chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Fungal test negative, HIV test negative, Hyperreflexia, Lymphocyte percentage increased, Muscular weakness
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Musculoskeletal stiffness, Mycoplasma test positive, Neck pain, Nerve conduction studies normal, Neurogenic bladder
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Plasmapheresis, Pneumonia mycoplasmal, Radiculopathy, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Sensory loss, Urinary retention, Viral test negative, Visual evoked potentials normal, Vitamin B12 normal
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: West Nile virus test negative, White blood cell count decreased
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Hyperhidrosis, Laboratory test normal, Lymphadenopathy, Nausea, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Vaccination complication
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Cardiac enzymes normal, Chest discomfort, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Electrocardiogram normal, Lymph node pain, Lymphadenopathy, Myopericarditis, Night sweats
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Orthopnoea
Clinical narrative: This report was received from the investigator in a trial on 07 December 2010. A 26 year-old female subject received the following vaccines on 05 April 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); Tdap (unknown manufacturer, lot number not reported); and Varicella vaccine (manufacturer and lot number not reported). Nine days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject has no medical history. On 14 April 2010, the subject had an electrocardiogram and echocardiogram that were normal, and a normal Troponin I. An MRI of the brain, spinal cord, and heart; and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Alanine aminotransferase normal, Angiogram, Aspartate aminotransferase normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood potassium normal, C-reactive protein increased, Catheterisation cardiac normal, Chest X-ray normal, Chest pain
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Feeling hot
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Haematocrit normal, Haemoglobin normal, Myocarditis, Platelet count normal, Red blood cell sedimentation rate increased
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Red blood cell sedimentation rate normal, Troponin increased, White blood cell count normal
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: This report was received from the investigator (MILVAX) in a trial on 07 December 2010. A 21 year-old male subject received following vaccines on 05 May 2010: ACAM2000 (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and TYPHIM VI (reported as Typhoid ViCPS, lot number not reported). Twenty-two days after vaccination, the subject was diagnosed with unspecified myocarditis. The subject has no medical history; however it was noted that the medical record did not have confirmation of a positive or negative history of eczema. On 17 May 2010, the subject had an abnormal Troponin I of 04.29, and normal electrocardiogram. On 18 May 2010 the subject had a normal echocardiogram, and on 02 June 2010 the subject had a normal MRI of the heart. An MRI of the brain, spinal cord, and lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Loss of consciousness
Clinical narrative: PATIENT DESCRIBED SHE BECAME UNCONSCIOUS 2 HOURS LATER AT HOME AFTER RECEIVING TDAP AND INFLUENZA VACCINES ON 10/29/2010.  FAMILY MEMBER HAD TO CALL AN AMBULANCE BUT PATIENT WAS ABLE TO RECOVER WITHOUT TRANSFER TO HOSPITAL.  PATIENT WAS NOT ABLE TO TELL WHAT TXS WERE PROVIDED FROM AMBULANCE.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Dizziness, Loss of consciousness, Syncope
Clinical narrative: This spontaneous consumer report (initial receipt 02-DEC-2010) concerns a 14-year-old female patient. On 09-NOV-2010, the patient received AFLURIA injection (batch number: 11449111A). Approximately five minutes after the injection, the patient passed out and was transferred to the hospital by paramedics. She was unconscious for about 5-10 seconds before being revived. There was a comment made that she may have been having a panic attack but it was not confirmed. The mother said that the patient's arm was sore. The patient's outcome was unknown. The reporter considered the event possible in relation to the suspect drug, AFLURIA.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 02-DEC-2010) concerns a 14-year-old female patient. On 09-NOV-2010, the patient received AFLURIA injection (batch number: 11449111A). Approximately five minutes after the injection, the patient passed out and was transferred to the hospital by paramedics. She was unconscious for about 5-10 seconds before being revived. There was a comment made that she may have been having a panic attack but it was not confirmed. The mother said that the patient's arm was sore. The patient's outcome was unknown. The reporter considered the event possible in relation to the suspect drug, AFLURIA.
Age: 26.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blindness transient, Cough, Dizziness, Dysstasia, Fatigue
Clinical narrative: Same day vac given -> around 6pm - very dizzy with lost vision for few min. & ringing in the ears - came back after few min. Headache, fever, chills, very nauseous - lasted whole night. 2nd day -> all sym. were much less - feeling much better but still little nauseous HA.
Age: 26.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Headache, Myalgia, Nausea, Pain, Presyncope
Clinical narrative: Same day vac given -> around 6pm - very dizzy with lost vision for few min. & ringing in the ears - came back after few min. Headache, fever, chills, very nauseous - lasted whole night. 2nd day -> all sym. were much less - feeling much better but still little nauseous HA.
Age: 26.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Same day vac given -> around 6pm - very dizzy with lost vision for few min. & ringing in the ears - came back after few min. Headache, fever, chills, very nauseous - lasted whole night. 2nd day -> all sym. were much less - feeling much better but still little nauseous HA.
