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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: 877715 (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 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: ESSEQIRUS202004012

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 This case was reported as a part of unpublished literature article.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, 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: 877716 (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 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: ESSEQIRUS202004013

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, 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: 877717 (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 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: ESSEQIRUS202004014

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, 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: 877718 (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 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: ESSEQIRUS202004016

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. Possible cause of the coronavirus pandemic: Immunological interference between adjuvant influenza vaccine?s POLYSORBATE 80 and SARS CoV-2. 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, 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: 877719 (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 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: ESSEQIRUS202004018

Write-up: COVID-19; This is a spontaneous 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, 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: 877720 (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 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: ESSEQIRUS202004019

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, 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: 877721 (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 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: ESSEQIRUS202004022

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 case 202003982 (the same source).This case is linked to cases 202003981, 202003982, 202004008, 202004009, 202004010, 202004011, 202004012, 202004013, 202004014, 202004015, 202004016, 202004017, 202004018, 202004019, 202004020, 202004021, 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: 877801 (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 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: ESSEQIRUS202004023

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. 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, 202004020, 202004021, 202004022, 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: 878118 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202003982

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878119 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004024

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878120 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004025

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878121 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004026

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878122 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004027

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878123 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004028

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878124 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004029

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878125 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004030

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878126 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004031

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878127 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004032

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878128 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004033

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027 202004028, 202004029, 202004030, 202004031, 202004032, 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004034

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 an inmate from a nursing home. On 08-Nov-2019, this nursing home counted 94 inmates. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027 202004028, 202004029, 202004030, 202004031, 202004032, 202004033, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878130 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004035

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878131 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004036

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878132 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004037

Write-up: COVID-19; This is spontaneous case from country initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and 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 from a nursing home. On 08-Nov-2019, this nursing home counted 94. 80 patients were vaccinated according to manual registry of Primary Care of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878133 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004038

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033, 202004034, 202004035, 202004036, 202004037, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878134 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004039

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033, 202004034, 202004035, 202004036, 202004037, 202004038, 202004040, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878135 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004040

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004041, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878136 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004041

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was an patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patient. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004042, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878137 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004042

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004043, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004043

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033, 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004044, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878139 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004044

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004045, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878140 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004045

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was a patient from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 202004021, 202004022, 202004023, 202004024, 202004025, 202004026, 202004027, 202004028, 202004029, 202004030, 202004031, 202004032, 202004033 202004034, 202004035, 202004036, 202004037, 202004038, 202004039, 202004040, 202004041, 202004042, 202004043, 202004044, 202004046 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 878141 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
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: 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: ESSEQIRUS202004046

Write-up: COVID-19; This is spontaneous case initially received from other health professional on 24-Jul-2020, concerning a patient of unspecified age and gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was from a nursing home. On 08-Nov-2019, this nursing home counted 94 patients. 80 patients were vaccinated according to registry of vaccination in the residence. The patient''s medical history and concomitant medications were not reported. On an unspecified 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 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. Overall, 24 patients who were vaccinated died of COVID-19. Per reporters, the data found let 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, 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 (the same source). Company comment: On an unspecified date, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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, a patient of unspecified age was administered INN Flu Vaccine Seasonal. 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: Died from COVID-19


VAERS ID: 880377 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2020SA218902

Write-up: GBS (Guillain-Barre syndrome); paralyzed; Initial information received on 19-Aug-2020 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional via social media. This case involves an unknown demographic patient who died due to Guillain-Barre syndrome (GBS) with symptom of paralyzed (paralysis), while received INFLUENZA VACCINE. The patient''s medical history, past medical treatment, past vaccination, family history and concomitant medication were not reported. On an unknown date of 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via an unknown route and administration site for prophylactic vaccination. On an unknown date of 2019, the patient developed a serious event Guillain-Barre syndrome (GBS) and died after four months of being completely paralyzed (paralysis) few months following the administration of INFLUENZA VACCINE Details of laboratory data was not reported. It was not reported if the patient received any corrective treatment. The outcome of the events Guillain-Barre syndrome (GBS) and paralysis was fatal. It was unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome (GBS). There will be no information available on the batch number for this case.; Sender''s Comments: This poorly documented social medial case concerns an unknown demographic patient who died due to Guillain-barre syndrome following the vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of vaccine. However, the patient''s medical history, concomitant medications, condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: GBS


