chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein increased, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: I received ZOSTAVAX September 07. Immediately the injection site became swollen, hot, red and itchy. This reaction subsided with in 2 weeks. After the initial reaction I started to get severe pain and weakness in all my joints extremities. On or about 12-10-07 I had non extremely high (2 x normal) sedimentation rate and was diagnosed with Polymyaigia Rheumatic (PMR). I was given cortisone at 20 min.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: I received ZOSTAVAX September 07. Immediately the injection site became swollen, hot, red and itchy. This reaction subsided with in 2 weeks. After the initial reaction I started to get severe pain and weakness in all my joints extremities. On or about 12-10-07 I had non extremely high (2 x normal) sedimentation rate and was diagnosed with Polymyaigia Rheumatic (PMR). I was given cortisone at 20 min.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arterial occlusive disease, Cardiac operation, Chest pain, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arterial occlusive disease, Blood chloride normal, Chest discomfort, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cough, Dyspnoea, Dyspnoea at rest, Dyspnoea exertional, Electrocardiogram abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Endarterectomy, Epigastric discomfort, Fibrin D dimer increased, Haemoptysis, Intracardiac thrombus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint injury, Lymphadenopathy, Palpitations, Productive cough, Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary infarction, Tachycardia, Tachypnoea, Vena cava thrombosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with allergic reaction to bee sting, herniated disc, lyme disease, alcohol use and pain in fingers, was vaccinated IM with the third dose of GARDASIL (lot # 658558/1061U) into her right arm on 11-FEB-2009. In February 2009, the patient experienced chest pain, short of breath and cough. On 11-FEB-2009, chest computed axial tomography (CT) was performed with right pulmonary artery occlusion secondary to massive pulmonary embolism (PE). On 11-FEB-2009, patient's D-dimer was 1960. The patient was hospitalized. On 12-FEB-2009 right atriotomy removal of right atrial mass. On 11-SEP-2009 Hospital records received from 11-FEB-2009 to 17-FEB-2009. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. The patient experienced achycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. Echocardiogram was abnormal. Abdomen, chest, pelvis CT abnormal. Heart rate 107-123/min, chloride 100 (L). On 22-Sep-2009, ICD-9 codes received-429.99. 415.19. 287.5. 286.9. 453.2. 416.8. 785.0. 785.6. 722.10. 447.6. V183. V1200 and V586.9. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID number is 356662. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 40.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Chest discomfort
Clinical narrative: Developed shortness of breath and tightness of chest within 15 minutes of immunization.
Age: 40.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Developed shortness of breath and tightness of chest within 15 minutes of immunization.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), UNK
Symptoms: Dyskinesia, Extrapyramidal disorder
Clinical narrative: EPS like symptoms (approx 40-45 post vaccine). Involuntary/ uncontrollable shaking of B1 upper ext (rest/active). Tovlscolosis of neck. Rx given Benadryl IM 25mg IM (full recovery post Rx).
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), UNK
Symptoms: Dyskinesia, Extrapyramidal disorder, Tremor
Clinical narrative: EPS like symptoms (approx 40-45 post vaccine). Involuntary/ uncontrollable shaking of B1 upper ext (rest/active). Tovlscolosis of neck. Rx given Benadryl IM 25mg IM (full recovery post Rx).
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Erythema, Myalgia, Pain, Pyrexia
Clinical narrative: redness, soreness, fever, chills, swelling
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: redness, soreness, fever, chills, swelling
Age: 26.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood test, Chest X-ray, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath, swelling of tongue and throat, tingling of hands and arms, lightheadedness, dizziness, increased heart rate. 11/19/09 and 11/20/09 Medical records received for date 11/13/09. DX: Anaphylactic rx secondary to H1N1 vax vs. sushi. Pt. presented w/ c/o receiving H1N1 vax same day and later c/o SOB, tongue "fullness" after consuming sushi. Pt states allergic to clams and muscles. Assessment: pharyngeal swelling, SOB.
