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From the 11/19/2021 release of VAERS data:

Found 4,746 cases where Vaccine is COVID19 and Manufacturer is MODERNA and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 41 out of 48

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VAERS ID: 1356588 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Drop attacks, Hypoaesthesia oral, Tongue paralysis, Transient ischaemic attack
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; SIVASTIN; EUTIROX; LASIX [FUROSEMIDE]; CONGESCOR; UROREC; RELVAR ELLIPTA [FLUTICASONE PROPIONATE;VILANTEROL TRIFENATATE]; OMEPRAZEN [OMEPRAZOLE]; SPIRIVA
Current Illness: Benign prostatic hypertrophy; Bronchitis chronic; Dyslipidemia; Fibrillation; Post surgical hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aneurysm; Cognitive deterioration; Incontinence; Other hernia; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK, HYPOAESTHESIA ORAL, TONGUE PARALYSIS , DROP ATTACKS and CONFUSIONAL STATE in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Other hernia, Abdominal aneurysm, Thoracic aortic aneurysm, Incontinence and Cognitive deterioration. Concurrent medical conditions included Fibrillation since 04-May-2021, Bronchitis chronic, Dyslipidemia, Post surgical hypothyroidism and Benign prostatic hypertrophy. Concomitant products included APIXABAN (ELIQUIS), SIMVASTATIN (SIVASTIN), LEVOTHYROXINE SODIUM (EUTIROX), FUROSEMIDE (LASIX [FUROSEMIDE]), BISOPROLOL FUMARATE (CONGESCOR), SILODOSIN (UROREC), FLUTICASONE PROPIONATE, VILANTEROL TRIFENATATE (RELVAR ELLIPTA [FLUTICASONE PROPIONATE;VILANTEROL TRIFENATATE]), OMEPRAZOLE (OMEPRAZEN [OMEPRAZOLE]) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication. On 27-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml in total. On 28-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (seriousness criterion death), HYPOAESTHESIA ORAL (seriousness criterion death), TONGUE PARALYSIS (seriousness criterion death), DROP ATTACKS (seriousness criterion death) and CONFUSIONAL STATE (seriousness criterion death). The patient died on 27-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received included death details On 24-May-2021: Additional information received included medical history details and concomitant medication details.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1356832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Interstitial lung disease
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrosis lung
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Progressive fibrosing interstitial lung disease
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP); Toename van dyspnoe; This regulatory authority case was reported by a physician and describes the occurrence of INTERSTITIAL LUNG DISEASE (Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP)) and DYSPNOEA (Toename van dyspnoe) in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fibrosis lung. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERSTITIAL LUNG DISEASE (Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP)) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (Toename van dyspnoe) (seriousness criteria death and hospitalization). The patient died on 23-Apr-2021. The reported cause of death was euthanasie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram thorax: abnormal (abnormal) Progressive fibrosing interstitial lung disease. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. The concomitant medications and treatment details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Euthanasie


VAERS ID: 1356843 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal behaviour, Amnesia, Body temperature, Fall, Fatigue, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; BIPERIDEN; AMLODIPINE BESILATE; SIMVASTATIN; APIXABAN; GLICLAZIDE; METOPROLOL TARTRATE; DEPAKINE ENTERIC
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: pyrexia; Result Unstructured Data: 38-40.5 degrees celsius
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ABNORMAL BEHAVIOUR, FALL, AMNESIA , FATIGUE, MALAISE and PYREXIA in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN, BIPERIDEN, AMLODIPINE BESILATE, SIMVASTATIN, APIXABAN, GLICLAZIDE, METOPROLOL TARTRATE and VALPROATE SODIUM (DEPAKINE ENTERIC) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (seriousness criterion death) and MALAISE (seriousness criterion death). On 24-Apr-2021, the patient experienced ABNORMAL BEHAVIOUR (seriousness criteria death and hospitalization), FALL (seriousness criteria death and hospitalization) and AMNESIA (seriousness criteria death and hospitalization). On an unknown date, the patient experienced PYREXIA (seriousness criterion death). The patient died on 03-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Body temperature: 38-40.5 (High) For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: A 74-year-old female patient who received mRNA-1273 experienced ABNORMAL BEHAVIOUR and FALL after 2 days and was hospitalized. Patient died 10 days after the first dose. No medical conditions or conmeds were given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided. Further information is not expected.; Sender''s Comments: A 74-year-old female patient who received mRNA-1273 experienced ABNORMAL BEHAVIOUR and FALL after 2 days and was hospitalized. Patient died 10 days after the first dose. No medical conditions or conmeds were given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1359103 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Decompensation cardiac; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Malaise cardiaque-Heart attack; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Malaise cardiac-Heart attack) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Parkinson''s disease and Decompensation cardiac. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CARDIAC FAILURE (Malaise cardiac-Heart attack) (seriousness criteria death and medically significant). The patient died on 14-Apr-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. No relevant concomitant medication information provided. The patient suffered from heart failure appeared to have not withstood the trauma. Examinations - The link of causality was mentioned by the emergency doctor that accompanied the SMUR [Emergency Medical Services] during the attempt to resuscitate. Treatment included resuscitation. Very limited information regarding this event has been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Translation provided for the Reporter''s comments; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1359596 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; GERD; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Cardiac insufficiency; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Cardiac insufficiency) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042698) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Schizophrenia, GERD and Cardiac insufficiency. On 12-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 18-Feb-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC FAILURE (Cardiac insufficiency) (seriousness criteria death and medically significant). The patient died on 18-Feb-2021. The reported cause of death was Cardiac insufficiency. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided/ unknown. Treatment was not provided/ unknown.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1359613 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUOPLAVIN; PANTORC; RANEXA; TILDIEM
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA and PAIN in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included RANOLAZINE (RANEXA) and DILTIAZEM HYDROCHLORIDE (TILDIEM) for Angina attack, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTORC) for Hiatal hernia, ACETYLSALICYLIC ACID, CLOPIDOGREL BISULFATE (DUOPLAVIN) for Ischemic heart disease prophylaxis. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (seriousness criterion death) and PAIN ((seriousness criterion death). The patient died on 05-May-2021. The reported cause of death was Dyspnea and Diffuse pain. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24 MAY 2021 and does not contain any new information. On 25-May-2021: Follow-up information received on 25 May 2021, does not contain any significant information.; Reported Cause(s) of Death: Dyspnea; Diffuse pain


VAERS ID: 1359795 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-05-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fibrin D dimer, Haptoglobin, Platelet count, Reticulocyte count, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDEKA
Current Illness: Fibrillation atrial
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Cerebrovascular accident; Fracture; Lymphocytic lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: d-dimeer; Result Unstructured Data: measured 48 hours after collection -which is not validated; Test Date: 20210506; Test Name: Haptoglobine; Result Unstructured Data: test of 04-05-2021 resulted on 06-05-2021; Test Date: 20210504; Test Name: thrombocyten; Result Unstructured Data: 115 10/9 per liter; Test Date: 20210506; Test Name: Reticulocyten; Result Unstructured Data: test of 04-05-2021 resulted on 06-05-2021
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fracture, Cerebrovascular accident and Aneurysm aortic. Concurrent medical conditions included Lymphocytic lymphoma and Fibrillation atrial. Concomitant products included BENDAMUSTINE HYDROCHLORIDE (BENDEKA) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 05-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Platelet count: 115 10/9 per liter 115 10/9 per liter. On 06-May-2021, Fibrin D dimer: 0.99 milligram per litre measurement 48 hours after collection-which is not validated. On 06-May-2021, Haptoglobin: 1.24 gram per litre test of 04-05-2021 resulted on 06-05-2021. On 06-May-2021, Reticulocyte count: 49.4 10/9 per liter test of 04-05-2021 resulted on 06-05-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.; Reported Cause(s) of Death: Unclear, given setting, a thrombotic event could have played a role, but unclear whether this is vaccination related. Also known in the past with atrial fibrillation, CVA and aneurysm of the thoracic aorta (which on this week''s CT did not change).


