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From the 4/30/2021 release of VAERS data:

Found 1,936 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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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: 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: 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: 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: 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: 816074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: AUSA2019SA143797

Write-up: died after a flu shot; Initial information received on 22-May-2019 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via Social Media. This case involves male patient (friends father/age not reported) who died after a flu shot, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (expiry date, dose and dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient died (death NOS) following the administration of INFLUENZA VACCINE (Flu Shot). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) died after a flu shot. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as Death NOS. There will be no information available on the batch number for this case. Documents held by the sender: none.; Sender''s Comments: This is a poorly documented case extracted from Social media concerns an adult male patient who died after a Flu shot (INFLUENZA VACCINE). It was unknown if an autopsy was conducted. This case being insufficiently documented, further information on the condition/circumstances of the patient at the time of death, cause of death, medical history (especially if any congenital anomaly), results of investigations etc. will be needed for complete assessment. Without a complete clinical history, no assessment could be made; Reported Cause(s) of Death: death nos


VAERS ID: 818537 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRID BIOMEDICAL CORPORATI

Write-up: Guillain Barre syndrome; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a adult subject who received Flu vaccine for prophylaxis. On an unknown date, less than a year after receiving Flu vaccine, the subject developed guillain barre syndrome. Serious criteria included death, hospitalization and GSK medically significant. The outcome of guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome. The investigator considered that there was a reasonable possibility that the guillain barre syndrome may have been caused by Flu vaccine. Additional information was reported. This case was reported in a literature article and described the occurrence of Guillain-Barre syndrome (GBS) in a patient aged between 13 and 51 years of unspecified gender who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of study that aimed to evaluate the results of clinical and laboratory features of cases of GBS that developed following immunization. The study was a retrospective review of additional epidemiological investigations for the expert committee between 2002 and 2014. No information on patient''s medical family history or concomitant medication were provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). Age at vaccination was not provided. [In this study, all had a history of influenza vaccination with either monovalent (n=35) or trivalent (n=13)]. On an unspecified date, within 43 days after vaccination, the patient developed GBS and subsequently hospitalised. On an unspecified date, the patient died due to GBS. It was reported the outcome at discharge was death. It was unknown if autopsy was performed. This case has been considered as serious due to death and hospitalisation. Treatment was unknown. The author stated, "The present study analyzed the clinical and laboratory characteristics of 48 cases of GBS that occurred after immunization between 2002 and 2014. The present study also found that 83.3% of the total GBS cases were associated with the monovalent influenza vaccine." The author concluded "The criteria are used worldwide for the evaluation of GBS following immunization. In order to increase diagnostic accuracy when symptoms develop within 6 weeks of immunization and in the absence of alternative diagnoses to explain the symptoms and clear causative factors such as previous infection, vaccine-related GBS should be suspected. Detailed tests should be subsequently performed to aid early diagnosis. Due to the nature of NCS and CSF tests, follow-up testing need to be performed 1-2 weeks after the presentation of symptoms. The article corresponding to this case is not available for submission due to copyright restriction.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 819851 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection 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 influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 30 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 819852 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection 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 influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 60 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 819891 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. (The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection 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 influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient corresponds to table 2 in this literature article. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 90 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 823379 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: RELENZA; TAMIFLU
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2019AM

Write-up: patients died from some adverse effects of the medications; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received zanamivir (Relenza) unknown for drug use for unknown indication. Co-suspect products included oseltamivir phosphate (Tamiflu) for drug use for unknown indication and Flu unspecified (Influenza vaccine) for drug use for unknown indication. On an unknown date, the patient started Relenza at an unknown dose and frequency, Tamiflu at an unknown dose and frequency and Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Relenza and Influenza vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Relenza and Influenza vaccine. Additional Details: it is unknown if the patients died from influenza or if they died from some adverse effects of the medications. It was unknown if the reporter considered the unknown cause of death to be related to Tamiflu.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 824983 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: NZGLAXOSMITHKLINENZ2019AP

Write-up: death NOS; This case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient passed away after receiving Flu Vaccine as it had interacted with current medication (unspecified). There was no information about current medication and cause of death follow up request was raised. The reporter did not give consent to follow up.; Reported Cause(s) of Death: Death NOS


VAERS ID: 825802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Death, Influenza, Influenza B virus test positive, Influenza like illness, Septic shock, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Sepsis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2017; Test Name: Influenza B virus test; Result Unstructured Data: Test Result: Influenza B (Phuket strain) positive, Test Result Unit: unknown
CDC Split Type: AUGLAXOSMITHKLINEAU2019GS

Write-up: Vaccination failure; Influenza B (Phuket strain) infection; Influenza-like illness; Acute Respiratory Failure; Septic Shock; This case was reported in a literature article and described the occurrence of vaccination failure in a 40-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis. On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, 122 days after receiving Fluarix Tetra, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza b virus infection (serious criteria death), influenza like illness (serious criteria death), acute respiratory failure (serious criteria death and GSK medically significant) and septic shock (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure, influenza b virus infection, influenza like illness, acute respiratory failure and septic shock were fatal. The reported cause of death was influenza b virus infection, influenza like illness, acute respiratory failure, septic shock and vaccination failure. The reporter considered the vaccination failure, influenza b virus infection, influenza like illness, acute respiratory failure and septic shock to be related to Fluarix Tetra. Additional information provided as follows: This case was reported in a literature article and described the vaccination failure in a 40-year-old female patient who was vaccinated with Fluarix Tetra vaccine (GlaxoSmithKline) for prophylaxis. This case corresponds to page no. 20 (severity of outcomes) reported in this literature article. The patient was part of the Australian passive surveillance data for adverse events following immunization (AEFI) for 2017 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. The post-marketing surveillance of AEFI was particularly important to detect signals of rare, late onset or unexpected events, which are difficult to detect in pre-registration vaccine trials. No information on patient''s medical or family history or concurrent condition or concomitant condition was provided. On an unspecified date between 1st January 2000 and 31st December 2017, the patient had received Fluarix Tetra vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 1st January 2000 and 31st December 2017, 4 months after vaccination, the patient had an influenza-like illness for one week and presented to the emergency department in acute respiratory failure and septic shock. She was transferred to another hospital via ambulance but died on route. The patient tested positive for Influenza B (Phuket strain) found in the 2017, Fluarix Tetra. The patient was died on unspecified date. It was unknown if an autopsy was performed. This case has been considered as serious due vaccination failure and death. The author commented, "In summary, all deaths following immunization reported to the TGA were investigated by the TGA and where relevant, other relevant authorities, based on the information received from reporters. Two deaths were due to vaccine failure, not adverse events following immunization. Vaccine effectiveness varies by vaccine type, as well as vaccine recipient and pathogen characteristics." The author concluded, "The number of reported AEFI increased in 2017 compared with 2016 though the majority were non-serious transient events. The data reported here are consistent with an overall high level of safety for vaccines used when used according to clinical recommendations contained within the Immunization Handbook". The article corresponding to this case is not available for submission due to copyright restriction. This is 1 of the 4 valid cases reported in this literature article.; Reported Cause(s) of Death: Influenza B virus infection; Influenza like illness; Acute Respiratory Failure; Septic Shock; Vaccination failure


