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Found 8,467 cases where Patient Died

Case Details

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VAERS ID: 796586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and never smoked. The patient''s age at the time of enrollment was 70.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 15 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and cerebrovascular disorder. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of hypertension and cerebrovascular disease and never smoked. The patient''s age at the time of enrollment was 67.3-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 27 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac valve disease; Cerebrovascular disorder; Chronic bronchitis; Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes, hypertension, cardiac valve disease, cerebrovascular disorder, chronic bronchitis and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine , the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes, hypertension, heart valve disease, cerebrovascular disease and chronic bronchitis and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 78.4-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 40 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Smoker (Patient still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic kidney disease and smoker (Patient still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic kidney disease and the patient still smokes or ever smoked but stopped less than 1 month. The patient''s age at the time of enrollment was 81.2-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 37 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Chemotherapy; Hypertension; Smoker (Still smokes or ever smoked but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension, smoker (Still smokes or ever smoked but stopped smoking less than 1 month), cancer and chemotherapy. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer, hypertension and underwent chemotherapy. The patient still smokes or ever smoked but stopped less than 1 month. The patient''s age at the time of enrollment was 71.6-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes and hypertension never smoked. The patient''s age at the time of enrollment was 69.4-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 47 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Smoker (Still smokes or ever smoked but stop less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic kidney disease and smoker (Still smokes or ever smoked but stop less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic kidney disease and the patient still smokes or ever smoked but stopped less than 1 month. The patient''s age at the time of enrollment was 85.1-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 49 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and cancer. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and hypertension and never smoked. The patient''s age at the time of enrollment was 80.4-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 34 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796736 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, H3N2 influenza, Influenza, Influenza A virus test positive, Influenza B virus test, Polymerase chain reaction positive, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data: Test Name: Influenza A virus test positive; Result Unstructured Data: Test Result: influenza A (H3N2) virus infection, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a male subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included diabetes, coronary artery disease and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included influenza a virus infection, acute respiratory tract infection with serious criteria of GSK medically significant, cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included influenza a virus infection (unknown), acute respiratory tract infection (unknown), cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza a virus infection, acute respiratory tract infection, cough and unknown cause of death may have been caused by trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates, the patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found positive for influenza A (H3N2) virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza A virus test positive result was influenza A (H3N2) virus infection unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a male aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes and coronary artery disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 66.7-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 1 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found positive for influenza A (H3N2) virus. On unspecified date, at week 40 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates, the patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found positive for influenza A (H3N2) virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and never smoked The patient''s age at the time of enrollment was 80.0-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 2 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chemotherapy; Chronic liver disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic liver disease and chemotherapy. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic liver disease, chemotherapy and never smoked. The patient''s age at the time of enrollment was 80.3-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 27 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Hypertension; Neuromuscular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, neuromuscular disorder nos and hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer, neuromuscular disease, hypertension and never smoked. The patient''s age at the time of enrollment was 66.1-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 14 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes, chronic kidney disease and never smoked. The patient''s age at the time of enrollment was 75.1-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 32 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic kidney disease and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic Kidney disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 77.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 47 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796742 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes, chronic Kidney disease and never smoked. The patient''s age at the time of enrollment was 75.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 48 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of hypertension and never smoked The patient''s age at the time of enrollment was 81.9-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 41 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes, cancer and hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer, diabetes, hypertension and never smoked. The patient''s age at the time of enrollment was 76.0-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 40 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796745 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included coronary artery disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of coronary artery disease and never smoked. The patient''s age at the time of enrollment was 71.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 9 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Chronic Obstructive Pulmonary Disease and never smoked. The patient''s age at the time of enrollment was 72.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 45 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796747 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Diabetes; Neuromuscular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes, cerebrovascular disorder and neuromuscular disorder NOS. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of diabetes, cerebrovascular disease and neuromuscular disorder. The patient had never smoked. The patient''s age at enrollment was 79.2 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 1 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 18 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, chronic obstructive pulmonary disease and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory- confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of cancer and chronic obstructive pulmonary disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 71.3 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 1 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 37 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and cerebrovascular disorder. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of hypertension and cerebrovascular disease. The patient never smoked. The patient''s age at enrollment was 68.7 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted by phone at week 2 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 12 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796750 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Smoker (The patient had a smoking status but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and smoker (The patient had a smoking status but stopped smoking less than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of hypertension. The patient had a smoking status but stopped smoking less than 1 month. The patient''s age at enrollment was 70.6 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 5 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 5 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 13 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Chronic kidney disease; Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease, asthma and chronic kidney disease. On an unknown date, 14 days after receiving Flu seasonal TIV Dresden, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to Flu seasonal TIV Dresden. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of chronic Obstructive Pulmonary Disease, asthma and chronic kidney disease. The patient had never smoked. The patient''s age at enrollment was 86.7 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 7 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 7 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 44 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796752 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac valve disease; Cerebrovascular disorder; Coronary artery disease; Neuromuscular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included neuromuscular disorder nos, coronary artery disease, cardiac valve disease and cerebrovascular disorder. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of neuromuscular disorder, coronary artery disease, heart valve disease and cerebrovascular disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 67.8 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 8 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 20 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Hypertension; Neuromuscular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included neuromuscular disorder nos, hypertension and cerebrovascular disorder. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of neuromuscular disorder, hypertension and cerebrovascular disease. The patient never smoked. The patient''s age at enrollment was 94.1 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 2 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 9 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 18 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in Thailand, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796754 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Cancer; Pulmonary tuberculosis
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included pulmonary tuberculosis, cancer, asthma and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of pulmonary tuberculosis, cancer and asthma. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 72.8 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 20 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 52 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Additional subject notes included None. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had no comorbidity. The patient had never smoked. The patient''s age at enrollment was 78.1 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 30 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 39 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796870 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Influenza A virus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: End stage renal disease (ESRD); Hemodialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BESA2019SA011379

Write-up: Initial unsolicited report received from the literature on 12-Jan-2019. The following is the abstract from the article- Background: The World Health Organization (WHO) recommends influenza virus vaccination (IVV) for high-risk populations especially those with end-stage renal disease (ESRD)-to increase the annual vaccination rate to 90%. For hemodialysis (HD) patients, there is a lack of evidence on the effectiveness of IVV, which varies from 25% to 50% in five country studies, depending on vaccination coverage and composition of the vaccine. When ESRD patients seem infected during the epidemic, despite IVV status, influenza virus detection by polymerase chain reaction (PCR) methods is a promising tool but has not yet been validated. Methods: We performed a retrospective analysis in our hemodialysis centre (n = 130 patients) from December 2017 to April 2018. We report the proportion of patients infected by the influenza virus, the vaccination rate and the type of virus (A or B). The primary objective was to assess the group of HD patients who were infected by the influenza virus type A or B and their vaccination status. The secondary objectives were to determine whether C-reactive protein (CRP) analysis and influenza virus detection by PCR assay help to distinguish bacterial or viral infection and improve patient care. Results: Out of the 130 analyzed patients, 86 (66%) were vaccinated (quadrivalent vaccine: 96%). Unvaccinated patients were sceptical about the effectiveness of IVV (n = 26), missed IVV (n = 11), had already side effects because of a prior IVV (n = 6) or were afraid of needles (n = 1). During the period of the study, we performed influenza virus PCR on 48 patients (37%) presenting symptoms suggestive of flu and/or unexplained CRP. Twenty-nine patients (22%) were confirmed infected by the influenza virus type A (n = 7) or B (n = 22), of whom half of them (n = 16/29) were vaccinated, only with a quadrivalent vaccine. In vaccinated patients, rate of influenza type A and type B infection was, respectively, 7% (n = 6/86) and 11.6% (n = 10/86). One of the patients infected by type A influenza virus died despite prior vaccination (H1N1 subtype), another (unvaccinated) presented myocardial infarction during a type B infection (Yamagata subtype). In the ''PCR positive'' group (n = 29), 20 patients were empirically treated with antibiotics in comparison with 7 patients in the ''PCR negative'' group (n = 19). When the PCR returned positive, we immediately stopped the antibiotics in a large majority of patients (n = 13/20), except for bacterial superinfection (n = 7/20). In the ''PCR negative'' group, all patients treated with antibiotics completed their treatment except for one patient (persistent CRP). In the ''PCR positive'' group, mean CRP was 61.6 mg/L at diagnosis (61.5 mg/L in the ''PCR negative'' group) and reached a mean peak of 82.5 mg/L vs. 52.2 mg/L in the ''PCR negative'' group. CRP ranges were, respectively: 2 to 363 mg/L (''PCR positive'' group) vs. 2 to 190 mg/L (''PCR negative'' group). Conclusion: In our study, IVV rate in our HD centre was higher than those published in the literature but it does not reach the goal of the WHO. Half of infected HD patients were vaccinated which confirms the country data and the relative lack of effectiveness of the vaccine in this population. For this 2017-2018 epidemic, vaccinated HD patients were more infected by influenza virus type B than type A in our centre. This might suggest that influenza virus type B was more virulent or not well covered by the quadrivalent vaccine. Interestingly, high CRP level was frequently seen and not helpful to discriminate bacterial or viral infection. However, we suggest that PCR analysis on nasopharyngeal swabs is a promising tool to reduce the rate of futile antibiotic treatment. This case involves an unknown age and gender patient who was infected by type A influenza virus died despite prior vaccination (h1n1 subtype) with INFLUENZA VACCINE. The patient''s concomitant medication and family history were not provided. At the time of the event, the patient had ongoing End stage renal disease and Haemodialysis. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious patient infected by type A influenza virus died despite prior vaccination (h1n1 subtype) (influenza A virus infection) with Unknown latency following the administration of INFLUENZA VACCINE. This event was leading to death. Lab data was not provided. Final diagnosis was (fatal) patient infected by type A influenza virus died despite prior vaccination (h1n1 subtype). It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for patient infected by type A influenza virus died despite prior vaccination (h1n1 subtype). It is unknown if an autopsy was done. The cause of death was reported as Influenza A virus test positive. List of documents held by sender- none. Sender''s Comments: This literature article describes unknown age patient who was infected by type A influenza virus (H1N1 subtype) and died despite prior vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Time to onset for influenza infection is unknown. At the time of the event, the patient had ongoing End stage renal disease and Haemodialysis. Moreover, patient''s immune status and medical condition at the time of vaccination and lab data was not provided. There is no autopsy report confirming the cause of death. Based upon the reported information, a case of vaccination failure and the role of the vaccine cannot be assessed at this stage. Reported Cause(s) of Death: Influenza A virus subtype H1N1 test positive.


VAERS ID: 796873 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-09-27
Onset:2017-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (TETRACOQ) / SANOFI PASTEUR - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131901JPN001462J

Write-up: Information has been received from other medical expert concerning a 3-month-old male infant. The infant patient had no underlying disease. On 27-SEP-2017, the patient was immunized with recombinant sedimentation hepatitis B vaccination (derived from yeast) (product name unknown) for preventive measure (no dose was reported). Other concomitant medication included ACT HIB (date of starting the immunization: 27-SEP-2017, dose: unknown, indication: unknown) and PREVENAR 13 (date of starting the immunization: 27-SEP-2017, dose: unknown, indication: unknown), SQUAREKIDS (date of starting immunization: 27-SEP-2017, dose: unknown, indication: unknown), and LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE(date of starting immunization: 27-SEP-2017, dose: unknown, indication: unknown). No other concomitant medication was reported. On 27-SEP-2017, the patient was immunized with recombinant sedimentation hepatitis B vaccination (derived from yeast), haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjoined twins), sedimentation 13-valent pneumococcal combined vaccine (non-toxic variant diphtheria toxic conjoined twins), diphtheria toxoid, pertussis whole cell vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid, and LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE (as described above). At the night of the day after the immunizations, the patient experienced vomiting and transferred to the hospital. On the way to the hospital, the patient was immediately changed the state. On 28-SEP-2017, the patient was confirmed to be dead. None of the cause of the death or information concerning whether autopsy was performed was reported. Reporter''s comment: not provided. The reporting other medical expert considered the vomiting was serious (death and medically significant). The reporting other medical expert considered the vomiting to be related to recombinant sedimentation hepatitis B vaccination (derived from yeast). The reporting medical expert considered haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjoined twins), sedimentation 13-valent pneumococcal combined vaccine (non-toxic variant diphtheria toxic conjoined twins), and diphtheria toxoid, pertussis whole cell vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid were to be suspected medications. Reported Cause(s) of Death: Death.