VAERS ID: 1359816 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, Peripheral embolism
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Myocardial infarction; Embolism limb; This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and PERIPHERAL EMBOLISM (Embolism limb) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Atherosclerosis and Diabetes. On 27-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 10:30 AM, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant) and PERIPHERAL EMBOLISM (Embolism limb) (seriousness criterion death). The patient died on 03-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Seriousness per Authority assessment and IME listing; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per HA Authority reporting. Seriousness per Authority assessment and listing; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1359838 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIMODERNATX, INC.MOD20211

Write-up: Unresponsive to stimuli; Difficulty breathing; Hemoptysis; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Difficulty breathing), HAEMOPTYSIS (Hemoptysis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001654) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion death) and HAEMOPTYSIS (Hemoptysis) (seriousness criterion death). On 24-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criteria death and medically significant). The reported cause of death was Difficulty breathing, Hemoptysis and Unresponsive to stimuli. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DYSPNOEA (Difficulty breathing), HAEMOPTYSIS (Hemoptysis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) to be unlikely related. Concomitant medications were not reported Treatment information was not provided; Reported Cause(s) of Death: Difficulty breathing; Hemoptysis; Unresponsive to stimuli


VAERS ID: 1362702 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Apathy, Asthenia, Cardiovascular examination, Concomitant disease aggravated, Confusional state, Decreased appetite, Dysphagia, Fall, Haematoma, Head titubation, Memory impairment, Pneumonia, SARS-CoV-2 test, Tremor, Urinary incontinence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLEOVIT D3; CALCIDURAN VIT. D3; ABILIFY; MOLAXOLE; AMLODIPINE; VENLAFAXINE; SAROTEN
Current Illness: Cardiac insufficiency; General debility; Lower extremities weakness of; Pulmonary function impairment; Scoliosis; Urine incontinence
Preexisting Conditions: Medical History/Concurrent Conditions: Birth trauma; Neonatal hypoxia
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: ; Result Unstructured Data: Test Name: COVID-19 PCR test; Test Result: Negative; Result Unstructured Data: PCR-Test; Test Name: COVID-19; Test Result: Negative; Result Unstructured Data: PCR-Test
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Neonatal hypoxia and Birth trauma. Concurrent medical conditions included Scoliosis, Pulmonary function impairment, Cardiac insufficiency, Lower extremities weakness of, General debility, and Urine incontinence. Concomitant products included OLEOVIT D3, CALCIUM CARBONATE, COLECALCIFEROL (CALCIDURAN VIT. D3), ARIPIPRAZOLE (ABILIFY), MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOLAXOLE), AMLODIPINE, VENLAFAXINE and AMITRIPTYLINE HYDROCHLORIDE (SAROTEN) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced CONCOMITANT DISEASE AGGRAVATED. On 24-Mar-2021, the patient experienced MEMORY IMPAIRMENT, HEAD TITUBATION, TREMOR, DECREASED APPETITE, ASTHENIA, CONFUSIONAL STATE, AGITATION, APATHY, and URINARY INCONTINENCE. On 25-Mar-2021, the patient experienced FALL. On 26-Mar-2021, the patient experienced HAEMATOMA. On 22-Apr-2021, the patient experienced DYSPHAGIA. On 25-Apr-2021, the patient experienced PNEUMONIA(seriousness criteria death and medically significant). The patient died on 26-Apr-2021. The reported cause of death was PNEUMONIA. It is unknown if an autopsy was performed. At the time of death, DYSPHAGIA, FALL and HAEMATOMA outcome was unknown and MEMORY IMPAIRMENT, HEAD TITUBATION, TREMOR, DECREASED APPETITE, ASTHENIA, CONFUSIONAL STATE, CONCOMITANT DISEASE AGGRAVATED, AGITATION, APATHY and URINARY INCONTINENCE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Cardiovascular examination: On an unknown date, SARS-CoV-2 test: negative (Negative) PCR-Test and negative (Negative) PCR-Test For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates, seriousness and outcomes captured per Regulatory Authority reporting; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates, seriousness and outcomes captured per Regulatory Authority reporting; Reported Cause(s) of Death: PNEUMONIA.


VAERS ID: 1362706 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEXALEN; ACEMIN [ACECLOFENAC]; OLEOVIT D3; ELIQUIS; CONCOR; VIMOVO; CAL-D-VITA; SEDACORON
Current Illness: Atrial fibrillation; Cardiac insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma (2015/2016, 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Lymphoma (2015/2016, 2020) in 2015. Concurrent medical conditions included Atrial fibrillation and Cardiac insufficiency. Concomitant products included PARACETAMOL (MEXALEN), ACECLOFENAC (ACEMIN [ACECLOFENAC]), COLECALCIFEROL (OLEOVIT D3), APIXABAN (ELIQUIS), BISOPROLOL FUMARATE (CONCOR), ESOMEPRAZOLE MAGNESIUM, NAPROXEN (VIMOVO), CALCIUM CARBONATE, COLECALCIFEROL (CAL-D-VITA) and AMIODARONE HYDROCHLORIDE (SEDACORON) for an unknown indication. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PNEUMONIA BACTERIAL (seriousness criteria death and medically significant). The patient died on 26-Apr-2021. The reported cause of death was Pneumonia bacterial and Cardiac insufficiency. An autopsy was not performed. Treatment information was not provided. Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Additional information received on 20 May 2021. Updated death details and cause of death. Added concomitant medications.; Reporter''s Comments: Sender''s Comments: Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Reported Cause(s) of Death: Pneumonia bacterial; Cardiac insufficiency


VAERS ID: 1362783 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vascular stent thrombosis
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness: Chronic ischaemic heart disease, unspecified; Essential hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Obesity; Ventricular fibrillation; Ventricular flutter
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of VASCULAR STENT THROMBOSIS in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Obesity, Ventricular flutter, Ventricular fibrillation and Aortic valve insufficiency. Concurrent medical conditions included Essential hypertension and Chronic ischaemic heart disease, unspecified. Concomitant products included WARFARIN for an unknown indication. On 25-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VASCULAR STENT THROMBOSIS (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 28-Apr-2021. The reported cause of death was coronary stent thrombosis of the left anterior descending artery. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. This is a case of death in a 64 -year-old male subject with a hx of Obesity, Essential Hypertension, Ventricular flutter, Ventricular fibrillation, Chronic ischaemic heart disease, unspecified and Aortic valve insufficiency, who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Medical history and concomitant medications added. Narrative updated.; Sender''s Comments: This is a case of death in a 64 -year-old male subject with a hx of Obesity, Essential Hypertension, Ventricular flutter, Ventricular fibrillation, Chronic ischaemic heart disease, unspecified and Aortic valve insufficiency, who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Coronary stent thrombosis of the left anterior descending artery


VAERS ID: 1362915 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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: FIMODERNATX, INC.MOD20211

Write-up: Cerebral infarction; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL INFARCTION (Cerebral infarction) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBRAL INFARCTION (Cerebral infarction) (seriousness criteria death and medically significant). It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Regulatory Authority reporting.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Regulatory Authority reporting


VAERS ID: 1362928 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deficiency mental; Glaucoma; Hypercholesterolaemia; Hypertension arterial; Myocardial necrosis
Allergies:
Diagnostic Lab Data: Test Date: 20201124; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial, Glaucoma, Hypercholesterolaemia, Deficiency mental and Myocardial necrosis. On 14-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 03-May-2021 The patient died on 03-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Company comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1362993 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Reduced general condition; This regulatory authority case was reported by a physician and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Aortic valve replacement. Concurrent medical conditions included Hypertension arterial. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In April 2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) (seriousness criterion death). The patient died on 03-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021049969 Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Sender''s Comments: Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363034 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer; Atrial fibrillation; Cardiac failure; Hypertension arterial; Infarct myocardial; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Infarct myocardial; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Infarct myocardial) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Infarct myocardial, Atrial fibrillation, Cardiac failure, Type 2 diabetes mellitus, Hypertension arterial, Artificial cardiac pacemaker wearer and Vascular dementia. On 27-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 29-Apr-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications and treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Company Comment: Although very limited amount of details has been provided at this time, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Although very limited amount of details has been provided at this time, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1363336 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (death) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 30-Apr-2021 The patient died on 30-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Company Comment: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363353 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-20
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; NovoRapid insulin; LINAGLIPTIN; CLOPIDOGREL; ATENOLOL; ADENURIC; LANTUS; ISOSORBIDE MONONITRATE; LISINOPRIL; LERCANIDIPINE
Current Illness: Hypertension; Insulin-requiring type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Gout; Hyperlipidaemia; IHD; Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20211

Write-up: RIP; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (RIP) in a 77-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3001177 and 3001177) for COVID-19 vaccination. The patient''s past medical history included Unspecified cerebrovascular disease, Chronic renal failure, Gout, Hyperlipidaemia and IHD. Concurrent medical conditions included Insulin-requiring type 2 diabetes mellitus and Hypertension. Concomitant products included FEBUXOSTAT (ADENURIC) from 01-Jan-2000 to 20-Apr-2021 for Gout, LISINOPRIL from 01-Jan-2000 to 20-Apr-2021 and LERCANIDIPINE from 01-Jan-2000 to 20-Apr-2021 for Hypertension, CLOPIDOGREL from 01-Jan-2000 to 20-Apr-2021, ATENOLOL from 01-Jan-2000 to 20-Apr-2021 and ISOSORBIDE MONONITRATE from 01-Jan-2000 to 20-Apr-2021 for IHD, ATORVASTATIN from 01-Jan-2000 to 20-Apr-2021 for IHD and Hypercholesterolaemia, NovoRapid insulin from 01-Jan-2000 to 20-Apr-2021, LINAGLIPTIN from 01-Jan-2000 to 20-Apr-2021 and INSULIN GLARGINE (LANTUS) from 01-Jan-2000 to 20-Apr-2021 for Insulin-requiring type 2 diabetes mellitus. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to First dose. Death occurred on 20-Apr-2021 The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363380 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 2
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: ITMODERNATX, INC.MOD20211