Age: 26.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia, Pharyngeal oedema, Swollen tongue
Clinical narrative: Shortness of breath, swelling of tongue and throat, tingling of hands and arms, lightheadedness, dizziness, increased heart rate. 11/19/09 and 11/20/09 Medical records received for date 11/13/09. DX: Anaphylactic rx secondary to H1N1 vax vs. sushi. Pt. presented w/ c/o receiving H1N1 vax same day and later c/o SOB, tongue "fullness" after consuming sushi. Pt states allergic to clams and muscles. Assessment: pharyngeal swelling, SOB.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Feeling abnormal, Impaired driving ability, Malaise
Clinical narrative: couldn't think straight.called for a ride home as i felt ill and strange.no luck so drove home 10 min. away and fell asleep at wheel...was able to get back on my side of road before any accident.for 4 days felt weird and couldn't think straight.chills fever.huge red lump that went from back of arm to the front.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mass, Pyrexia, Somnolence, Thinking abnormal
Clinical narrative: couldn't think straight.called for a ride home as i felt ill and strange.no luck so drove home 10 min. away and fell asleep at wheel...was able to get back on my side of road before any accident.for 4 days felt weird and couldn't think straight.chills fever.huge red lump that went from back of arm to the front.
Age: 24.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anxiety, Blood test, Chest X-ray, Cough, Dyspnoea
Clinical narrative: I received the H1N1 vaccine. Cramps in legs the same day as administration, Heart Racing, trouble breathing, A feeling of heat rushing from my chest through my upper and lower body, feelings said to be associated with anxiety but I have had reactions like this before, one to anesthesia and another time to Paxil. I visited the hospital 4 times because of the racing heart and other symptoms, I thought I was dying. I was given strong tranquilizer medication, ALAZOPRAM, that failed to keep the symptoms at bay after about a day of treatment, then I was given Lorazepam. That is failing to work. I kept telling the doctors I think I am scared by the feelings I am having not causing the feelings I am having because I am scared. I think I am being written off an that scares me too, because there may just be a problem. At one hospital they did a chest X-ray and found something in the lower right lobe of my lung, and at the other hospital they said my X-ray was clear, the following day! The "anxiety" comes on at different times, at first it seemed like it was at night but then it was this afternoon too. I am kept up by the feeling, and every time I tried to sleep without the assistance of tranquilizers, I jump awake and am shaking. I am going to continue to seek treatment for what I do agree is in part anxiety but I am concerned there is something else going on. Is there anything you can do to help me or direct me to a source that could make sure this isn't a dangerous reaction that could be harmful is neglected? I also failed to mention that the exhaustion has continued although immediately after the shot I felt a distinctively euphoric feeling. At one of the trips to the hospital, they said I had a virus when looking in my throat that is still extremely red and somewhat sore, three weeks later. I have a bit of a dry cough that was never there either. Something doesn't feel right and I know my body, and I just hope that this will turn out alright. I have given up on the doctors because they just brush my claims off.
Age: 24.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Electrocardiogram, Euphoric mood, Fatigue, Fear, Feeling abnormal
Clinical narrative: I received the H1N1 vaccine. Cramps in legs the same day as administration, Heart Racing, trouble breathing, A feeling of heat rushing from my chest through my upper and lower body, feelings said to be associated with anxiety but I have had reactions like this before, one to anesthesia and another time to Paxil. I visited the hospital 4 times because of the racing heart and other symptoms, I thought I was dying. I was given strong tranquilizer medication, ALAZOPRAM, that failed to keep the symptoms at bay after about a day of treatment, then I was given Lorazepam. That is failing to work. I kept telling the doctors I think I am scared by the feelings I am having not causing the feelings I am having because I am scared. I think I am being written off an that scares me too, because there may just be a problem. At one hospital they did a chest X-ray and found something in the lower right lobe of my lung, and at the other hospital they said my X-ray was clear, the following day! The "anxiety" comes on at different times, at first it seemed like it was at night but then it was this afternoon too. I am kept up by the feeling, and every time I tried to sleep without the assistance of tranquilizers, I jump awake and am shaking. I am going to continue to seek treatment for what I do agree is in part anxiety but I am concerned there is something else going on. Is there anything you can do to help me or direct me to a source that could make sure this isn't a dangerous reaction that could be harmful is neglected? I also failed to mention that the exhaustion has continued although immediately after the shot I felt a distinctively euphoric feeling. At one of the trips to the hospital, they said I had a virus when looking in my throat that is still extremely red and somewhat sore, three weeks later. I have a bit of a dry cough that was never there either. Something doesn't feel right and I know my body, and I just hope that this will turn out alright. I have given up on the doctors because they just brush my claims off.