VAERS ID: 839595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Albumin urine present, Albuminuria, Anaemia, Beta 2 microglobulin increased, Blood immunoglobulin G increased, C-reactive protein increased, Chest X-ray abnormal, Cognitive disorder, Computerised tomogram thorax abnormal, Condition aggravated, Cough, Death, Electrophoresis protein abnormal, Haemoglobin decreased, Hypogammaglobulinaemia, Immunoglobulin therapy, Immunology test, Light chain analysis abnormal, Light chain analysis decreased, Plasma cell myeloma, Platelet count decreased, Pleural effusion, Pneumonia, Protein urine present, Proteinuria, Pyrexia, Rales, Thrombocytopenia
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cognitive disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Albumin urine; Result Unstructured Data: Test Result: 288, Test Result Unit: mg/day; Test Name: B2 microglobulin; Test Result: 2 mg/dl; Test Name: Immunoglobulin G; Test Result: 310 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Computerized tomography; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 121, Test Result Unit: mg/litre; Test Name: Serum protein electrophoresis; Result Unstructured Data: Test Result: hypogammaglobulinemia, Test Result Unit: unknown; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 9.4, Test Result Unit: g/dL; Test Name: Immunofixation; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Kappa/Lambda light chain ratio; Result Unstructured Data: Test Result: 4.95 (with absence of lambda chains in the urines), Test Result Unit: unknown; Test Name: Lambda light chain analysis; Test Result: 39 mg/dl; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Platelet count; Result Unstructured Data: Test Result: 100000, Test Result Unit: /uL; Test Name: Protein urine 24 hour; Result Unstructured Data: Test Result: 4600, Test Result Unit: mg/day
CDC Split Type: ITGLAXOSMITHKLINEIT2019GS

Write-up: Fever; Cough; Thrombocytopenia; Cognitive Worsening; bilateral pleural effusion; crackles on the left lung; Anaemia; Proteinuria; Albuminuria; micromolecular myeloma/Multiple Myeloma; Hypogammaglobulinemia; left pneumonia; This case was reported in a literature article and described the occurrence of multiple myeloma in a 87-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included cognitive disorder. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced multiple myeloma (serious criteria death and GSK medically significant), hypogammaglobulinemia (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), fever (serious criteria hospitalization), cough (serious criteria hospitalization), thrombocytopenia (serious criteria GSK medically significant), cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria. The patient was treated with antibiotics nos (Antibiotic Therapy (Drug Name Unknown)) and immunoglobulin. On an unknown date, the outcome of the multiple myeloma was fatal and the outcome of the hypogammaglobulinemia, fever, cough, thrombocytopenia, cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria were unknown and the outcome of the pneumonia was recovered/resolved. The reported cause of death was multiple myeloma. The reporter considered the multiple myeloma, hypogammaglobulinemia, pneumonia, fever, cough, thrombocytopenia, cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria to be related to Influenza vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of cognitive worsening, bilateral pleural effusion (mild), pneumonia (left); hypogammaglobulinemia and micromolecular myeloma (a rare form of multiple myeloma) in a 87-year-old female patient who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient had the current history of the cognitive. No information on patient''s past medical or family history or concomitant condition was provided. deterioration On unspecified date, the patient had received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, unknown period after vaccination, the patient with an initial cognitive worsening was admitted to department for fever and cough started. On admission the patient was feverish, physical examination evidenced a mild bilateral pleural effusion, with crackles on the left lung, without significant alterations on abdomen and heart. A chest-radiography and a successive computed tomography (CT) showed a bilateral pleural effusion and a left pneumonia. At laboratory tests, the patient had mild anaemia (hemoglobin Hb 9.4 g/dl), thrombocytopenia (Platelet count 100000/ul) and elevation of C - reactive protein (CRP), (121 mg/l). The serum proteins electrophoresis showed hypogammaglobulinemia, with Immunoglobulin G (IgG), 310 mg/dl, B2 microglobulin was increased (2 mg/dl, normal value less than 0.24) and the patient had proteinuria (4600 mg/24 h; albuminuria: 288 mg/24h). They performed the serum free light chains determination with evidence of low lambda chains level (39 mg/dl, normal value more than 90) and elevation of kappa/lambda ratio (4.95, normal value less than 2.65), with absence of lambda chains in the urines; a successive serum/urine immunofixation showed a monoclonal kappa light chain component. The patient started an empirical antibiotic therapy for pneumonia and intravenous Immunoglobulin infusion. Considering the poor expectative of life and the general conditions of the patient and they decided, according with family, not to perform a bone marrow biopsy; after pneumonia resolution the patient returned home, where the patient died a month later. It was unknown, whether the patients autopsy was performed or not. As the final diagnosis was probably "micromolecular myeloma" with secretion of k light chain only, a rare form of Multiple Myeloma. The cause of death was micromolecular myeloma. This case has been considered as serious due to hospitalization and death. The author did not comment on relationship between the events and unspecified influenza vaccine. The authors stated, "A rare case of hypogammaglobulinemia in elderly age". The author concluded "The final diagnosis was probably "micromolecular myeloma", with secretion of k light chain only, a rare form of Multiple Myeloma". Lab Comments: On an unknown date lab test were performed. physical examination evidenced a mild bilateral pleural effusion, with crackles on the left lung, without significant alterations on abdomen and heart. A chest-radiography and a successive computed tomography (CT) showed a bilateral pleural effusion and a left pneumonia. a successive serum/urine immunofixation showed a monoclonal kappa light chain component. As the final diagnosis was probably "micromolecular myeloma" with secretion of k light chain only, a rare form of Multiple Myeloma.; Reported Cause(s) of Death: micromolecular myeloma


VAERS ID: 843697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Cardiac disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality); Multiple congenital abnormalities; Neurodevelopmental disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality); Respiratory disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2019SA295057

