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This is VAERS ID 806644

History of Changes from the VAERS Wayback Machine

First Appeared on 7/14/2019

VAERS ID: 806644
VAERS Form:2
Age:78.0
Sex:Female
Location:Foreign
Vaccinated:2018-12-10
Onset:2019-02-26
Submitted:0000-00-00
Entered:2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, Interstitial lung disease, Pneumonia, Vaccination failure, Sopor, Influenza A virus test positive, Polymerase chain reaction positive, H3N2 influenza

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-03-08
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC 'Split Type': ITSEQIRUS201902655

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


Changed on 12/24/2020

VAERS ID: 806644 Before After
VAERS Form:2
Age:78.0
Sex:Female
Location:Foreign
Vaccinated:2018-12-10
Onset:2019-02-26
Submitted:0000-00-00
Entered:2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, Interstitial lung disease, Pneumonia, Vaccination failure, Sopor, Influenza A virus test positive, Polymerase chain reaction positive, H3N2 influenza

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-03-08
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC 'Split Type': ITSEQIRUS201902655

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


Changed on 12/30/2020

VAERS ID: 806644 Before After
VAERS Form:2
Age:78.0
Sex:Female
Location:Foreign
Vaccinated:2018-12-10
Onset:2019-02-26
Submitted:0000-00-00
Entered:2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, Interstitial lung disease, Pneumonia, Vaccination failure, Sopor, Influenza A virus test positive, Polymerase chain reaction positive, H3N2 influenza

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-03-08
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC 'Split Type': ITSEQIRUS201902655

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


Changed on 5/7/2021

VAERS ID: 806644 Before After
VAERS Form:2
Age:78.0
Sex:Female
Location:Foreign
Vaccinated:2018-12-10
Onset:2019-02-26
Submitted:0000-00-00
Entered:2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, Interstitial lung disease, Pneumonia, Vaccination failure, Sopor, Influenza A virus test positive, Polymerase chain reaction positive, H3N2 influenza

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-03-08
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC 'Split Type': ITSEQIRUS201902655

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

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