VAERS ID: 797035 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac valve disease; Coronary artery disease; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension, coronary artery disease and cardiac valve disease. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test negative result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of hypertension, coronary artery disease and heart valve disease. The patient had never smoked. The patient''s age at enrollment was 85 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza season year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 1 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 5 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Cancer. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 75.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 21 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797037 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and smoker (The patient had a smoking status but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Hypertension. The patient had a smoking status but stopped equal to or more than 1 month. The patient''s age at the time of enrollment was 80.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 21 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and hypertension and never smoked. The patient''s age at the time of enrollment was 69.2year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 11 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and cancer. On an unknown date, less than a year after receiving inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and diabetes and never smoked. The patient''s age at the time of enrollment was 74.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 19 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Smoker (The patient was still a smoker or had a smoking status but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and smoker (The patient was still a smoker or had a smoking status but stopped smoking less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 69.6year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 21 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and chronic obstructive pulmonary disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer and Chronic Obstructive Pulmonary Disease and the patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 70.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 45 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had no comorbidity and never smoked. The patient''s age at enrollment was 65.9 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 9 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 38 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis; Chronic liver disease; Smoker (The patient still smokes or ever smoked but stop less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic bronchitis, chronic liver disease and smoker (The patient still smokes or ever smoked but stop less than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of chronic bronchitis and chronic liver disease. The patient still smokes or ever smoked but stop less than 1 month. The patient''s age at enrollment was 68.3 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza season year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 3 days after ARI, the patient collected the nasal swab. The patient was contacted by phone at week 23 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 58 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797044 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Cough, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Neuromuscular disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and neuromuscular disorder nos. On an unknown date, 14 days after receiving Flu seasonal TIV Dresden, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to Flu seasonal TIV Dresden. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient''s Study Identification Number (qid) was C198043.The patient had comorbidity of cancer and neuromuscular disorder. The patient had never smoked. The patient''s age at enrollment was 68.8 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 3 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 23 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 56 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic kidney disease. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of chronic kidney disease. The patient had never smoked. The patient''s age at enrollment was 66.4 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 2 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 27 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 43 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pulmonary tuberculosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included pulmonary tuberculosis. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of pulmonary tuberculosis. The patient had never smoked. The patient''s age at enrollment was 67 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 28 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 32 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of cancer. The patient had never smoked. The patient''s age at enrollment was 84.7 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 28 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 48 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The patient had comorbidity of Chronic Obstructive Pulmonary Disease. The patient had never smoked. The patient''s age at enrollment was 87 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. Same day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 31 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 67 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Additional subject notes included None. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had no comorbidity. The patient had never smoked. The patient''s age at enrollment was 76 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 4 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 36 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 61 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of hypertension. The patient had never smoked. The patient''s age at enrollment was 76.4 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 3 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 44 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 86 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Additional subject notes included None. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had no comorbidity. The patient had never smoked. The patient''s age at enrollment was 66 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 2 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 46 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 48 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in country, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 797052 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (patient had no comorbidity, had a smoking status but stopped smoking equal to or more than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (The patient had no comorbidity and had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had no comorbidity and had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 83 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 3 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 47 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Cerebrovascular disorder; Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, cerebrovascular disorder and chronic bronchitis. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine , the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of cancer, cerebrovascular disease and chronic bronchitis. The patient had never smoked. The patient''s age at enrollment was 70.6 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 56 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 93 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797054 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Cancer; Chronic obstructive pulmonary disease; Hypertension; Smoker (The patient still smokes or ever smoked but stopped less than 1 month.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, hypertension, chronic obstructive pulmonary disease, asthma and smoker (The patient still smokes or ever smoked but stopped less than 1 month.). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of cancer, hypertension, chronic obstructive pulmonary disease and asthma. The patient still smokes or ever smoked but stopped less than 1 month. The patient''s age at enrollment was 71 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 3 days after ARI, the patient collected the nasal swab. The patient was contacted in person at week 59 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 73 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in country, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month.)
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, diabetes and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed acute respiratory tract infection. Serious criteria included GSK medically significant. Additional event(s) included cough and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015-May 2017. The patient had comorbidity of cancer and diabetes. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 82 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced acute respiratory infection (ARI). [In this study, ARI was defined as new onset of cough or worsening of a chronic cough with or without self-reported fever]. 1 day after ARI, the patient collected the nasal swab. The patient was contacted in person at week 81 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 99 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A (H1N1), influenza A (H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Pyrexia, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month.)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: more than 38.0, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month.). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed severe - grade 3 acute respiratory tract infection. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included fever with serious criteria of hospitalization, unknown cause of death with serious criteria of death and GSK medically significant and cough with serious criteria of hospitalization. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included fever (unknown), unknown cause of death (fatal) and cough (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, fever, unknown cause of death and cough to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was more than 38.0 degree C. On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of as evere cute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of Chronic Obstructive Pulmonary Disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at enrollment was 73.2 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced severe acute respiratory infection (ARI). [In this study, SARI was defined as new onset of cough, worsening of chronic cough or difficulty breathing with a fever equal to or more than 38.0 degree C that required hospitalization]. 7 days after SARI, the patient collected the nasopharyngeal swab. The patient was contacted in person at week 23 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (The patient still smokes or ever smoked but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: equal to or more than 38.0, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (The patient still smokes or ever smoked but stopped smoking less than 1 month). On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed severe - grade 3 acute respiratory tract infection. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included cough with serious criteria of hospitalization, fever with serious criteria of hospitalization and unknown cause of death with serious criteria of death and GSK medically significant. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown), fever (unknown) and unknown cause of death (fatal). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough, fever and unknown cause of death to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was equal to or more than 38.0 degree C. On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of severe acute respiratory infection (ARI) in a male patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had no comorbidity. The patient had a smoking status (still smokes or ever smoked but stopped smoking less than 1 month). The patient''s age at enrollment was 72.4 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced severe acute respiratory infection (ARI). [In this study, SARI was defined as new onset of cough, worsening of chronic cough or difficulty breathing with a fever equal to or more than 38.0 degree C that required hospitalization]. 2 days after SARI, the patient collected the nasal swab. The patient was contacted in person at week 29 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 53 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in a specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza virus test negative, Polymerase chain reaction, Pyrexia, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Body temperature; Result Unstructured Data: Test Result: equal to or more than 38, Test Result Unit: degree C
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic kidney disease. On an unknown date, 14 days after receiving trivalent inactivated influenza vaccine, the subject developed severe - grade 3 acute respiratory tract infection. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included cough with serious criteria of hospitalization, unknown cause of death with serious criteria of death and GSK medically significant and fever with serious criteria of hospitalization. The outcome of acute respiratory tract infection was unknown. The outcome(s) of the additional event(s) included cough (unknown), unknown cause of death (fatal) and fever (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the acute respiratory tract infection, cough, unknown cause of death and fever to be related to trivalent inactivated influenza vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was equal to or more than 38 degree C. On an unknown date, Influenza virus test result was negative unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of acute respiratory infection (ARI) in a female patient aged equal to or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from from May 2015-May 2017. The patient had comorbidity of chronic kidney disease. The patient had never smoked. The patient''s age at enrollment was 80.1 years. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date in the same influenza season, at least 14 days after vaccination, the patient experienced severe acute respiratory infection (ARI). [In this study, SARI was defined as new onset of cough, worsening of chronic cough or difficulty breathing with a fever equal to or more than 38.0 degree C that required hospitalization]. 2 days after SARI, the patient collected the nasopharyngeal swab. The patient was contacted in person at week 68 of follow up. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. On unspecified date, at week 77 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in country, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The patient''s sample was tested for influenza by rRT-PCR analysis to specifically identify influenza virus type and subtype, including influenza A(H1N1), influenza A(H3N2), and influenza B. [In this study, a specimen was considered to have tested positive for influenza virus if the rRT-PCR analysis yielded a cycle threshold value of greater than 37]. The patient was found negative for influenza virus. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 797882 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131901JPN001883J

Write-up: Information has been received from a physician concerning a 0-year-old infant (gender unknown). On an unspecified date, the patient was subcutaneously vaccinated with HEPTAVAX-II for prophylaxis (dose and lot number not reported). No concomitant medications were reported. On an unspecified date (the day after inoculation), the patient died. The cause of death was not reported. Information regarding autopsy was not provided. Reporter''s comment: I think there is no causal relationship. The reporting physician considered death to be not related to hepatitis B vaccine (recombinant). Company Causality Assessment: Based on the limited information currently available for this case, a reasonable causal association between HEPTAVAX-II and the reported event of death cannot be established. Missing clinically important information includes the patient''s concurrent conditions, medical history and detail clinical course including the cause of death. Company Comment - No changes to the HEPTAVAX-II product safety information are warranted at this time. Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the product. Reported Cause(s) of Death: Death.


VAERS ID: 798324 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRPFIZER INC2019029875

Write-up: This is a spontaneous report from a contactable non-healthcare professional (hospital staff) and a contactable physician based on information received by Pfizer from Vaccine Corporation, manufacturer control number SKV-PV-01-162(S) and SKV-PV-02-036(S), license party for PREVENAR 13. A patient received injection of PREVENAR 13. After the vaccination of PREVENAR 13, the patient died. The causal relationship could not be identified. The reporter (hospital staff) requested for medical evidence and consultation. Death after vaccination of PREVENAR 13 occurred. Re-vaccination: No. Information about batch number would be requested. Sender''s Comments: Based on the limited narrative information provided, a causal association between the suspect drug, PREVENAR 13 and the reported event Death cannot be totally excluded until sufficient information is available to confirm an unrelated cause of death. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: death.


VAERS ID: 798554 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-20
Onset:2019-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: School       Purchased by: ?
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Familial risk factor (His sister was diagnosed by anomaly)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AE0095075131901ARE007852

Write-up: Initial and follow up information was received from a physician, and refers to a 7 year old male patient. Information about the patient''s medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was not provided. Furthermore, it was stated that the patient''s family history included her sister was diagnosed by anomaly. On 20-JAN-2019, the patient was vaccinated with a dose of M-M-R II VAX VACCINE by his school health nurses, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). It was also reported that all measures were taken by the nurse who gave the vaccines, where the patient was waiting for 15 mins after the vaccine and he did not develop any symptoms the whole day at school. On 21-JAN-2019, the patient died as he was found non-responsive in the morning. The cause of death was not reported and it was unknown if an autopsy was performed. The causality assessment between the patient''s death and the therapy with M-M-R II VAX VACCINE was not provided.


VAERS ID: 798556 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Autopsy, Brain injury, Cerebrovascular accident, Condition aggravated, Death, Dyspnoea, Life support
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation (had a 40 year medical history)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2019SA018211

Write-up: Initial information received on 19-Jan-2019 regarding an unsolicited valid serious case received from a consumer (patients daughter). This case involves a 91 years old female patient who experienced massive stroke which completely damaged the left hemisphere of her brain, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing 40-year medical history of atrial fibrillation. On 27-Nov-2018, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious shortness of breath (dyspnoea) and atrial fibrillation with unknown latency, lasting 3 weeks and on 28-Dec-2018, the patient developed a serious massive stroke which completely damaged the left hemisphere of her brain (cerebrovascular accident) 1 month 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were leading to death. Lab data was not provided. Final diagnosis was (fatal) massive stroke which completely damaged the left hemisphere of her brain. On 19-Dec-18, the patient was seen by her doctor who put her on BISOPROLOL. The patient was put on life support and died on 03-JAN-19. The events were not recovered at the time of death of patient on 03-Jan-2019. It was unknown if an autopsy was done. The cause of death was reported as Cerebrovascular accident, Dyspnoea and Atrial fibrillation. List of documents held by sender- none. Sender''s Comments: This case concerns a 90-year old female with reported 40 years medical history of atrial fibrillation, was vaccinated with FLUZONE HIGH-DOSE. Following vaccination she experienced shortness of breath and atrial fibrillation for several weeks after vaccination. The patient was prescribed bisoprolol by her physician, and 9 days later experienced a massive stroke of left hemisphere of her brain. Autopsy results confirmed cause of death along with laboratory evaluations performed should be provided. Based on available information, and patient medical history, it is unlikely that influenza vaccination played a role in reported events. Reported Cause(s) of Death: Stroke; shortness of breath; atrial fibrillation.


VAERS ID: 799081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA022522

Write-up: Initial information received on 23-Jan-2019 regarding an unsolicited valid serious case received from a consumer (patient''s brother) via social media. This case involves a male patient (age unknown) for whom it was reported that disease killed my brother, while he received vaccine Inactivated Influenza Vaccine (Tetravalent). The patients past medical history, concomitant medication and family history were not provided. Concomitant therapy not reported. On an unknown date, the patient received a dose of suspect Inactivated Influenza Vaccine (Tetravalent) produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On an unknown date, the patient developed a serious disease that killed the patient (death) with unknown latency following the administration of Influenza Vaccine (Tetravalent). This event was also assessed as medical important event. This event led to death of the patient and date of death was 24-Dec-2018. Lab data was not provided. Final diagnosis was, (fatal) Severe disease killed my brother. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for disease killed my brother. It is unknown if an autopsy was done. List of documents held by sender- none. Sender''s Comments: This poorly documented case received from social media concerns a male patient with unknown age who died due to unspecified disease after vaccination with Inactivated Influenza Vaccine (Tetravalent) produced by unknown manufacturer. The time to onset is unknown. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with any lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Death NOS.


VAERS ID: 799643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test negative, Central nervous system viral infection, Death, Poor quality product administered, Product quality issue, Viral test positive
SMQs:, Medication errors (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT0095075131901ITA010841

Write-up: some girls deceased; dangerous adventitious viruses that bind to aluminum have been found, the same ones detected in the brains of some girls; Gardasil 9 against papilloma virus, 2 of the nine antigens were not identified, traces of human and mouse DNA and dangerous adventitious viruses that bind to aluminum have been found; Gardasil 9 against papilloma virus, 2 of the nine antigens were not identified, traces of human and mouse DNA and dangerous adventitious viruses that bind to aluminum have been found; Gardasil 9 against papilloma virus, 2 of the nine antigens were not identified, traces of human and mouse DNA and dangerous adventitious viruses that bind to aluminum have been found; This spontaneous report was received from a pharmaceutical chemist via company employee and refers to an unspecified number of female patients of unknown age (reported as "some girls"). The information was reported in an online article. There was no information about the patients'' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (doses, dose numbers, sites and routes of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date, in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) against papilloma virus, two of the nine antigens were not identified, traces of human and mouse DNA and dangerous adventitious viruses that bind to aluminum were found. On an unknown date, the same viruses were detected in brains of the patients. They deceased after the administration. It was unknown whether an autopsy was performed. The cause of death was not provided.. The outcome of the events: central nervous system viral infection, product quality issue, poor product administered, antibody test negative and the relatedness between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccines (yeast) (GARDASIL 9) were not reported. Upon internal review, the event of central nervous system viral infection was considered to be medically significant.


VAERS ID: 799668 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-14
Onset:2018-11-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Feeling unwell
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201900711

Write-up: Pulmonary embolism; Bronchopneumonia; This is a spontaneous case, initially reported by physician to regulatory authority (regulatory reference number: GB-MHRA-EYC 00192948) and initially retrieved by Seqirus on 22-Jan-2018, concerning a 73-year-old, elderly, female patient of weight 61 kg and height 157 cm. The patient did not have any history of previous allergy or allergic reaction to vaccine or its components. The patient''s current condition included malaise (reported as feeling unwell). On 14-Nov-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date and anatomical location: not reported] for influenza immunisation. On 15-Nov-2018, one day after the vaccination, the patient died after receiving influenza vaccine due to pulmonary embolism and bronchopneumonia. It was unknown if the autopsy was performed. The reporter assessed this case as serious (fatal and medically significant).; Reporter''s Comments: A 73-year-old female patient with current condition of feeling unwell at the time of vaccination with Fluad (TIV), died one day after vaccination due to pulmonary embolism and bronchopneumonia. The event bronchopneumonia will usually have infectious aetiology and current condition of feeling unwell denotes possible underlying infectious aetiology. Hence, the event bronchopneumonia was assessed as not related to suspect vaccine. The case provides minimal information regarding exact details of current condition, cause of death and autopsy details. Based on the minimal information, the event pulmonary embolism can be explained by bronchopneumonia rather than suspect vaccine, hence assessed as not related to suspect vaccine.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 799754 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-01-13
Onset:2018-10-19
   Days after vaccination:644
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Sopor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tachipirina; NUROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mechanical ventilation; Percutaneous endoscopic gastrostomy; Tetraplegia; Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 37,4 international unit(s)-(under 100), Test Result Unit: iu; Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 39,5 international unit(s)-(under 100), Test Result Unit: iu
CDC Split Type: ITGLAXOSMITHKLINEIT201901