Write-up: respiratory progressing to cardiac arrest, was unable to be resuscitated; febrile after flu vaccine; child passed away; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a physician. This case involves a eight months old male patient who experienced respiratory progressing to cardiac arrest, was unable to be resuscitated (cardio-respiratory arrest), febrile (pyrexia) and passed away, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUQUADRI JUNIOR]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing condition: severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality. 17-Oct-2019, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown, the patient experienced a serious respiratory progressing to cardiac arrest, was unable to be resuscitated (cardio-respiratory arrest) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown, the patient experienced a serious febrile after flu vaccine (pyrexia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event. On an unknown, the patient passed away due to unknown reason (death) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant and was leading to death. Other relevant tests were not reported. Final diagnosis was cardio-respiratory arrest, pyrexia and death. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown for cardio-respiratory arrest and pyrexia. The patient had passed away due to unknown reason. It was unknown if an autopsy was done. The cause of death was not reported. The reporter assessed the causal relationship with suspect vaccine as possible. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a eight months old male who presented with cardio-respiratory arrest and pyrexia one day after vaccination with FLUQUADRI JUNIOR and passed away. Patient''s medical condition includes multiple congenital abnormalities and was severely disabled with significant cardiac, respiratory and neurodevelopment problems related to a genetic abnormality. Origin of the fever was not reported nor lab tests. Autopsy results were not reported neither. Based upon the limited reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: child passed away


VAERS ID: 846254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haematemesis, Laboratory test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lactose intolerance
Preexisting Conditions: Medical History/Concurrent Conditions: Neurodermatitis
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Laboratory test; Result Unstructured Data: Test Result: Globuli against Lactose intolerance, Test Result Unit: unknown
CDC Split Type: DEGLAXOSMITHKLINEDE201920

Write-up: HCP was informed by the police that a patient that received the vaccine died.; vomit was a little amount of blood; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 45-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. On 4th November 2019, the patient received Influsplit Tetra 2019/2020. On an unknown date, less than a week after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). In November 2019, the outcome of the unknown cause of death was fatal. The patient died in November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influsplit Tetra 2019/2020. Additional case details were reported as follows: The reporter was a healthcare assistant. The age at vaccination was not reported, however the patient could be 44 or 45 years. The reporter informed that as per her knowledge, the patient did not use any other medication. The healthcare professional (HCP) was informed by the police that the patient died, not sure if it happened on 4th or 5th November 2019. The HCP was contacted for batch number. This was a potential legal case. The reporter consented to follow up and it was preferred via email. This case has been linked with case DE2019EME202247, reported by same reporter. Follow up information received form physician on 6th November 2019: The patient''s historical condition included neurodermitis. Historical drug included creams, if required and hepatitis vaccination. In 2019, globuli against lactose intolerance were detected. In November 2019, less than a week after receiving Influsplit Tetra, the patient vomited with a little amount of blood. Till the evening of 4th November 2019, the patient worked and was in contact with his girlfriend. The patient died in the night from 4th November 2019 to 5th November 2019. The patient has obviously vomited, in the vomit was a little amount of blood. It was reported that obduction would be done. The physician would provide the batch number with the adverse event from which she would fill out and send back. A colleague from the medical department would contact her as well, as the physician had also a medical question. Physician wanted a quality investigation of the vaccine and it was requested to forward the case to the Quality department. Due to the physician, there was a timely relation between the vaccination and the death of the patient. The reporter considered the unknown cause of death to be possibly related to Influsplit Tetra 2019/2020. It was unknown if the reporter considered the vomiting blood to be related to Influsplit Tetra 2019/2020.; Reported Cause(s) of Death: Death NOS


VAERS ID: 846437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Cardio-respiratory arrest, Influenza, Influenza like illness, Influenza virus test positive, Intensive care, Lung infiltration, Polymerase chain reaction positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiovascular disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESIDBIOMEDICALCORPORATION

Write-up: Suspected vaccination Failure; Influenza infection; Cardiorespiratory arrest; Flu like symptoms; pulmonary infiltrates; Acute respiratory distress syndrome; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 82-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Concurrent medical conditions included cardiovascular disease, unspecified. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization), cardiopulmonary arrest (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization), lung infiltration (serious criteria hospitalization) and acute respiratory distress syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome were unknown. The reported cause of death was vaccination failure and influenza. The reporter considered the vaccination failure, influenza, cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 82-years-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 2 reported in this literature article. The patient was the part of the prospective registry that aimed to determine the incidence, presentation, and prognosis of influenza virus infections in a cardiac intensive cardiac care unit and secondary to analyze the impact of an active surveillance program for early diagnosis. [In this study, the study was performed in a university hospital with 1,550 beds serving a population of 715,000 inhabitants. The study comprises two different influenza seasons (2014 and 2015), with two differentiated phases. During the first period (baseline), influenza diagnosis was made in accordance with the attending physician''s indication, who requested tests based on clinical suspicion, and no systematic screening was performed (from November 2013 to January 2014). During the second phase (intervention), systematic influenza infection screening was performed in all patients admitted on Monday to Friday. This phase included the last weeks of the first influenza season (February 2014) and the second season period (from January to March 2015)]. The patient had the pre-existing cardiovascular disease. No information on patient family history and concomitant medications. On unspecified date, the patient had received unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between November 2013 and March 2015), unknown period after vaccination, the patient was admitted to the cardiac ICU due to the cause of cardiorespiratory arrest. Before hospital admission (i.e previous 7 days) and at the time of admission, the patient had flu like symptoms and has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction (RT-PCR). Also the patient was diagnosed with the pulmonary infiltrates and acute respiratory distress syndrome (ARDS). On an unspecified date, the patient died. It was unknown, whether the autopsy was performed or not. The cause of death was influenza infection.[In this study, during the study period (baseline phase from November 2013 to January 2014 and intervention phase in February 2014 and from January to March 2015), 227 patients were admitted to the cardiac ICU, and 17 were diagnosed with influenza infection. Influenza A predominated in 2014 (10 patients) and influenza B in 2015 (5 patients). During the non-screening period (Baseline phase), only 6 patients out of 90 were diagnosed with influenza infection. In contrast, during the screening phase (intervention phase), 4 patients out of 34 were diagnosed in the 2014 season and 7 patients out of 102 in 2015. The presence of flu-like symptoms throughout the admission was common in infected patients, specially fever, headache, and dyspnea. Out of 17 influenza infection, the patient had the flu like symptoms such as fever (8), cough (7), runny nose (5), headache (4), myalgias (2), dyspnea (8) and respiratory failure (7). However, 3 patients who were admitted to the coronary unit for presenting a cardiac arrest, who also were diagnosed with influenza infection, did not suffer any clear-cut influenza symptom. Patients were tested for influenza A or B. Nasopharyngeal swabs were obtained for microbiological diagnosis, but lower respiratory tract samples were also accepted if clinically indicated. A reverse transcriptase polymerase chain reaction (RT-PCR) was used. Influenza A H1N1 and influenza B were detected with real-time RTPCR (RT-PCR Flu A/B Typing Real-time Detection Anyplex)]. This case has been considered as suspected vaccination failure as time to onset was unknown. This case has been considered as serious due to suspected vaccination failure; hospitalization and death. Treatment was unknown. [In this study, improved survival in severe cases was related to early antiviral administration. Out of 17 infected patients, 6 were on mechanical ventilation, 4 patients during no screening phase, and 2 patients during systematic screening. 8 were on Inotropes/vasopressors, 2 were on renal replacement therapy, 1 patient during no screening phase, 1 patient during systematic screening and 5 were on Antimicrobials prescribed at admission) The outcome of other events cardiorespiratory arrest pulmonary infiltrates and acute respiratory distress syndrome (ARDS) were not reported. [In this study, 3 had the death during hospitalization and 2 patients during no screening phase, 1 patient during systematic screening]. The author commented, "In our study, the majority of patients infected with influenza virus did not present an ischemic event, and heart failure was the most common diagnosis of admission. The viral infection could have acted as a trigger for heart failure decompensation in these patients. In fact, patients with influenza infection suffered respiratory distress and extra-hospital cardiac arrest more frequently. It is remarkable that in our study influenza-infected patients were sicker, requiring more often advanced therapies such as respiratory, renal, or inotropic support and had a higher mortality rate, especially those admitted for a cardiac arrest. Previous studies stated that acute respiratory distress syndrome secondary to influenza-related viral pneumonia is the leading cause of mortality. We found a higher mortality among influenza-infected patients and a higher rate of respiratory complications. However, as we have stated, cardiac arrest was the primary reason of admission in deceased patients in this registry. Nevertheless, our study shows that susceptible patients admitted to a cardiac ICU still have a very low rate of influenza vaccination. This proportion is markedly low, taking into account that most of the patients admitted to our unit had factors that increased the risk of complications. Vaccination was not associated with a reduced mortality risk in our study." The author concluded, "Influenza infection is associated with increased morbidity and mortality in patients admitted to the cardiac ICU. Fever and respiratory failure are the hallmark symptoms. During the flu season, a multidisciplinary systematic surveillance program improves the early detection and management of influenza in a cardiac ICU." This is 1 of the 10 valid cases reported in this literature article. Lab Comments: On an unspecified date between November 2013 and March 2015, the patient has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction.; Reported Cause(s) of Death: Suspected Vaccination Failure; Influenza Infection