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY OEDEMA (01/05/2021) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 01-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milligram in total. On 06-May-2021, the patient experienced PULMONARY OEDEMA (01/05/2021) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Edema lung. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant was given. No laboratory details was given. No treatment information was given. Very limited information regarding the event has been provided at this time. Further information is not expected.; Reporter''s Comments:; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Edema lung


VAERS ID: 1363666 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARAN; FELODIPIN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Stroke; This regulatory authority case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no.) for COVID-19 vaccination. The patient''s past medical history included Stroke in 1980. Concomitant products included WARFARIN SODIUM (WARAN), FELODIPINE (FELODIPIN) and METOPROLOL for an unknown indication. On 26-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 04-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Very limited information regarding this event has been provided at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Stroke


VAERS ID: 1364411 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Hypoxia, Pneumonia, SARS-CoV-2 antibody test, Ultrasound scan, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; XELJANZ; MEDROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis (Epicura -Notion of ethyl cirrhosis (alcoholism weaned since 2018)); Elbow bursitis (MSSA bursitis in the right elbow one year ago, currently cured); Seronegative rheumatoid arthritis (Seronegative rheumatoid arthritis or psoriatic arthritis)
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: IgG antiSARCOV2; Result Unstructured Data: 611.4AU/mL, 86.9 BAU/mL Very few SARS-CoV-2 IgG antibodies 15days after second vaccine; Test Date: 2021; Test Name: ultrasound scan; Result Unstructured Data: typical ground glass attack occupying more than 30% of the lung fields (compatible with Covid-19 infection)
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Infection COVID-19 vaccination; Infection COVID-19 vaccination; Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Infection COVID-19 vaccination), COVID-19 (Infection COVID-19 vaccination), DEATH (Death), HYPOXIA and PNEUMONIA in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Seronegative rheumatoid arthritis (Seronegative rheumatoid arthritis or psoriatic arthritis), Alcoholic cirrhosis (Epicura -Notion of ethyl cirrhosis (alcoholism weaned since 2018)) and Elbow bursitis (MSSA bursitis in the right elbow one year ago, currently cured). Concomitant products included ALLOPURINOL, TOFACITINIB CITRATE (XELJANZ) and MEDROL for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Infection COVID-19 vaccination) (seriousness criterion death), COVID-19 (Infection COVID-19 vaccination) (seriousness criterion death), DEATH (Death) (seriousness criteria death and medically significant), HYPOXIA (seriousness criteria death and medically significant) and PNEUMONIA (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was refractory hypoxemia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 antibody test: low (Low) 611.4AU/mL, 86.9 BAU/mL Very few SARS-CoV-2 IgG antibodies 15days after second vaccine. In 2021, Ultrasound scan: abnormal (abnormal) typical ground glass attack occupying more than 30% of the lung fields (compatible with Covid-19 infection). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The patient was admitted on 25-Apr-2021 for bilateral hypoxemic pneumonia. The patient was an immunosuppressed patient who developed very fewantiSARSCOV2 antibodies. He received plasma containing antiSARSCOV2 Abs from convalescent patients on, without gain. No bacterial or other viral superinfection was demonstrated. It was reported that the patient died in the context of refractory hypoxemia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Company Comment: This is a case of death in a 74 -year-old male subject with hx of Seronegative rheumatoid arthritis, Alcoholic cirrhosis and Elbow bursitis who died on 09May2021, after receiving second dose of vaccine (date unknown). Very limited information has been provided at this time. No further information has been requested. Based on biological implausibility the event of COVID-19 causality is assessed as not applicable in relation to mRNA-1273.; Sender''s Comments: This is a case of death in a 74 -year-old male subject with hx of Seronegative rheumatoid arthritis, Alcoholic cirrhosis and Elbow bursitis who died on 09May2021, after receiving second dose of vaccine (date unknown). Very limited information has been provided at this time. No further information has been requested. Based on biological implausibility the event of COVID-19 causality is assessed as not applicable in relation to mRNA-1273.; Reported Cause(s) of Death: refractory hypoxemia


VAERS ID: 1364441 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood chloride, Blood culture, Blood sodium, C-reactive protein, Cheyne-Stokes respiration, Computerised tomogram, Computerised tomogram head, Culture urine, Haemoglobin, Lumbar puncture, Pyrexia, SARS-CoV-2 test, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; COPD; Diabetes mellitus (Diabetes Typ II); Vascular dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Chloride; Test Result: Borderline ; Result Unstructured Data: boarder line; Test Date: 20210331; Test Name: Blood culture; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Sodium; Test Result: Borderline ; Result Unstructured Data: borderline; Test Date: 20210331; Test Name: chest cT scan; Test Result: Negative ; Result Unstructured Data: Chest ct scan negative; Test Date: 20210331; Test Name: Head Ct; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: C-reactive protein; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210331; Test Name: urine culture; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Haemoglobin; Result Unstructured Data: normal; Test Date: 20210331; Test Name: Lumbar puncture; Test Result: Negative ; Result Unstructured Data: Negative - no infection focus with elevated CRP; Test Date: 20210331; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: 8.5
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Cheyne Stokes; This regulatory authority case was reported by a physician and describes the occurrence of CHEYNE-STOKES RESPIRATION and PYREXIA in an 84-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Vascular dementia, COPD, Diabetes mellitus (Diabetes Typ II) and Arterial hypertension. On 25-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEYNE-STOKES RESPIRATION (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 06-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood chloride: 109 (Borderline) boarder line. On 31-Mar-2021, Blood culture: negative (Negative) negative. On 31-Mar-2021, Blood sodium: 147 (Borderline) borderline. On 31-Mar-2021, C-reactive protein: 80.6 (Positive) positive. On 31-Mar-2021, Computerised tomogram: negative (Negative) Chest ct scan negative. On 31-Mar-2021, Computerised tomogram head: negative (Negative) negative. On 31-Mar-2021, Culture urine: negative (Negative) negative. On 31-Mar-2021, Haemoglobin: 12 (normal) normal. On 31-Mar-2021, Lumbar puncture: negative (Negative) Negative - no infection focus with elevated CRP. On 31-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 31-Mar-2021, White blood cell count: 8.5 (Inconclusive) 8.5. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided Patient was treated with Piperacillin-Tazobactam (from 31-Mar-2021 to 03-Apr-2021) with a rapid clinical improvement. The tests performed on Mar 03, 2021 do not reveal any abnormality nor any sign of infection. This is a case of death in a 84-year-old male subject with a medical history of Vascular dementia, COPD, Diabetes Type II and Arterial hypertension, who died 12 days after receiving the second dose of vaccine. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: translated document added; Sender''s Comments: This is a case of death in a 84-year-old male subject with a medical history of Vascular dementia, COPD, Diabetes Type II and Arterial hypertension, who died 12 days after receiving the second dose of vaccine. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1364445 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lymphoma; Squamous cell carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death NOS; Diarrhoa; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lymphoma and Squamous cell carcinoma. On 14-Apr-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced DIARRHOEA (Diarrhoa). On 15-Apr-2021, DIARRHOEA (Diarrhoa) outcome was unknown. The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DIARRHOEA (Diarrhoa) to be possibly related and DEATH (Death NOS) to be unlikely related. Concomitant product use was not provided. Treatment information was not provided. Company comment: Based on reporter''s causality of unlikely and the patient''s advanced age and underlying medical conditions, the event of Death is assessed as unlikely related to mRNA-1273. Concerning the event of Diarrhoea, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on reporter''s causality of unlikely and the patient''s advanced age and underlying medical conditions, the event of Death is assessed as unlikely related to mRNA-1273. Concerning the event of Diarrhoea, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1364540 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Pulmonary embolism
SMQs:, Dementia (broad), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 4
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: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL . On 28-Apr-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was lung embolism and organs failure. An autopsy was performed, but no results were provided. At the time of death, FEELING ABNORMAL had not resolved. Concomitant medications were not provided. Treatment information was not provided. Company comment: This regulatory report case concerns a 64-year-old male subject who experienced the unexpected events of pulmonary embolism and feeling abnormal and died on 28-APR-2021. The event of pulmonary embolism occurred 5 days after receiving the first vaccine dose, the reported cause of death was lung embolism and organs failure. Causality is confounded by the subject''s age. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: This regulatory report case concerns a 64-year-old male subject who experienced the unexpected events of pulmonary embolism and feeling abnormal and died on 28-APR-2021. The event of pulmonary embolism occurred 5 days after receiving the first vaccine dose, the reported cause of death was lung embolism and organs failure. Causality is confounded by the subject''s age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Lung embolism and organs failure