Write-up: Pyrexia; Sopor; This case was reported by a physician via regulatory authority and described the occurrence of fever in a 4-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included NUSINERSEN (SPINRAZA) for spinal muscular atrophy type i. The patient''s past medical history included tracheostomy, tetraplegia, percutaneous endoscopic gastrostomy and mechanical ventilation. Concomitant products included paracetamol (Tachipirina) and ibuprofen (Nurofen). On 19th October 2018, the patient received Bexsero (intramuscular) 1 dosage form(s). On 13th January 2017, the patient received SPINRAZA (intrathecal). On 19th October 2018, less than a day after receiving Bexsero, the patient experienced fever (serious criteria death) and sopor (serious criteria death). On 19th October 2018, the outcome of the fever and sopor were fatal. The patient died on 19th October 2018. The reported cause of death was pyrexia and sopor. It was unknown if the reporter considered the fever and sopor to be related to Bexsero. Additional details: On 19th October 2018 body temperature of patient was reported as 37,4 international unit(s)-(under 100) and 39,5 international unit(s)-(under 100) It was unknown if the reporter considered the pyrexia and sopor to be related to SPINRAZA. Initial information was received from a Physician via regulatory authority on 28th January 2019: On 19/10/2018, at 21 pm hyperthermia 37.3 ? C, administered tachipirina without benefit, BT arrived at 39.8 ? C, given nurofen without benefit, conditions worsened in about 2 hours, drowsiness and then death.; Reported Cause(s) of Death: Pyrexia; Sopor


VAERS ID: 800653 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2019GS

Write-up: Adverse event; This case was reported in a literature article and described the occurrence of adverse event in a subject who received DTPa vaccine for prophylaxis. On an unknown date, unknown after receiving DTPa vaccine, Poliomyelitis vaccine oral Trivalent and Haemophilus influenzae type b vaccine, the subject developed adverse event. Serious criteria included death and GSK medically significant. The outcome of adverse event was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the adverse event may have been caused by DTPa vaccine, Poliomyelitis vaccine oral Trivalent and Haemophilus influenzae type b vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of unspecified adverse event in a patient of unspecified age and gender who was vaccinated with unspecified oral polio vaccine (OPV); unspecified diphtheria, tetanus, and acellular pertussis (DTaP) and unspecified haemophilus influenzae type B (HiB) vaccine (manufacturer unknown for all) for prophylaxis. The patient was a part of the study that reviewed and analysed reports of deaths after immunization from 2010 - 2015 to understand the epidemiological characteristics, causes of death, and risk of death following vaccination. Deaths which were suspected to be related to the vaccinations, with dates of death from 1st January 2010 to 31st December 2015 were extracted from Adverse Events Following Immunization Information System and included in this study. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified OPV, DTaP and HiB vaccines (administration route and site unspecified; dosages unknown; batch number not provided for all). The age of vaccinations was not provided. On an unspecified date, an unknown period after vaccination, the patient developed unspecified adverse event. On an unspecified date, the patient died due to unspecified adverse event. It was unknown if an autopsy was performed. According to the causality assessment, the patient''s death was classified as vaccine reactions. This case has been considered serious due to death. The authors concluded, "Vaccines are among the safest medical products in use. However, parents will naturally become concerned when serious adverse events occur after vaccination, even though the event may only be temporally related to immunization. A functional vaccine safety surveillance system and thorough AEFI investigation for causality assessment can provide valuable information for both national regulatory authorities and the public. Our study showed that the risk of death following vaccination was extremely small and did not identify specific safety concerns with vaccines used. Because passive surveillance might be stimulated by media reports and public concerns, continuous monitoring and scientific causality assessment of serious AEFI reports, including AEFI-associated deaths, is imperative to ensure public confidence in the immunization program." This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 800654 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2019GS

Write-up: Adverse event; This case was reported in a literature article and described the occurrence of adverse event in a neonate subject who received Hepatitis B vaccine for prophylaxis. On an unknown date, less than a year after receiving Hepatitis B vaccine, the subject developed adverse event. Serious criteria included death and GSK medically significant. The outcome of adverse event was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the adverse event may have been caused by Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of unspecified adverse event in a neonate of unspecified gender who was vaccinated with unspecified hepatitis B vaccine (HepB) (manufacturer unknown) for prophylaxis. This case corresponds to section 3.3 in this literature article. The patient was a part of the study that reviewed and analysed reports of deaths after immunization from 2010 - 2015 to understand the epidemiological characteristics, causes of death, and risk of death following vaccination. Deaths which were suspected to be related to the vaccinations, with dates of death from 1st January 2010 to 31st December 2015 were extracted from Adverse Events Following Immunization Information System (AEFIS) and included in this study. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified hepatitis B vaccine (HepB) (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccinations was not provided. On an unspecified date between 2013 and 2014, an unknown period after vaccination, the patient developed unspecified adverse event. On an unspecified date, the patient died due to unspecified adverse event [In this study, during 2013-2014, out of 47 neonatal deaths were reported and 44 of those were related to HepB (with concurrent vaccines)]. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author considered the death was causally related to vaccination. The authors concluded, "Vaccines are among the safest medical products in use. However, parents will naturally become concerned when serious adverse events occur after vaccination, even though the event may only be temporally related to immunization. A functional vaccine safety surveillance system and thorough AEFI investigation for causality assessment can provide valuable information for both national regulatory authorities and the public. Our study showed that the risk of death following vaccination was extremely small and did not identify specific safety concerns with vaccines used. Because passive surveillance might be stimulated by media reports and public concerns, continuous monitoring and scientific causality assessment of serious AEFI reports, including AEFI-associated deaths, is imperative to ensure public confidence in the immunization program." This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 801034 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / OT
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131902USA003188

Write-up: mortality rate of HPV vaccine was 37 times higher than that of cervical cancer; manufacturer origin unknown; This initial spontaneous report was received from a Company Representative who forwarded an article that was posted on a social media website that refers to an unspecified amount of patients who received the human papilloma virus (HPV) vaccine (manufacturer not specified). The title further included the following information: The "trial" revealed that the mortality rate of HPV vaccine in was 37 times higher that that of cervical cancer. The causality of mortality rate 37 times higher than that of cervical cancer was considered to be related to HPV vaccine. No further information was provided. Upon internal review, death was considered to be medically significant. This is one of several reports received from the same reporter.; Sender''s Comments: US-009507513-1608USA000622: US-009507513-1902USA003189: US-009507513-1902USA003190: US-009507513-1902USA003191: US-009507513-1902USA003193:; Reported Cause(s) of Death: death cause unknown


VAERS ID: 801161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-02-01
Onset:2019-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZASA2019SA033666

Write-up: Patient passed away; rash; Initial information received on 04-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a 20 months old male patient who had rash and passed away while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s past medical history and concomitant medication was not reported. On 01-Feb-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 02-Feb-2019, one day after the vaccination the patient experienced serious rash and at night passed away. Rash was assessed as medically significant and other event was leading to death. (Other relevant tests included no lab data.) Final diagnosis was rash and (fatal) patient passed away. It was not reported if the patient received a corrective treatment. The event outcome was reported as Fatal on 02-Feb-2019 for patient passed away and as Unknown for rash. It was unknown if an autopsy was done. The cause of death was not reported. List of documents held by sender: none.; Sender''s Comments: This is a case involves a 20 months male who experienced rash one day after vaccination with Menactra and passed away in the night. Patient''s medical history and concomitant medication were not reported. There is no information regarding patient''s medical condition at time of vaccination and previous vaccination history, as well as no investigation results ruling out alternative etiologies. The autopsy report was not provided. Adequate information is not available in this report for a complete medical assessment.; Reported Cause(s) of Death: Death nos


VAERS ID: 801536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Pneumonia pneumococcal, Serology test
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: NI
CDC Split Type: MTPFIZERINC2019043429

Write-up: invasive pneumococcal pneumonia; pneumococcal menigitis; invasive pneumococcal pneumonia; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A currently 4-year-old male patient was administered 4 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on unspecified dates at single doses for prevention of pneumococcal disease. The patient''s medical history and concomitant medications were not reported. On an unspecified date the child died from pneumococcal meningitis as a consequence of invasive pneumococcal pneumonia. The patient had been vaccinated (4 doses, unknown frequency) with pneumococcal 13-val conj vac (dipht crm197 protein) when he was a baby/toddler but frequency unknown. Serotyping of infective organism was being carried out. No underlying medical condition. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded. Further information like serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumococcal meningitis; invasive pneumococcal pneumonia; invasive pneumococcal pneumonia


VAERS ID: 801742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2019SA042764

Write-up: patient passed away; patient was ill; Initial information regarding an unsolicited valid serious case received from a non-healthcare professional (reporter-friend of patient''s mother) to the Business Partner which forwarded the case to the Pharmacovigilance Department, on 12-Feb-2019. This case involves 18 months old female patient who was ill, while she received vaccine INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2018, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient was ill (ill-defined disorder) following the administration of INFLUENZA VACCINE (TRIVALENT). The patient passed away after 2 days. it was classified as not expected and causality was not evaluated. No exposition during pregnancy. There was no immunization error. It was not intentional use off-label, no occupational error occurred, no suspect of lack of efficacy, no unexpected therapeutically benefit observed. (Other relevant tests included no lab data.) Final diagnosis was (fatal) death NOS and patient was ill. It was not reported if the patient received a corrective treatment. It was reported that patient died on an unknown date. It was unknown if an autopsy was done. The cause of death was unknown.; Sender''s Comments: An 18 months old female patient who presented with illness and passed away 2 days after receiving vaccine INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer. Exact nature of illness was not specified. Additional information regarding patient''s past history, medical condition at the time of vaccination, lab test excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed; Reported Cause(s) of Death: death NOS


VAERS ID: 802305 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-02-12
Onset:2019-02-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R017112 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131902CHN005949

Write-up: death; This spontaneous report was received from a Center of Disease Control and refers to a 10-week-old female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. The patient was sent to intensive care unit (ICU) just after birth. On 12-FEB-2019, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot# R017112, expiration date 22-APR-2020 (exact dose and strength were not reported) for prophylaxis and a dose of unspecified pentacomponent vaccine. On 14-FEB-2019 at about 05:00, the patient died. Autopsy was scheduled. There was no confirmed conclusion that whether the patient''s death was related to the vaccines or not.


VAERS ID: 802505 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-06-01
Submitted: 0000-00-00
Entered: 2019-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Autonomic nervous system imbalance, CSF test, Death, Dyspnoea, Electrolyte imbalance, Inappropriate schedule of product administration, Intensive care, Lyssavirus test positive, Nervous system disorder, Neutralising antibodies, Paralysis, Pyrexia, Rabies
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies Vaccine; Rabies Vaccine; Rabies Vaccine; Rabies Vaccine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten by dog in right leg. The patient had World Health Organization (WHO) category III exposure)
Allergies:
Diagnostic Lab Data: Test Date: 201606; Test Name: CSF test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201606; Test Name: Rabies virus test positive; Result Unstructured Data: Test Result: rabies infection, Test Result Unit: unknown; Test Date: 2016; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 60, Test Result Unit: iu/ml; Test Date: 2016; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 240, Test Result Unit: iu/ml; Test Date: 201606; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 15, Test Result Unit: iu/ml
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: autonomic dysfunction; neurological disorder; electrolyte imbalance; rabies; fever; breathlessness; paralysis; aerophobia; Inappropriate schedule of vaccine administered (the patient received the first dose of vaccine on day 12 of exposure instead of day day 0); This case was reported in a literature article and described the occurrence of rabies in a 13-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten by dog in right leg. The patient had World Health Organization (WHO) category III exposure). Concomitant products included Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, the patient received the 5th dose of Rabies Vaccine (intramuscular). In June 2016, less than a year after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death, hospitalization and GSK medically significant), fever (serious criteria hospitalization), breathlessness (serious criteria hospitalization), paralysis (serious criteria hospitalization and GSK medically significant), aerophobia (serious criteria hospitalization) and electrolyte imbalance (serious criteria hospitalization). On an unknown date, the patient experienced autonomic dysfunction (serious criteria hospitalization), neurological disorder nos (serious criteria hospitalization) and inappropriate schedule of vaccine administered. The patient was treated with medication unknown (Anticonvulsant). On an unknown date, the outcome of the rabies was fatal and the outcome of the fever, breathlessness, paralysis, aerophobia, autonomic dysfunction, electrolyte imbalance, neurological disorder nos and inappropriate schedule of vaccine administered were unknown. The reported cause of death was rabies. The reporter considered the rabies, fever, breathlessness, paralysis, aerophobia, autonomic dysfunction, electrolyte imbalance and neurological disorder nos to be related to Rabies Vaccine. It was unknown if the reporter considered the inappropriate schedule of vaccine administered to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a 13-year-old male who was vaccinated with unspecified purified chick embryo cell rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case no. 1 from table 1 in this literature article. The patient was bitten by dog in right leg. The patient had World Health Organization (WHO) category III exposure. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, 12 days after dog bite, the patient received 5 doses of unspecified purified chick embryo cell rabies vaccine intramuscularly (administration site unspecified; batch number not provided). The patient had not received the rabies immunoglobulin. The age of vaccination was not provided. On an unspecified date in June 2016, an unknown period after vaccination, the patient presented clinical feature like fever of 2 weeks duration, breathlessness, paralysis, and aerophobia. The incubation period was of 90 days. Cerebrospinal fluid-1 (CSF-1) sample was collected 28 days post onset of symptoms and the neutralizing antibody titres were 15 IU/mL. Serum-1 sample was collected 14 days post onset of symptoms and the neutralizing antibody titres were 60 IU/mL. For CSF-2, test was not requested, or sample not received. Serum-2, sample was collected 28-day post onset of symptoms and neutralizing antibody titers were 240 IU/mL. The patient was diagnosed with laboratory-confirmed rabies infection. The patient was managed in the intensive care unit with supportive care, including correction of fluid and electrolyte imbalance, management of autonomic dysfunction, and anticonvulsants. The patient has severe neurological sequelae. On an unspecified date, the patient died after 5 months of survival (as of June 30, 2018). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. The author commented, "Significantly, all had received at least three doses of ARV initiated on the day of the bite, except one patient (case 1), where ARV was delayed. However, it is likely that they developed rabies due to omission of RIG, which is vital and considered life-saving in WHO category III exposures." The authors concluded, "good intensive care with supportive measures may help the occasional patient with rabies encephalitis to survive, but there is an urgent need for novel antivirals and newer therapeutic strategies to improve the outcomes. This case series also highlights the tragic occurrence of the disease despite vaccination-mostly due to omission of RIG and other serious deviations in PEP protocols. The primary focus, therefore, should be on the "prevention" of rabies by increasing awareness about the disease and PEP protocols among the public and health-care professionals in rabies endemic countries." This is 1 of the 8 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified date. The incubation period was of 90 days. Cerebrospinal fluid-1 (CSF-1) sample was collected 28 days post onset of symptoms and the neutralizing antibody titres were 15 IU/mL. Serum-1 sample was collected 14 days post onset of symptoms and the neutralizing antibody titres were 60 IU/mL. For CSF-2, test was not requested, or sample not received. Serum-2, sample was collected 28-day post onset of symptoms and neutralizing antibody titers were 240 IU/mL. The patient was diagnosed with laboratory-confirmed rabies infection.; Reported Cause(s) of Death: rabies