Age: 24.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Feeling hot, Immediate post-injection reaction, Insomnia, Morbid thoughts, Muscle spasms
Clinical narrative: I received the H1N1 vaccine. Cramps in legs the same day as administration, Heart Racing, trouble breathing, A feeling of heat rushing from my chest through my upper and lower body, feelings said to be associated with anxiety but I have had reactions like this before, one to anesthesia and another time to Paxil. I visited the hospital 4 times because of the racing heart and other symptoms, I thought I was dying. I was given strong tranquilizer medication, ALAZOPRAM, that failed to keep the symptoms at bay after about a day of treatment, then I was given Lorazepam. That is failing to work. I kept telling the doctors I think I am scared by the feelings I am having not causing the feelings I am having because I am scared. I think I am being written off an that scares me too, because there may just be a problem. At one hospital they did a chest X-ray and found something in the lower right lobe of my lung, and at the other hospital they said my X-ray was clear, the following day! The "anxiety" comes on at different times, at first it seemed like it was at night but then it was this afternoon too. I am kept up by the feeling, and every time I tried to sleep without the assistance of tranquilizers, I jump awake and am shaking. I am going to continue to seek treatment for what I do agree is in part anxiety but I am concerned there is something else going on. Is there anything you can do to help me or direct me to a source that could make sure this isn't a dangerous reaction that could be harmful is neglected? I also failed to mention that the exhaustion has continued although immediately after the shot I felt a distinctively euphoric feeling. At one of the trips to the hospital, they said I had a virus when looking in my throat that is still extremely red and somewhat sore, three weeks later. I have a bit of a dry cough that was never there either. Something doesn't feel right and I know my body, and I just hope that this will turn out alright. I have given up on the doctors because they just brush my claims off.
Age: 24.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oropharyngeal pain, Palpitations, Pharyngeal erythema, Tremor, Viral infection
Clinical narrative: I received the H1N1 vaccine. Cramps in legs the same day as administration, Heart Racing, trouble breathing, A feeling of heat rushing from my chest through my upper and lower body, feelings said to be associated with anxiety but I have had reactions like this before, one to anesthesia and another time to Paxil. I visited the hospital 4 times because of the racing heart and other symptoms, I thought I was dying. I was given strong tranquilizer medication, ALAZOPRAM, that failed to keep the symptoms at bay after about a day of treatment, then I was given Lorazepam. That is failing to work. I kept telling the doctors I think I am scared by the feelings I am having not causing the feelings I am having because I am scared. I think I am being written off an that scares me too, because there may just be a problem. At one hospital they did a chest X-ray and found something in the lower right lobe of my lung, and at the other hospital they said my X-ray was clear, the following day! The "anxiety" comes on at different times, at first it seemed like it was at night but then it was this afternoon too. I am kept up by the feeling, and every time I tried to sleep without the assistance of tranquilizers, I jump awake and am shaking. I am going to continue to seek treatment for what I do agree is in part anxiety but I am concerned there is something else going on. Is there anything you can do to help me or direct me to a source that could make sure this isn't a dangerous reaction that could be harmful is neglected? I also failed to mention that the exhaustion has continued although immediately after the shot I felt a distinctively euphoric feeling. At one of the trips to the hospital, they said I had a virus when looking in my throat that is still extremely red and somewhat sore, three weeks later. I have a bit of a dry cough that was never there either. Something doesn't feel right and I know my body, and I just hope that this will turn out alright. I have given up on the doctors because they just brush my claims off.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Rash
Clinical narrative: Vaccination site (right deltoid) with bruising, mild swelling, and redness noted.