VAERS ID: 847920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, H1N1 influenza, Headache, Influenza A virus test, Influenza like illness, Influenza virus test, Pyrexia, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: influenza virus A (H1NI), Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; influenza A (H1NI) infection; Influenza-like symptoms; Fever; Cough; Headache; This case was reported in a literature article and described the occurrence of vaccination failure in a 1-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 57 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), influenza-like symptoms, fever, cough and headache. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the influenza-like symptoms, fever, cough and headache were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, influenza-like symptoms, fever, cough and headache to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 01-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 1 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called (System) and was the part of the National System. The main objective of system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 57 days after vaccination, the patient do not had an sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. The patient meets the operational definition of TSI [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the agency, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by National network of the agency. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 18 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since agency captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: influenza virus A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; Influenza virus A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 2-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 93 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), influenza-like symptoms, fever, cough, headache, acute respiratory tract infection (serious criteria GSK medically significant) and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the influenza-like symptoms, fever, cough, headache, acute respiratory tract infection and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, influenza-like symptoms, fever, cough, headache, acute respiratory tract infection and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in 2-years-old male patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality.[In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was the part of the National Epidemiological Surveillance System. The main objective of the surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [[The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, 93 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the National Network of Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was unknown. The patient died after 3 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847922 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. The subject was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the vaccination failure in an patient of unspecified age and gender who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was the part of the National Epidemiological Surveillance System. The main objective of the surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza. [In this study, the patient. 5 comorbidities of Mellitus diabetes (21), Arterial hypertension (21), Morbid obesity (15), Chronic renal failure (12), Smoking, Immunosuppression (21), COPD (7), Heart disease (7), Asthma (2), Other comorbidity (7), And HIV AIDS (2)]. No information on patient''s medical or family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had an onset of fever greater than or equal to 38 degree celcius and cough. The patient met the one of the operational definition of TSI/ETI or IRAG. [In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the National Network of Public Health Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death is subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five. [In this study, only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. [In this study, In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. On unspecified date, 13 days after the onset of the symptoms, the patient had received antiviral medication. On unspecified date, 17 days after, the onset of the symptoms, the patient died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since in 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 847923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, H1N1 influenza, Headache, Influenza A virus test positive, Influenza like illness, Pyrexia, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (HINI) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H1NI) infection; Influenza-like symptoms; Fever; Cough; Headache; This case was reported in a literature article and described the occurrence of vaccination failure in a 38-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 50 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), influenza-like symptoms, fever, cough and headache. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the influenza-like symptoms, fever, cough and headache were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, influenza-like symptoms, fever, cough and headache to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 38-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called surveillance system and was the part of the National Epidemiological Surveillance System. The main objective of surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 50 days after vaccination, the patient do not had an sudden onset of influenza like symptoms (TSI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. The patient meets the operational definition of TSI [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by Public Health Laboratories. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died unknown period after symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, H1N1 influenza, Influenza A virus test positive, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (HINI) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; influenza A (H1NI) PMD infection; Severe acute respiratory infection; Fever; Cough; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 46-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 66 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), fever, cough and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the acute respiratory tract infection, fever, cough and difficulty breathing were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, acute respiratory tract infection, fever, cough and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 46-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 4 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In country, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called Surveillance System and was the part of the Surveillance System. The main objective of Surveillance System was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) in country and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 66 days after vaccination, the patient do not had an sudden onset of IRAG such as person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient meets the operational definition of IRAG [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by Health Laboratories. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died 2.3 days after symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since Surveillance System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the country population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 51 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), influenza-like symptoms, fever, cough, headache and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in 82-years-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system and was the part of the National Epidemiological Surveillance System. The main objective of surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 51 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient also experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 10 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program. This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 86-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 44 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), influenza-like symptoms, fever, cough, headache and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 86-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 6 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called (System) and was the part of the National System. The main objective of system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 44 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient also experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 4 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program.?? This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847927 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXIDBIOMEDICALCORPORATION

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an patient unspecified age and gender who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to comorbidities section reported in this literature article. The patient was a part of descriptive cross-sectional study that that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality.[In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called Epidemiological Surveillance System and was the part of the Epidemiological Surveillance System. The main objective of System was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza. [In this study, the patient had an ]. The patient had an 5 comorbidities of Mellitus diabetes (21), Arterial hypertension (21), Morbid obesity (15), Chronic renal failure (12),Smoking, Immunosuppression (21), COPD (7), Heart disease (7), Asthma (2), Other comorbidity (7), And HIV AIDS (2)]. The patient had 5 comorbidities which were unspecified. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had an onset of fever greater than or equal to 38 degree celcius and cough. The patient met the one of the operational definition of TSI/ETI or IRAG. [In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Network Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death is subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five.]. On an unspecified date, the patient died. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by network Laboratories. The patient was diagnosed with the influenza infection. On an unspecified date, the patient died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. [In this study, In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. The patient died on an unknown date. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza (type and subtype unknown). It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. [In this study, Only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. The authors commented "Since System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Epidemiological Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 847928 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXIDBIOMEDICALCORPORATION

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details provided as follows: On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had fever greater than or equal to 38 degree celcius and cough. The patient was diagnosed with influenza (type unknown). The patient met the one of the operational definition of TSI/ETI or IRAG.[In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death : a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Network Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five]. On an unspecified date, the patient died. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by network Laboratories. The patient was diagnosed with the influenza infection. In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. On an unspecified date, the patient was died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as suspected vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. [In this study, only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. The authors commented "Since System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 848433 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2019SA319392

Write-up: influenza; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a physician and non-healthcare professional. This case involves a patient of unknown demographics who experienced influenza (influenza), while he/she received vaccine INFLUENZA VACCINE. The patient''s past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. In 2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious influenza (influenza) Unknown latency following the administration of INFLUENZA VACCINE. This event was leading to death. Date of death was not reported. No lab test was reported. Final diagnosis was (fatal) influenza. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Influenza. The information on the batch number was requested.; Sender''s Comments: This poorly documented case concerns a patient of unknown demographics who died on an unknown latency due to Influenza after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. No cause of death has been reported. 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: influenza


VAERS ID: 849005 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: FRSA2019SA323689

Write-up: patients died; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a pharmacist. This case involves 3 patients who died, after they received vaccine INFLUENZA VACCINE. The patients past medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site. On an unknown date, the patients died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Lab data was not reported. The patient outcome was reported as Fatal. It was unknown if an autopsy was done. The cause of death was not reported. Information on batch number is requested.; Sender''s Comments: This case concerns 3 patients who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). More details regarding time of death, health status at the time of vaccination, patient''s past medical history, detailed autopsy report, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, no conclusion can be drawn.; Reported Cause(s) of Death: death NOS


VAERS ID: 849685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, Pneumonia
SMQs:, 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: 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: SESA2019SA326003

Write-up: pneumonia; a terrible cold; Initial information received on 21-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves a male patient who experienced pneumonia (pneumonia) and terrible cold (nasopharyngitis), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No previous disease. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a horrible cold (nasopharyngitis) and pneumonia (pneumonia), unknown latency following the vaccination of INFLUENZA VACCINE. Both the events were leading to death. Pneumonia (pneumonia) was also assessed as medically significant. Other relevant tests were not reported. Final diagnosis was (fatal) pneumonia and (fatal) cold. It was not reported if the patient received a corrective treatment. The outcome of the events was fatal. It was not reported if an autopsy was done. The cause of death was reported as Nasopharyngitis and Pneumonia. There will be no information available on the batch number for this case.; Sender''s Comments: This case involves a male patient who experienced (fatal) pneumonia and (fatal) cold after few days vaccination and passed away. Time to onset is compatible with the role of vaccine. 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: pneumonia; a terrible cold


VAERS ID: 850127 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: CASA2019SA327759

Write-up: patient had adverse reaction and died; Initial information received on 25-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp via social media. This case is linked to case 2019SA327755 (same reporter). This case involves patient of an unknown demographics who died (death) due to unknown reason, while patient received INFLUENZA VACCINE. Medical history, medical treatment, vaccination 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 not reported via unknown route in unknown administration site. On an unknown date, the patient died (death), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The reporter stated that this was the consequences of getting flu shot. Other relevant tests were not reported. Final diagnosis was death NOS. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This case concerns a patient of an unknown demographics who had unknown adverse reaction and died after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient''s past medical history, condition at the time of vaccination, concomitant medications, lab data 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: 851585 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA340093

Write-up: death NOS; Initial information received on 05-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp via a web newspaper. This case involves a 31 years old male patient who died because of unspecified reason (Death), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient died because of unspecified reason (not otherwise specified) (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was reported that the patient entered to emergency room and indicated that on Sunday morning (01-Dec-2019) he was vaccinated in his job and it could be an adverse event which altered his health, and in the end it caused him the death. Other relevant tests were not reported. Final diagnosis was (fatal) death NOS. It was not reported if the patient received a corrective treatment. The patient died on an unknown date and cause of death was not reported. It was unknown whether the autopsy was performed or not. There will be no information available on the batch number for this case.; Sender''s Comments: This is a poorly documented case received from a social media (web newspaper) involves a 31 years old male patient who died due to an unspecified reason after receiving INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. In addition, there is no information regarding patient''s past medical history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS


VAERS ID: 852037 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: Asthmatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FISA2019SA339854

Write-up: My asthmatic friend was murdered with this shot (influenza vaccine) last winter; Initial information received through Company site (social media) on 04-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. The outsourced vendor responsible for social media monitoring noticed the case on 04-Dec-2019 and it was forwarded to PV unit the same day/04-Dec-2019. This case involves an adult patient (below 60 years old) who died (cause was not specified), while he/she received vaccine INFLUENZA VACCINE. The patient''s concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. Reporter stated that the patient was perfectly healthy. At the time of the event, the patient had ongoing Asthma. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died (death) (cause was not specified) Unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The reporter stated that my asthmatic friend was murdered with this shot [ influenza vaccine] last winter. Date of death was not reported. No lab test was reported. Final diagnosis was (fatal) death (cause was not specified. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date. It is unknown if an autopsy was done. The cause of death was not reported (conservatively considered as Death NOS). There will be no information available on the batch number.; Sender''s Comments: This poorly documented case received from Company site (social media) which concerns an adult patient (below 60 years old) who died due to unspecified cause after vaccination with INFLUENZA VACCINE 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 any lab tests performed if any are not available. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: My asthmatic friend was murdered with this shot (influenza vaccine) last winter


VAERS ID: 852042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza A virus test positive, Influenza like illness
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA341911