VAERS ID: 802506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-01-01
Submitted: 0000-00-00
Entered: 2019-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Apallic syndrome, Autonomic nervous system imbalance, CSF test, Death, Electrolyte imbalance, Intensive care, Lethargy, Lyssavirus test positive, Nervous system disorder, Neutralising antibodies, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Pyrexia, Rabies
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies Vaccine; Rabies Vaccine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten by dog in right thigh and right loin. category III exposure)
Allergies:
Diagnostic Lab Data: Test Date: 201501; Test Name: CSF test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201501; Test Name: Rabies virus test positive; Result Unstructured Data: Test Result: rabies infection, Test Result Unit: unknown; Test Date: 201501; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 60, Test Result Unit: iu/ml; Test Date: 2015; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 60, Test Result Unit: iu/ml; Test Date: 201501; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201501; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: rabies; fever; lethargy; altered sensorium; autonomic dysfunction; electrolyte imbalance; neurological disorder; This case was reported in a literature article and described the occurrence of rabies in a 10-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten by dog in right thigh and right loin. The patient had World Health Organization (WHO) category III exposure). Concomitant products included Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, the patient received the 3rd dose of Rabies Vaccine (intramuscular). In January 2015, less than a month after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death, hospitalization and GSK medically significant), fever (serious criteria hospitalization), lethargy (serious criteria hospitalization), altered state of consciousness (serious criteria hospitalization and GSK medically significant), autonomic dysfunction (serious criteria hospitalization), electrolyte imbalance (serious criteria hospitalization) and neurological disorder nos (serious criteria hospitalization). The patient was treated with medication unknown (Anticonvulsant). On an unknown date, the outcome of the rabies was fatal and the outcome of the fever, lethargy, altered state of consciousness, autonomic dysfunction, electrolyte imbalance and neurological disorder nos were unknown. The reported cause of death was rabies. The reporter considered the rabies, fever, lethargy, altered state of consciousness, autonomic dysfunction, electrolyte imbalance and neurological disorder nos to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a 10-year-old male patient who was vaccinated with unspecified purified chick embryo cell rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case no. 2 from table 1 in this literature article. The patient was bitten by dog in right thigh and right loin. The patient had World Health Organization (WHO) category III exposure. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, on the day of the bite, the patient received 3 doses of unspecified purified chick embryo cell rabies vaccine intramuscularly (administration site unspecified; batch number not provided). The patient had not received the rabies immunoglobulin. The age of vaccination was not provided. On an unspecified date in January 2015, an unknown period after vaccination, the patient presented clinical feature like fever of 7 days duration, lethargy, and altered sensorium since 2 days. 8 days after the onset of symptoms, magnetic resonance imaging findings revealed bilateral bulky and long basal ganglia (right more than left). Gyral swelling in the right posterior parietal cortex, showing mild diffusion restriction. The incubation period was of 17 days. Antemortem diagnostic tests for detection of viral RNA by real-time polymerase chain reaction revealed: negative for cerebrospinal fluid -1 (CSF-1), positive for nuchal skin and negative for saliva. Cerebrospinal fluid-1 (CSF-1) and serum-1 sample was collected 13 days post onset of symptoms and the neutralizing antibody titres were 60 and 60 IU/mL respectively. For CSF-2 and serum-2, the test was not requested, or sample not received. The patient was diagnosed with laboratory-confirmed rabies infection. The patient was managed in the intensive care unit with supportive care, including correction of fluid and electrolyte imbalance, management of autonomic dysfunction, and anticonvulsants. The patient has severe neurological sequelae and discharged from the hospital in a vegetative state. On an unspecified date, the patient died after 6 months of survival (as of June 30, 2018). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. The author commented, "Five of eight (62.5%) patients were not administered RIG. These deviations in the PEP protocol can be attributed to inadequate awareness about rabies in the community as well as among health professionals, and shortage of rabies biologicals, especially RIG, at many health-care facilities." The authors concluded, "good intensive care with supportive measures may help the occasional patient with rabies encephalitis to survive, but there is an urgent need for novel antivirals and newer therapeutic strategies to improve the outcomes. This case series also highlights the tragic occurrence of the disease despite vaccination-mostly due to omission of RIG and other serious deviations in PEP protocols. The primary focus, therefore, should be on the "prevention" of rabies by increasing awareness about the disease and PEP protocols among the public and health-care professionals in rabies endemic countries." This is 1 of the 8 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. 8 days after the onset of symptoms, magnetic resonance imaging findings revealed bilateral bulky and long basal ganglia (right more than left). Gyral swelling in the right posterior parietal cortex, showing mild diffusion restriction. The incubation period was of 17 days. Antemortem diagnostic tests for detection of viral RNA by real-time polymerase chain reaction revealed: negative for cerebrospinal fluid -1 (CSF-1), positive for nuchal skin and negative for saliva. Cerebrospinal fluid-1 (CSF-1) and serum-1 sample was collected 13 days post onset of symptoms and the neutralizing antibody titres were 60 and 60 IU/mL respectively. For CSF-2 and serum-2, the test was not requested, or sample not received. The patient was diagnosed with laboratory-confirmed rabies infection; Reported Cause(s) of Death: rabies


VAERS ID: 802507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-12-01
Submitted: 0000-00-00
Entered: 2019-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Apallic syndrome, Autonomic nervous system imbalance, CSF test, Death, Electrolyte imbalance, Lyssavirus test positive, Nervous system disorder, Neutralising antibodies, Pyrexia, Rabies, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies Vaccine; Rabies Vaccine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten by dog in right leg. category III exposure.)
Allergies:
Diagnostic Lab Data: Test Date: 201612; Test Name: CSF test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201612; Test Name: Rabies virus test positive; Result Unstructured Data: Test Result: rabies infection, Test Result Unit: unknown; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: more than 15, Test Result Unit: iu/ml; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 240, Test Result Unit: iu/ml; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: more than 480, Test Result Unit: iu/ml; Test Date: 201612; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: 7.5, Test Result Unit: iu/ml; Test Name: PCR
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: rabies; fever; vomiting; drowsiness; altered sensorium; autonomic dysfunction; electrolyte imbalance; neurological disorder; This case was reported in a literature article and described the occurrence of rabies in a 5-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten by dog in right leg. category III exposure.). Concomitant products included Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, the patient received the 3rd dose of Rabies Vaccine (intramuscular). In December 2016, less than a month after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death, hospitalization and GSK medically significant), fever (serious criteria hospitalization), vomiting (serious criteria hospitalization), drowsiness (serious criteria hospitalization and GSK medically significant), altered state of consciousness (serious criteria hospitalization and GSK medically significant), autonomic dysfunction (serious criteria hospitalization), electrolyte imbalance (serious criteria hospitalization) and neurological disorder nos (serious criteria hospitalization). The patient was treated with medication unknown (Anticonvulsant). On an unknown date, the outcome of the rabies was fatal and the outcome of the fever, vomiting, drowsiness, altered state of consciousness, autonomic dysfunction, electrolyte imbalance and neurological disorder nos were unknown. The reported cause of death was rabies. The reporter considered the rabies, fever, vomiting, drowsiness, altered state of consciousness, autonomic dysfunction, electrolyte imbalance and neurological disorder nos to be related to Rabies Vaccine. Additional information was provided. case was reported in a literature article and described the occurrence of rabies infection in a 5-year-old female patient who was vaccinated with unspecified purified chick embryo cell rabies vaccine (manufacturer unknown) for prophylaxis. The patient was bitten by dog in right leg. The patient had World Health Organization (WHO) category III exposure. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, on the day of the bite, the patient received 3 doses of unspecified purified chick embryo cell rabies vaccine intramuscularly (administration site unspecified; batch number not provided). The patient had not received the rabies immunoglobulin. The age of vaccination was not provided. On an unspecified date in December 2016, an unknown period after vaccination, the patient presented clinical feature like fever of 10 days duration, followed by vomiting and drowsiness, and altered sensorium of 1-week duration. The incubation period was of 20 days. Antemortem diagnostic tests for detection of viral RNA by real-time polymerase chain reaction revealed: negative for cerebrospinal fluid -1 (CSF-1); test was not requested, or sample not received for nuchal skin and saliva. Cerebrospinal fluid-1 (CSF-1) and serum-1 sample was collected 10 days post onset of symptoms and the neutralizing antibody titres were 7.5 and more than 15 IU/mL respectively. For CSF-2 and serum-2, the samples were collected 30-day post onset of symptoms and neutralizing antibody titers were 60 IU/mL and more than 480 IU/mL respectively. The patient was diagnosed with laboratory-confirmed rabies infection. The patient was managed in the intensive care unit with supportive care, including correction of fluid and electrolyte imbalance, management of autonomic dysfunction, and anticonvulsants. The patient has severe neurological sequelae and discharged from the hospital in a vegetative state. On an unspecified date, the patient died after 8 months of survival (as of June 30, 2018). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. The author commented, "Five of eight (62.5%) patients were not administered RIG. These deviations in the PEP protocol can be attributed to inadequate awareness about rabies in the community as well as among health professionals, and shortage of rabies biologicals, especially RIG, at many health-care facilities." The authors concluded, "good intensive care with supportive measures may help the occasional patient with rabies encephalitis to survive, but there is an urgent need for novel antivirals and newer therapeutic strategies to improve the outcomes. This case series also highlights the tragic occurrence of the disease despite vaccination-mostly due to omission of RIG and other serious deviations in PEP protocols. The primary focus, therefore, should be on the "prevention" of rabies by increasing awareness about the disease and PEP protocols among the public and health-care professionals in rabies endemic countries." This is 1 of the 8 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified dates. The incubation period was of 20 days. Antemortem diagnostic tests for detection of viral RNA by real-time polymerase chain reaction revealed: negative for cerebrospinal fluid -1 (CSF-1); test was not requested, or sample not received for nuchal skin and saliva. Cerebrospinal fluid-1 (CSF-1) and serum-1 sample was collected 10 days post onset of symptoms and the neutralizing antibody titres were 7.5 and more than 15 IU/mL respectively. For CSF-2 and serum-2, the samples were collected 30-day post onset of symptoms and neutralizing antibody titers were 60 IU/mL and more than 480 IU/mL respectively. The patient was diagnosed with laboratory-confirmed rabies infection.; Reported Cause(s) of Death: rabies


VAERS ID: 802510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA049352

Write-up: vaccine killed my friend; Initial information received on 19-Feb-2019 regarding an unsolicited valid serious case received from a consumer (patients friend) via social media. This case involves male patient with unknown age, who died after receiving vaccine TETRAVALENT INACTIVATED INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injectable solution of suspect TETRAVALENT INACTIVATED INFLUENZA VACCINE, produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On an unknown date, the patient died (death NOS), following the administration of TETRAVALENT INACTIVATED INFLUENZA VACCINE. Intensity severe. Reporter stated that the vaccine killed the patient. Lab data was not provided. Final diagnosis was death NOS. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. Cause of death was unknown. List of documents held by sender- none.; Sender''s Comments: This poorly documented case received from social media concerns a male patient with unknown age who died due to unspecified disease after vaccination with INACTIVATED INFLUENZA VACCINE (TETRAVALENT) produced by unknown manufacturer. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death nos


VAERS ID: 802512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-10
Onset:2018-10-01
Submitted: 0000-00-00
Entered: 2019-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Asthenia, Computerised tomogram head abnormal, Crying, Culture positive, Death, Decompression sickness, Disorientation, Dyspnoea, Emotional distress, Endotracheal intubation, Epilepsy, Feeding disorder, Gastroenteritis norovirus, Haemorrhagic stroke, Intensive care, Ischaemic stroke, Joint hyperextension, Muscle strain, Phobia, Pyrexia, Rash, Resuscitation, Rotavirus infection, Screaming, Sepsis, Skin warm, Urine analysis, Vomiting, Weight gain poor, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-14
   Days after onset: 136
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2018; Test Name: Body temperature; Result Unstructured Data: Test Result: 40, Test Result Unit: degree C; Test Date: 20181104; Test Name: Computerized tomogram; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown; Test Date: 20181020; Test Name: Urine analysis; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown; Test Date: 20181020; Test Name: Leukocyte count; Result Unstructured Data: Test Result: slightly increased, Test Result Unit: unknown
CDC Split Type: PLGLAXOSMITHKLINEPL2019GS