Age: 15.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Dizziness, Headache, Heart rate abnormal
Clinical narrative: Severe stomach cramps, headache, dizziness, low heart rate. Child was taken by ambulance to local hospital.
Age: 36.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: VOMITING, STOMACH CRAMPS
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose increased, Cardiac stress test, Dizziness, Echocardiogram, Fatigue
Clinical narrative: Elevated BP and BS 11-13-08 to 1-28-09. Exhaustion, cold 11-14-08. Irregular heart beat 11-14-08 to 1-26-09. Dizzy spell 11-13-08. Palpitations 11-13-08 to 1-26-09. Coreg 20 CR tried 1-6-09 (slow pulse) changed to Coreg 10 CR on 1-14-09 after 2+months!
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate irregular, Hypertension, Laboratory test, Nasopharyngitis, Palpitations
Clinical narrative: Elevated BP and BS 11-13-08 to 1-28-09. Exhaustion, cold 11-14-08. Irregular heart beat 11-14-08 to 1-26-09. Dizzy spell 11-13-08. Palpitations 11-13-08 to 1-26-09. Coreg 20 CR tried 1-6-09 (slow pulse) changed to Coreg 10 CR on 1-14-09 after 2+months!
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Pulse pressure decreased
Clinical narrative: Elevated BP and BS 11-13-08 to 1-28-09. Exhaustion, cold 11-14-08. Irregular heart beat 11-14-08 to 1-26-09. Dizzy spell 11-13-08. Palpitations 11-13-08 to 1-26-09. Coreg 20 CR tried 1-6-09 (slow pulse) changed to Coreg 10 CR on 1-14-09 after 2+months!
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pruritus, Rash macular, Skin warm, Urticaria
Clinical narrative: Describe adverse events(s) (symptoms, signs, time course) and treatment, if any. She received seasonal flu shot in right arm 4 weeks prior to H1N1 shot. She received H1N1 shot on 11/4/09 at 10 AM in left arm. At 4:30 PM she felt her head itching, the scalp, and itching behind left ear. On 11/5/09 AM she had several welts on left side of her hairline, they were like red blotches and warm to the touch about the size on a dime an elongated. By midmorning her left ear was itching. On 11/6/09 AM she had welts all around her hairline and on her cheeks to near her nose. On 11/7/09 2 AM she was itching and had hives all over her body, they were concentrated on her lower back, up the spine, under her breasts, her face. She saw her doctor on 11/7/09 at 11:30 AM at 11:30 AM and was put on Medrol pack. On 11/8/09 most of the hives were gone and by 11/10/09 they were all gone. ON 11/13/09 she had hives on her ankles and inside her upper lip. On 11/14/09 she had welts on the scar that runs up her back, also on her legs, arms and face. She was restarted on Medrol on Saturday. She is still taking it.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt rec'd 1st dose of VARIVAX then at the site of injection developed 3 blisters that were very itchy followed by a red tender 3 x 4 cm patch that is tender but not warm to the touch.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Injection site mass, Injection site pain, Local swelling, Pain
Clinical narrative: Large local swelling 09/22/2009. Arm had an egg size knot where she received the vaccine, pain down to the elbow and when lifting arm up. The swelling lasted for a week. She also reported an asthma attack on 10/21/09, she did go to the emergency room and was treated with I.A, she was diagnosed with asthma in January. Her previous dose of flu vaccine was in 1989 and at that time her arm was swollen from shoulder to elbow, cold and red. She gets hives after she eats fresh tomatoes.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Large local swelling 09/22/2009. Arm had an egg size knot where she received the vaccine, pain down to the elbow and when lifting arm up. The swelling lasted for a week. She also reported an asthma attack on 10/21/09, she did go to the emergency room and was treated with I.A, she was diagnosed with asthma in January. Her previous dose of flu vaccine was in 1989 and at that time her arm was swollen from shoulder to elbow, cold and red. She gets hives after she eats fresh tomatoes.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysphagia, Fluid replacement, Paraesthesia
Clinical narrative: After shot-light headed and cheeks were tingling about 3 hours later my hands and fall was tingling and 1 was having difficulty swallowing, went to ED, recovered IV, Benadryl and pepcid.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: right arm red, swollen, tender
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Bone pain, Chills, Feeling hot, Headache, Influenza like illness
Clinical narrative: Flu like symptoms: Chills, body aches, muscle aches, bone pain, headaches, feeling like fever w/o fever. Lasting about 6-10 hours and occuring about once a week since vaccine taken. Not sure when this will end??
