chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Laboratory test, Lymphocyte count decreased, Mean platelet volume increased, Monocyte percentage decreased, Neutrophil count increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal, Oral dysaesthesia, Paraesthesia, Thyroxine free increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: CSF protein increased, Condition aggravated, Dizziness, Dysaesthesia, Dysarthria
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dysgeusia, Eosinophil percentage decreased, Full blood count abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Headache, Hypertension, Hypoaesthesia, Immunoglobulin therapy, Laboratory test
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Lymphocyte percentage decreased, Mean platelet volume increased, Monocyte percentage decreased, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Oral dysaesthesia, Paraesthesia, Thyroxine free increased, White blood cell count increased
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Death, Immediate post-injection reaction, Injury, Road traffic accident
Clinical narrative: Vaccine Adverse Event Reporting System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of live, attenuated monovalent vaccine (LAMV) and 10 after receipt of monovalent inactivated, split virus or subunit vaccine (MIV) through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with monovalent inactivated, split virus or subunit vaccine (MIV). Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00015, -00016, -00017, -00019, -00020. A 56-year-old female patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration were not reported. Immediately post vaccination the patient experienced trauma. It was reported that she was involved in a motor vehicle crash leaving clinic after H1N1 vaccination. No additional information was reported. Documents held by sender: None.
Age: 38.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Death, Respiratory failure
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009 (Agency number US-SP-2010-00011). Vaccine Adverse Event Reporting System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of live, attenuate monovalent vaccine (LAIV) and 10 after receipt of monovalent inactivated, split virus or subunit vaccines (MIV) through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00015, -00016, -00017, -00018, -00019, -00020. A 38-year-old male patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration was not reported. The patient developed respiratory failure and died (date not reported). Vaccination to onset was reported as 19 days. Past medical history noted the patient had been immunocompromised. At the time of the report, autopsy results were under review. No additional information was reported. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Anxiety, Bacteria urine, Blood culture, Coagulopathy
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Computerised tomogram abnormal, Condition aggravated, Depression, Dyspnoea, Electromyogram
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Guillain-Barre syndrome, Haemoglobin decreased, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture normal, Muscular weakness, Myalgia, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Paraesthesia, Paraparesis, Pleuritic pain, Pneumonia
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Respiratory distress, Thrombophlebitis superficial, Urinary incontinence, Urine analysis abnormal
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urine leukocyte esterase positive, Virus culture, Walking aid user
Clinical narrative: Initial case received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 369201-1. A 31-year-old female patient had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP002AA) on 26 October 2009. The patient has a medical history of protein S deficiency with multiple DVT's (blood clots), hypercoagulable state, pulmonary embolism, gastroparesis, anxiety, postpartum depression, back pain, thoracic outlet syndrome, C-section, miscarriage, cholecystectomy, laparoscopy, and drug allergies to REGLAN and ZOFRAN. Concomitant medications included WELLBUTRIN, COUMADIN, AMBIEN, FIORICET, and Prenatal vitamins. Time to onset for initial symptoms was reported as 6 years after vaccination. The patient presented to the emergency room on 15 November 2009 complaining of pain and weakness in her extremities over the past two weeks. She was admitted to the hospital for ascending weakness. It was noted that left sided weakness was greater than right. The weakness occurred primarily at night and the pain was worse after rest. She had numbness in her feet and fingers, tingling (crawling) sensation in the lower extremities, unsteady incontinence. The patient developed respiratory distress and anxiety. Pleuritic chest pain and fever was also noted. Treatments received were not reported. The patient was discharged on 21 November 2009. Discharge diagnosis included: paresthesias, myalgias, weakness, paraparesis, nausea, coagulopathy, depression/anxiety, insomnia, pneumonia, and superficial venous thrombosis. Assessment was presumed to be GBS. Follow-up visit revealed the patient was using a walker and continued with shortness of breath and difficulty with activities of daily life. At the time of this report, the patient had not recovered. Laboratory data included: MRI was negative; lumbar puncture was negative with viral culture pending; CT scan of chest revealed pneumonia; EMG (result not reported); urine abnormality, urine leukocytes esterase positive, bacteria urine (unspecified); virus culture (result not reported); blood culture (result not reported); hemoglobin decreased, and other tests were pending. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Death, Pneumonia, Respiratory failure
Clinical narrative: Initial report was received on 29 December 2009 (US-SP-2010-0011) .Vaccine Adverse Event Reporting System received 13 reports of deaths occurring after receipt of H1N1 vaccine. three deaths occurred after receipt of LAMV and 10 after receipt of MIV through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00014, -00015, -00016, -00017, -00018, -00019, -00020. A 19-year-old female patient had received a dose of H1N1 vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration was not reported. The patient experienced bilateral pneumonia and respiratory failure, and died (exact date of death not reported). Vaccination to onset was reported as 9 days. Past medical history included Rett syndrome, severe muscle wasting and physical disability. No additional information was reported. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, CSF test, CSF test abnormal, Chest discomfort, Chills
Clinical narrative: Initial report received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 370925-1. A 39-year-old male patient received H1N1 PANDEMIC INFLUENZA VACCINE (manufacturer not reported, lot reported as UP619AA - not a valid sanofi pasteur lot number) on 22 November 2009. Medical history was reported as none. One week prior to vaccination, on 16 November 2009, the patient was diagnosed with an upper respiratory infection / viral illness with symptoms of earache, sore throat, chest tightness, loose stool, myalgia, cough, nasal congestion, and chills. The patient was treated for the symptoms. The patient received the vaccine a week later and within 4 hours of vaccination, he developed progressively ascending paresthesias in legs and hands and into the buttocks. He was seen in his physician's office on 23 November 2009 and noted to have left leg and arm tingling. He complained of numbness and tingling in the extremities with heaviness and a feeling of weakness. He also complained of persistent diarrhea. On 30 November 2009 he was admitted to the hospital where he was noted to have nasal congestion, cough, distal weakness, and distal hypo reflexes. CSF analysis showed elevated protein with no WBC-albuminocytologic dissociation consistent with acute inflammatory demyelinating polyradiculoneuropathy. He was diagnosed with acute inflammatory demyelinating polyradiculopathy / GBS. Treatment medications were not reported. Outcome was not reported. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Diarrhoea, Ear pain, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial report received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 370925-1. A 39-year-old male patient received H1N1 PANDEMIC INFLUENZA VACCINE (manufacturer not reported, lot reported as UP619AA - not a valid sanofi pasteur lot number) on 22 November 2009. Medical history was reported as none. One week prior to vaccination, on 16 November 2009, the patient was diagnosed with an upper respiratory infection / viral illness with symptoms of earache, sore throat, chest tightness, loose stool, myalgia, cough, nasal congestion, and chills. The patient was treated for the symptoms. The patient received the vaccine a week later and within 4 hours of vaccination, he developed progressively ascending paresthesias in legs and hands and into the buttocks. He was seen in his physician's office on 23 November 2009 and noted to have left leg and arm tingling. He complained of numbness and tingling in the extremities with heaviness and a feeling of weakness. He also complained of persistent diarrhea. On 30 November 2009 he was admitted to the hospital where he was noted to have nasal congestion, cough, distal weakness, and distal hypo reflexes. CSF analysis showed elevated protein with no WBC-albuminocytologic dissociation consistent with acute inflammatory demyelinating polyradiculoneuropathy. He was diagnosed with acute inflammatory demyelinating polyradiculopathy / GBS. Treatment medications were not reported. Outcome was not reported. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hyporeflexia, Myalgia, Nasal congestion, Oropharyngeal pain, Paraesthesia
