further problems reported R/C to this incident. Treated for unrelated Febrile episode/seizure 2". Sent home that morning with mother. Spoke with nurse at hospital also and she had the same understanding from clinic - r/o seizure 2 hours imms - seizure 2 hours febrile episode.  3/19/08  Reviewed ER medical records of 8/21/2007. FINAL ER Dx: Seizure disorder Records reveal patient experienced seizure activity during sleep with shaking, foaming at the mouth, incoherent, eyes rolled back, urinary incontinence.  Post ictal in ER.  Transferred to higher level of care. 4/4/08 Reviewed 2nd ER medical records of 8/21/2007. FINAL DX: new onset seizure. Records reveal patient experienced s/s as noted at previous ER.  Patient very sleepy.  Discussed w/neuro
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Patient has had complaints of pain to shot site for 3 weeks.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1/11/08 patient states started having low grade fever the night of 1/8/08.  1/9/08 temp of 101.8.  Arm red at site about size of quarter and swelling on 1/10/08.  Redness increased to about 8" in size.  Arm warm to touch and painful.  The fatigue and restless increased from 1/8/08.  States had been taking Ibuprofen and took Benadryl.  States has called into MD.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Restlessness
Clinical narrative: 1/11/08 patient states started having low grade fever the night of 1/8/08.  1/9/08 temp of 101.8.  Arm red at site about size of quarter and swelling on 1/10/08.  Redness increased to about 8" in size.  Arm warm to touch and painful.  The fatigue and restless increased from 1/8/08.  States had been taking Ibuprofen and took Benadryl.  States has called into MD.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: 12/3/07 at 0930, Tdap 0.5cc and HPV 0.5cc IM LD.  Client immediately lost consciousness.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient has since discovered she's pregnant - was on depo, menstrual irregular.  Very possibly pregnant on day of immunization.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Paraesthesia oral, Throat tightness, Tremor
Clinical narrative: Patient calls 2 hours after vaccination administered.  Complained of nausea, shaky, tingling of lips and tongue.  Went to hospital when tightness in throat began.  Was treated with Benadryl, Phenergan, Cortisone and released.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash generalised
Clinical narrative: Client's mother in LHU for services today 10/4/07 - states daughter had reaction to Gardasil given on Monday, 8/27/07.  States Tuesday, she had fine rash all over body, went away by Wednesday afternoon.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Oedema peripheral, Skin warm
Clinical narrative: Complained of muscle spasms from hand to neck and shoulder blades that started day after vaccine.  Arm swollen, warm to touch for 7 days.  No fever, no chills, still complaining of spasms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Throat tightness, Wheezing
Clinical narrative: Patient reports approximately 10pm 11/01 when went to bed developed wheezing, tightness in chest and throat lasting 30 minutes.  Did not seek medical care.  No problems since.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 24-48 hours after Double softball size, red, swollen, hand and hot to touch area. Treated with Benadryl prn.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Immediate post-injection reaction, Vomiting projectile
Clinical narrative: Immediately after receiving 1-2 drops of the ROTATEQ vaccine, the infant's face turned red and had projectile vomitus.  Second attempt a few minutes later (1-2 drops) the same outcome.  ROTATEQ stopped.  Referred to hospital today.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Pyrexia, Urticaria, Wheezing
Clinical narrative: Felt fatigue and febrile for several days after vaccine.  On 3-10-2008, noted onset of urticaria and wheezing.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pruritus, Urticaria
Clinical narrative: Patient BF was given IM Tdap at 1750, then Rocephin 2 grams IM at 1825.  At approximately 1850 patient reported having itching/redness/hives.  Patient was given 0.3cc EPL 1:1000 SC/Benadryl 50mg IM/Solu-Medrol 250 IV mixed with 500cc NS (IV).  4L 02 via nasal cannula and transported to ER.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Back pain, Urticaria
Clinical narrative: Right lower lumbar, pain with rash present with localized hive
Age: 24.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Diarrhoea, Throat lesion, Vomiting
Clinical narrative: 10 days post MMR #1 and TDAP #1 client felt OK in am Monday. Then in afternoon started vomiting all thru Tuesday 2/19/08 had diarrhea and noted spots in her throat on that day.  Still feeling very weak.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Seen in office 3/7/08 at 1430 for mild erythema of approx 3x3 cm area on left deltoid. Dr stated redness and swelling already subsiding. Ice and Motrin recommended.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Platelet count decreased, Rash
Clinical narrative: 3/6/08 Thousands of reds dots - bilat legs thigh (upper) to ankles. Also less severe rash on back, hips, flanks, bilat arms. Dots not painful, not itchy, denies fever, or malaise. States she feels fine. Patient recently showered and shaved legs, but rash is on more areas of body. No other changes in soaps, detergents, lotions. Complained of right arm very sore, claims shot was in bone.  4/1/08 Reviewed hematology outpatient clinic note of 3/7/08. FINAL DX: severe idiopathic thrombocytopenia. Records reveal patient experienced petechiae all over LEs that spread to abdomen & arms, nosebleeds, gums bleeding, bloody vaginal discharge, intermittent HA.  Exam also revealed mucosal petechiae & purpura.  Rubbery lymph nodes at jaw.  Spleen questionably palpable.  Tx w/WinRho & was to f/u w/her pcp.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antibody test negative, Antinuclear antibody negative, Blood immunoglobulin G normal, Brown-Sequard syndrome, CSF cell count normal
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: CSF oligoclonal band present, CSF white blood cell count increased, Cardiolipin antibody negative, DNA antibody negative, Demyelination
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test positive, Gait disturbance, Hemiparesis, Hypoaesthesia
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyporeflexia, Immunology test normal, Injection site anaesthesia, Laboratory test normal, Liver function test normal
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lumbar puncture, Movement disorder, Muscular weakness, Myelitis transverse, Nausea
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Peripheral sensory neuropathy, Red blood cells CSF positive, Sensory disturbance, Serology negative, Spinal cord disorder
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Stomach discomfort
Clinical narrative: Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.