chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Immunodeficiency, Lipodystrophy acquired, Lung infiltration, Mechanical ventilation
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Respiratory distress, Scab, Secretion discharge, Skin lesion
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sputum culture positive, Sputum purulent, Staphylococcal infection, Staphylococcus test positive, Varicella virus test positive
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bacteraemia, Biopsy skin abnormal, Blister, Blood culture positive, Bronchoscopy abnormal
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Central obesity, Chest X-ray abnormal, Cushingoid, Death, Dyspnoea
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Erythema, General physical health deterioration, Herpes virus infection, Immunosuppression
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lipodystrophy acquired, Lung infiltration, Mechanical ventilation, Rash, Respiratory distress
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab, Skin lesion, Sputum culture positive, Sputum purulent, Staphylococcal infection
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Staphylococcus test positive, Varicella virus test positive, Viral test positive
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Erythema, General physical health deterioration, Haemodialysis, Haemorrhage
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Immunodeficiency, Lipodystrophy acquired, Lung infiltration, Mechanical ventilation
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Respiratory distress, Scab, Secretion discharge, Skin lesion
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sputum culture positive, Sputum purulent, Staphylococcal infection, Staphylococcus test positive, Varicella virus test positive
Clinical narrative: It was reported in a Letter to the Editor that was published as literature article. A 62-year-old man who had granulomatosis with polyangiitis (Wegener granulomatosis) diagnosed 5 years previously had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. In February 2015, the patient was admitted to the Medical Center with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms, and legs. At the time of admission, he was taking prednisone, 40 mg/d orally, plus mycophenolate mofetil, 500 mg orally twice daily. He also was undergoing hemodialysis thrice weekly. He had accidentally received a subcutaneous injection of ZOSTAVAX, 0.65 mL, at an outpatient clinic 47 days before admission. In the emergency department of the Medical Center, the patient was short of breath and was noted to have cushingoid features (moon facies, lipodystrophy, and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to a lab, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, vancomycin, and cefapime. Although the bacteremia cleared and there was crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. Cause of death was not reported. Upon internal review, the events death and respiratory distress were considered to be medically significant. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Electromyogram, Imaging procedure, Injection site pain
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Blood test, Discomfort, Headache, Injection site pain, Mass
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Monoplegia, Neck pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Sleep disorder, X-ray
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Discomfort, Headache, Neck pain, Neoplasm skin, Pain
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a consumer (the patient). A 75-year-old male patient (ethnicity reported as other) received PREVNAR 13 and Tdap (unknown manufacturer) both via an unspecified route of administration, in left deltoid, on 02Sep2015 at 10:33, at 0.5 ml single. His podiatrist sent him for a tetanus shot because he hurt his big toe and he was borderline diabetic. Concomitant medications included metformin (unknown manufacturer) from unknown date and ongoing at 500 mg 2x/day for diabetes. The patient reported that the physician wanted him to get also PREVNAR 13 vaccine and she put this second injection in the same deltoid, in the same hole where the patient had received the other vaccine. The patient said that he had a hurt that went through his whole body when PREVNAR 13 was injected. The patient said that it made his arm felt paralyzed after he got home. The patient had a lot of pain on his left arm since 02Sep2015. He felt a slight discomfort and experienced some growth going out of his chest 4 days afterwards on unknown date. The patient stated that he could not sleep on his left arm, and no attention the pain was migrating up through his left side of neck up into his head. The patient received treatment for pain. He underwent X-ray, blood work and nuclear magnetic resonance imaging (MRI). The patient did not recover from arm pain migrating up through his left side of neck up into his head. The outcome of the other reported events was unknown. After two hours he ended up in emergency room and (9 months before initial report) and still he could not sleep on his left. Follow up (29Jun2016): New information from the same contactable consumer includes: updated patient weight, medical history details, vaccines anatomical location detail, additional events 'paralyzed' and 'pain during injection', case upgraded to serious.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Infectious mononucleosis, Mononucleosis heterophile test, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL (lot, dosage regimen unknown) by "injection" route. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post-mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not sought medical attention and no treatment was given for the adverse events. The outcome of the events was unknown. Product quality complaint (PQC) was not filed. Causality assessment for the event of mononucleosis was not provided. Follow up information has been received from the nurse practitioner on 06-JUN-2016. The patient was a non-smoker with no known allergy. The patient was vaccinated with three doses of GARDASIL on 29-OCT-2014 09:18 (lot# K006124, in left deltoid), 08-JAN-2015 09:01 (lot# K009482, in right deltoid) and 15-JUN-2015 15:21 (lot# K014191, in right deltoid) via intramuscular respectively. On an unknown date the patient experienced Attention-Deficit Hyperactivity Disorder (ADHD), dysuria (recovered on 15-JUN-2015), left breast mass (recovered on 15-JUN-2015) and underwent ear tube insertion. The patient also complained of vertigo intermittently, always being tired, headache, wired rashes on different spots (2-3 months) lasting only a couple hours and episodes of facial twitching to her right cheek by her nose lasted for 4 days (only felt it, not visible). The patient had episodes of abdominal pain and constipation and diarrhea and celiac disease. On 30-NOV-2015, the patient tested positive for Epstein-Barr virus (EBV) and the white blood cell (WBC) was decreased at that time. Blood in toilet was noticed 2-3 weeks ago (February 2016), initially after stool. The patient had episode of blood in toilet and on paper without bowel movement in the night on 06-MAR-2016. The patient was on period but did not feel it is related to that. The patient's mother was concerned that it was related to the 3rd dose of vaccine along with multiple other health related concerns. On 07-MAR-2016, physical examination of the patient was normal. Complete blood count (CBC) and urinalysis were normal. WBC was 5.7, red blood cell count was 4.91 and hemoglobin was 13.8. The rectal bleeding was suspected to be related with constipation by the reporter. The causality between the events except rash and fatigue was not provided. The outcome of the other events that was not mentioned above was unknown. Upon internal review, rectal bleeding was determined to be medically significant. Additional information is not expected as all correspondence was received. Patient information, product, event, narrative and serious criteria were all updated.