chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 51-year old female patient. On 20-Dec-2014, the patient received intramuscular AFLURIA injection (batch number T50907) in the left arm. On 22-Dec-2014, after the influenza shot, the patient complained of muscle pain and described it like she was given a tetanus shot. Two days later, she felt more of an ache. On 12-Feb-2015, she went to the physician and was told that she could have bursitis and was referred to an orthopedic surgeon and MRI (Magnetic Resonance Imaging). The patient received tramadol, NSAIDS (Non-Steroidal Anti-Inflammatories) and was told to ice. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Chest X-ray abnormal, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax normal, Intensive care
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 32 year old male patient. The patient's current illness included low back pain. His concomitant medications included methocarbamol, naproxen and ketorolac tromethamine. On 23-Feb-2015, the patient received AFLURIA injection (batch number 'CL2026'). On the same day, he also received adenovirus vaccine type 4 and 7 (batch number 34600149). On 27-Feb-2015, the patient was found to be unresponsive and was resuscitated. He was admitted to ICU and remained unresponsive on ventilator with the diagnosis of respiratory failure. He had CT of head/neck/chest performed and all results were negative. The patient initially had thrombocytopenia but was now stable. His current chest X-ray showed BLL infiltrates and the patient also had history of fever at 101.2. The patient received ID MD questions if reacted to adenovirus vaccine. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as they were life threatening and required hospitalisation, and reported symptoms of computerised tomogram head normal, computerised tomogram normal, computerised tomogram thorax normal, intensive care, mechanical ventilation and resuscitation.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Lung infiltration, Mechanical ventilation, Pyrexia, Respiratory failure, Resuscitation
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 32 year old male patient. The patient's current illness included low back pain. His concomitant medications included methocarbamol, naproxen and ketorolac tromethamine. On 23-Feb-2015, the patient received AFLURIA injection (batch number 'CL2026'). On the same day, he also received adenovirus vaccine type 4 and 7 (batch number 34600149). On 27-Feb-2015, the patient was found to be unresponsive and was resuscitated. He was admitted to ICU and remained unresponsive on ventilator with the diagnosis of respiratory failure. He had CT of head/neck/chest performed and all results were negative. The patient initially had thrombocytopenia but was now stable. His current chest X-ray showed BLL infiltrates and the patient also had history of fever at 101.2. The patient received ID MD questions if reacted to adenovirus vaccine. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as they were life threatening and required hospitalisation, and reported symptoms of computerised tomogram head normal, computerised tomogram normal, computerised tomogram thorax normal, intensive care, mechanical ventilation and resuscitation.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Thrombocytopenia, Unresponsive to stimuli
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 32 year old male patient. The patient's current illness included low back pain. His concomitant medications included methocarbamol, naproxen and ketorolac tromethamine. On 23-Feb-2015, the patient received AFLURIA injection (batch number 'CL2026'). On the same day, he also received adenovirus vaccine type 4 and 7 (batch number 34600149). On 27-Feb-2015, the patient was found to be unresponsive and was resuscitated. He was admitted to ICU and remained unresponsive on ventilator with the diagnosis of respiratory failure. He had CT of head/neck/chest performed and all results were negative. The patient initially had thrombocytopenia but was now stable. His current chest X-ray showed BLL infiltrates and the patient also had history of fever at 101.2. The patient received ID MD questions if reacted to adenovirus vaccine. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as they were life threatening and required hospitalisation, and reported symptoms of computerised tomogram head normal, computerised tomogram normal, computerised tomogram thorax normal, intensive care, mechanical ventilation and resuscitation.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Confusional state, Dyspnoea, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 64 year old male patient. The patient had medical history of coronary heart disease, reflux, asthma, hypertension, diverticulosis, cardiac heart failure, hyperphoria, granuloma annulare and vitamin D deficiency. His current illness included iron deficiency anemia. On 23-Sep-2014, the patient received AFLURIA injection (batch number: T50607) in the left arm. On 23-Sep-2014, the patient was diagnosed with chest pain and was admitted to the hospital for observation. He also experienced confusion, fever and dyspnoea. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as serious as the patient was hospitalised for two days.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, Periarthritis, Synovitis
Clinical narrative: Case number PHHY2015US047894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568319) web site on 21 Apr 2015. This report refers to a 68 year old male patient. Historical conditions included atrial fibrillation. Historical drug included penicillin and statins. Current condition included hypothyroidism and hypertension. His concomitant medications were sotalol, SYNTHROID, hydrochlorothiazide, losartan, LIVALO, magnesium, potassium and fish oil. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on 04 Nov 2014. On 09 Nov 2014, the patient experienced pain in arm, frozen shoulder and synovitis in the biceps of left arm. Patient could not take anti-inflammatory medication and pain and immobility continued. The patient visited emergency room and x-ray and magnetic resonance imaging (MRI) were done, but results were not reported. Outcome of the events was reported as condition unchanged. The events were reported as non-serious, but the events frozen shoulder and synovitis were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US047894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568319) web site on 21 Apr 2015. This report refers to a 68 year old male patient. Historical conditions included atrial fibrillation. Historical drug included penicillin and statins. Current condition included hypothyroidism and hypertension. His concomitant medications were sotalol, SYNTHROID, hydrochlorothiazide, losartan, LIVALO, magnesium, potassium and fish oil. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on 04 Nov 2014. On 09 Nov 2014, the patient experienced pain in arm, frozen shoulder and synovitis in the biceps of left arm. Patient could not take anti-inflammatory medication and pain and immobility continued. The patient visited emergency room and x-ray and magnetic resonance imaging (MRI) were done, but results were not reported. Outcome of the events was reported as condition unchanged. The events were reported as non-serious, but the events frozen shoulder and synovitis were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: ADAMTS13 activity decreased, Abdominal pain, Acquired Von Willebrand's disease, Anaphylactic reaction, Blood creatinine normal