Clinical narrative: Initial report received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 370925-1. A 39-year-old male patient received H1N1 PANDEMIC INFLUENZA VACCINE (manufacturer not reported, lot reported as UP619AA - not a valid sanofi pasteur lot number) on 22 November 2009. Medical history was reported as none. One week prior to vaccination, on 16 November 2009, the patient was diagnosed with an upper respiratory infection / viral illness with symptoms of earache, sore throat, chest tightness, loose stool, myalgia, cough, nasal congestion, and chills. The patient was treated for the symptoms. The patient received the vaccine a week later and within 4 hours of vaccination, he developed progressively ascending paresthesias in legs and hands and into the buttocks. He was seen in his physician's office on 23 November 2009 and noted to have left leg and arm tingling. He complained of numbness and tingling in the extremities with heaviness and a feeling of weakness. He also complained of persistent diarrhea. On 30 November 2009 he was admitted to the hospital where he was noted to have nasal congestion, cough, distal weakness, and distal hypo reflexes. CSF analysis showed elevated protein with no WBC-albuminocytologic dissociation consistent with acute inflammatory demyelinating polyradiculoneuropathy. He was diagnosed with acute inflammatory demyelinating polyradiculopathy / GBS. Treatment medications were not reported. Outcome was not reported. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Protein total increased, Sensation of heaviness, Upper respiratory tract infection, Viral infection
Clinical narrative: Initial report received from the Centers for Disease Control (CDC) on 08 January 2010, under VAERS ID number 370925-1. A 39-year-old male patient received H1N1 PANDEMIC INFLUENZA VACCINE (manufacturer not reported, lot reported as UP619AA - not a valid sanofi pasteur lot number) on 22 November 2009. Medical history was reported as none. One week prior to vaccination, on 16 November 2009, the patient was diagnosed with an upper respiratory infection / viral illness with symptoms of earache, sore throat, chest tightness, loose stool, myalgia, cough, nasal congestion, and chills. The patient was treated for the symptoms. The patient received the vaccine a week later and within 4 hours of vaccination, he developed progressively ascending paresthesias in legs and hands and into the buttocks. He was seen in his physician's office on 23 November 2009 and noted to have left leg and arm tingling. He complained of numbness and tingling in the extremities with heaviness and a feeling of weakness. He also complained of persistent diarrhea. On 30 November 2009 he was admitted to the hospital where he was noted to have nasal congestion, cough, distal weakness, and distal hypo reflexes. CSF analysis showed elevated protein with no WBC-albuminocytologic dissociation consistent with acute inflammatory demyelinating polyradiculoneuropathy. He was diagnosed with acute inflammatory demyelinating polyradiculopathy / GBS. Treatment medications were not reported. Outcome was not reported. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Areflexia, Asthenia, Balance disorder, Blood calcium increased, Blood creatinine normal
Clinical narrative: Information received on 08 January 2010 from the CDC (Centers for Disease Control), VAERS reference number 371821-1. A 54 year old female patient with a history of hypercalcemia, cellulitis, and a recent sting ray sting developed symptoms of Guillain-Barre syndrome 13 days after receiving a first dose of MONOVALENT Vaccine - Preservative (lot number UP010AA) on 04 November 2009. On 17 November 2009, the patient awoke from her sleep by irrectractable pain in the right arm. In the middle of the night on 19 November 2009, she had pain in the posterior extremities. In the middle of the night on 20 November 2009, the patient had pain in her scapula and flanks and subsequently went to the emergency room. On 21 November 2009, the patient had paresthesia of both hands and her feet were unsteady. On 22 November 2009, the complained of a gait weakness. On 25 November 2009, the patient had deep tendon reflux absent but increasing in both legs. On 27 November 2009, the patient was diagnosed with Guillain-Barre Syndrome/Acute inflammatory demyelinating polyneuropathy. A discharge summary indicated progressive weakness and paresthesias, primarily involving both legs, but also hands and arm; diminished deep tendon reflexes and absent achilles reflexes; hypertension; and recent weight loss. Laboratory data included normal CPM, WBC, ESR, chest X-ray, creatinine protein, and MRI of the brain. LP protein was elevated at 155 and calcium was at 10.6. The patient was not recovered. Additional information provided in the VAERS report included LIPITOR 20mg and ASA 325mg listed as other meds. List of Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest X-ray normal, Demyelinating polyneuropathy, Gait disturbance, Guillain-Barre syndrome, Hypertension