VAERS ID: 1365610 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had previously been healthy and well. The patient''s medical history was not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Found dead; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found dead) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001654) for COVID-19 vaccination. The patient had previously been healthy and well. The patient''s medical history was not reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The patient''s concomitant medication was not reported. No treatment information was provided. This is a case of death in a 73-year-old female subject with unknown medical history, who died 4 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 73-year-old female subject with unknown medical history, who died 4 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1365611 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SULFAMETHIZOL; DIPROSALIC; ANTABUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal behavior (Changes in behavior that could indicate dementia); Alcohol problem; Aneurysm cerebral; Cystitis; Skin disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Found death.; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found death.) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The patient''s past medical history included Aneurysm cerebral in 1982. Concurrent medical conditions included Abnormal behavior (Changes in behavior that could indicate dementia) in 2020, Cystitis on 12-Apr-2021, Skin disorder on 27-Jan-2021 and Alcohol problem on 13-Mar-2021. Concomitant products included DISULFIRAM (ANTABUS) from 13-Mar-2012 to 23-Apr-2021 for Alcohol problem, SULFAMETHIZOL from 12-Apr-2021 to 23-Apr-2021 for Cystitis, BETAMETHASONE DIPROPIONATE, SALICYLIC ACID (DIPROSALIC) from 27-Jan-2017 to 23-Apr-2021 for Skin disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 23-Apr-2021 The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered DEATH (Found death.) to be not related. No treatment medication information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant medication Diprosalic was used in strength 0.5+20 milligram per gram in 2 dosage form. Based on reporter''s causality and past medical history of aneurism and other central nervous system affections, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: Based on reporter''s causality and past medical history of aneurism and other central nervous system affections, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: death from natural causes


VAERS ID: 1365613 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Death, Electrocardiogram, Haemoglobin, Heart rate, Neutrophil count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN "KRKA"; ALLOPURINOL; TOSTRAN; ANCOZAN
Current Illness: Atherosclerosis (Severe atherosclerotic changes from previous cardiac thrombosis found on autopsy); Atrial fibrillation (Suspected AFLI due to auscultation 13mar2021 (pulse irregular and fast).); Dyspnoea (Consultation 13mar2021 due to increasing breathing difficulty and dyspnoea post activities. The dyspnoea was recovering around christmas, but then worsening.); Shooting pain (beneath last rib. no radiation.)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); Cardiac thrombosis (Previous cardiac thrombosis found on autopsy); COVID-19 (Close to hospitalisation due to affeced general condition.); Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: Nothing abnormal except hem, CRP and neu. above; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18 (slightly increased) Units not specified; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: See sender''s comments.; Test Date: 20210509; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected leftsided ventricular hypertrophy with repolarising chenges in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia) Units not specified; Test Date: 20210409; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 117 heart beats per minute; Test Date: 20210409; Test Name: Blood neutrophils; Result Unstructured Data: 7.5 (slightly increased) Units not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: death 1.5 days after vaccination.; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death 1.5 days after vaccination.) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The dyspnoea was recovering around christmas, but then worsening. The patient''s past medical history included COVID-19 (Close to hospitalisation due to affeced general condition.) in November 2020, Alcohol abuse (No alcohol in a year.) in 2020, Atherosclerosis (Severe atherosclerotic changes from previous cardiac thrombosis found on autopsy) since an unknown date and Cardiac thrombosis (Previous cardiac thrombosis found on autopsy). Concurrent medical conditions included Dyspnoea (Consultation 13mar2021 due to increasing breathing difficulty and dyspnoea post activities. The dyspnoea was recovering around christmas, but then worsening.) since November 2020, Shooting pain (beneath last rib. no radiation.) since December 2020 and Atrial fibrillation (Suspected AFLI due to auscultation 13mar2021 (pulse irregular and fast).). Concomitant products included SIMVASTATIN (SIMVASTATIN "KRKA") from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM (ANCOZAN) from 07-Jan-2015 to an unknown date for Blood pressure high, ALLOPURINOL from 01-Feb-2013 to an unknown date for Gout, TESTOSTERONE (TOSTRAN) from 06-Mar-2019 to an unknown date for Testosterone low. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Apr-2021 The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) Nothing abnormal except hem, CRP and neu. above. On 09-Apr-2021, C-reactive protein: 18 (High) 18 (slightly increased) Units not specified. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) See sender''s comments.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia) Units not specified. On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute and 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. On 09-May-2021, Electrocardiogram: sinus tachycardia. Sinus tachycardia. Incomplete left sided bundle branch block. Suspected leftsided ventricular hypertrophy with repolarising chenges in all leads.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. This is a case of death in a 70-year-old male subject with unknown medical history of HTN, A fib, Alcohol abuse, gout, high cholesterol and recent Covid-19 infection, who died 2 days after receiving the first dose of vaccine. No significant information was provided with the last follow up. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated. On 20-May-2021: Significant FU; Sender''s Comments: This is a case of death in a 70-year-old male subject with unknown medical history of HTN, A fib, Alcohol abuse, gout, high cholesterol and recent Covid-19 infection, who died 2 days after receiving the first dose of vaccine. No significant information was provided with the last follow up; Reported Cause(s) of Death: unknown cause of death; Death


VAERS ID: 1366089 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-28
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN; MILURIT; AMLODIPINE
Current Illness: Hypertension; Uraemia of renal origin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 rapid POC test; Result Unstructured Data: Negative
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: diarrhoea; renal insufficiency; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhoea) and RENAL FAILURE (renal insufficiency) in a 76-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. Concurrent medical conditions included Uraemia of renal origin and Hypertension. Concomitant products included VALSARTAN, ALLOPURINOL (MILURIT) and AMLODIPINE for an unknown indication. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 28-Apr-2021, the patient experienced DIARRHOEA (diarrhoea) (seriousness criterion death) and RENAL FAILURE (renal insufficiency) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Diarrhoea and Renal insufficiency. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DIARRHOEA (diarrhoea) and RENAL FAILURE (renal insufficiency) to be unlikely related. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company comment: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reporter''s Comments: Sender Comment: Diarrhoea and renal insufficiency is not expected and not listed adverse events in the Product Information of COVID-19 VACCINE MODERNA. TTO is 27 days. Based on the patient''s medical history, the causal relationship is unlikely between the suspected drug and the adverse events. The case is serious due to fatal outcome.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: diarrhoea; renal insufficiency


VAERS ID: 1366092 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HUMULIN R; XETER; EDNYT; MILURIT; DOXAZOSIN; ACETYLSALICYLIC ACID; PREDNISOLON RICHTER; ADVAGRAF; HUMULIN N; CONTROLOC; FUROSEMIDE; BETALOC ZOK; KALDYUM; MYFORTIC
Current Illness: Allergy to antibiotic; ARDS; Insulin therapy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; COVID-19 pneumonia; Diabetes mellitus; Kidney failure chronic; Kidney transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: POSITIVE
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19 pneumonia; Vaccination failure; COVID-19; This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION FAILURE (Vaccination failure) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included COVID-19, COVID-19 pneumonia, Kidney failure chronic and Kidney transplant in June 2015. Concurrent medical conditions included Insulin therapy, ARDS, Allergy to antibiotic and Diabetes mellitus. Concomitant products included INSULIN HUMAN (HUMULIN R), ROSUVASTATIN CALCIUM (XETER), ENALAPRIL MALEATE (EDNYT), ALLOPURINOL (MILURIT), DOXAZOSIN, ACETYLSALICYLIC ACID, PREDNISOLONE (PREDNISOLON RICHTER), TACROLIMUS (ADVAGRAF), INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), PANTOPRAZOLE SODIUM SESQUIHYDRATE (CONTROLOC), FUROSEMIDE, METOPROLOL SUCCINATE (BETALOC ZOK), POTASSIUM CHLORIDE (KALDYUM) and MYCOPHENOLATE SODIUM (MYFORTIC) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 (COVID-19) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death, hospitalization and medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criteria death and hospitalization). The patient died on 22-Apr-2021. The reported cause of death was COVID-19 pneumonia, Vaccination failure and covid-19. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION FAILURE (Vaccination failure) to be possibly related. No further causality assessments were provided for COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19). Treatment medicines were not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Very limited information regarding this events has been provided at this time.; Sender''s Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure; COVID-19