Write-up: did not have appetite/ eating worse/ stopped eating; cried/ terrible cry; knee warmth; knee pain; high fever; sepsis/ bacteria was discovered; weakness; extensive ischemic stroke with multiply bleeds; extensive ischemic stroke with multiply bleeds; loss of breath; suspicion of rotavirus infection; worse eating/ stopped eating/ lack of appetite/ did not have appetite; anxiety; frequent cry; episodes of screaming of a terrified child/ squeal/ terrible cry; episodes of screaming of a terrified child/ terrible cry; small weight gain/ less body gain; vomiting; norovirus; straining; suspicion of epilepsy; was not present/ did not look on subjects and people; spots on the face; hyperextension; bends; was tormented; This case was reported by a consumer via other and described the occurrence of ischemic stroke in a infant female patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNB005AE, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-IPV+Hib (Infanrix-IPV + Hib) (batch number A20CB480G, expiry date unknown) for prophylaxis, Rota (Rotarix) for prophylaxis and hepatitis B vaccine (Euvax B) for prophylaxis. Previously administered products included BCG vaccine (received on 16th August 2018) and Euvax B (1st dose received on 16th August 2018). On 10th October 2018, the patient received the 1st dose of Synflorix and the 1st dose of Infanrix-IPV + Hib. On 25th October 2018, the patient received the 1st dose of Rotarix (oral). On 10th October 2018, the patient started Euvax B at an unknown dose and frequency. On 10th October 2018, less than a day after receiving Synflorix and Infanrix-IPV + Hib and not applicable after receiving Rotarix, the patient experienced unable to eat (serious criteria death and hospitalization), anxiety (serious criteria death and hospitalization), crying (serious criteria death and hospitalization), screaming (serious criteria death and hospitalization) and phobia (serious criteria death and hospitalization). In October 2018, the patient experienced poor weight gain (serious criteria death and hospitalization) and vomiting (serious criteria death and hospitalization). On 30th October 2018, the patient experienced rotavirus infection (serious criteria death and hospitalization). On 3rd November 2018, the patient experienced difficulty breathing (serious criteria death and hospitalization) and crying (serious criteria death and hospitalization). On 4th November 2018, the patient experienced ischemic stroke (serious criteria death, hospitalization and GSK medically significant) and hemorrhagic stroke (serious criteria death, hospitalization and GSK medically significant). On 4th February 2019, the patient experienced weakness (serious criteria death and hospitalization), gastroenteritis norovirus (serious criteria death, hospitalization and GSK medically significant), strain (serious criteria death and hospitalization), epilepsy (serious criteria death, hospitalization and GSK medically significant), disorientation (serious criteria death, hospitalization and GSK medically significant), rash (serious criteria death and hospitalization), hyperextension of knee (serious criteria death and hospitalization), the bends (serious criteria death and hospitalization) and emotional distress (serious criteria death and hospitalization). On an unknown date, the patient experienced skin warm (serious criteria death and hospitalization), knee pain (serious criteria death and hospitalization), fever (serious criteria death and hospitalization), sepsis (serious criteria death, hospitalization and GSK medically significant) and unable to eat (serious criteria death and hospitalization). The patient was treated with operations and procedures (Intubation), antibiotics nos (Antibiotic (Drug Name Unknown)) and operations and procedures (Physical Rehabilitation). On an unknown date, the outcome of the ischemic stroke, hemorrhagic stroke, unable to eat, anxiety, crying, screaming, phobia, poor weight gain, rotavirus infection, vomiting, difficulty breathing, skin warm, knee pain, fever, sepsis, weakness, gastroenteritis norovirus, strain, epilepsy, disorientation, rash, hyperextension of knee, the bends, emotional distress, unable to eat and crying were fatal. The patient died on 14th February 2019. The reported cause of death was ischemic stroke, hemorrhagic stroke, unable to eat, anxiety, crying, screaming, phobia, poor weight gain, rotavirus infection, vomiting, difficulty breathing, skin warm, knee pain, fever, sepsis, weakness, gastroenteritis norovirus, strain, epilepsy, disorientation, rash, hyperextension of knee, the bends and emotional distress. The reporter considered the ischemic stroke, hemorrhagic stroke, unable to eat, anxiety, crying, screaming, phobia, poor weight gain, rotavirus infection, vomiting, difficulty breathing, skin warm, knee pain, fever, sepsis, weakness, gastroenteritis norovirus, strain, epilepsy, disorientation, rash, hyperextension of knee and the bends to be related to Synflorix and Infanrix-IPV + Hib. It was unknown if the reporter considered the emotional distress to be related to Synflorix, Infanrix-IPV + Hib and Rotarix. It was unknown if the reporter considered the ischemic stroke, hemorrhagic stroke, poor weight gain, rotavirus infection, vomiting, difficulty breathing, skin warm, knee pain, fever, sepsis, weakness, gastroenteritis norovirus, strain, epilepsy, disorientation, rash, hyperextension of knee and the bends to be related to Rotarix. The reporter considered the unable to eat and crying to be related to Rotarix. Additional details were provided as follows: This case was reported via a press media search. The patient was born on 38 weeks of pregnancy by Cesarean delivery. The patient''s mother by whole pregnancy was under medical supervision, prenatal researches were done 3 times. The patient was born healthy, energic and had good appetite. All vaccinations were done in compliance with vaccination calendar. On 10th October 2018 less than a day after vaccination the patient started to eat worse, was anxious, cry frequently, experienced scream episodes like a terrified child. After pediatrist consultation the modified milk was recommended (the mother was feeding the child by breast milk). But introduction of the modified milk did not help. The patient eat less, was crying frequently and was anxious. The hospital consultation was recommended since of less body gain. On 20th October 2018, the patient was on emergency department at the hospital. There were made morphology, urine test, laryngologist consultation. The leucocytes were slightly increased. The patient was released home. On 22nd October 2018, Monday the patient felt good, but on Tuesday stopped eating again. on 25th October 2018 the patient received the first dose of Rotarix and was vomiting and did not have appetite. On 30th October 2018 the patient was on the hospital emergency department. The rotavirus infection was suspected since. On 01st November 2018, the patient had changed milk and after this started to eat and appetite returned and on Monday the practitioners planned released the patient home. On 03rd November 2018 at 20:00 the patient eaten, at 21:30 the patient cried and started to lose breath, cannot do breath. The patient was resuscitated (but the hearth did not stop). The patient was intubated and to ICU of the hospital. Some tests were done and on 4th November 2018, Sunday computer tomography was done. The diagnosis of extensive ischemic stroke with multiply bleeds was confirmed. At the first days the parents observed that left knee is warmth and the patient feel pain since each movement of this leg caused terrible cry. The physicians told it is not anything special. The patient experienced 40 C fever and after this the physicians interested of this. They started to do all tests, puncture of knee was done and this bacteria was discovered. But any doctor did not said it is sepsis or anything. The doctors were saying only it is awful bacteria and the patient receiving good antibiotic. The patient had 3 knee punctures. It was sepsis on the infant department. On 07th January 2019 until 25th January 2019 the patient was at the hospital and was rehabilitated. The patient had good appetite, was eating without help. The patient had one day worse and probe was done and the rigor of eating was given. The patient was vomiting but the recommendation as to feed the child. After 3 months first time the patient was at home. In the last days in the hospital the patient was eating worse, started to vomit once a day. On 03rd February 2019 was vomiting often. On 04th February 2019 stopped eating and was only vomiting. In the evening the patient had breathing problems, was not equal, the patient was weak. The patient was taken to the hospital emergency ward. At the hospital norovirus was diagnosed and the practitioners said it is partially the reason of the patient condition. During hospitalization the patient started to straining, epilepsy was suspected. The patient was not present, weak, cannot look on subjects. The cry had changed, it was rather squeal. On the face the spots occurred, few episodes of hyperextension and bends occurred and next vomiting. Since the patient did not have possibility to vomit it was tormented her. On 11th February 2019 the appetite come back a little bit and vomiting stopped. The last meal the patient ate at 12:00 pm from 13th February to 14th February, she had 100 ml of milk was eaten. 12:45 am was sleeping and was breathing. About 3 am on 14th February the father touched the child who was cold, was not breathing. The resuscitation was done immediately by an hour. The patient died on 14 February 2019. It was unknown if the reporter considered the ischemic stroke, hemorrhagic stroke, appetite absent, anxiety, crying, screaming, phobia, poor weight gain, rotavirus infection, vomiting, difficulty breathing, skin warm, knee pain, fever, sepsis, weakness, gastroenteritis norovirus, strain, epilepsy, loss of consciousness, rash, hyperextension of knee and the bends to be related to Euvax B as well.; Reported Cause(s) of Death: Ischemic stroke; Hemorrhagic stroke; Unable to eat; Anxiety; crying; screaming; Phobia; poor weight gain; Rotavirus infection; Vomiting; Difficulty breathing; Skin warm; Knee pain; Fever; Sepsis; Weakness; Gastroenteritis norovirus; strain; Epilepsy;


VAERS ID: 802616 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-15
Onset:2019-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD199A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX756AA / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X46171 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA014CA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201903

Write-up: unexpected sudden death 4 days after vaccinations given; This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 13-week-old male patient who received Rota (Rotarix liquid formulation) (batch number AROLA014CA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD199A, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX756AA, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number X46171, expiry date unknown) for prophylaxis. On 15th January 2019, the patient received Rotarix liquid formulation (unknown), Infanrix hexa (intramuscular), Bexsero (intramuscular) and PREVENAR 13 (intramuscular). On 19th January 2019, 4 days after receiving Rotarix liquid formulation, Infanrix hexa and Bexsero, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On 19th January 2019, the outcome of the sudden infant death was fatal. The patient died on 19th January 2019. The reported cause of death was sudden infant death. An autopsy was performed. It was unknown if the reporter considered the sudden infant death to be related to Rotarix liquid formulation, Infanrix hexa and Bexsero. Additional details: Age at vaccination was not reported however patient could be 12 or 13 weeks old at time of vaccination. Batch number for ROTARIX was reported as AROLCO14CA , however on batch number review it was corrected as AROLA014CA. It was unknown if the reporter considered the sudden infant death to be related to Prevenar 13. Initial information was received from a physician via regulatory authority on 20th February 2019. unexpected sudden death 4 days after vaccinations given. Note: Route of administration for Rotarix was discrepantly reported as Intramuscular however it was supposed to be administered orally.; Reported Cause(s) of Death: Sudden infant death


VAERS ID: 802985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-01
Onset:2018-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blast cell crisis, Blast cell proliferation, Death, Extra dose administered, Product administered to patient of inappropriate age
SMQs:, Blood premalignant disorders (narrow), Myelodysplastic syndrome (broad), Medication errors (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-01
   Days after onset: 153
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leukemia
Preexisting Conditions: Medical History/Concurrent Conditions: Stem cell transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019GS

Write-up: blast crisis; inappropriate age at vaccine administration; extra dose administered; inappropriate age at vaccine administration; This case was reported by a physician via sales rep and described the occurrence of blast cell proliferation in a 75-year-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) for prophylaxis, Flu Seasonal QIV Dresden (Influsplit Tetra 2017/2018) for prophylaxis, Flu Seasonal QIV Dresden (Influsplit Tetra 2017/2018) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX 23) for prophylaxis. The patient''s past medical history included stem cell transplant. Concurrent medical conditions included leukemia. In May 2018, the patient received the 1st dose of Infanrix hexa. In June 2018, the patient received the 2nd dose of Infanrix hexa. In May 2018, the patient received the 1st dose of Influsplit Tetra 2017/2018. In June 2018, the patient received the 2nd dose of Influsplit Tetra 2017/2018. In May 2018, the patient received PNEUMOVAX 23. In May 2018, unknown after receiving Infanrix hexa and not applicable after receiving Infanrix hexa, Influsplit Tetra 2017/2018 and Influsplit Tetra 2017/2018, the patient experienced inappropriate age at vaccine administration. In June 2018, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the patient experienced blast cell proliferation (serious criteria death). In October 2018, the outcome of the blast cell proliferation was fatal. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and extra dose administered were unknown. The patient died in October 2018. The reported cause of death was blast cell proliferation. It was unknown if the reporter considered the blast cell proliferation to be related to Infanrix hexa, Infanrix hexa, Influsplit Tetra 2017/2018 and Influsplit Tetra 2017/2018. Additional details were provided as follows: This case was received from an anonymous physician. The physician wanted to stay anonymous as the case possibly was reported by another physician or a clinic. By duplication search the case was found locally. The age at vaccination was not reported. The patient with underlying leukemia was vaccinated two times with Infanrix Hexa and influenza vaccine (probably Influsplit Tetra). The batch numbers were not reported. In a longer timely distance to the vaccinations the patient experienced a blast crisis and died in October 2018. It was not reported, whether two doses of Infanrix hexa and the additional influenza vaccine were given accidentally or intentionally. Follow up would be requested.; Reported Cause(s) of Death: blast crisis


VAERS ID: 803010 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-01-31
Onset:2019-02-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNB062DE / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131902NLD008041

Write-up: Death; op 3-2-2019 is het kind overleden (''s nachts door moeder levenloos op slaapplek aangetroffen); Information has been downloaded from (NL-LRB-00318009). Information has been received from a healthcare professional referring to an 8-week-old female patient. The patient''s concurrent condition, medical history and concomitant therapy were not reported. On 31-JAN-2019, the patient was vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) (1 dosage form in her left leg, lot# reported as R009565, strength, frequency and expiration date were unknown) intramuscularly for vaccination as part of the vaccination program for babies and children (National Immunization Program). Other suspect therapy included pneumococcal 10v conj vaccine (protein D/dip toxoid/tet toxoid) (SYNFLORIX) (lot# ASPNB062DE, strength, dose, frequency and expiration date were unknown) intramuscularly for vaccination as part of the vaccination program for babies and children (National Immunization Program). On 03-FEB-2019, the patient at night was found lifeless by mother in the sleeping place. It was unknown if the autopsy was done. The death reason was unknown. The agency considered the event was related to diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) and pneumococcal 10v conj vaccine (protein D/dip toxoid/tet toxoid) (SYNFLORIX).; Reported Cause(s) of Death: at night found lifeless by mother in the sleeping place


VAERS ID: 803558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA055139

Write-up: person died because he was vaccinated; Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer (patients acquaintance) via social media. This case involves male patient with unknown age, who was reported to had died after receiving vaccine TETRAVALENT INACTIVATED INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injectable solution of suspect TETRAVALENT INACTIVATED INFLUENZA VACCINE, produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On an unknown date, the patient died (death NOS) with unknown cause with unknown latency following the administration of TETRAVALENT INACTIVATED INFLUENZA VACCINE. Intensity severe. This event caused death. Lab data was not provided. Final diagnosis was person died because he was vaccinated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for person died because he was vaccinated. It is unknown if an autopsy was done. List of documents held by sender- none.; Sender''s Comments: This poorly documented case received from social media concerns a male patient with unknown age who died due to unspecified disease after vaccination with INACTIVATED INFLUENZA VACCINE (TETRAVALENT) produced by unknown manufacturer. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 803779 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Biopsy brain, Biopsy skin, Blood test, CSF test, Death, Lyssavirus test positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RABIES IMMUNOGLOBULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (The patient was bitten on eyelid)
Allergies:
Diagnostic Lab Data: Test Name: Rabies virus test positive; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: suspected vaccination failure; rabies; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included immunoglobulin human anti-rabies (Rabies Immunoglobulin) for prophylaxis. Concurrent medical conditions included animal bite (The patient was bitten on eyelid). On an unknown date, unknown after receiving Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure and rabies may have been caused by Rabies Vaccine. Relevant Tests: Lab tests were performed on unspecified date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Lyssavirus test positive result was positive . [In this study, the clinical samples included, CSF, blood (serum), saliva, nuchal skin and brain biopsy collected ante-mortem, and brain tissue obtained post-mortem]. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified anti-rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). The patient was a part of the retrospective analysis that was undertaken to examine the ante-mortem diagnostic utility and prognostic value of antibody detection in cerebrospinal fluid (CSF)/serum samples received from clinically suspected human rabies cases from January 2015 to December 2017. The patient was bitten by animal on eyelid. No information on patient''s family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified anti-rabies vaccine (administration route and site unspecified; dosages unknown; batch number not provided) intramuscularly. Age of vaccination was not provided. The patient had also received rabies immunoglobulin (RIG). It was reported that the patient had no apparent deviations in PEP protocol and bite wound was sutured after administered of RIG. On an unspecified date, an unknown period after vaccination, the patient was suspected for rabies infection. The patient''s clinical sample was obtained. [In this study, the clinical samples included, CSF, blood (serum), saliva, nuchal skin and brain biopsy collected ante-mortem, and brain tissue obtained post-mortem]. Subsequently, the patient was diagnosed with laboratory confirmed rabies infection. On an unspecified date, the patient died of rabies infection. It was unknown if an autopsy was performed. This case has been considered suspected vaccination failure being full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The author considered this case as PEP failure. The author concluded, "This study highlights the challenges of ante-mortem rabies diagnosis and reiterates that the best approach for maximizing the sensitivity and accuracy of ante-mortem diagnosis of rabies is through testing of multiple/serial samples using multiple modalities. Despite the challenges in interpretation, detection of specific antibodies in the CSF and/or serum is a valuable adjunctive/confirmatory ante-mortem diagnostic tool in human rabies, especially when other tests may be non-contributory, particularly in the context of a changing clinical profile of rabies (vaccinated cases with protracted course of illness) in rabies endemic countries in recent years-which may not conform to the clinical and laboratory profile of rabies described several years ago, that the scientific community even today largely identifies with. Early presence of CSF neutralizing antibodies in previously vaccinated/unvaccinated rabies cases can also potentially be used to help guide decisions regarding intensive /supportive / palliative care in patients along with several other factors and as a prognostic marker to predict outcomes, albeit with limited value." This is 1 of the 10 valid cases reported in the same literature article. Lab Comments: Lab tests were performed on unspecified date. [In this study, the clinical samples included, CSF, blood (serum), saliva, nuchal skin and brain biopsy collected ante-mortem, and brain tissue obtained post-mortem].; Reported Cause(s) of Death: rabies