Clinical narrative: Information received on 08 January 2010 from the CDC (Centers for Disease Control), VAERS reference number 371821-1. A 54 year old female patient with a history of hypercalcemia, cellulitis, and a recent sting ray sting developed symptoms of Guillain-Barre syndrome 13 days after receiving a first dose of MONOVALENT Vaccine - Preservative (lot number UP010AA) on 04 November 2009. On 17 November 2009, the patient awoke from her sleep by irrectractable pain in the right arm. In the middle of the night on 19 November 2009, she had pain in the posterior extremities. In the middle of the night on 20 November 2009, the patient had pain in her scapula and flanks and subsequently went to the emergency room. On 21 November 2009, the patient had paresthesia of both hands and her feet were unsteady. On 22 November 2009, the complained of a gait weakness. On 25 November 2009, the patient had deep tendon reflux absent but increasing in both legs. On 27 November 2009, the patient was diagnosed with Guillain-Barre Syndrome/Acute inflammatory demyelinating polyneuropathy. A discharge summary indicated progressive weakness and paresthesias, primarily involving both legs, but also hands and arm; diminished deep tendon reflexes and absent achilles reflexes; hypertension; and recent weight loss. Laboratory data included normal CPM, WBC, ESR, chest X-ray, creatinine protein, and MRI of the brain. LP protein was elevated at 155 and calcium was at 10.6. The patient was not recovered. Additional information provided in the VAERS report included LIPITOR 20mg and ASA 325mg listed as other meds. List of Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Laboratory test, Lumbar puncture abnormal, Metabolic function test, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Information received on 08 January 2010 from the CDC (Centers for Disease Control), VAERS reference number 371821-1. A 54 year old female patient with a history of hypercalcemia, cellulitis, and a recent sting ray sting developed symptoms of Guillain-Barre syndrome 13 days after receiving a first dose of MONOVALENT Vaccine - Preservative (lot number UP010AA) on 04 November 2009. On 17 November 2009, the patient awoke from her sleep by irrectractable pain in the right arm. In the middle of the night on 19 November 2009, she had pain in the posterior extremities. In the middle of the night on 20 November 2009, the patient had pain in her scapula and flanks and subsequently went to the emergency room. On 21 November 2009, the patient had paresthesia of both hands and her feet were unsteady. On 22 November 2009, the complained of a gait weakness. On 25 November 2009, the patient had deep tendon reflux absent but increasing in both legs. On 27 November 2009, the patient was diagnosed with Guillain-Barre Syndrome/Acute inflammatory demyelinating polyneuropathy. A discharge summary indicated progressive weakness and paresthesias, primarily involving both legs, but also hands and arm; diminished deep tendon reflexes and absent achilles reflexes; hypertension; and recent weight loss. Laboratory data included normal CPM, WBC, ESR, chest X-ray, creatinine protein, and MRI of the brain. LP protein was elevated at 155 and calcium was at 10.6. The patient was not recovered. Additional information provided in the VAERS report included LIPITOR 20mg and ASA 325mg listed as other meds. List of Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Weight decreased
Clinical narrative: Information received on 08 January 2010 from the CDC (Centers for Disease Control), VAERS reference number 371821-1. A 54 year old female patient with a history of hypercalcemia, cellulitis, and a recent sting ray sting developed symptoms of Guillain-Barre syndrome 13 days after receiving a first dose of MONOVALENT Vaccine - Preservative (lot number UP010AA) on 04 November 2009. On 17 November 2009, the patient awoke from her sleep by irrectractable pain in the right arm. In the middle of the night on 19 November 2009, she had pain in the posterior extremities. In the middle of the night on 20 November 2009, the patient had pain in her scapula and flanks and subsequently went to the emergency room. On 21 November 2009, the patient had paresthesia of both hands and her feet were unsteady. On 22 November 2009, the complained of a gait weakness. On 25 November 2009, the patient had deep tendon reflux absent but increasing in both legs. On 27 November 2009, the patient was diagnosed with Guillain-Barre Syndrome/Acute inflammatory demyelinating polyneuropathy. A discharge summary indicated progressive weakness and paresthesias, primarily involving both legs, but also hands and arm; diminished deep tendon reflexes and absent achilles reflexes; hypertension; and recent weight loss. Laboratory data included normal CPM, WBC, ESR, chest X-ray, creatinine protein, and MRI of the brain. LP protein was elevated at 155 and calcium was at 10.6. The patient was not recovered. Additional information provided in the VAERS report included LIPITOR 20mg and ASA 325mg listed as other meds. List of Documents held by sender: none.