VAERS ID: 1366173 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 97-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. The patient died on 30-Apr-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication were reported by the reporter.Treatment medications for these events were not reported by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. Very limited information regarding the event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24 May 2021 has no new information.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1366178 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea, Fatigue, Ventricular arrhythmia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: ITMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK, VENTRICULAR TACHYCARDIA, FATIGUE, DYSPNOEA and VENTRICULAR ARRHYTHMIA in a 42-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 24-Apr-2021, the patient experienced CARDIOGENIC SHOCK (seriousness criteria death and medically significant), VENTRICULAR TACHYCARDIA (seriousness criteria death and medically significant), FATIGUE (seriousness criterion death), DYSPNOEA (seriousness criterion death) and VENTRICULAR ARRHYTHMIA (seriousness criteria death and medically significant). The reported cause of death was Cardiogenic shock, Ventricular tachycardia, Breath shortness and Arrhythmic storm. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The treatment information was not provided. Company Comment: This is a case of death in a 42 -year-old male subject with unknown medical hx who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 42 -year-old male subject with unknown medical hx who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Cardiogenic shock; Ventricular tachycardia; Breath shortness; Arrhythmic storm


VAERS ID: 1369908 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-13
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blindness; Chronic ischaemic heart disease, unspecified; Chronic migraine; Hypertension arterial; Prethrombosis retinal
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DIARRHOEA and VOMITING in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001946 and 3001442) for COVID-19 vaccination. Previously administered products included for an unreported indication: OMEPRAZEN [OMEPRAZOLE], CARDIOASPIRIN, NORVASC and SAFLUTAN. Concurrent medical conditions included Hypertension arterial, Chronic ischaemic heart disease, unspecified, Prethrombosis retinal, Chronic migraine and Blindness. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced DIARRHOEA (seriousness criterion death) and VOMITING (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. This report refers to a case of an 85-year-old male patient with medical history of hypertension arterial, chronic ischaemic heart disease, prethrombosis retinal, chronic migraine and blindness who developed Diarrhoea and Vomiting and died. Very limited information regarding these events has been provided at this time. It is unknown whether an autopsy was done. No further information is expected.; Sender''s Comments: This report refers to a case of an 85-year-old male patient with medical history of hypertension arterial, chronic ischaemic heart disease, prethrombosis retinal, chronic migraine and blindness who developed Diarrhoea and Vomiting and died. Very limited information regarding these events has been provided at this time. It is unknown whether an autopsy was done. No further information is expected.; Reported Cause(s) of Death: cause of death unknown


VAERS ID: 1369918 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchitis, Cardiac failure, Death, Dyspnoea, Haemoglobin, Polycythaemia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MADOPAR DISPERSIBL; CARDICOR; DIBASE; ACTONEL; LANSOX; SERTRALINE; COUMADIN
Current Illness: Atrial fibrillation; Hypokinetic-rigid syndrome; Ischaemic heart disease; Parkinsonism; Vascular encephalopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Hemoglobin; Result Unstructured Data: increased
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), CARDIAC FAILURE, BRONCHITIS, POLYCYTHAEMIA and DYSPNOEA in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cerebral ischemia. Concurrent medical conditions included Hypokinetic-rigid syndrome, Parkinsonism, Atrial fibrillation, Vascular encephalopathy and Ischaemic heart disease. Concomitant products included BENSERAZIDE HYDROCHLORIDE, LEVODOPA (MADOPAR DISPERSIBL), BISOPROLOL FUMARATE (CARDICOR), COLECALCIFEROL (DIBASE), RISEDRONATE SODIUM (ACTONEL), LANSOPRAZOLE (LANSOX), SERTRALINE and WARFARIN SODIUM (COUMADIN) for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 22-Apr-2021, the patient experienced CARDIAC FAILURE (seriousness criterion life threatening), BRONCHITIS (seriousness criterion medically significant), POLYCYTHAEMIA (seriousness criterion medically significant) and DYSPNOEA (seriousness criterion medically significant). On 08-May-2021, CARDIAC FAILURE, BRONCHITIS, POLYCYTHAEMIA and DYSPNOEA outcome was unknown. The patient died on 08-May-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Haemoglobin: high increased. This is a case of death in a 82-year-old male subject with hx of Cerebral Ischemia, Pakinsonism, Atrial Fibrillation and Ischemic Heart Disease , who died 23 days after receiving the first dose of the vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 82-year-old male subject with hx of Cerebral Ischemia, Pakinsonism, Atrial Fibrillation and Ischemic Heart Disease , who died 23 days after receiving the first dose of the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1369924 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
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: ITMODERNATX, INC.MOD20211

Write-up: MORTE; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (MORTE) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 17-Apr-2021 The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Very limited information regarding this event/s has been provided at this time. Since it is a RA report follow up is not required.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Since it is a RA report follow up is not required.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1370163 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood pressure measurement, Heart rate
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BURINEX; LANOXIN; ISOPTIN RETARD; XARELTO
Current Illness: Atrial fibrillation; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Blood pressure; Result Unstructured Data: Low; Test Date: 20210402; Test Name: Pulse rate; Result Unstructured Data: Low
CDC Split Type: NOMODERNATX, INC.MOD20211

Write-up: ACUTE RENAL FAILURE; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001530) for COVID-19 vaccination. Concurrent medical conditions included Heart failure and Atrial fibrillation. Concomitant products included DIGOXIN (LANOXIN) from 02-May-2014 to 02-Apr-2021, VERAPAMIL HYDROCHLORIDE (ISOPTIN RETARD) from 04-May-2014 to 02-Apr-2021 and RIVAROXABAN (XARELTO) from 01-May-2014 to 02-Apr-2021 for Atrial fibrillation, BUMETANIDE (BURINEX) from 10-Nov-2020 to 02-Apr-2021 for Heart failure. On 31-Mar-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) (seriousness criteria death and medically significant). The patient died on 04-Apr-2021. The reported cause of death was Acute renal failure, Drop in blood pressure and Pulse rate decrease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: low (Low) Low. On 02-Apr-2021, Heart rate: low (Low) Low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) to be possibly related. Treatment information was not provided. This case concerns an 83-year-old female patient with medical history of heart failure and atrial fibrillation who developed acute kidney injury with associated drop in blood pressure and pulse rate decreased and died. Very limited information regarding this event has been provided at this time. It is unknown if autopsy was performed. No further information is expected.; Sender''s Comments: This case concerns an 83-year-old female patient with medical history of heart failure and atrial fibrillation who developed acute kidney injury with associated drop in blood pressure and pulse rate decreased and died. Very limited information regarding this event has been provided at this time. It is unknown if autopsy was performed. No further information is expected.; Reported Cause(s) of Death: ACUTE RENAL FAILURE; DROP IN BLOOD PRESSURE; PULSE RATE DECREASE