VAERS ID: 803858 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-12
Onset:2019-02-04
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2019-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLBA334AB / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardiogenic shock, Chest X-ray abnormal, Cough, Death, Dyspnoea, Electrocardiogram ST segment abnormal, Influenza, Influenza A virus test positive, Lung infiltration, Nausea, Pneumonia, Pneumonia influenzal, Pyrexia, Troponin increased, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-12
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis (Left ventricular ejection fraction (LVEF) 43 percent); Coronary heart disease; Malnutrition (BMI 18kg/m2)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190207; Test Name: Chest X-ray; Result Unstructured Data: Test Result: starting infiltrate, Thorax AP, lying position, Test Result Unit: unknown; Test Date: 201902; Test Name: Culture nose; Result Unstructured Data: Test Result: positive for Influenza A (subtype unknown), Test Result Unit: unknown; Test Date: 20190209; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: pathological ST, Test Result Unit: unknown; Test Date: 201902; Test Name: Troponin; Result Unstructured Data: Test Result: clearly increased, Test Result Unit: unknown
CDC Split Type: CHGLAXOSMITHKLINECH2019GS

Write-up: vaccination failure; influenza A infection; influenza A pneumonia; increasing dyspnoea; fever; nausea; non-productive cough; cardiogenic shock; acute renal failure; community-acquired pneumonia; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 95-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2018-2019 season) (batch number AFLBA334AB, expiry date June 2019) for prophylaxis. Concurrent medical conditions included aortic stenosis (Left ventricular ejection fraction (LVEF) 43 percent), coronary heart disease and malnutrition (BMI 18kg/m2). On 12th November 2018, the patient received Fluarix Tetra 2018-2019 season .5 ml. On 4th February 2019, 84 days after receiving Fluarix Tetra 2018-2019 season, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), influenza a virus infection (serious criteria death and hospitalization), pneumonia influenzal (serious criteria death, hospitalization and GSK medically significant), dyspnea (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), cough nonproductive (serious criteria hospitalization) and pneumonia (serious criteria GSK medically significant). On an unknown date, the patient experienced cardiogenic shock (serious criteria death and GSK medically significant) and acute renal failure (serious criteria death and GSK medically significant). The patient was treated with ceftriaxone (Ceftriaxon), oseltamivir phosphate (Tamiflu), non-drug therapy (Palliative Care (Nos)), morphine and heparin (nos) (Heparin). On 12th February 2019, the outcome of the influenza a virus infection, pneumonia influenzal, cardiogenic shock and acute renal failure were fatal. On an unknown date, the outcome of the vaccination failure was fatal and the outcome of the dyspnea, fever, nausea, cough nonproductive and pneumonia were unknown. The patient died on 12th February 2019. The reported cause of death was cardiogenic shock and acute renal failure. An autopsy was not performed. It was unknown if the reporter considered the vaccination failure, influenza a virus infection, pneumonia influenzal, cardiogenic shock, acute renal failure, dyspnea, fever, nausea, cough nonproductive and pneumonia to be related to Fluarix Tetra 2018-2019 season. Additional details were provided as follows: On 7th February 2019, the patient was admitted to hospital by the emergency service with increasing dyspnoea, fever, nausea (no vomiting) and with increasing non-productive cough since 2 to 3 days. A community-acquired pneumonia right was hypothesized and antibiotic therapy with Ceftriaxon intravenous was started. Over the course, he was tested positive for Influenza A (subtype unknown) and treatment with Tamiflu (Oseltamivir (ut Oseltamiviri phosphas) oral was added. On 7th February 2019 the patient experienced a rapid respiratory worsening and thorax complaints. On 9th February 2019, the electrocardiogram again showed ST elevations and troponin was clearly increased. In the differential diagnosis, a decompensation of the known severe aortic stenosis in relation to the infect treatment was reported. The patient''s family was decided that, to provide palliative therapy with continuous morphine administration and heparin therapy was given for 3 days. On 12th February 2019, the patient died due to a cardiogenic shock and acute renal failure. The hospital physician stated that the primary cause of death were the cardiac causes and secondary the influenza A infection as well as other factors in this multimorbid patient. No autopsy was performed. Lab Comments: The patient''s rapid respiratory condition was worsening. In the differential diagnosis, a decompensation of the known severe aortic stenosis in relation to the infect treatment; Reported Cause(s) of Death: cardiogenic shock; acute renal failure


VAERS ID: 804234 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumonia streptococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2019093279

Write-up: Drug ineffective; Patient die from Streptococcus pneumoniae infection, even the patient was given Prevenar 13 vaccination before; This is a spontaneous report from a contactable physician via sales representative. A child with unknown age and gender started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via unknown route of administration at single dose on an unspecified date for immunization. Patient''s relevant medical history and concomitant medication were unknown. On an unknown date, the patient die from Streptococcus pneumoniae infection, even the patient was given Prevenar 13 vaccination before. Therapeutic measure taken in response to the event was not provided and outcome of event was fatal. No follow up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Patient die from Streptococcus pneumoniae infection


VAERS ID: 804402 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-02-18
Submitted: 0000-00-00
Entered: 2019-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Serology test
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: still not identified
CDC Split Type: BRPFIZERINC2019088888

Write-up: booster dose at age of 2 years and 2 days at the hospital; Meningitis pneumococcal; Meningitis pneumococcal; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 28-month-old (2 years and 4 months) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), first dose at age of 2 months, second does at age of 4 months, third dose at age of 6 months at clinic and fourth dose (booster dose) at age of 24 months old (2 years and 2 days) at the hospital, all via an unspecified route of administration on unspecified dates at single doses for immunization. The patient''s medical history and concomitant medications were not reported. A nurse from clinic reported that the patient from physician died on 18Feb2019 at the hospital due to meningitis pneumococcal still not identified the serotype. Being that patient received the 4 doses of pneumococcal 13-val conj vac (dipht crm197 protein) at age of 2 months, 4 months and 6 months at clinic and booster dose at age of 2 years and 2 days at the hospital. It was not reported if an autopsy was performed. The batch number has been requested in follow-up activities.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Meningitis pneumococcal


VAERS ID: 804404 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019082233

Write-up: Pneumococcal meningitis; Pneumococcal meningitis; This is a spontaneous report from a contactable physician received via a sales representative. A male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration, first dose when he was 2 months old and second dose when he was 4 months old, both on an unknown date for vaccination. The patient medical history and concomitant medications were not reported. The patient experienced pneumococcal meningitis on an unspecified date. The patient was hospitalized for the event on an unknown date. The patient died on an unspecified date. The cause of death was pneumococcal meningitis. It was not reported if an autopsy was performed. Information regarding lot number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumococcal meningitis; pneumococcal meningitis


VAERS ID: 805571 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-25
Onset:2019-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254682 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Haemophagocytic lymphohistiocytosis, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201902550

Write-up: Sepsis; Macrophage activation syndrome; This is a spontaneous case, initially reported by a physician to regulatory authority (regulatory reference number: GB-MHRA-EYC 00195313) and initially retrieved by Seqirus on 04-Mar-2019, concerning a 66-year-old, elderly, male patient. The patient''s current condition included hypertension. The patient did not have any known allergies and otherwise was very well. The patient''s concomitant medication included atorvastatin. On 25-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, batch number: 254682, route of administration: intramuscular, anatomical location and expiry date: not reported] as flu vaccination. On 26-Jan-2019, one day after vaccination, the patient experienced macrophage activation syndrome and on unspecified date, the patient experienced sepsis. The patient was hospitalised and died on 28-Jan-2019. The autopsy was done. The cause of death was reported as macrophage activation syndrome. The reporter assessed this case as serious (fatal and hospitalization).; Reporter''s Comments: A 66-year-old male patient experienced macrophage activation syndrome (MAS), one day after vaccination with Fluad TIV. Considering the plausible temporal relationship between vaccination to event onset, possible autoimmune inflammatory basis of the event, the company assessed causality of MAS as related to suspect vaccine. The patient also had sepsis, unspecified period after receipt of suspect vaccine. However, considering the inactivated nature of vaccine and infective nature of the event, the causal role of suspect vaccine can be ruled out. The sepsis could have contributed to MAS.; Reported Cause(s) of Death: Macrophage activation syndrome


VAERS ID: 805794 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (unknown time of evolution); Diabetes mellitus (unknown time of evolution)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA068778

Write-up: FLU; for unknown reasons, the patient died; Initial information received on 11-Mar-2019 regarding an unsolicited valid serious case received about an adverse event reported by the vendor during a Market Research and reported on 12-Mar-2019 by the Sanofi''s pharmacovigilance department. This case involves male patient of an unknown age who experienced flu and from unknown reasons, the patient died, while he received vaccine INFLUENZA VACCINE (QUADRIVALENT). The patient''s past medical history included Hypertension with unknown time of evolution and Diabetes mellitus with unknown time of evolution. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious flu (influenza like illness) following the administration of INFLUENZA VACCINE (QUADRIVALENT). on an unknown date, after the application of the vaccine, for unknown reasons, the patient died in 2016. It was reported that, the patient presented flu and 6 months later, from unknown reasons, the patient died in 2016 (exact date was not provided). Also assessed as medically important. (Other relevant tests included no lab data.) Final diagnosis was flu and (fatal) death nos. It was not reported if the patient received a corrective treatment. The outcome is reported as unknown for flu. It was not known if an autopsy was performed and the cause of death unknown. Documents held by sender: none.; Sender''s Comments: A male patient of an unknown age had flu unknown number of days after vaccination with INFLUENZA VACCINE (QUADRIVALENT) (from unknown manufacturer). Six-months after having flu the patient died and cause of death is not known. It is not known if subject still had flu at time of death. The time to onset (for event of death) is unknown. The patient past medical history included Hypertension and Diabetes mellitus with unknown time of evolution. The patient concomitant medications were not reported. It was unknown if an autopsy was performed. Additional information regarding patient''s condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 806070 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Flu-like illness
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZSA2019SA072401

Write-up: cardiac arrest; Initial information regarding unsolicited literature case was received on 14-Mar-2019 from health care professional via Health Authorities. This case is linked to cases 2019SA072426, 2019SA072326, 2019SA072320, 2019SA072355, 2019SA072376, 2019SA072409 and 2019SA072422. This case involves a patient of unknown demography who experienced cardiac arrest, while he/she received vaccine INFLUENZA VACCINE and VARICELLA ZOSTER VACCINE. The patient''s past medical history included severe coronary artery disease. At the time of the event, the patient had ongoing Influenza like illness (it was reported as underlying flu like illness). The patient''s past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, the patient received a dose of suspect VARICELLA ZOSTER VACCINE not produced Sanofi Pasteur (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced cardiac arrest. This event was leading to death. (Other relevant tests included no lab data.) Final diagnosis was (fatal) cardiac arrest. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for cardiac arrest. It is unknown if an autopsy was done. The cause of death was reported as Cardiac arrest. Reporter causality: The death was considered to be due to cardiac arrest and the patients associated background history, and not related to the vaccines. List of documents held by sender: none.; Sender''s Comments: This case involves a patient of unknown demography who experienced cardiac arrest following vaccination. This event was leading to death. More details regarding patient''s medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 806246 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2018-12-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R011204 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dermatomyositis, Erythema, Hypoaesthesia, Interstitial lung disease, Oedema, Pyrexia, Skin erosion
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-04
   Days after onset: 82
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131903JPN001620J

Write-up: Interstitial pneumonia acute exacerbation; Dermatomyositis; pyrexia, red skin, erosion, oedema and numbness in both hands; Information has been received for a direct report from the Agency (V18100877) on 15-MAR-2019, regarding a case provided by physician. Information has been received from a physician concerning a 65-year-old female patient. The patient had no family history. In the pre-examination sheet, there were no points to note, including underlying disease, allergies, vaccination or illness within one month around the time of reporting, medications during administration, past adverse reaction history, and growth status. On 10-DEC-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection (PNEUMOVAX NP) for prophylaxis (lot number, R011204; the dose was not reported). No concomitant medications were reported. On 10-DEC-2018, the body temperature before vaccination was 36 degrees Celsius. Pneumococcal vaccine, polyvalent (23-valent) injection. On approximately 12-DEC-2018, pyrexia, red skin, erosion and oedema, and numbness in both hands appeared and the patient changed various hospitals. (onset of "dermatomyositis; pyrexia, red skin, erosion, oedema, and numbness in both hands".) On 19-JAN-2019, the patient visited the reporting hospital and was referred to hospital A. In 2019, the patient''s condition worsened, and was treated at hospital B. On 04-MAR-2019, the patient died of interstitial pneumonia acute exacerbation with dermatomyositis at hospital B. The causes of death were "dermatomyositis; pyrexia, red skin, erosion, oedema, and numbness in both hands'' and interstitial pneumonia acute exacerbation. Information regarding autopsy was not reported. Reporter''s comment: Because she was a healthy patient, I guessed that the cause of the disease was pneumococcal vaccine, polyvalent (23-valent). The causal relationship was unclear, but there was a possibility that the drug was at least contributory to the onset. The reporting physician considered that "dermatomyositis; pyrexia, red skin, erosion, oedema, and numbness in both hands" was related to pneumococcal vaccine, polyvalent (23-valent), and that dermatomyositis and interstitial pneumonia were other causative factors. The reporting physician did not assess the relationship of interstitial pneumonia acute exacerbation to pneumococcal vaccine, polyvalent (23-valent). The reporting physician considered "dermatomyositis; pyrexia, red skin, erosion, oedema, and numbness in both hands" and interstitial pneumonia acute exacerbation to be serious due to death. Upon internal review, "dermatomyositis; pyrexia, red skin, erosion, oedema" and interstitial pneumonia acute exacerbation were determined to be medically significant. Lot number [R011204] has been verified to be a valid lot number for pneumococcal Vaccine, Polyvalent (23-valent).; Reported Cause(s) of Death: Dermatomyositis; pyrexia, red skin, erosion, oedema and numbness in both hands; Interstitial pneumonia acute exacerbation


VAERS ID: 806499 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-13
Onset:2018-11-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 1030A1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac failure, Cranial nerve disorder, Death, Miller Fisher syndrome, Paraparesis
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-03
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONGESCOR; ARANESP; XANAX
Current Illness: Chronic renal failure; Secondary anemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201902621