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood fibrinogen increased, Blood lactate dehydrogenase increased, Chromaturia, Confusional state, Coombs direct test negative
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: HIV test negative, Headache, Hepatitis viral test negative, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Increased tendency to bruise, Influenza like illness, Plasmapheresis, Platelet count decreased, Red blood cell schistocytes present
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Thrombocytopenia, Thrombotic thrombocytopenic purpura
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Anaphylactic reaction, Blood creatinine normal, Blood fibrinogen increased, Blood lactate dehydrogenase increased
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood smear test abnormal, Chromaturia, Confusional state, Coombs direct test negative, Cough
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, HIV test negative
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Hepatitis viral test negative, Immediate post-injection reaction, Impaired work ability, Increased tendency to bruise
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness, Plasmapheresis, Platelet count decreased, Red blood cell schistocytes present, Thrombotic thrombocytopenic purpura
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Von Willebrand's disease
Clinical narrative: Case number PHHY2015US051510 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 568437) web site on 21 Apr 2015. This report refers to a 40 year old female patient. Her medical history or family history was not reported. Her current conditions included hypertension, hyperlipidaemia and type 2 diabetes mellitus. Her concomitant medications were ZOCOR, metformin, lisinopril, hydrochlorothiazide and TOPROL XL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. Immediately after vaccination, she developed cough and flu like symptoms which lasted for a week. The following week, she started to experience fatigue, headache, dizziness, abdominal pain, confusion and dark urine that prevented her from being able to complete her tasks at work. Two week after vaccination, she was admitted to medical facility complaining of diarrhea and a feeling of severe lightheadedness. Upon initial examination, she was found to be short of breath and to have increased tendency to bruise; although her observations were within normal limits and the rest of the examination was unremarkable according to the authors. She was treated with prednisone. On hospital admission, she had following abnormal results: platelet count was 1000, lactate dehydrogenase was 800, fibrinogen level was 419 and peripheral smear revealed schistocytes. Her level od ADAMTS-13 was 3%. Other investigations including direct Coombs test, human immunodeficiency virus and hepatitis panel were negative. She was reported to have a normal creatinine level. She was diagnosed with acute thrombotic thrombocytopenic purpura by autoantibody mediated ADAMTS-13 deficiency, fourteen days after vaccination. On an unknown date she experienced von Willebrand's disease. She commenced on plasmapheresis for treatment, but she had an anaphylactic reaction during the fourth round. At the time of discharge, her platelet level was above 200,000. On an unknown date, cough and influenza like symptoms recovered. The outcome of thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increase tendency to bruise were unknown. The reporter considered the causality of the events; thrombotic thrombocytopenic purpura, acquired Von Willebrand's disease, cough, influenza-like symptoms, fatigue, headache, dizziness, abdominal pain, confusion, dark urine, diarrhea, shortness of breath and increased tendency to bruise as probably related to administration of influenza vaccine.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram head abnormal, Dysarthria, Eye irritation, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US048887, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568743) website on 21 Apr 2015. This report refers to a 60-year old male patient. The patient has no medical history. Concomitant medications included fish oil, Aspirin, Glucosamine and Men's Multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Nov 2012. On 29 Apr 2013, the patient developed eye irritation, then numbing of face and slurred speech. Following the events, the patient visited emergency room and was put on stroke alert. The patient underwent CT scan of head and was diagnosed with Bell's palsy. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'Bell's palsy' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event slurred speech was linked to Bell's palsy (previously slurred speech was standalone event).
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram abnormal, Dysarthria, Eye irritation, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US048887, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568743) website on 21 Apr 2015. This report refers to a 60-year old male patient. The patient has no medical history. Concomitant medications included fish oil, Aspirin, Glucosamine and Men's Multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Nov 2012. On 29 Apr 2013, the patient developed eye irritation, then numbing of face and slurred speech. Following the events, the patient visited emergency room and was put on stroke alert. The patient underwent CT scan of head and was diagnosed with Bell's palsy. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'Bell's palsy' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event slurred speech was linked to Bell's palsy (previously slurred speech was standalone event).
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Chest pain, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Case number PHHY2015US048886, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 568828) website on 21 Apr 2015. This report refers to a 28-year old male patient. Past medical history included Helicobacter Pylori infection (one year ago). Concurrent condition included ADD (attention deficit/hyperactivity disorder) since the age of five years. The patient's gall bladder was removed and the patient had no birth defects and allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Feb 2015. On 17 Feb 2015, the patient experienced trouble in swallowing, chest pain and shortness of breath. Further, the patient's thyroid feels swollen to touch and it was causing difficulty swallowing. On 06 Mar 2015, the patient was seen in emergency room due to paralysis of face, burning in scalp and extreme fatigue.  The symptoms were getting worse. The patient went to a doctor and was treated with prednisone and tetracycline for the described symptoms. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'paralysis of face' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event burning in scalp was linked to facial paralysis and difficulty swallowing was linked to thyroid feels swollen (previously burning sensation and swallowing difficult were standalone events).