VAERS ID: 1370933 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-08
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood pressure measurement, Blood urea, C-reactive protein, Culture throat, Glomerular filtration rate, Heart rate, International normalised ratio, Oxygen saturation, Platelet count, Pneumonia, Prothrombin time, Prothrombin time ratio, Thrombin time, Ventilation/perfusion scan
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Furon; Pradaxa; DETRALEX; Lusopres 1/2; Gopten 2 mg; Letrox 100; Verospiron 25; ALOPURINOL
Current Illness: Aortic stenosis (gradient maximally 42 mm Hg, progressing); Chronic venous insufficiency (CEAP classification 6); Dyslipidemia (on diet); Extrasystoles ventricular (Pradaxa anticoagulation); Fasting hyperglycemia (dispensarised to internist); Hypertension (compensated); Hyperuricemia; Ischaemic heart disease (of dysrythmic type with atrial fibriloflutter); Lower limb ischemia (lower limbs - differentiated atherosclerotic changes from groin, bilateral occlusions of peripheral arteries according to angiologic examination); Monoparesis (central, left arm)
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchopneumonia; Infection urinary tract (Escherichia coli); Lung embolism (pulmonary embolism with vena saphena magna lateris dextri and vena saphena parva lateris sinistri thrombosis); Meningoencephalitis (when 28-year-old with following central monoparesis of left upper limb - permanent); Strumectomy (strumectomy total subtotal due to struma nodosa); Thrombophlebitis (repeatedly deep and superficial thromboflebitis on the right side with repeated ulcerations)
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: activated partial thromboplastin time; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Activated partial thromboplastin time ratio; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Fibrinogen; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Glucose; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Potassium; Result Unstructured Data: abnormal; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 90/60 mmHg; Test Date: 20210409; Test Name: Urea; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 202104; Test Name: Throat swab; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: CKD-EPI; Test Date: 202104; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: International normalised ratio; Result Unstructured Data: abnormal; Test Date: 202104; Test Name: Oxygen saturation; Result Unstructured Data: Result: 90%; Test Date: 20210409; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Prothrombin test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Prothrombin time ratio; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Thrombin time; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 202104; Test Name: Lung scan; Result Unstructured Data: on the right perihiliously, in all fields and in the lower lung field on the right on the periphery there are flowing areas of the character of post-inflammatory residues or incipient inflammatory changes
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA in a 90-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included Lung embolism (pulmonary embolism with vena saphena magna lateris dextri and vena saphena parva lateris sinistri thrombosis) in 1996, Bronchopneumonia (lateris dextri, etiologically Proteus) in January 2019, Infection urinary tract (Escherichia coli), Thrombophlebitis (repeatedly deep and superficial thromboflebitis on the right side with repeated ulcerations) in December 2008, Meningoencephalitis (when 28-year-old with following central monoparesis of left upper limb - permanent) and Strumectomy (strumectomy total subtotal due to struma nodosa). Concurrent medical conditions included Ischaemic heart disease (of dysrythmic type with atrial fibriloflutter), Lower limb ischemia (lower limbs - differentiated atherosclerotic changes from groin, bilateral occlusions of peripheral arteries according to angiologic examination) since 2009, Hyperuricemia, Aortic stenosis (gradient maximally 42 mm Hg, progressing) since 2016, Chronic venous insufficiency (CEAP classification 6), Monoparesis (central, left arm) since 1958, Extrasystoles ventricular (Pradaxa anticoagulation), Hypertension (compensated), Fasting hyperglycemia (dispensarised to internist) and Dyslipidemia (on diet). Concomitant products included FUROSEMIDE (Furon), DABIGATRAN ETEXILATE (Pradaxa), DIOSMIN, HESPERIDIN (DETRALEX), NITRENDIPINE (Lusopres 1/2), TRANDOLAPRIL (Gopten 2 mg), LEVOTHYROXINE SODIUM (Letrox 100), SPIRONOLACTONE (Verospiron 25) and ALLOPURINOL (ALOPURINOL) for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PNEUMONIA (seriousness criteria death, hospitalization, disability, medically significant and life threatening). The patient was hospitalized from 08-Apr-2021 to 12-Apr-2021 due to PNEUMONIA. The patient died on 12-Apr-2021. The reported cause of death was terminal bronchopneumonia. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Activated partial thromboplastin time: 142 (Inconclusive) Inconclusive. On 09-Apr-2021, Activated partial thromboplastin time ratio: 2.57 (Inconclusive) Inconclusive. On 09-Apr-2021, Blood creatinine: 211 (Inconclusive) Inconclusive. On 09-Apr-2021, Blood fibrinogen: 5.18 (abnormal) abnormal. On 09-Apr-2021, Blood glucose: 6 (abnormal) abnormal. On 09-Apr-2021, Blood potassium: 5.7 (abnormal) abnormal. On 09-Apr-2021, Blood urea: 27.1 (abnormal) abnormal. On 09-Apr-2021, C-reactive protein: 164.4 mg/l (Inconclusive) Inconclusive. On 09-Apr-2021, Glomerular filtration rate: 0,29 ml/s/1,73m2 (Inconclusive) CKD-EPI. On 09-Apr-2021, International normalised ratio: 2.79 (abnormal) abnormal. On 09-Apr-2021, Platelet count: 198 (Inconclusive) Inconclusive. On 09-Apr-2021, Prothrombin time: 0.25 (Inconclusive) Inconclusive. On 09-Apr-2021, Prothrombin time ratio: 2,57 (Inconclusive) Inconclusive. On 09-Apr-2021, Thrombin time: $g60 (Inconclusive) Inconclusive. In April 2021, Blood pressure measurement: other (abnormal) 90/60 mmHg. In April 2021, Culture throat: klebsiella pneumoniae (abnormal) abnormal. In April 2021, Heart rate: 50-60 (Inconclusive) Inconclusive. In April 2021, Oxygen saturation: 90% (abnormal) Result: 90%. In April 2021, Ventilation/perfusion scan: other (abnormal) on the right perihiliously, in all fields and in the lower lung field on the right on the periphery there are flowing areas of the character of post-inflammatory residues or incipient inflammatory changes. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment details provided. This regulatory authority case was received from Czech Republic CZ-CZSUKL-21005385. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Translated source document included no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: terminal bronchopneumonia


VAERS ID: 1372183 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-26
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30001653 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-alcohol user; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30001653) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial and Ex-alcohol user. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 26-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Company Comment: This regulatory report case concerns a 83-year-old male subject who experienced the unexpected event of sudden death. The event occurred 18 days after receiving the first vaccine dose, the cause of death was unknown. Causality is confounded by the subject''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021051536; Sender''s Comments: This regulatory report case concerns a 83-year-old male subject who experienced the unexpected event of sudden death. The event occurred 18 days after receiving the first vaccine dose, the cause of death was unknown. Causality is confounded by the subject''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1373959 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Metastases to peritoneum
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (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: ESMODERNATX, INC.MOD20211

Write-up: Carcinomatosis peritoneal; Dyspnoea; This regulatory authority case was reported by a physician and describes the occurrence of METASTASES TO PERITONEUM (Carcinomatosis peritoneal) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced DYSPNOEA (Dyspnoea). On an unknown date, the patient experienced METASTASES TO PERITONEUM (Carcinomatosis peritoneal) (seriousness criterion death). The patient died in 2021. The reported cause of death was Peritoneal carcinomatosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Dyspnoea) outcome was unknown. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 14-Apr-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-May-2021 was significant and included the event death, date of death reported as ??-???-2021, autopsy done was reported as unknown and cause of death as peritoneal carcinomatosis.; Sender''s Comments: This regulatory report case concerns a 70-year-old female patient who experienced the unexpected events of metastasis to peritoneum and dyspnoea. The patient died in 2021 and the reported cause of death was peritoneal carcinomatosis. Causality is confounded by the patient''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Peritoneal carcinomatosis


VAERS ID: 1373981 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-01
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, COVID-19 pneumonia, Chest X-ray, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: inflammatory parameters indicating COVID-19, increased fibrin D dimer; Test Date: 20210413; Test Name: Chest X-ray; Result Unstructured Data: no alterations; Test Date: 20210413; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: vaccination failure; COVID-19 pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) and VACCINATION FAILURE (vaccination failure) in an 84-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 626761A and 626761A) for COVID-19 immunization. Concurrent medical conditions included Alzheimer''s disease and Dementia. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 09-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced VACCINATION FAILURE (vaccination failure) (seriousness criterion death). In April 2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was COVID-19 pneumonia and Vaccination failure. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: abnormal (abnormal) inflammatory parameters indicating COVID-19, increased fibrin D dimer. On 13-Apr-2021, Chest X-ray: normal (normal) no alterations. On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. No treatment information provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up report was received on 01-June-2021, and included lab dates and COVID pneumonia as event and COVID-19 positive as a lab test.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1374612 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001651 and UNK) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment details were provided Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1377208 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VIMOVO; ACEMIN [ACECLOFENAC]; SEDACORON; ELIQUIS; MEXALEN; CONCOR; CAL-D-VITA; OLEOVIT D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Heart failure and atrial fibrillation(but condition was stable according to internist)); Cardiac insufficiency (Heart failure and atrial fibrillation(but condition was stable according to internist)); COVID-19 PCR test negative
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: Bilateral bacterial pneumonia; Flu symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral bacterial pneumonia) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Cardiac insufficiency (Heart failure and atrial fibrillation(but condition was stable according to internist)), Atrial fibrillation (Heart failure and atrial fibrillation(but condition was stable according to internist)) and COVID-19 PCR test negative. Concomitant products included ACECLOFENAC (ACEMIN [ACECLOFENAC]) for COVID-19 vaccination, ESOMEPRAZOLE MAGNESIUM, NAPROXEN (VIMOVO), AMIODARONE HYDROCHLORIDE (SEDACORON), APIXABAN (ELIQUIS), PARACETAMOL (MEXALEN), BISOPROLOL FUMARATE (CONCOR), CALCIUM CARBONATE, COLECALCIFEROL (CAL-D-VITA) and COLECALCIFEROL (OLEOVIT D3) for an unknown indication. On 10-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PNEUMONIA (Bilateral bacterial pneumonia) (seriousness criterion death) and INFLUENZA (Flu symptoms). On 26-Apr-2021, INFLUENZA (Flu symptoms) outcome was unknown. The patient died on 26-Apr-2021. The reported cause of death was Pneumonia and Decompensation cardiac. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Treatment medications were not reported. Very limited information regarding this patient''s death has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Translation received on 02-JUN-2021 and added lab data.; Sender''s Comments: Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Pneumonia; Decompensation cardiac


