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This is VAERS ID 422660

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History of Changes from the VAERS Wayback Machine

First Appeared on 5/13/2011

VAERS ID: 422660
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(10-11): INFLUENZA (SEASONAL) (NO BRAND NAME 10-11) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 7/12/2011

VAERS ID: 422660 Before After
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
FLU(10-11): INFLUENZA (SEASONAL) (NO BRAND NAME 10-11) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 7/7/2013

VAERS ID: 422660 Before After
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 6/14/2014

VAERS ID: 422660 Before After
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 8/14/2014

VAERS ID: 422660 Before After
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 12/14/2016

VAERS ID: 422660 Before After
VAERS Form:
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 9/14/2017

VAERS ID: 422660 Before After
VAERS Form:(blank) 1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 2/14/2018

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 6/14/2018

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 8/14/2018

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 9/14/2018

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 10/14/2018

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 12/24/2020

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 12/30/2020

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 5/7/2021

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


Changed on 5/14/2021

VAERS ID: 422660 Before After
VAERS Form:1
Age:69.0
Sex:Male
Location:Unknown
Vaccinated:2010-09-03
Onset:2011-04-18
Submitted:2011-05-10
Entered:2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Blood pressure decreased, Botulism, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Protein total normal, Quadriplegia, Respiratory paralysis, Quadriparesis, Balance disorder, Autopsy, CSF glucose increased, Computerised tomogram head, Spinal myelogram, Nuclear magnetic resonance imaging spinal cord abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2011-04-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC 'Split Type': PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.

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