chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-JUL-2012, the patient was inoculated with the ZOSTAVAX, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001032: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007393: US-009507513-1806USA001032.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA001032.
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Acute disseminated encephalomyelitis, Angiogram normal, Anti-NMDA antibody negative, Balance disorder
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Beta-2 glycoprotein antibody positive, Body temperature increased, C-reactive protein, CSF glucose normal, CSF oligoclonal band absent
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF virus no organisms observed, CSF white blood cell count increased, Cardiolipin antibody positive
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Clonus, Disorientation, Headache, Hyperreflexia, Laboratory test abnormal
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Lethargy, Lumbar puncture abnormal, Memory impairment, Mental status changes
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Photosensitivity reaction, Red blood cell sedimentation rate increased, Serology negative
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Speech disorder, Tandem gait test abnormal, Unresponsive to stimuli, Viral test negative, Vomiting
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased, White matter lesion
Clinical narrative: This is a literature case, initially received on 04-Jun-2018, reported by a Physician and concerns a 62-year-old, adult female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). After 3 days of vaccination, the patient suddenly developed headache. The headache worsened and it was associated with photosensitivity and vomiting. The next day, the patient was lethargic. That night, the patient's husband stated that, she sat up in bed and started 'speaking in tongues' (as reported) as if she was 'possessed'. The patient was taken to the emergency room and was found to be extremely disoriented and could not follow commands. Subsequently, the patient was hospitalized. Upon presentation, the patient's temperature was 101.2 F but was afebrile later. The patient experienced diffused hyperreflexia with ankle clonus bilaterally. Lab tests performed included serum white blood count which was 12.2, red blood cell sedimentation rate (ESR) was 51, C-reactive protein (CRP) was 3.40, anti-cardiolipin IgM and beta-2-glycoprotein were elevated. Other serological studies were unremarkable, including anti-NMDA antibodies, tick born infections, and viral studies. Computer tomography angiography (CTA) of the head and neck were found to be unremarkable. Lumbar puncture showed protein of 57, white cells was 87, red cells was 36, glucose was normal, viral studies and oligoclonal bands were negative. MRI of brain showed hyperintensities in the bilateral mesial temporal lobes, frontoparietal white matter and basal ganglia and was diagnosed with acute disseminated encephalomyelitis (ADEM). The patient was treated was treated with intravenous (IV) steroids for 5 days followed by prednisone tapered over 1 month. The patient's mental status improved dramatically each day and the score on Montreal cognitive assessment (MOCA) test was 19/30 upon discharge. One month later, during the follow-up, the patient complained of some problems with short-term memory and balance, but was normal otherwise. Upon physical examination MOCA was 26/30 and had trouble with tandem gait, mild hyperreflexia without clonus. Neurologic examination was found to be normal. Cardiolipin IgM, beta-2-glycoprotein, ESR and CRP were decreased. Repeat MRI demonstrated, resolution of diffusion restriction and improvement in the size and number of hyperintensities without new lesions were noted. At the time of this report, the patient was recovering from the events. The assumed mechanism of immune-mediated demyelination was triggered by infection or rarely vaccination and for most vaccines, incidence rates of ADEM are as low as 0.1 per 100,000 vaccinated individuals. Hence, the reporter assessed the event as related to the suspect vaccine.
Age: 32.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash generalised
Clinical narrative: Telephone call from client 2 wks post vaccine Var/Tdap reports generalized rash, except at vaccine administration site, x 10 days post vaccine. Pt report concurrently taking Amoxicillin. Resolved without intention.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: PATIENT DEVELOPED ZOSTER 18 HOURS AFTER THE ADMINISTRATION OF THE VACCINE. HE HAD A LOT OF PAIN AND HE IS YET SUFFERING FROM THIS CONDITION. HE VISITED THE MD TWO DAYS AFTER THE VACCINE AND WAS PRESCRIBED VALACYCLOVIR 1GM THREE TIMES A DAY. ON JUNE 14, 2018 HE VISITED A PAIN MANAGEMENT MD AND PRESCRIBED LIDOCAINE 5% PATCHES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Pt. received SHINGRIX Vaccine 6/15/18. Has experienced fever (highest 100.0F yesterday), slight redness, pain and warm approx. 3" in diameter surrounding injection site. Has not taken any otc meds. RN recommended acetaminophen/ibuprofen per instructions on label as well as to apply ice and monitor s/s.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient began to run fever and have chills on the evening 06/16/2018. Patient right arm began to swell and become red.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Very sore arm at site of injection plus about 7 raised welts. Three days later soreness is a little less but the welts are blending together.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Headache, Injection site erythema, Injection site pain
Clinical narrative: Throbbing headache, fever, joint pain to the point it was difficult to walk, nausea, swollen, sore muscles at the injection site, huge red hot welt at the injection site. All of these appeared the day following the day of the injection and lasted until nightime. (I thought about going to an UrgiCare Center because it was a Saturday and my doctor's office was closed. But I called my sister, who had the SHINGRIX vaccine the same day that I did, and she was experiencing the same symptoms so I figured it was because of the vaccine.)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Throbbing headache, fever, joint pain to the point it was difficult to walk, nausea, swollen, sore muscles at the injection site, huge red hot welt at the injection site. All of these appeared the day following the day of the injection and lasted until nightime. (I thought about going to an UrgiCare Center because it was a Saturday and my doctor's office was closed. But I called my sister, who had the SHINGRIX vaccine the same day that I did, and she was experiencing the same symptoms so I figured it was because of the vaccine.)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Throbbing headache, fever, joint pain to the point it was difficult to walk, nausea, swollen, sore muscles at the injection site, huge red hot welt at the injection site. All of these appeared the day following the day of the injection and lasted until nightime. (I thought about going to an UrgiCare Center because it was a Saturday and my doctor's office was closed. But I called my sister, who had the SHINGRIX vaccine the same day that I did, and she was experiencing the same symptoms so I figured it was because of the vaccine.)