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Myalgia, Pain
Clinical narrative: Flu like symptoms: Chills, body aches, muscle aches, bone pain, headaches, feeling like fever w/o fever. Lasting about 6-10 hours and occuring about once a week since vaccine taken. Not sure when this will end??
Age: 36.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Increased upper airway secretion, Influenza, Myalgia, Pyrexia
Clinical narrative: Full blown flu with muscle aches, weakness, fever of 101.5 deg F even with anti-inflammatory drugs.  Discharge of phlegm from respiratory tract still occurred 8 days after onset of symptoms.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), FLUN3
Symptoms: Convulsion, Influenza serology negative, Myoclonus, Polymerase chain reaction
Clinical narrative: Encephalitis syndrome beginning with focal one sided myoclonic jerking with progression to more generalized seizure activity - Relative (cousin) with close contact had subsequent H1N1 - confirmed illness with seizures.  11/23/09 Medical records and discharge summary received for DOS 10/25-11/05. Final DX: Presumed viral encephalitis, seizure disorder.  HA, R facial twitching, feeling limp, febrile, 3 R focal seizures. Secondary generalized seizures. Slurred speech, confusion. PICU. All cultures neg. MRI brain and EEG abnormal. bilateral hypoxic ischemic encephalopathy.  Bilious vomiting. Small bowel dilation, illeus or incomplete obstruction. Lungs scattered crackles. D/C to home.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypertension, Pruritus, Rash, Tachycardia, Tremor
Clinical narrative: H1N1 shot at 11 AM. Approximately 3 PM noticed itching of chest and arms. Rash and hives on chest and arms, shaking of hands. Gave 25 mg BENADRYL and cimetidine 300 mg at 15:40. Blood pressure high 173/110, HR 131, going down. No breathing problems.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: H1N1 shot at 11 AM. Approximately 3 PM noticed itching of chest and arms. Rash and hives on chest and arms, shaking of hands. Gave 25 mg BENADRYL and cimetidine 300 mg at 15:40. Blood pressure high 173/110, HR 131, going down. No breathing problems.
Age: 21.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Chills, Insomnia, Lethargy, Muscular weakness
Clinical narrative: Vomiting, fever, chills, insomnia, stomach ache, weakness in muscles, runny nose, lethargy.