VAERS ID: 880378 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-24
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: AUSA2020SA220573

Write-up: patient was fully vaccinated and still died from influenza; Initial information received on 19-Aug-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional. This case is linked to case 2020SA220469 (same reporter). This case involves a patient (unknown demographics) who was fully vaccinated with INFLUENZA VACCINE and still died from influenza (influenza). The patient''s medical history, past medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient was fully vaccinated and still died from influenza (influenza) unknown latency following the administration of INFLUENZA VACCINE. This event was leading to death. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, outcome was fatal for the event influenza. It was unknown if an autopsy was done. The cause of death was reported as Influenza. There will be no information available on the batch number for this case.; Sender''s Comments: The patient (unknown demographics) who died from influenza (influenza) unknown latency following the administration of INFLUENZA VACCINE from Unknown manufacturer. Time to onset is not reported. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.; Reported Cause(s) of Death: patient was fully vaccinated and still died from influenza


VAERS ID: 880943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2020SA224765

Write-up: the patient was killed by this vaccine; Mild case of pneumonia; developed influenza; Initial information received on 22-Aug-2020 regarding an unsolicited valid serious case from a consumer (patient'' caregiver) via social media. This case involves a male patient (unknown age) who developed mild pneumonia (pneumonia) and influenza while he received INFLUENZA VACCINE and it was reported that the patient was killed by this vaccine (death). The patient was in aged care and was very fragile. The patient did not have flu before vaccination. Other relevant medical history, past medical treatment, 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 (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, 2 weeks following vaccination, the patient developed influenza and mild pneumonia (pneumonia). Pneumonia was assessed as medically significant event and Influenza was assessed as non-serious event. It was reported that on an unknown date the patient was killed by this vaccine (death) (unknown latency) after the administration of INFLUENZA VACCINE. This event was assessed as medically significant because it led to death. It was reported that vaccine was administered without family consent. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. The patient had not recovered from pneumonia and influenza at the time of death. It was not reported if autopsy was done or not, hence cause of death was unknown. There will be no information available for the batch number for this case.; Sender''s Comments: This case involves a male patient of an unknown age who developed mild pneumonia and influenza and died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was compatible for pneumonia, influenza and unknown for event death. The patient was in aged care and was very fragile. Additional information regarding patient''s relevant medical history, health condition at time of vaccination, concomitant medication and investigations ruling out other infectious etiologies, autopsy results for cause of death is needed for complete assessment of the case.; Reported Cause(s) of Death: this vaccine killed the patient


VAERS ID: 884471 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, 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: COSA2020SA251359

Write-up: person who apply it and killed him. One more step to death; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case from a non-health care professional. This case involves a male patient (age not reported) who died after receiving INFLUENZA VACCINE, it was reported that "a person who apply it and killed him. one more step to death (Death)". Medical history, medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (brand name not reported) (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination. On an unknown date, the patient died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant as it led to death of the patient. Comment made by other user as, "I met a person who apply it and killed him. One more step to death". No laboratory data reported. It was not reported if the patient received a corrective treatment. Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported. Reported that "Drug related adverse event: yes". There will be no information available for the batch number for this case (Additional information was not obtained during immediate follow because the reporter did not provide contact information). Sender''s Comments: A case was reported, which involves a patient of unknown demographics who died after vaccination with INFLUENZA VACCINE (unknown manufacturer).Time to onset was unknown for event death. Additional information regarding patient''s relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Reported Cause(s) of Death: death nos


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