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Patient experienced bloody stools. Labs were drawn. Symptoms have been resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium decreased, Dizziness, Hyperhidrosis, Pruritus, Rash
Clinical narrative: Woke up at 2:30 am June 14 itching with a rash from neck down to groin, feeling light headed and dizzy. Did not throw up. Temperature was 98.5 but I was sweating. Went to the ER at Hospital around 3:30am.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: Patient received the vaccination in the afternoon of 6/15/18. She stated that by the evening her arm was swollen and tender. She said she did not think much about it but by Saturday morning she was not feeling well and had flu like symptoms. Her blood pressure was 190/85 and she reached a fever of 101.1. She stated that she felt dizzy and exhausted as well. She slept the entire day on Sunday and by Monday morning she felt much better. Her normal blood pressure runs between 140-150/80.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient received the vaccination in the afternoon of 6/15/18. She stated that by the evening her arm was swollen and tender. She said she did not think much about it but by Saturday morning she was not feeling well and had flu like symptoms. Her blood pressure was 190/85 and she reached a fever of 101.1. She stated that she felt dizzy and exhausted as well. She slept the entire day on Sunday and by Monday morning she felt much better. Her normal blood pressure runs between 140-150/80.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site warmth, Somnolence
Clinical narrative: Headache; drowsiness; Injection site is hot to touch and redness about 3 inches wide on top of arm (band).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash vesicular
Clinical narrative: 6/10/18 developed a vesicular rash along posterior trunk only and oval patch at site of injection.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Blister, Erythema
Clinical narrative: Red area 40 mm on left side chest above Breast open area 15mm 2 small vesicles 5mm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm with significant swelling, warm to the touch, redness and pain. Swelling resolved by the third day. Redness resolved within a week. Ache and Itch continue.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: Redness at site, soreness through arm, radiating to L eblow that has persisted 4 days later, warmth to the touch.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever- 102.9 degrees F in the evening on 6/15/18, High fever -104.0 degrees F in the evening on 6/16/18. Controlled with TYLENOL. Rash starting on her face then moved down her neck and on to her stomach. Rash doesn't seem to bother her. 6/17/18- took her temperature before bed - 98.9 degrees F. Rash still present.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Headche, significant muscle/body aches, fatigue, injection site swollen, red and hot to the touch, arm pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Headche, significant muscle/body aches, fatigue, injection site swollen, red and hot to the touch, arm pain.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site reaction: red, swollen, pain. Ice applied to area. Re-assess in 20 minutes showed improvement. Follow up phone call in evening: discomfort and advised TYLENOL. Next day follow up call with father report improved and no new concerns at the time.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt experienced fainting within 5 minutes after the injection, but awake and alert after 5 minutes.  Pt was doing fine 1 hour after fainting.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Begin with diarrhea night of immunization with concern for blood in stool x2. Follow up appointment in office on Monday. Attempt stool sample unsuccessful d/t liquid nature of stool in diaper.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Insomnia, Pain
Clinical narrative: WOKE UP MORNING AFTER VACCINE AND FELT LIKE "GOT HIT BY A BUS," ACHY ALL OVER HIS ENTIRE BODY, DID NOT HAVE AN APPETITE AND COULD NOT SLEEP. FELT BETTER 2 DAYS LATER.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain on left , Dr gave her TORADOL and MOTRIN.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site reaction, Injection site warmth, Migraine
Clinical narrative: Pain, warm, red rash at injection site. Extreme fatigue, nausea. Migraine headache. No temp. Patient experienced extreme fatigue and nausea the evening of the 12th. The rash she did not notice until 6/17 and it also was itchy. There is also what looks like a potential bite on her left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash erythematous, Rash pruritic
Clinical narrative: Pain, warm, red rash at injection site. Extreme fatigue, nausea. Migraine headache. No temp. Patient experienced extreme fatigue and nausea the evening of the 12th. The rash she did not notice until 6/17 and it also was itchy. There is also what looks like a potential bite on her left arm.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cough, Diarrhoea, Tremor
Clinical narrative: AFTER ONE DOSE PATIENT HAD SEVERE GI DISTRESS, DIARRHEA, FOLLOWED BY 1 MONTH OF COUGH AND NEW LEFT HAND TREMOR.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Ear pain, Headache, Malaise, Nausea, Pain
Clinical narrative: 24 hours after vaccination patient experienced fever, body aches, nausea, and ear pain. 1 episode of vomiting 24 hours later. Also presented with headache. Symptoms improved 24 hours later but still had general feeling of unwellness. Took MOTRIN x 1 dose. Patient was observed and monitored, stable. Advised RTO if no further improvement or worsening of symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: 24 hours after vaccination patient experienced fever, body aches, nausea, and ear pain. 1 episode of vomiting 24 hours later. Also presented with headache. Symptoms improved 24 hours later but still had general feeling of unwellness. Took MOTRIN x 1 dose. Patient was observed and monitored, stable. Advised RTO if no further improvement or worsening of symptoms.
Age: 84.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an adult patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. This is a non-valid case due to lack of patient identifiers. On unknown dates (reported as since an unspecified amount of time), the patient has been vaccinated with two combine pediatric doses of RECOMBIVAX HB injection for prophylaxis (strength, route, dosage schedule, anatomical location, lot # and expiry date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-DEC-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 01-OCT-2015, the patient was treated by a physician for a blistering vesicular eruption, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.