chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-NMDA antibody negative, Asthenia, Bacterial test negative, CSF cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: CSF culture negative, CSF glucose increased, CSF lymphocyte count increased, CSF protein increased, Computerised tomogram head normal
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Depressed level of consciousness, Enterovirus test negative, Extensor plantar response, Flow cytometry, Fungal test negative
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: HIV test negative, Herpes simplex serology negative, Human herpes virus 6 serology negative, Hyperreflexia, JC virus test
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Mechanical ventilation, Mental status changes, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Plasmapheresis, Pleocytosis, Polymerase chain reaction, Pyrexia, Varicella virus test negative
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Viral test negative, White matter lesion
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date for prophylaxis. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date for prophylaxis. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELEN-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, RNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of Systemic Lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza (unknown route and injection site, batch number not provided). 12 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine unspecified (manufacturer unspecified). Subject's medical condition included systemic lupus erythematosus. On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 systemic lupus erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improvement management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators, using xMAP technology. SLE patients who exhibited disease flare and significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
Sex: M
Vaccine: FLU3, HEP
Symptoms: Apgar score normal, Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a consumer (subject's father) and described the occurrence of wrong vaccine administered in a neonate male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on 28 October 2013. Concurrent medications included Vitamin K. On 28 October 2013 at 18:00 the subject received unspecified dose of FLUARIX (.5 ml, unknown) and experienced wrong vaccine administered and inappropriate age at vaccine administration. The newborn subject mistakenly received an adult dose of FLUARIX instead of hepatitis B vaccine. The hospital kept the subject and mother for one and half days following the birth for observation due to the maladministration. The time of birth was 15:40 on 28 October 2013 and the vaccine was administered approximately three hours after birth. The subject was healthy and alert; Apgar score of 8-9. There were no complications at birth. No adverse events have been reported.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2 and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.