Age: 26.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blindness, Chills, Dizziness, Headache, Nausea
Clinical narrative: Same day vac given -> around 6pm - very dizzy with lost vision for few min. & ringing in the ears - came back after few min. Headache, fever, chills, very nauseous - lasted whole night. 2nd day -> all sym. were much less - feeling much better but still little nauseous HA.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3, FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, Foetal growth restriction, Intra-uterine death, Ultrasound antenatal screen abnormal
Clinical narrative: Initial report was received 07 December 2010 from a consumer who is also the patient. A 30-year-old pregnant woman had received an intramuscular right deltoid injection of FLUZONE, lot number U3562CA on 19 October 2010 when she was 14 weeks, 3 days gestation and approximately four day later, she experienced a spontaneous abortion. All relevant diagnostic tests and laboratory data had been normal. Her last menstrual period occurred on 11 July 2010 and her estimated date of delivery was 16 April 2011. At the time of vaccination, the baby had a heart beat; however, when the patient went for her visit on 16 November, there was no heart beat. On 17 November, the patient went for a D & E. Concomitant medications consisted of prenatal vitamins. She had no risk factors, no known allergies and no medical history. She had received an Influenza vaccination last year and she had not experienced any adverse events following prior vaccinations. She had no previous miscarriages. At the time of the report, the patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3, FLU(H1N1), FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal, Uterine dilation and curettage
Clinical narrative: Initial report was received 07 December 2010 from a consumer who is also the patient. A 30-year-old pregnant woman had received an intramuscular right deltoid injection of FLUZONE, lot number U3562CA on 19 October 2010 when she was 14 weeks, 3 days gestation and approximately four day later, she experienced a spontaneous abortion. All relevant diagnostic tests and laboratory data had been normal. Her last menstrual period occurred on 11 July 2010 and her estimated date of delivery was 16 April 2011. At the time of vaccination, the baby had a heart beat; however, when the patient went for her visit on 16 November, there was no heart beat. On 17 November, the patient went for a D & E. Concomitant medications consisted of prenatal vitamins. She had no risk factors, no known allergies and no medical history. She had received an Influenza vaccination last year and she had not experienced any adverse events following prior vaccinations. She had no previous miscarriages. At the time of the report, the patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3, FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Ultrasound antenatal screen abnormal, Uterine dilation and evacuation
Clinical narrative: Initial report was received 07 December 2010 from a consumer who is also the patient. A 30-year-old pregnant woman had received an intramuscular right deltoid injection of FLUZONE, lot number U3562CA on 19 October 2010 when she was 14 weeks, 3 days gestation and approximately four day later, she experienced a spontaneous abortion. All relevant diagnostic tests and laboratory data had been normal. Her last menstrual period occurred on 11 July 2010 and her estimated date of delivery was 16 April 2011. At the time of vaccination, the baby had a heart beat; however, when the patient went for her visit on 16 November, there was no heart beat. On 17 November, the patient went for a D & E. Concomitant medications consisted of prenatal vitamins. She had no risk factors, no known allergies and no medical history. She had received an Influenza vaccination last year and she had not experienced any adverse events following prior vaccinations. She had no previous miscarriages. At the time of the report, the patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3, FLU(H1N1), FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test normal, Uterine dilation and evacuation
Clinical narrative: Initial report was received 07 December 2010 from a consumer who is also the patient. A 30-year-old pregnant woman had received an intramuscular right deltoid injection of FLUZONE, lot number U3562CA on 19 October 2010 when she was 14 weeks, 3 days gestation and approximately four day later, she experienced a spontaneous abortion. All relevant diagnostic tests and laboratory data had been normal. Her last menstrual period occurred on 11 July 2010 and her estimated date of delivery was 16 April 2011. At the time of vaccination, the baby had a heart beat; however, when the patient went for her visit on 16 November, there was no heart beat. On 17 November, the patient went for a D & E. Concomitant medications consisted of prenatal vitamins. She had no risk factors, no known allergies and no medical history. She had received an Influenza vaccination last year and she had not experienced any adverse events following prior vaccinations. She had no previous miscarriages. At the time of the report, the patient's outcome was not reported. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Initial report received on 30 November 2010 from another manufacturer, report # WAES 1010USA02610. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered nurse concerning 3 patients who recently in 2010 were vaccinated with PNEUMOVAX 23 (Lot # not specified). Recently in 2010 the patients had developed localized reactions. The patients' outcome was unknown. It was unspecified if the patient's sought medical attention. Follow-up information has been received from the registered nurse concerning a 63-year-old female patient with atrial fibrillation, hypertension, hypothyroidism, and gastroesophageal reflux disease and no illness at time of vaccination who on 28 September 2010, at 12:15 PM, was vaccinated IM into the left deltoid with the second dose of PNEUMOVAX 23 (lot number 667418/0978Z), and the fifth dose of FLUZONE (lot number U3645AA). Concomitant therapy included BYSTOLIC, JANTOVEN, CELEBREX and PROTONIX. On 30 September 2010 at 9:00 AM the patient was seen in office complaining of erythema and tenderness in left deltoid. Area of erythema was 5 cm. The patient was treated with AUGMENTIN. The patient was recovered without complication. No diagnostic laboratory tests were performed. The 5 cm area erythema and tenderness in left deltoid were considered to be other important medical events by the registered nurse. This is one of several reports received from the same source." Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy muscle, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Plasmapheresis
Clinical narrative: No signs or symptoms exhibited at time of administration. Patient no longer active at this facility due to regaining function of kidney. Notified by patient. Physician on 11/30/2010 that patient had been hospitalized with neurological symptoms and diagnosed with Guillain-Barre's syndrome.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Neurological symptom
Clinical narrative: No signs or symptoms exhibited at time of administration. Patient no longer active at this facility due to regaining function of kidney. Notified by patient. Physician on 11/30/2010 that patient had been hospitalized with neurological symptoms and diagnosed with Guillain-Barre's syndrome.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Cough, Muscle twitching, Productive cough
Clinical narrative: Seizure on 11-24-10 hx seizure VP shunt (seen at ER) started on KEPPRA.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Retching, Scan brain, Staring
Clinical narrative: Seizure on 11-24-10 hx seizure VP shunt (seen at ER) started on KEPPRA.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: Seizure on 11-24-10 hx seizure VP shunt (seen at ER) started on KEPPRA.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Headache, Lethargy, Pyrexia
Clinical narrative: Vaccine given at 1pm; pt developed chills, shakes & fever at 4p - T-102.4 - max. 103.3 on 12/9/10 with severe H/A, weakness, lethargy; given TYLENOL 2 q 4 hours & Ibuprofen, ice packs to groin & bilat axilla; cool compress to neck & forehead; use of Incentive Spirometer & increased fluids; contacted Dr. x 3.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Vaccine given at 1pm; pt developed chills, shakes & fever at 4p - T-102.4 - max. 103.3 on 12/9/10 with severe H/A, weakness, lethargy; given TYLENOL 2 q 4 hours & Ibuprofen, ice packs to groin & bilat axilla; cool compress to neck & forehead; use of Incentive Spirometer & increased fluids; contacted Dr. x 3.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pruritus, hives.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Culture stool, Haematochezia, Intussusception, Urinary tract infection, Vomiting
Clinical narrative: 6 month old female - got ROTATEQ on 12/3/10. On 12/8/10 evening started vomiting - admitted to hosp. Dx UTI - started on Cephalexin - home 12/9/10 in AM - Pt had a current jelly bloody stool in mid day - seen in our office 12/9/10 with in the after noon. Stable - in view of vomiting current jelly bloody stool. Dx of intussusception with spontaneous resolution.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Within 5 minutes after patient received the flu shot pt had rashes on the right arm, bumps and it was itching and swollen, pt had also rashes on the neck within 10 min and started to feel weird.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hyperhidrosis, Injection site pain, Oedema peripheral, Pain
Clinical narrative: Pt sts PNEUMOVAX burned upon administration in left arm. Pt sts pain continued after left facility and swelling started to occur. Swelling and redness continued down arm through afternoon to evening and caused sweating and vomiting. Pt visited ER late evening/early morning due to swelling down arm and reported wedding ring hurts to get off.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Pt sts PNEUMOVAX burned upon administration in left arm. Pt sts pain continued after left facility and swelling started to occur. Swelling and redness continued down arm through afternoon to evening and caused sweating and vomiting. Pt visited ER late evening/early morning due to swelling down arm and reported wedding ring hurts to get off.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Insomnia, Ocular hyperaemia, Wheezing
Clinical narrative: Two hours after vaccination, patient had wheezing, difficulty breathing and red eyes. He was not able to sleep during the night. Symptoms resolved at 2 PM next day. No doctor consulted by patient.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Oropharyngeal pain
Clinical narrative: Sore, red, swollen arm at injection site, headache, sore throat
Age: 51.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Vaccination hurt more than is usual. I was told to expect my arm to hurt, which it did, especially when lifting it. However, the pain never went away, and in fact has gotten much worse. It is now Dec. 13, and I cannot lift my arm to put on clothes or put my seatbelt on because of excruciating pain in my upper arm. I researched online and found that many people are experiencing the exact same thing.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Abdominal mass, Barium enema, Diarrhoea, Intestinal malrotation, Intussusception
Clinical narrative: STARTED WITH VOMITING AND DIARRHEA ON 11/26/2010.  PRESENTED IN OFFICE ON 11/27/2010 WITH A SOFT, MOBILE SAUSAGE-SHAPED MASS IN LLQ/MID-ABDOMEN.  SENT TO ER FOR EVALUATION.  INTUSSUSCEPTION FOUND AND TRIED TO REDUCE TWICE WITHOUT SUCCESS.  SURGERY DONE TO CORRECT.  ALSO DISCOVERED MALROTATION WHICH REQUIRED SURGERY.