Write-up: Miller Fisher''s syndrome; Flaccid tetraparesis; Cranial nerve deficit; Decompensation cardiac; Acute respiratory failure; This is a spontaneous case reported by a physician to Regulatory Authority (regulatory reference number: IT-MINISAL02-535338) and initially retrieved on 11-Mar-2019, concerning an 85-year-old, elderly female patient. The patient''s current conditions included chronic renal failure with secondary anaemia. The concomitant medications included Congescor (bisoprolol fumarate), Aranesp (darbepoetin alfa) and Xanax (alprazolam). On 13-Nov-2018 at 15:00, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 1030A1A, anatomical location and expiry date: not reported] for flu prevention. On 14-Nov-2018, one day after vaccination, the patient experienced cranial nerve deficit, flaccid tetraparesis and probable Miller Fisher''s syndrome (as reported). On 03-Dec-2018, the patient died. It was unknown whether autopsy was performed. The cause of death was reported as decompensation cardiac and acute respiratory failure. The reporter assessed the case as serious (death).; Reporter''s Comments: An 85-year-old female patient with concurrent medical condition chronic renal failure and secondary anaemia experienced symptoms of Miller Fisher''s syndrome, 1 day after receipt of Fluad TIV. Considering the plausible temporal relationship between vaccination and reported event, plausible immunological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event Miller Fisher''s syndrome as possibly related to suspect vaccine. The patient died, 19 days post vaccination and the cause of death was reported as decompensation cardiac and acute respiratory failure. Despite the plausible temporal relationship, the event acute respiratory failure can be alternately explained by the Miller Fisher''s syndrome syndrome, rather than suspect vaccine. The event decompensation cardiac can be alternately explained by underlying medical condition chronic renal failure, anaemia and precipitated by acute respiratory failure. Hence, causality of these events assessed as not related to suspect vaccine. The company assessed the event ''acute respiratory failure'' as serious (medically significant).; Reported Cause(s) of Death: Decompensation cardiac; Acute respiratory failure


VAERS ID: 806644 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2019-02-26
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, H3N2 influenza, Influenza A virus test positive, Interstitial lung disease, Pneumonia, Polymerase chain reaction positive, Sopor, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-08
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC Split Type: ITSEQIRUS201902655

Write-up: Cardiogenic Shock; Bronchopneumonic outbreak [in interstitial lung disease]; [Bronchopneumonic outbreak] in interstitial lung disease; Sopor; Influenza A H3N2; Dry cough; Dyspnoea; Inefficacy of flu vaccination; Positive results, for influence A H3N2; This is a spontaneous case from country, reported by a physician to Agency (regulatory reference number: IT-MINISAL02-536805) and initially retrieved on 18-Mar-2019, concerning a 78-year-old, elderly female patient. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 0942A1A, anatomical location and expiry date: not reported] for vaccination. On 26-Feb-2019, 2 months and 16 days after vaccination, the patient experienced dry cough, dyspnoea and sopor. On an unspecified date, the patient was hospitalized. During hospitalization, polymerase chain reaction (PCR) on nasal buffer was performed and the results were positive for influenza A H3N2 (reported as vaccination failure). On 28-Feb-2019, the patient experienced bronchopneumonia outbreak in interstitial lung disease. On 04-Mar-2019, the patient was transferred to a different hospital. On 08-Mar-2019, the patient experienced cardiogenic shock and died. The reporter assessed the case as serious (death and hospitalization).; Reporter''s Comments: A 78-year-old female patient experienced dry cough, dyspnoea, sopor and was diagnosed to have influenza, 2 months and 16 days after Fluad (TIV) vaccination (coded to H3N2 influenza and vaccination failure). The patient subsequently experienced bronchopneumonia outbreak in interstitial lung disease, cardiogenic shock and died. Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the fatal event of H3N2 influenza cannot be ruled out and were assessed as related to suspect vaccine. Despite temporal association between vaccination and fatal events of bronchopneumonia outbreak in interstitial lung disease and cardiogenic shock, the clinical course suggests the reported influenza and its complications as a more plausible explanation for the events. Hence, the company assessed the causality as not related to suspect vaccine.The company assessed the events cardiogenic Shock, H3N2 influenza and vaccination failure as serious (medically significant).; Reported Cause(s) of Death: Cardiogenic shock; Sopor; Bronchopneumonic outbreak; Interstitial lung disease; Influenza A H3N2; Inefficacy of flu vaccination


VAERS ID: 806860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131903GRC010500

Write-up: a promising vaccine against the virus which is incriminated for cervical cancer turns out to be the source of extremely serious side effects, even deaths, of young girls and boys.; a promising vaccine against the virus which is incriminated for cervical cancer turns out to be the source of extremely serious side effects, even deaths, of young girls and boys.; Information has been received from a pediatrician via company representative referring to unknown age female patient(reported as young girls) included in an on-line article located at the electronic newspaper. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with HPV vaccine: quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route , lot # and expiration date were not reported) On an unknown date, it was reported that the vaccine(reported as a promising vaccine against the virus which was incriminated for cervical cancer) turns out to be the source of extremely serious side effects, even deaths. The outcome of side effects was unknown. It was unknown if autopsy was performed. The cause of death was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment was related. This is one of several reports received from the same reporter.; Sender''s Comments: GR-009507513-1903GRC010501: GR-009507513-1903GRC010502: GR-009507513-1903GRC010503: GR-009507513-1903GRC010504: GR-009507513-1903GRC008911: US-009507513-1903USA010618:


VAERS ID: 806935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Wheelchair user
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131903GRC010503

Write-up: How perfectly healthy young women (and now men also) suddenly lose their energy, moving with wheelchairs, or even die; How perfectly healthy young women (and now men also) suddenly lose their energy, moving with wheelchairs, or even die; Information has been received from a pediatrician via company representative referring to unknown age female patient(reported as young women) included in an on-line article located at the electronic newspaper. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with HPV vaccine: quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route , lot # and expiration date were not reported). On an unknown date, it was reported that the patients suddenly lose their energy, moving with wheelchairs(Disability), or even die. The outcome of lose energy was unknown. It was unknown if autopsy was performed. The cause of death was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment between the events and the suspect vaccine was related (reported as linked to). This is one of several reports received from the same reporter.; Sender''s Comments: GR-009507513-1903GRC010500: GR-009507513-1903GRC010501: GR-009507513-1903GRC010502: GR-009507513-1903GRC010504: GR-009507513-1903GRC008911: US-009507513-1903USA010618:


VAERS ID: 806956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131903GRC010502

Write-up: a promising vaccine against the virus which was incriminated for cervical cancer turns out to be the source of extremely serious side effects, even deaths.; a promising vaccine against the virus which was incriminated for cervical cancer turns out to be the source of extremely serious side effects, even deaths.; Information has been received from a pediatrician via company representative referring to unknown age male patient(reported as young boys) included in an on-line article located at the electronic newspaper. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with HPV vaccine: quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route , lot # and expiration date were not reported) On an unknown date, it was reported that the vaccine ( reported as a promising vaccine against the virus which was incriminated for cervical cancer) turns out to be the source of extremely serious side effects, even deaths. The outcome of side effects was unknown. It was unknown if autopsy was performed. The cause of death was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment was related. This is one of several reports received from the same reporter.; Sender''s Comments: GR-009507513-1903GRC010500: GR-009507513-1903GRC010501: GR-009507513-1903GRC010503: GR-009507513-1903GRC010504: US-009507513-1903USA010618: GR-009507513-1903GRC008911:


VAERS ID: 806957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Wheelchair user
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131903GRC010504

Write-up: How perfectly healthy young women (and now men also) suddenly lose their energy, moving with wheelchairs, or even die; How perfectly healthy young women (and now men also) suddenly lose their energy, moving with wheelchairs, or even die; Information has been received from a pediatrician via company representative referring to unknown age male patient included in an on-line article located at the electronic newspaper. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with HPV vaccine: quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route , lot # and expiration date were not reported). On an unknown date, it was reported that the patients suddenly lose their energy, moving with wheelchairs (disability), or even die. The outcome of lose energy was unknown. It was unknown if autopsy was performed. The cause of death was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment between the events and suspected vaccine was related (reported as linked to). This is one of several reports received from the same reporter.; Sender''s Comments: GR-009507513-1903GRC010502: GR-009507513-1903GRC010503: GR-009507513-1903GRC010500: GR-009507513-1903GRC010501: GR-009507513-1903GRC008911: US-009507513-1903USA010618:


VAERS ID: 807024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131903BRA010645

Write-up: Mothers report that HPV vaccine killed 3 girls; This spontaneous report was received from a consumer via local vendor and this was reported on an online newspaper. This report refers to 3 female patients of unknown age. The patients'' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with an unspecified human papillomavirus (HPV) vaccine: human papillomavirus (types 6,11,16,18) recomb. Vaccine (or) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, dose #, route, lot and expiration date were not provided). The article stated, "mothers reported that HPV vaccine killed 3 girls" (Death). The cause of death was not reported. It was unknown, if an autopsy was performed. The reporter considered event to be related to HPV vaccination. This is one of the two reports received from the same reporting source.; Sender''s Comments: BR-009507513-1903BRA010498:; Reported Cause(s) of Death: HPV vaccine killed 3 girls


VAERS ID: 807133 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-01-26
Onset:2019-02-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2019-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLUPRED
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic hepatitis C; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019123534

Write-up: NASAL BLEEDING; died on 08Feb2019 due to unknown cause; This is a spontaneous report from a contactable consumer downloaded from the Agency-WEB, regulatory authority number FR-AFSSAPS-MA20190440. A 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot # was not reported) intramuscularly on 02Feb2019 at single dose for immunization and prednisolone metasulfobenzoate sodium (SOLUPRED) oral from 26Jan2019 to 06Feb2019 at 80 mg, 1x/day for asthma. Medical history included chronic obstructive pulmonary disease, chronic hepatitis C, asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced nasal bleeding on 07Feb2019 with outcome of unknown. The patient died on 08Feb2019 due to unknown cause. The reporter assessed the event serious as medically significant. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 807202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131903BRA010948

Write-up: mothers claim that HPV vaccine left 15 girls with sequelae and killed three; Product origin unknown; This spontaneous report as received from a consumer referring to three females patients of unknown age. No information regarding patients current conditions, medical history, concomitant medications, drug allergies or reactions were provided. On an unspecified date, the patients were vaccinated with human papillomavirus (HPV) vaccine (manufacture unknown) (strength, dose, dose number, administration route, anatomical site of injection, lot number and expiration date were not reported) for prophylaxis. On 03-AUG-2018, two on line news papers posted an article. No information regarding the cause of death was provided, and the reporter related the event with human papillomavirus (HPV) vaccine (manufacture unknown). This is one of two cases from the same reporter.; Sender''s Comments: US-009507513-1903BRA010941:; Reported Cause(s) of Death: killed three


VAERS ID: 807348 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-17
Onset:2018-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254677 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Fatigue, Feeling cold, Influenza like illness, Pneumonia
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-12-10
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201902657

Write-up: Pneumonia; Feeling cold; Influenza like ilness; Fatigue; Diarrhoea; This is a spontaneous case, reported by other non-healthcare professional (consumer) to regulatory authority and initially retrieved on 18-Mar-2019 by Seqirus from regulatory authority (regulatory reference number: GB-MHRA-EYC 00195192), concerning an 86-year-old, elderly, female patient of weight: 50 kg and height: 157 cm. On 17-Nov-2018, the patient was administered Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml (reported as 1 DF), route of administration: parenteral, batch number: 254677, expiry date and anatomical location: not reported) for influenza immunization. On 18-Nov-2018, one day after vaccination, the patient developed diarrhoea, fatigue, some influenza like illness, pneumonia and was feeling cold. It was reported that, the patient didn''t go out of house between vaccination and her death, however one of the patient''s relative had visited her. On 10-Dec-2018, the patient died mysteriously due to pneumonia suddenly. It was unknown whether autopsy was performed or not. The patient had not recovered from the events feeling cold, flu-like symptoms, fatigue and diarrhoea. The reporter assessed the events as serious (fatal, life-threatening).; Reporter''s Comments: An 86-year-old female patient experienced symptoms of pneumonia and diarrhoea, 1 day after receipt of Fluad TIV. The patient died due to pneumonia, 22 days post vaccination. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event diarrhoea as possibly related to suspect vaccine. Considering the onset latency and infectious etiology of the event pneumonia, the causal role of inactivated company suspect vaccine is ruled out. Hence, causality assessed as not related.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 807417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-05
Onset:2018-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N019136 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Basophil count increased, Basophil percentage increased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood lactate dehydrogenase increased, Blood lactic acid increased, Blood methaemoglobin present, Blood phosphorus increased, Blood potassium increased, Blood sodium normal, Blood urea normal, Blood uric acid normal, C-reactive protein normal, Calcium ionised increased, Carboxyhaemoglobin normal, Cardiac massage, Cyanosis, Death, Endotracheal intubation, Eosinophil count increased, Eosinophil percentage, Gamma-glutamyltransferase increased, Haematocrit increased, Haemoglobin normal, Laboratory test, Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume increased, Mean platelet volume normal, Mononucleosis heterophile test positive, Neutrophil count normal, Neutrophil percentage decreased, Pallor, Platelet count normal, Protein total decreased, Pulse absent, Pupil fixed, Red blood cell count normal, Red cell distribution width increased, Respiratory arrest, Resuscitation, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Corpus callosum agenesis; Fallot''s tetralogy; Major aortopulmonary collateral artery; Pulmonary artery atresia
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea; Hospitalisation
Allergies:
Diagnostic Lab Data: Test Name: BASO; Test Result: 2.6 %; Test Name: BILI RUBIN TOTAL; Test Result: 0.2 mg/dl; Test Name: CALCIUM; Test Result: 10.6 mg/dl; Test Name: CREATININE ENZ.CHILD; Test Result: 0.31 mg/dl; Test Name: GLUCOSE; Test Result: 192 mg/dl; Test Name: GLUCOSE; Test Result: 177 mg/dl; Test Name: LACTATE; Test Result: 187 mg/dl; Test Name: METHEMOGLOBIN-OXIMET; Test Result: 2.2 %; Test Name: PHOSPHORUS; Test Result: 10.8 mg/dl; Test Name: urea; Test Result: 16 mg/dl; Test Name: URIC ACID; Test Result: 4.7 mg/dl; Test Name: CARBOXYHEMOGLO-OXIME; Test Result: 0.3 %; Test Name: C-REACTIVE PROTEIN; Test Result: 0.29 mg/dl; Test Name: eos; Test Result: 3 %; Test Name: HCT; Test Result: 49.5 %; Test Name: LYM; Test Result: 59.8 %; Test Name: NEUT; Test Result: 15.1 %; Test Name: RDW; Test Result: 15.5 %
CDC Split Type: IL0095075131903ISR011153