Write-up: Influenza A H1N1 PMD; influenza-like illness; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case was linked to cases 2019SA341932, 2019SA341944, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Article Summary: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 01 years old female patient who developed Influenza A H1N1 PMD (Influenza A virus test positive) while she received vaccine INFLUENZA VACCINE. The patient medical history, concomitant therapy and family history were not provided. Patient had a history of vaccination (brand name not specified). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious Influenza A H1N1 PMD (Influenza A virus test positive), influenza-like illness (Influenza like illness/ILI) 57 days following the administration of INFLUENZA VACCINE. These events were leading to death. The onset of symptoms to death was 18 days. Date of death was not reported. Deceased patient who has met the operational definition of ILI/SARI with a positive result for influenza was issued by one of the laboratories. Final diagnosis was (fatal) Influenza A virus test positive. It was reported that the patient received an unspecified antiviral corrective treatment. It was unknown if an autopsy was done. The cause of death was conservatively considered as Influenza A virus test positive and Influenza like illness. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 01 year old female patient who died post developing Influenza A H1N1 (Influenza A virus subtype H1N1 test positive) with symptom Influenza like illness, 57 days after the vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The onset of symptoms to death was 18 days. The time to onset was compatible with a potential vaccination failure. Positive result for influenza was issued by laboratory examination. The patient''s medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the available information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: influenza-like illness; Influenza A H1N1 PMD


VAERS ID: 852043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H3N2 influenza, Influenza, Influenza like illness, Respiratory tract infection
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA341932

Write-up: Influenza A H3; influenza-like illness; severe acute respiratory infection; Influenza A H3; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case was linked to cases 2019SA341911, 2019SA341944, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Article Summary: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 02 years old male patient who developed A H3 (H3N2 influenza) while she received vaccine INFLUENZA VACCINE. The patient medical history, concomitant therapy and family history were not provided. Patient had a history of vaccination (brand name not specified). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious A H3 (H3N2 influenza) (Influenza A virus infection), influenza-like illness (Influenza like illness/ILI), severe acute respiratory infection/SARI (Respiratory tract infection) 93 days following the administration of INFLUENZA VACCINE. These events were leading to death.The onset of symptoms to death was 3 days. Date of death was not reported. Deceased patient who has met the operational definition of ILI/SARI with a positive result for influenza was issued by one of the laboratories. Final diagnosis was (fatal) influenza. It was reported that the patient received an unspecified antiviral corrective treatment. It was unknown if an autopsy was done. The cause of death was conservatively considered as H3N2 influenza, Influenza A virus infection, Influenza like illness/ILI, severe acute respiratory infection/SARI. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 02 years old male patient who died post developing H3N2 influenza, Influenza like illness, severe acute respiratory infection 93 days after the vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The onset of symptoms to death was 3 days. The time to onset was compatible with a potential vaccination failure. Positive result for influenza was issued by laboratory examination. The patient''s medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the available information, the role of the vaccine cannot be ruled out.; Reported Cause(s) of Death: A H3; influenza-like illness; severe acute respiratory infection; Influenza A H3


VAERS ID: 852044 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza, Influenza A virus test positive, Influenza like illness
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:
Allergies:
Diagnostic Lab Data: Test Name: A h1n1; Result Unstructured Data: positive
CDC Split Type: MXSA2019SA341944

Write-up: A H1N1 PMD; Influenza like illness; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case is linked to cases 2019SA341911, 2019SA341932, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 38 years old female patient who developed A H1N1 PMD (influenza) and influenza like illness (influenza like illness), while she received vaccine INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious A H1N1 PMD (influenza) and influenza like illness 50 days following the administration of INFLUENZA VACCINE. These events were leading to death. Relevant laboratory test results included: H1N1 influenza - On an unknown date: positive. Final diagnosis was (fatal) influenza. It was not reported if the patient received a corrective treatment. The patient died because of influenza. It is unknown if an autopsy was done. The cause of death was reported as influenza like illness and influenza. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 38 years old female patient who died due to the influenza (A H1N1 PMD virus infection) 50 days after the vaccination with INFLUENZA VACCINE. The time to onset was compatible with a potential vaccination failure. The patient''s past medical history, concomitant medications and lab data ruling out other etiologies 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: Influenza like illness; Influenza A virus infection


VAERS ID: 852045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza A virus test positive, Respiratory tract infection
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:
Allergies:
Diagnostic Lab Data: Test Name: A H1N1; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341964

Write-up: influenza A H1N1; severe acute respiratory infection; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case is linked to case 2019SA341944, 2019SA341977, 2019SA341932 (same reporter). The following is verbatim from the article: Introduction: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential.1,2 Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations.New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious The efficacy and effectiveness of the influenza vaccine depends on multiple factors such as age, immunocompetence, the degree of similarity between the viruses contained in the vaccine and the circulating viruses, among others.After vaccination, the levels of viral hemagglutinin proteins and neuraminidase slowly decrease; the reduction can exceed 50% after 600 days.3,5 In adults over 60 years of age, seroprotection after vaccination against influenza type A has been reported; this has been greater than four months in components H3N2 and H1N1.6 A study concluded that people with a history of vaccination greater than 200 days have a higher risk of contracting the disease than those who have done so a few days prior.7 The range of effectiveness in 2011-2012 for influenza A (H3N2) was estimated at 53% in people vaccinated less than three months prior and 12% in those vaccinated three or more months prior. This case involves a 46 year old female patient who was diagnosed with influenza A H1N1 (H1N1 influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, vaccination 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 not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious influenza A H1N1 (H1N1 influenza) and severe acute respiratory infection (respiratory tract infection) 66 days following the administration of INFLUENZA VACCINE. This event were assessed as medically significant and were leading to death (23 days after onset of symptoms to death). Other relevant tests included Influenza A virus test positive. Final diagnosis was (fatal) H1N1 influenza. It was not reported if the patient received a corrective treatment. On an unknown date, the event outcome was reported as fatal for influenza. It is unknown if an autopsy was done. The cause of death was reported as H1N1 influenza. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 46 years old female patient who died due to the influenza (AH1N1 virus infection) 66 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible. The patient''s past medical history, concomitant medications, concomitant diseases, and lab data ruling out other etiologies or confirming the diagnosis as well as cause of death 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: influenza H1N1; Respiratory tract infection


VAERS ID: 852046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Influenza A virus test positive, Influenza like illness, Respiratory tract infection
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:
Allergies:
Diagnostic Lab Data: Test Name: Influenza A virus infection; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341972