VAERS ID: 1378676 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-05-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOROURACILO; IRINOTECAN
Current Illness: Metastatic colon cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Embolism pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. Co-suspect product included non-company product PANITUMUMAB for Metastatic colon cancer. The patient''s past medical history included Dyslipidaemia and Embolism pulmonary in 2012. Concurrent medical conditions included Metastatic colon cancer. Concomitant products included FLUOROURACILO from an unknown date to 29-Apr-2021 and IRINOTECAN from an unknown date to 29-Apr-2021 for Colon cancer. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started PANITUMUMAB (unknown route) at an unspecified dose. On 01-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant). The patient died on 01-May-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The co-suspect product was started on an unknown date in 2021. Treatment details were not provided. Very limited information regarding the events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1380073 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; SIRDALUD; FURON [FUROSEMIDE]; VITAMIN D3; SKUDEXA; THEOSPIREX [THEOPHYLLINE]; FEMIFLO; KALDYUM; PANTOPRAZOLE
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Hip dislocation; Kidney failure chronic; Multiple sclerosis; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210509; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Covid-19 v?rus; COVID-19 pneumonia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2021 and was forwarded to Moderna on 31-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (Covid-19 v?rus) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Multiple sclerosis, Kidney failure chronic, COVID-19 pneumonia, Suspected COVID-19 and Hip dislocation. Concurrent medical conditions included Hypertension. Concomitant products included PERINDOPRIL, TIZANIDINE HYDROCHLORIDE (SIRDALUD), FUROSEMIDE (FURON [FUROSEMIDE]), COLECALCIFEROL (VITAMIN D3), DEXKETOPROFEN TROMETAMOL, TRAMADOL HYDROCHLORIDE (SKUDEXA), THEOPHYLLINE (THEOSPIREX [THEOPHYLLINE]), FLUCONAZOLE (FEMIFLO), POTASSIUM CHLORIDE (KALDYUM) and PANTOPRAZOLE for an unknown indication. On 06-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced SUSPECTED COVID-19 (Covid-19 v?rus) (seriousness criterion death) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was COVID-19 pneumonia and Suspected COVID-19. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered SUSPECTED COVID-19 (Covid-19 v?rus) and COVID-19 PNEUMONIA (COVID-19 pneumonia) to be unlikely related. Treatment for the events were not provided. Company Comment: According to the SmPC of COVID-19 VACCINE MODERNA, immunity usually develops 14 days after the second dose of the vaccine. The patient started having Covid-19 symptoms 1 day after the second dose, therefore immunity may have not developed yet. Covid pneumonia was also confirmed. Based on the above, the causal relationship is unlikely between the adverse events and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Sender''s Comments: According to the SmPC of COVID-19 VACCINE MODERNA, immunity usually develops 14 days after the second dose of the vaccine. The patient started having Covid-19 symptoms 1 day after the second dose, therefore immunity may have not developed yet. Covid pneumonia was also confirmed. Based on the above, the causal relationship is unlikely between the adverse events and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: COVID-19 Pneumonia; Suspected COVID-19