Age: 21.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting, fever, chills, insomnia, stomach ache, weakness in muscles, runny nose, lethargy.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLUX, PNC
Symptoms: Facial palsy
Clinical narrative: Right side facial drooping consistent with Bells Palsy
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Headache, chills, fever, swelling and erythema of injection site
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: hives
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN(H1N1), IPV
Symptoms: Abnormal behaviour, Aphasia, Blood culture negative, Convulsion, Drooling
Clinical narrative: Day 1: Strange behavior.  Drooling.  Inability to talk.  Leading up to prolonged seizure at approximately 10:45 AM. Day 3: Febrile seizure at 5:42 AM.  ER.  Prescribed medication to control fever as well as anti-seizure medication (Keppra). Day 4: Test positive for H1N1. Day 6: Facial spasms. Day 7: To be continued... 11/20/09 Medical records received for dates 11/14/09 to 11/16/09. DX: viral syndrome, febrile seizure. Presenting SX: Pt at OV for f/u seizure. Pt. parent states fever x1 wk ago then a 15 min tonic clonic seizure, taken to hosp. by EMS. Following day another seizure w/ upper body stiffness, taken to ER placed on meds. (+)family h/o febrile seizures. Assessment (+)runny nose, congestion, cough, irritable. EMS records 11/15/09: EMS called found pt. in full body seizure, hot to touch, pt. became alert en route to ER.  ER DX: complex febrile seizure, acute febrile illness.  11/15/09 Neuro consult. DX: seizures.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN(H1N1), IPV
Symptoms: Facial spasm, Febrile convulsion, Influenza, Laboratory test, Urine analysis normal
Clinical narrative: Day 1: Strange behavior.  Drooling.  Inability to talk.  Leading up to prolonged seizure at approximately 10:45 AM. Day 3: Febrile seizure at 5:42 AM.  ER.  Prescribed medication to control fever as well as anti-seizure medication (Keppra). Day 4: Test positive for H1N1. Day 6: Facial spasms. Day 7: To be continued... 11/20/09 Medical records received for dates 11/14/09 to 11/16/09. DX: viral syndrome, febrile seizure. Presenting SX: Pt at OV for f/u seizure. Pt. parent states fever x1 wk ago then a 15 min tonic clonic seizure, taken to hosp. by EMS. Following day another seizure w/ upper body stiffness, taken to ER placed on meds. (+)family h/o febrile seizures. Assessment (+)runny nose, congestion, cough, irritable. EMS records 11/15/09: EMS called found pt. in full body seizure, hot to touch, pt. became alert en route to ER.  ER DX: complex febrile seizure, acute febrile illness.  11/15/09 Neuro consult. DX: seizures.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Pyrexia
Clinical narrative: On 10/27/2009 Dr. reported to me (pharmacist) that his patient had a low grade fever, mild cellulitis in most of the right arm; redness in the injection site.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysgeusia, Salivary hypersecretion
Clinical narrative: After given H1N1 vaccine - salty taste in mouth - watery mouth as if nauseous, thick head.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eyelid oedema, Face oedema, Lip oedema, Urticaria
Clinical narrative: Reported to Employee Health with urticaria, mild edema of eyelids, chin and upper lip.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysgeusia, Pallor
Clinical narrative: Became dizzy, pale, c/o metallic taste in her mouth. Transported to ER at 11:20 AM.
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Decreased appetite, Disturbance in attention, Feeling abnormal, Feeling drunk
Clinical narrative: The evening of the date of vaccination, mom reports he said he did not feel like himself, he felt "funny" like a drunken person. Over the next 6 days he developed headache, subjective (tactile) fever, decreased appetite, stomach ache, decreased concentration, difficulty sleeping, and more defiant behavior.  By a wk later, he reverted back to his baseline appetite and behavior. Other than observation and encouragement of rest by his mother, no specific treatment was provided.