Write-up: A H3; severe acute respiratory infection; Influenza like illness; potential vaccination failure; Initial unsolicited valid serious case report received from the literature on 03-Dec-2019. This case is linked to cases 2019SA341944, 2019SA341932, 2019SA341964 and 2019SA341977 (same literature). The following is verbatim from the article: Introduction: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential.1,2 Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations.New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious The efficacy and effectiveness of the influenza vaccine depends on multiple factors such as age, immunocompetence, the degree of similarity between the viruses contained in the vaccine and the circulating viruses, among others (Table 1).After vaccination, the levels of viral hemagglutinin proteins and neuraminidase slowly decrease; the reduction can exceed 50% after 600 days.3,5 In adults over 60 years of age, seroprotection after vaccination against influenza type A has been reported; this has been greater than four months in components H3N2 and H1N1.6 A study concluded that people with a history of vaccination greater than 200 days have a higher risk of contracting the disease than those who have done so a few days prior.7 In the country, the range of effectiveness in 2011-2012 for influenza A (H3N2) was estimated at 53% in people vaccinated less than three months prior and 12% in those vaccinated three or more months prior. This case involves an 82 years old female patient who experienced A H3 (Influenza), while she received vaccine INFLUENZA VACCINE. Medical history, past medical treatment, past vaccination 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 and other dosing details were not reported). On an unknown date, the patient developed A H3 (Influenza) with severe acute respiratory infection (respiratory tract infection) and influenza like illness (influenza like illness), 51 days following the administration of INFLUENZA VACCINE. The event influenza was assessed as medically significant and these events were leading to death. It was reported that, the patient died 10 days after the onset of events. It was also a case of potential vaccination failure Relevant laboratory test results included: On an unknown date, influenza was positive. Final diagnosis was (fatal) influenza. It was not reported if the patient received any corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Influenza.; Sender''s Comments: This case concerns a 82 years old female patient who died due to influenza (AH3 virus infection) 51 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible with a potential vaccination failure. However, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: A H3; Influenza like illness; severe acute respiratory infection; potential vaccination failure


VAERS ID: 852047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H3N2 influenza, Influenza A virus test positive, Influenza like illness, Respiratory tract infection
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:
Allergies:
Diagnostic Lab Data: Test Name: A H3; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341977

Write-up: AH3; severe acute respiratory infection; influenza-like illness; potential vaccination failure; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 86 years old female patient who was diagnosed with AH3 (influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) and potential vaccination failure (vaccination failure) while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious AH3 (influenza), severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) 44 days following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and were leading to death (4 days after onset of symptoms to death). It was also a case of potential vaccination failure. Relevant laboratory test results included: On an unknown date the Influenza A virus test: Positive. Final diagnosis was influenza (fatal) Patient also recieved antiviral. On an unknown date, the event outcome was reported as fatal for influenza. It was unknown if an autopsy was done. The cause of death was conservatively captured as AH3 (influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) and potential vaccination failure (vaccination failure) as exact cause of death was not reported. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 86 years old female patient who died due to the influenza (AH3 virus infection) 44 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible. The patient''s past medical history, concomitant medications, cause of death, concomitant diseases and lab data confirming the diagnosis and relevant tests ruling out other etiologies 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: A H3; Influenza like illness; severe acute respiratory infection; potential vaccination failure


VAERS ID: 852529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: PLGLAXOSMITHKLINEPL2019EM

Write-up: death; This case was reported by a consumer via interactive digital media and described the occurrence of death in an upspecified number of patient''s who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, several months after receiving Influenza vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Influenza vaccine. Additonal details were provided as follows: The age at vaccination was not provided. Older patients were vaccinated against flu vaccine and each one of them died several months after the vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 852626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Pneumonia
SMQs:, 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: 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: Blood test
CDC Split Type: DKPFIZER INC2019536399

Write-up: Afterwards, the mother died from pneumonia; Afterwards, the mother died from pneumonia; This is a spontaneous report from a contactable nurse (daughter of the patient) via Medical Information. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) (batch number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient''s medical history and concomitant medications were not reported. It was reported that afterwards, the mother (patient) died from pneumonia on an unspecified date. The patient underwent lab test included blood tests on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the batch 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. Further information like confirmative pathological/serotype results and vaccination schedule 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: The mother died from pneumonia; The mother died from pneumonia


VAERS ID: 854693 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Influenza A virus test positive, Intensive care, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: type A influenza infection, Test Result Unit: unknown
CDC Split Type: CLGLAXOSMITHKLINECL2019GS

Write-up: Suspected vaccination failure; Influenza A virus infection; Death NOS; This case was reported in a literature article and described the occurrence of death nos in a elderly patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), vaccination failure (serious criteria hospitalization and GSK medically significant) and influenza a virus infection (serious criteria hospitalization). On an unknown date, the outcome of the death nos was fatal and the outcome of the vaccination failure and influenza a virus infection were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos, vaccination failure and influenza a virus infection to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of death NOS in a patient aged between 4 months and 93 years of unspecified gender, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The primary objective of this project was to characterize the clinical, epidemiological and microbiological aspects of patients with health care associated infections (IAAS) by influenza hospitalized in critical patient units (UPC: ICU and Intermediate Care-CI) and Special Care (EC). Secondary objectives assessed compliance with precautions in addition to standard precautions (PAPE) and adherence to influenza vaccination. It was included the patient was hospitalized in CCU and special care with hospital acquired influenza during 2014-2017. [Healthcare-associated infections due to influenza was defined as: symptom onset and/or positive influenza polymerase chain reaction (PCR) after more than 48 hours of hospital admission, without previous respiratory symptoms or previous negative influenza test study. (19/22) of patients had some co-morbidity being the most common high blood pressure (HTA) (13/22). (4/22) of patients were immunocompromised, including patients receiving TOS, TPH, corticosteroid user and newly diagnosed HIV patients]. The patient had at least two co-morbidities. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 2014 and 2017, an unknown period after the vaccination, the patient had symptoms of influenza. The patient had positive influenza by confirmed with polymerase chain reaction (PCR) after more than 48 hours of hospital admission. The patient had type A influenza infection. [In the institution RT-PCR is used as a technique of choice in hospitalized patients due to their high sensitivity and specificity, 95% for both viruses. IAAS cases were identified from positive RT-PCR records for influenza viruses processed in the laboratory. The infection was acquired between days 3 and 126 of hospitalization. Four patients died. All of the deceased had type A infection and were older patients, over 80 years of age, with the exception of a pediatric patient who was a recipient of hyperparathyroidism (HPT). All had at least two co-morbidities, half were immunocompromised, 75% were hospitalized in ICU and 50% with VM]. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date, the patient was died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death, hospitalization, suspected vaccination failure. Treatment was unknown. The author did not comment on the relationship between the event of influenza A infection, death NOS and unspecified influenza vaccine. The author stated, "Before the diagnosis of a patient hospitalized with influenza, the medical conduct is to evaluate the use of antiviral and the appearance of possible complications. With regard to the IAAS handling, it is fundamental to emphasize the adhesion to the recommendations of control of infections, wash of hands and use of PAPE. The vaccination is one of the preventive resources, available and without cost used in programmatic form to protect, between others, the persons older than 65 years and to those with factors of risk of complicated or serious evolution. The effectiveness of the vaccination in these years is not available; nevertheless, do numbers found in the Centers for Disease Control and Prevention (CDC) range between 20 and 48 % from the year 2014 to 2017." The author concluded, "HAI due to influenza occurred in chronic, older and unvaccinated patients. Education about HAIs and continuous high vaccination coverage must be reinforced. IAAS for influenza happened in chronic patients, of major age, which entered for the most part for cause not respiratory and not vaccinated. It is essential in the IAAS prevention for respiratory viruses, the education to the health personnel and the relatives, who can be the source of contagion of these patients, especially in the period peak of the seasonal influenza. As another prop of the prevention, it is necessary to insist on maintaining a high vaccination cover in these patients." This article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 2 valid cases reported in the same literature article. Lab Comments: On an unspecified date, between 2014 and 2017, lab test was done.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 857656 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2020EM