Write-up: death; Information has been received from a regulatory authority concerning a three months old male patient who was born with Tetralogy of Fallot (TOF), pulmonary atresia, major aortopulmonary collateral artery and partial absence of corpus collosum . On 05-MAR-2018, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch and lot # N019136, oral) for prophylaxis. On 06-MAR-2018, the patient died a day after receiving rotavirus vaccine, live, oral, pentavalent(ROTATEQ). The patient cyanotic and was found in bed by his mother with no respiration, his father (an emergency services volunteer) initiated resuscitation at home, the patient arrived at the center of emergency medicine by the emergency services in full resuscitation including massages and ventilation in LMA, with no drug therapy until arrival. The resuscitation was continued at the center of emergency medicine center with no success (The patient dilated non-responsive to light pupils, pulse was not palpated, extreme pallor. Full resuscitation including intubation by anesthesiologist, Intra-osseous catheter to tibia, advanced drug therapy). Despite the long resuscitation efforts, no response to therapy. Unfortunately, the baby died. The cause of death was unknown. It was unknown if autopsy was performed. Information about medical attention was not provided. The causality assessment was not provided. A release letter from hospital: Routine medications: Omeprazole(LOSEC) CAP and sildenafil citrate SUS. Parameters on admission: Temperature 36.7 ?C Pulse 62/minute Blood pressure 95/43 mmHg Capillary refill 3 Physical examination: General status: in full resuscitation, extreme pallor Eyes: Dilated non-responsive to light pupils Heart: no pulse Lungs: no respiratory Abdomen: soft abdomen Accessory tests: 26-February-2018 a trachea x-ray with copper filter Reason of referral There is a computerizes/scanned referral Were carried out: Chest x- ray on 26-February-2018 12:23 PM Chest x-ray; X-ray of trachea (with copper filter); Finding: PIG Bronchus suspected in RUL Main bronchi are narrow Central infiltrate from the right No pleural effusion Dilated heart shadow as known Summary: As detailed above in findings. A boy, External echocardiography TIE, Ultrasound 15-February-2018 Answer was not entered Echocardiography 15-February-2018 A known anatomy -TOF/PA/MAPCAs. Normal function, flow especially from, right to left in VSD. Good flow in AV valves and in the ventricles outlet to the aaorta with a mild aaortic leakage. Good flow in the arc and in tl1e abdominal aaorta - no significant retrograde flow. There is PFO with two-way flow. Flow in several collaterals was demonstrated. Infectious diseases and resistant bacteria Type ESBL Date of first time test was taken on 06-January-2018 18:00 PM Date of test was taken 06-January-2018 18:00 PM Status Carrier Time result was received: 05-March-2018 14: 13 PM Source of data: Laboratory Source of report: ESBL positive Summary Date: 06-March-2018 Time 02:56:00 Details despite long resuscitation efforts that include advanced drug therapy he dies at the emergency medicine center. Time of death 02:20 AM. Laboratory results: GLUCOSE (unknown date):192 mg/dl UREA (unknown date):16mg/dl SODIUM ((unknown date):141 mEq/l Potassium (unknown date):7.7 mEq/l CHLORIDE (unknown date):100 mEq/l PROTEIN-TOTAL (unknown date): 5.3 g/dl ALBUMIN (unknown date):3.6 g/dl CALCIUM (unknown date):10.6 g/dl PHOSPHORUS (unknown date):10.8 g/dl URIC ACID (unknown date):4.7 g/dl BILIRUBIN TOTAL (unknown date): 0.2 g/dl ALIK. PHOSPHATASE (unknown date):409 U/L LDH (unknown date): 793 U/L GOT(AST) (unknown date): 82.8 U/L GPT(ALT) (unknown date): 23.6 U/L GGT (unknown date): 43.7 U/L CREATININE ENZ.CHILD(unknown date):0.31 mg/dl C-REACTIVE PROTEIN (unknown date): 0.29 mg/dl White blood cell count(WBC)(06-MAR-2018):24.33 k/micl Red Blood Cell Count(RBC)(06-MAR-2018): 4.8M/micl HB (unknown date): 13.4g/dl HCT (unknown date):49.5% MCV (unknown date):102.9 fl MCH (unknown date): 27.8 pg MCHC (unknown date):27.0 g/dl RDW (unknown date): 15.5% Platelet count(PLT) (unknown date):282 K/MICL MPV (unknown date):8.9fl Macroscopic percent(MACRO) (unknown date):11.6% Microscopic percent (MICRO) (unknown date): 1.0% HYPO percent (unknown date): 85% HYPER percent (unknown date): 0.2% Mononucleosis (MONO) percent (unknown date):7.6% LUC percent (unknown date):11.9% Basophil(BASO)percent (unknown date): Neutrophils(NEUT) (unknown date):3.7 K/micl LYMP (unknown date):14.6 K/micl Mononucleosis (MONO) (unknown date):1.85 K/micl Basophil(BASO) (unknown date):0.6 K/micl Eosinophil(s)(EOS) (unknown date):0.7 K/micl LUC (unknown date):2.9 K/micl POTASSIUM (unknown date): 7.0 g/dl SODIUM (unknown date): 140 mEq/l CHLORIDE (unknown date): 105mEq/l CALCIUM IONIZED (unknown date): 1.44mmol/l LACTATE (unknown date): 187mg/dl METHEMOGLOBIN-OXIMET (unknown date): 2.2% GLUCOSE I (unknown date): 177 mg/dl CARBOXYHEMOGLO-OXIME (unknown date):0.3% Summary of hospitalization: Date of release date: 11-December-2017 Delivery at week 40.2 of gestation. Type of delivery-an urgent caesarian section. Head presentation. Birth weight 3475 grams. Apgar score minute 1 - 7 (Pulse - 2, Respiratory - 2, To nus - 1, Color - 1, reaction to catheter - 1). Apgar score minute 5 - 9 (Pulse - 2, Respiratory - 2, To nus - 2, Color - 1, reaction to catheter - 2). Treatment in delivery room: stimulation/suction of secretions/oxygen. Drugs and fluids in the delivery room: non. Course of pregnancy and maternal conditions: Healthy, takes SSRI- Cipralex. Week 40+2 of gestation after little pregnancy monitoring. A second delivery to the mother who takes SSRI during pregnancy. Was hospitalized for delivery induction because of decrease in embryo movements and alternating decreased variability on monitor. Because slowing down continued and with no advancement, she was referred to an emergency caesarian section. He was born through thick meconium, hypotonic and cyanotic, he needed suction of superficial secretions and ambient oxygen with good recovery. He was transferred for monitoring in the nursery where he hyperventilated, basal saturation of 82% at room air. Therefore, he was transferred in to the neonatal intensive care unit. Umbilical gas 2/62.4/24.1, Lactate 6.8, BE (-) 5. On admission to the neonatal intensive care unit: Upon admission alert and responsive, moderately tachypneic and dyspneic. Needed oxygen in HOOD. First blood gas in the nursery 7.25/55.3/24, glucose not measurable. Therefore, he was administered with a boost dose of glucose. Chest x-ray supported MAS, a very large boot shape heart shadow. Routine admission was taken, and antibiotic therapy was initiated. Course and discussion per organ systems: The nervous system Normal neurological examination during hospitalization. In blood count at birth 9000 normoblasts, neutropenia and coagulation disorder, no erythrocytes in urine - Picture characteristic of intra-uterine ischemia. No hepatic functions disorder. Brain ultrasound 10-DEC-2017 Symmetrical mildly dilated ventricles with prominent of the frontal horns. Ependymal uptake in their circumferences. Preserved midline. A mild dilation of the third ventricle. In midline - the corpus callosum has all its parts but it is slightly thin along the splenium. Bilateral echogenic periventricular brain tissue. No brain hemorrhage. Normal volume of extra-axial fluid. The respiratory system As mentioned, upon his admission to the neonatal intensive care unit he was supported by 95% oxygen in the HOOD. Under that, saturation of 96% with increases up to 100% for short period of times. Under that, ventilation with normal gas with maximal arterial PO2 of 54 mmHg. Later on the first day of his life a gradual decrease in Oxygen and at the age of 10 hours of his life he was supported only with 25 % oxygen in the incubator. After diagnosis was determined, support with Oxygen is being discontinued and since then he maintains 90% saturation at room air, mildly tachypneic with no dyspnea. To note: shadow of the thymus can be identified on chest x-rays. A mild bilateral grainy picture in repeat chest x-rays. The cardio-vascular system As mentioned, he was admitted with a systolic murmur, a very large boot shape heart on chest X-ray.On the first day of his life, echocardiogram was performed demonstrating Truncus arteriosus. Since left pulmonary artery was not identified, the possibility of a left pulmonary artery feeding from the ductus was raised, even though a clear ductal flow was not demonstrated. In light of that, he was placed on therapy witl1 Prostin empirically. However, still ductal flow was not demonstrated, therefore treatment was stopped. To note, all along a sufficient venous flow was demonstrated from the left pulmonary vein. because of a picture of ATN, the total fluid volume was restricted during hospitalization. Prior to transferring him, TF=75 cc/kg per day (of which 10 cc/kg/day by nutrition). During hospitalization he had normal perfusion, preserved capillary filling time, normal peripheral pulses. He is transferred to the Hospital to continue evaluation and treatment. The digestive system Considering his condition, he was treated with parenteral nutrition in the first two days of his life. On the third day feeding was initiated that was tolerated and absorbed normally. Metabolism and Jaundice During hospitalization he was treated with TPN as mentioned in ''Gastro '' As mentioned in his admission, there were repeat hypoglycemia episodes, he was treated with two boosts of glucose and afterwards with glucose IV with GIR around 7. 5 mg/kg/minute in order to maintain normal glucose values. During his hospitalization he had no acidosis shown in blood gases tests. Hypomagnesemia that was observed in the first day was normalized later, to note: normal calcium.. Bilirubin was below the treatment threshold. Kidneys On the first & second days of his life, a picture characteristic to ATN with Oliguria. Maximal creatinine value 1.13 mg /dl on 09-December-2017. Later, there was improvement in urine output and renal functions. Last renal functions before release: BUN 8, Creatinine 0.88 from 11-December-2017. Hematology Upon admission, an impression of excessive bleeding when umbilical catheters were inserted. Therefore, blood count was taken that showed thrombocytopenia and prolonged PT and low fibrinogen in coagulation functions. He was treated with two doses of FFP, Cryo dose and because of platelets < 50K - a dose of platelets. At night before he was transferred he was treated with platelets. Blood count before transfer 11-December-2017 - HCT 57, Platelets 73. Normal coagulation functions before transfer 11-December-2017 - Fibrinigen 280, INR 1.18, PTT 23.9, PT 13, D-dimer 2.11 Normal G6PD: 21.1 u/grHb, Neonatal blood type: A+,direct coombs: negative Orthopedy He was not examined by an orthopedic. Eyes He was not examined by an ophthalmologist. Infection diseases Blood culture was taken after birth and antibiotic therapy with Ampicillin and Garn1icin was initiated until receiving result of blood culture came out negative. To note: One dose of Gentamycin was high. Therefore, a dose was skipped. Surgeries He did not undergo surgeries. Summary of hospitalization Delivery on time after little monitoring during pregnancy. Delivery induction because of decrease in embryo movements and alternating decreased variability on monitor.Because of slowing down with no advancement continued, she was referred to urgent caesarian section. During the surgery the thick meconium expelled. He was born hypotonic and cyanotic, needed suction of secretions and ambient oxygen with good recovery. He was transferred to the nursery where there because of dyspnea and low basal saturations he was transferred to the neonatal intensive care unit. During his stay at the neonatal intensive care unit he presents two main problems: 1. Truncus arteriosus - on admission he was supported with 100 % oxygen in HOOD, yet arterial PO2 does not go above 60. A large boot-shape heart shadow on chest X-ray. In echocardiogram truncus arteriosus with no ductal flow (event under empiric treatment with Prostin). The left pulmonary artery joins the truncus distally. The right artery cannot be defined. With no stigmata of DiGeorge syndrome. Maintains saturation of 90% in room air. Before release he is mildly tachypneic, is being transferred when he is respiratory and hemodynamically stable. 2. Evidence of intra-uterine ischemia - in first blood count 9000 normoblasts, thrombocytopenia, coagulation disorder and hypoglycemia. He was treated with FFP, Caryo platelets until normalization of thrombocytopenia and coagulation factors and with glucose with GIR of about 7.5 mg/kg/hour to maintain glucose values.He is being transferred to the hospital for further evaluation and treatment. Examination on the day of release Alert, bright, responsive to examination, normal color, weight- 3560 grams, head circumference- 34 cm. Normal tonus, normotensive fontanelle, normal neonatal reflexes. Lungs - nom1al bilateral ventilation, heart - regular sounds, 3/6 holosystolic and diastolic murmur heard in all stations, abdomen - soft, not sensitive, not swollen, no organomegaly, femoral pulses were palpated bilaterally, Normal size and position of kidneys, intact palate, intact claviculae, normal male genitalia, mild bilateral hydrocele, testicles in scrotum, normal spread, normal red reflex to light.


VAERS ID: 807504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131903FRA010839

Write-up: multiple sclerosis; Information has been downloaded from regulatory authority (FR-SA-2019SA070153). This spontaneous report was received from a consumer via social media and refers to an adult male patient (exact age was unknown). The patient''s concurrent conditions, concomitant medications and past medical history were not provided. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) as prophylactic vaccination (dose, route of administration, lot # and expiration date were unknown). On an unknown date, after vaccination with hepatitis b vaccine (recombinant) (manufacturer unknown), the patient experienced multiple sclerosis and died. The cause of death was reported as multiple sclerosis. It was unknown whether an autopsy was performed. The reporter considered multiple sclerosis to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).; Reported Cause(s) of Death: multiple sclerosis


VAERS ID: 807853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eschar (at the sacred level treated by surgery since 2009); Suicide attempt (in 2005)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR201905

Write-up: Sclerosis multiple; This case was reported by a consumer via regulatory authority and described the occurrence of sclerosis multiple in a 22-year-old female patient who received Hepatitis B vaccine for prophylaxis. The patient''s past medical history included suicide attempt (in 2005). Concurrent medical conditions included eschar (at the sacred level treated by surgery since 2009). In 1987, the patient received Hepatitis B vaccine (unknown). In 1992, unknown after receiving Hepatitis B vaccine, the patient experienced sclerosis multiple (serious criteria death and GSK medically significant). In 2014, the outcome of the sclerosis multiple was fatal. The patient died on 30th June 2014. The reported cause of death was sclerosis multiple. It was unknown if the reporter considered the sclerosis multiple to be related to Hepatitis B vaccine. Additional details: The age at vaccination was not reported. Sclerosis multiple lasted for 22 years. Initial information was reported by a consumer and Other Health Professional via regulatory authority on 26th March 2019: Sclerosis multiple; Reported Cause(s) of Death: Sclerosis multiple


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