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Insomnia, Oppositional defiant disorder, Pyrexia
Clinical narrative: The evening of the date of vaccination, mom reports he said he did not feel like himself, he felt "funny" like a drunken person. Over the next 6 days he developed headache, subjective (tactile) fever, decreased appetite, stomach ache, decreased concentration, difficulty sleeping, and more defiant behavior.  By a wk later, he reverted back to his baseline appetite and behavior. Other than observation and encouragement of rest by his mother, no specific treatment was provided.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Influenza, Influenza serology positive
Clinical narrative: My son was given the H1N1 nasal mist on Oct. 14. On Nov. 3 he was diagnosed with H1N1 type A flu by his doctor.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye swelling, Headache, Ocular hyperaemia, Pain, Urticaria
Clinical narrative: Eyes red and swollen, hives, headache/body ache.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: C/O HA starting above L eye spreading to R eye then back of head. C/O feeling hot. Nausea and dizziness 15 mins after LAIV. Mother gave 600 mg ADVIL. Transported via EMS-hospital.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: A few minutes after receiving injectable H1N1 vaccine, c/o feeling lightheaded and dizzy.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Fatigue, Muscular weakness, Nausea
Clinical narrative: Extreme muscle weakness/fatigue which worsened and finally abated on 11/3. Nausea which peaked on 11/2 and abated by afternoon on 11/3.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Full blood count, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Sore, redness down arm, swollen,itchy, low grade temp.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Sore, redness down arm, swollen,itchy, low grade temp.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Malaise, Oropharyngeal pain
Clinical narrative: Feeling sick, chest hurt, throat hurt.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Wife reported 103 temp-body aches and chills. TYLENOL relieved symptoms. RPh told to give TYLENOL q 4-6h prn symptoms; symptoms persisted for approx 48 hours before resolution.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Excessive eye blinking, Eye swelling, Headache, Muscle twitching, Ocular hyperaemia
Clinical narrative: Eye swollen, red and he keeps blinking. Pt had/has twitching, headache, body ache.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain
Clinical narrative: Eye swollen, red and he keeps blinking. Pt had/has twitching, headache, body ache.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm sore; loss of mobility.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging, Tonic clonic movements
Clinical narrative: Seizure (tonic clonic) 15 minute duration. EMT's were called. He was transported to the ER. 11/24/09 ER records received for date 11/5/09. DX: seizure, new onset. EMS called for pt parent stating pt having seizure. Parent states pt was pale, lips blue, increased secretions, eyes deviated upward, snorting and jerky movements of whole body during active seizure. EMS state pt was disoriented, fussy upon their arrival. Pt has h/o vomiting, fever x4 days ago. Parent states H1N1 vax given 2 days prior to episode. Assessment: high risk for repeat seizures due to history.
Age: 0.16
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HEP, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None reported.
Age: 8.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Dizziness, Vomiting
Clinical narrative: Dizzy, vomiting weak post vaccination. EMS evaluation and released.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oropharyngeal pain, Pruritus, Rash, Respiratory tract congestion
Clinical narrative: Reports sore throat, congestion on 10/29/09. Developed rash with itching from chest to toes on 10/31/09. To PCP-treated with prednisone x 6 days. Returned to PCP 11/09/09-rash returned-advised to take ZYRTEC.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Brain oedema, Headache, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: Initial case report received from a health care professional on 04 NOV 2009. A 67-year-old male patient was vaccinated with FLUVIRIN 2009/2010 (batch no. 960356) into the left deltoid on 02 OCT 2009 or 03 OCT 2009. The reporter stated that the patient "later that evening" was experiencing numbness in his arm and began to feel a headache. He went to emergency room and had "swelling in his brain". Numbness had extended to his face. He did not experience a stroke. Patient had not recovered at date of the initial report. Company assessment: Seriousness criterion: hospitalization. Causality: insufficient data. The amount of data is insufficient to finally assess the causality. Need to get all available hospital reports from the reporter. Expectedness assessment according to agency and label; Brain swelling is unexpected, headache and numbness are expected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.; NA09-007566
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy
Clinical narrative: Initial case report received from a consumer via a lawyer on 23 OCT 2009. A female patient of unknown age was vaccinated with FLUVIRIN (batch no. unknown) on 31-OCT-2007. The patient developed pleurisy after vaccination and was hospitalized. The outcome was unknown at time of this report.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Axillary pain
Clinical narrative: Pain in armpit on left side EMT evaluated and released.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pruritus
Clinical narrative: Itchy - EMT evaluated and released. No breathing issues.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Local Rxn prox. left arm erythema, high temp to palpation; induration; edema.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood glucose decreased, Dizziness, Syncope
Clinical narrative: Dizzy, faint. Low blood sugar-EMT involved. No transport required.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Vagal response - dizzy, nauseated. Gave vaccine lying down due to previous fainting with vaccines.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash - ~ 10 mins after immunization BENADRYL 25 mg P.O. @ 10:18 AM, 10:30 - Rash on back - pacing.