Write-up: Suspected Vaccination failure; influenza - vaccination failure; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 80-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra unspecified season) for prophylaxis. On an unknown date, the patient received Influsplit Tetra unspecified season at an unknown dose. On an unknown date, unknown after receiving Influsplit Tetra unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influsplit Tetra unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient died in the nursing home due to proven influenza. This is 1 of the 4 cases reported by the same reporter. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation at the time of reporting were unknown.; Reported Cause(s) of Death: Influenza


VAERS ID: 861165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Heart transplant (20 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2020SA032045

Write-up: received a flu vaccination (vaccine unknown) and died from it; Initial information was received on 04-Feb-2020 regarding an unsolicited valid serious case from a pharmacist. This case involves female patient of an unknown age who died (death), while she received INFLUENZA VACCINE. Medical historyincluded heart transplant 20 years ago. Medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing rheumatic disorder. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Laboratory data was not provided. Final diagnosis was (fatal) death. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. It was reported that patient received a flu vaccination (vaccine unknown) and died from it. Information on the lot number was requested.; Sender''s Comments: This case concerns a female patient of an unknown age who died after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Medical history included heart transplant 20 years ago. At the time of the event, the patient had ongoing rheumatic disorder. 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 vaccine cannot be assessed.


VAERS ID: 867124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRID BIOMEDICAL CORPORATI

Write-up: reactions to the flu vaccine; reactions to the flu vaccine and was hospitalized and died; This case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and adverse event (serious criteria hospitalization). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the adverse event was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and adverse event to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter informed about the death of a company colleague. The patient received flu vaccine through the company flu vaccination campaign and had reactions to the flu vaccine. The patient was then hospitalized and died. The reporter informed that she did not have any other information about this case and she was not close to the family of patient. Follow up not possible. No other information was provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 877526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASEQIRUS202003984

Write-up: Died from the side effects of the shot; This case is an initial is report, reported by other non-health professional (consumer) via patient oriented program on 29-Jun-2020, concerning a male patient of unknown age. The patient''s medical history and concomitant medications were not provided. On an unknown date, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. On an unknown date, an unknown amount of time after vaccination, the patient developed side effects of the shot. On an unknown date, the patient died from the side effects of the shot. It was unknown if autopsy was performed. The event of ?vaccination adverse reaction'' was considered serious due to criterion of death. The reporter assessed the event of ?vaccination adverse reaction'' as related to INN Flu Vaccine Seasonal. Company comment: A male patient of unknown age, developed vaccination complication an unknown amount of time after receiving INN Flu Vaccine Seasonal. Reportedly, the patient died from the side effects of the shot. It was unknown if autopsy was performed. Chronology needs more clarification. More information regarding event, autopsy results, medical history and concomitant medications is needed. Due to lack of information, causal role of the suspect vaccine is unassessable.; Reporter''s Comments: The reporter stated that her husband had died from the side effects of the shot.; Sender''s Comments: A male patient of unknown age, developed vaccination complication an unknown amount of time after receiving INN Flu Vaccine Seasonal. Reportedly, the patient died from the side effects of the shot. It was unknown if autopsy was performed. Chronology needs more clarification. More information regarding event, autopsy results, medical history and concomitant medications is needed. Due to lack of information, causal role of the suspect vaccine is unassessable.; Reported Cause(s) of Death: Died from the side effects of the shot


VAERS ID: 877538 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003981

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877539 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004008

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045 and 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877540 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004009

Write-up: COVID-19; This is a spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from Agency and Agency point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital, and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045 and 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877541 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004011

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045 and 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877542 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004015

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital, and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, and 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877543 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004017

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital, and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877544 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004020

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital, and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877545 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004021

Write-up: COVID-19; This is a spontaneous case received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from The Regulatory Agency point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital, and the history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


VAERS ID: 877714 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202004010

Write-up: COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. This case was reported as a part of unpublished literature article. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of 17 patients who had the administration of the vaccine and its lot registered by primary care. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, mf59; dose, route of administration, anatomical location, batch number and expiry date; not reported] for an unknown indication. On an unknown date, an unspecified amount of time after vaccination, the patient developed COVID-19 infection. On an unknown date, the patient died of COVID-19 infection. It was not reported whether autopsy was performed. Per reporters, based on an epidemiological analysis of COVID-19 deaths in the Health Sector attended by the Hospital and the study of the pharmacotherapeutic history of affected patients, it was found that the most common drug to all the deceased was Chiromas. This led to the hypothesis that the influenza vaccination of the 2019-2020 campaign could be associated with an increased risk of deaths by COVID-19 in people over 65 years of age. The reporters proposed a hypothetical mechanism for possible immunological interference, which required the concurrence of 3 elements: previous exposure of the subject to the administration of POLYSORBATE 80 parenterally, either through the adjuvant vaccine or other parenteral drugs that contain it, non-optimal subject''s immune status: advanced age, concomitant autoimmune pathologies, immunosuppressive treatments and subsequent transmission with a strain of the SARS-CoV-2 coronavirus. Possible interference between acquired immunity against POLYSORBATE 80 and coronavirus infection would occur at the time of viral replication within infected cells, and in subjects with a non-100% efficient immune status. The event of COVID-19 was assessed as serious due to the criterion of medical significance and fatal outcome, per company. The reporters did not provide causality assessment for the event of ''COVID-19''. This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045 and 202004046 (the same source). Company comment: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Sender''s Comments: On an unspecified date, an elderly patient was administered Chiromas (TIV). An unknown amount of time after vaccination, the patient developed COVID-19 infection. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. This case was reported as a part of unpublished paper, which speculates that immunological interference between adjuvant influenza vaccine?s excipient POLYSORBATE 80 and SARS-CoV-2 led to an increased risk of deaths by COVID-19 in people over 65 years of age. There is no scientific evidence present in the paper to support this conclusion.; Reported Cause(s) of Death: COVID-19 death


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