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This is VAERS ID 850728

History of Changes from the VAERS Wayback Machine

First Appeared on 4/14/2020

VAERS ID: 850728
VAERS Form:2
Age:93.0
Sex:Female
Location:Foreign
Vaccinated:2019-11-13
Onset:2019-11-13
Submitted:0000-00-00
Entered:2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiomyopathy, Death, Expired product administered

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-11-14
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, 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: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death


Changed on 12/24/2020

VAERS ID: 850728 Before After
VAERS Form:2
Age:93.0
Sex:Female
Location:Foreign
Vaccinated:2019-11-13
Onset:2019-11-13
Submitted:0000-00-00
Entered:2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiomyopathy, Death, Expired product administered

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-11-14
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, 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: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death


Changed on 12/30/2020

VAERS ID: 850728 Before After
VAERS Form:2
Age:93.0
Sex:Female
Location:Foreign
Vaccinated:2019-11-13
Onset:2019-11-13
Submitted:0000-00-00
Entered:2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiomyopathy, Death, Expired product administered

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-11-14
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, 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: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death


Changed on 5/7/2021

VAERS ID: 850728 Before After
VAERS Form:2
Age:93.0
Sex:Female
Location:Foreign
Vaccinated:2019-11-13
Onset:2019-11-13
Submitted:0000-00-00
Entered:2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Cardiomyopathy, Death, Expired product administered

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2019-11-14
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, 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: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death

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