VAERS ID: 1380472 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004272L / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Aspartate aminotransferase, Autopsy, Base excess, Basophil percentage, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood culture, Blood glucose, Blood osmolarity, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Blood uric acid, Body temperature, C-reactive protein, Dyspnoea, Electrocardiogram, Embolism, Eosinophil percentage, Escherichia sepsis, Fibrin D dimer, Gallbladder enlargement, General physical health deterioration, Haematocrit, Haemoglobin, Hyperuricaemia, International normalised ratio, Left ventricular hypertrophy, Leukopenia, Liver injury, Lymphocyte percentage, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte percentage, Neutrophil percentage, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Platelet distribution width, Platelet-large cell ratio, Procalcitonin, Prothrombin time, Pyrexia, Red blood cell count, Red cell distribution width, Renal cyst, Respiratory failure, SARS-CoV-2 test, Troponin T, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atherosclerosis generalised (High-grade); Chronic cystitis; Chronic obstructive pulmonary disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Left ventricular hypertrophy; Lung neoplasm; Mediastinum neoplasm; Prostatic hyperplasia; Tobacco abuse
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: Autopsy; Test Result: Inconclusive ; Result Unstructured Data: Initial diagnosis: a lardaceous tumor of the hilus and lower lobe of the right lung, 7x70 cm in size and surrounded by satellite nodules of various sizes. Metastases to the lymph nodes of the right hilum of the lung and to the lymph nodes of the tracheal bifurcation. The entire right lung, except for the tumor, is gray, poppy and disintegrates when touched. Left lung with signs of hyperemia and emphysema. High-grade generalized atherosclerosis. Left ventricular hypertrophy. Aortic valve calcification. Significant enlargement of the gallbladder. Small cysts of the kidney cortex (0.5 cm in diameter). Chronic cystitis. Prostatic hypertrophy.; Test Date: 20210220; Test Name: Base excess; Test Result: Inconclusive ; Result Unstructured Data: -7.9 mmol/l; Test Date: 20210220; Test Name: Basophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 0; Test Date: 20210220; Test Name: Blood bicarbonate; Test Result: Inconclusive ; Result Unstructured Data: 16; Test Date: 20210220; Test Name: Bilirubin total; Test Result: Inconclusive ; Result Unstructured Data: 0.6; Test Date: 20210220; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 2.4; Test Date: 20210221; Test Name: Blood culture; Test Result: Inconclusive ; Result Unstructured Data: Investigation was terminated on 24-Feb-2021. E. coli was grown in anaerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0); Test Date: 20210221; Test Name: Blood culture; Test Result: Inconclusive ; Result Unstructured Data: Investigation was terminated on 24-Feb-2021. E. coli was grown in aerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0); Test Date: 20210220; Test Name: Blood glucose; Test Result: Inconclusive ; Result Unstructured Data: 120; Test Date: 20210221; Test Name: Glucose; Test Result: Inconclusive ; Result Unstructured Data: 7 am: 107mg% 5 pm: 82 mg%; Comments: glycemic profile; Test Date: 20210220; Test Name: Osmolality; Test Result: Inconclusive ; Result Unstructured Data: 269; Test Date: 20210220; Test Name: Blood potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.2; Test Date: 20210220; Test Name: Blood sodium; Test Result: Inconclusive ; Result Unstructured Data: 137; Test Date: 20210220; Test Name: TSH; Test Result: Inconclusive ; Result Unstructured Data: 1.57; Comments: CRPL2; Test Date: 20210220; Test Name: Blood urea; Test Result: Inconclusive ; Result Unstructured Data: 91.6; Test Date: 20210220; Test Name: Blood uric acid; Test Result: Inconclusive ; Result Unstructured Data: 8.88; Test Date: 20210219; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: up to 39 Celsius degrees; Test Date: 20210220; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 439; Comments: CRPL2; Test Date: 20210220; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: sinus rhythm accompanied by tachycardia, single ventricular beats; Test Date: 20210220; Test Name: Eosinophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 0; Test Date: 20210220; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 1731; Test Date: 20210220; Test Name: Hematocrit; Test Result: Inconclusive ; Result Unstructured Data: 35.9; Test Date: 20210220; Test Name: Haemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 12.1; Test Date: 20210220; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.4; Test Date: 20210220; Test Name: Lymphocyte percentage; Test Result: Inconclusive ; Result Unstructured Data: 19.2; Test Date: 20210220; Test Name: MCH; Test Result: Inconclusive ; Result Unstructured Data: 31.7; Test Date: 20210220; Test Name: MCHC; Test Result: Inconclusive ; Result Unstructured Data: 33.7; Test Date: 20210220; Test Name: MCV; Test Result: Inconclusive ; Result Unstructured Data: 94,m5; Test Date: 20210220; Test Name: Mean platelet volume; Test Result: Inconclusive ; Result Unstructured Data: 10.8; Test Date: 20210220; Test Name: Monocyte percentage; Test Result: Inconclusive ; Result Unstructured Data: 12; Test Date: 20210220; Test Name: Neutrophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 68.8; Test Date: 20210220; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 88; Test Date: 20210220; Test Name: Partial pressure CO2; Test Result: Inconclusive ; Result Unstructured Data: 28.4; Test Date: 20210220; Test Name: pH; Test Result: Inconclusive ; Result Unstructured Data: 7.370; Test Date: 20210220; Test Name: Physical examination; Test Result: Inconclusive ; Result Unstructured Data: Acute alveolar respiratory murmur over the lung fields, rales in the interscapular region on both sides, more to the right.; Test Date: 20210220; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 225; Test Date: 20210220; Test Name: Platelet distribution width; Test Result: Inconclusive ; Result Unstructured Data: 12.7; Test Date: 20210220; Test Name: Platelet-large cell ratio; Test Result: Inconclusive ; Result Unstructured Data: 32.1 %; Test Date: 20210220; Test Name: Partial pressure O2; Test Result: Inconclusive ; Result Unstructured Data: 58.3; Test Date: 20210220; Test Name: Procalcitonin; Test Result: Inconclusive ; Result Unstructured Data: 0.2 %; Test Date: 20210220; Test Name: Prothrombin time; Test Result: Inconclusive ; Result Unstructured Data: 62 %; Test Date: 20210220; Test Name: RBC count; Test Result: Inconclusive ; Result Unstructured Data: 3.82; Test Date: 20210220; Test Name: Red cell distribution width; Test Result: Inconclusive ; Result Unstructured Data: RDW-SD 47.4 fl RDW-CV 13.6 %; Test Date: 20210220; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210220; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 14.17; Test Date: 20210220; Test Name: WBC; Test Result: Inconclusive ; Result Unstructured Data: 2.92; Test Date: 20210220; Test Name: APTT; Test Result: Inconclusive ; Result Unstructured Data: 40; Test Date: 20210220; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 62.9; Test Date: 20210220; Test Name: Aspartate aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 62.6
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Escherishia coli sepsis; Suspicion of embolism; Small kidney cysts; Liver damage; Respiratory failure; Gallbladder enlargement; Left ventricular of heart hypertrophy; Hyperuricemia; Leukopenia; Deterioration of general condition; Dyspnoea; Acute renal failure; Fever; This regulatory authority case was reported by a physician and describes the occurrence of ESCHERICHIA SEPSIS (Escherishia coli sepsis), EMBOLISM (Suspicion of embolism), RENAL CYST (Small kidney cysts), LIVER INJURY (Liver damage), RESPIRATORY FAILURE (Respiratory failure), GALLBLADDER ENLARGEMENT (Gallbladder enlargement), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy), HYPERURICAEMIA (Hyperuricemia), LEUKOPENIA (Leukopenia), GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition), DYSPNOEA (Dyspnoea), ACUTE KIDNEY INJURY (Acute renal failure) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30004272L) for COVID-19 vaccination. The patient''s past medical history included Tobacco abuse, Lung neoplasm, Aortic valve calcification, Aortic valve calcification, Prostatic hyperplasia, Left ventricular hypertrophy and Mediastinum neoplasm. Concurrent medical conditions included Chronic cystitis, Type 2 diabetes mellitus, Chronic obstructive pulmonary disease and Atherosclerosis generalised (High-grade). On 18-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ESCHERICHIA SEPSIS (Escherishia coli sepsis) (seriousness criterion death), EMBOLISM (Suspicion of embolism) (seriousness criterion death), RENAL CYST (Small kidney cysts) (seriousness criterion death), LIVER INJURY (Liver damage) (seriousness criterion death), RESPIRATORY FAILURE (Respiratory failure) (seriousness criterion death), GALLBLADDER ENLARGEMENT (Gallbladder enlargement) (seriousness criterion death), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy) (seriousness criterion death), HYPERURICAEMIA (Hyperuricemia) (seriousness criterion death), LEUKOPENIA (Leukopenia) (seriousness criterion death), GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition) (seriousness criterion death), DYSPNOEA (Dyspnoea) (seriousness criterion death), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria death and medically significant) and PYREXIA (Fever) (seriousness criterion death). The patient died on 22-Feb-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: upto 39 (Inconclusive) up to 39 Celsius degrees. On 20-Feb-2021, Activated partial thromboplastin time: 40 (Inconclusive) 40. On 20-Feb-2021, Alanine aminotransferase: 62.9 (Inconclusive) 62.9. On 20-Feb-2021, Aspartate aminotransferase: 62.6 (Inconclusive) 62.6. On 20-Feb-2021, Base excess: -7.9 (Inconclusive) -7.9 mmol/l. On 20-Feb-2021, Basophil percentage: 0 (Inconclusive) 0. On 20-Feb-2021, Blood bicarbonate: 16 (Inconclusive) 16. On 20-Feb-2021, Blood bilirubin: 0.6 (Inconclusive) 0.6. On 20-Feb-2021, Blood creatinine: 2.4 (Inconclusive) 2.4. On 20-Feb-2021, Blood glucose: 120 (Inconclusive) 120. On 20-Feb-2021, Blood osmolarity: 269 (Inconclusive) 269. On 20-Feb-2021, Blood potassium: 4.2 (Inconclusive) 4.2. On 20-Feb-2021, Blood sodium: 137 (Inconclusive) 137. On 20-Feb-2021, Blood thyroid stimulating hormone: 1.57 (Inconclusive) 1.57. On 20-Feb-2021, Blood urea: 91.6 (Inconclusive) 91.6. On 20-Feb-2021, Blood uric acid: 8.88 (Inconclusive) 8.88. On 20-Feb-2021, C-reactive protein: 439 (Inconclusive) 439. On 20-Feb-2021, Electrocardiogram: unknown (Inconclusive) sinus rhythm accompanied by tachycardia, single ventricular beats. On 20-Feb-2021, Eosinophil percentage: 0 (Inconclusive) 0. On 20-Feb-2021, Fibrin D dimer: 1731 (Inconclusive) 1731. On 20-Feb-2021, Haematocrit: 35.9 (Inconclusive) 35.9. On 20-Feb-2021, Haemoglobin: 12.1 (Inconclusive) 12.1. On 20-Feb-2021, International normalised ratio: 1.4 (Inconclusive) 1.4. On 20-Feb-2021, Lymphocyte percentage: 19.2 (Inconclusive) 19.2. On 20-Feb-2021, Mean cell haemoglobin: 31.7 (Inconclusive) 31.7. On 20-Feb-2021, Mean cell haemoglobin concentration: 33.7 (Inconclusive) 33.7. On 20-Feb-2021, Mean cell volume: 94 (Inconclusive) 94,m5. On 20-Feb-2021, Mean platelet volume: 10.8 (Inconclusive) 10.8. On 20-Feb-2021, Monocyte percentage: 12 (Inconclusive) 12. On 20-Feb-2021, Neutrophil percentage: 68.8 (Inconclusive) 68.8. On 20-Feb-2021, Oxygen saturation: 88 (Inconclusive) 88. On 20-Feb-2021, PCO2: 28.4 (Inconclusive) 28.4. On 20-Feb-2021, PO2: 58.3 (Inconclusive) 58.3. On 20-Feb-2021, Physical examination: abnormal (Inconclusive) Acute alveolar respiratory murmur over the lung fields, rales in the interscapular region on both sides, more to the right.. On 20-Feb-2021, Platelet count: 225 (Inconclusive) 225. On 20-Feb-2021, Platelet distribution width: 12.7 (Inconclusive) 12.7. On 20-Feb-2021, Platelet-large cell ratio: 32.1 (Inconclusive) 32.1 %. On 20-Feb-2021, Procalcitonin: 0.2% (Inconclusive) 0.2 %. On 20-Feb-2021, Prothrombin time: 62% (Inconclusive) 62 %. On 20-Feb-2021, Red blood cell count: 3.82 (Inconclusive) 3.82. On 20-Feb-2021, Red cell distribution width: 47.4 (Inconclusive) RDW-SD 47.4 fl RDW-CV 13.6 %. On 20-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 20-Feb-2021, Troponin T: 14.17 (Inconclusive) 14.17. On 20-Feb-2021, White blood cell count: 2.92 (Inconclusive) 2.92. On 20-Feb-2021, pH body fluid: 7.370 (Inconclusive) 7.370. On 21-Feb-2021, Blood culture: unknown (Inconclusive) Investigation was terminated on 24-Feb-2021. E. coli was grown in anaerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0) and unknown (Inconclusive) Investigation was terminated on 24-Feb-2021. E. coli was grown in aerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0). On 21-Feb-2021, Blood glucose: 107 (Inconclusive) 7 am: 107mg% 5 pm: 82 mg%. On 24-Feb-2021, Autopsy: abnormal (Inconclusive) Initial diagnosis: a lardaceous tumor of the hilus and lower lobe of the right lung, 7x70 cm in size and surrounded by satellite nodules of various sizes. Metastases to the lymph nodes of the right hilum of the lung and to the lymph nodes of the tracheal bifurcation. The entire right lung, except for the tumor, is gray, poppy and disintegrates when touched. Left lung with signs of hyperemia and emphysema. High-grade generalized atherosclerosis. Left ventricular hypertrophy. Aortic valve calcification. Significant enlargement of the gallbladder. Small cysts of the kidney cortex (0.5 cm in diameter). Chronic cystitis. Prostatic hypertrophy.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DYSPNOEA (Dyspnoea), ACUTE KIDNEY INJURY (Acute renal failure) and PYREXIA (Fever) to be probably related and ESCHERICHIA SEPSIS (Escherishia coli sepsis), EMBOLISM (Suspicion of embolism), RENAL CYST (Small kidney cysts), LIVER INJURY (Liver damage), RESPIRATORY FAILURE (Respiratory failure), GALLBLADDER ENLARGEMENT (Gallbladder enlargement), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy), HYPERURICAEMIA (Hyperuricemia), LEUKOPENIA (Leukopenia) and GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition) to be possibly related. Additional medical history details included a tumor of the mediastinum and hilum of the right lung - in an ambulatory chest CT scan with contrast (09-Feb-2021), pathological infiltrative-nodal mass, also described peripherally from the tumor in the upper lobe at the apex of the segment 6 GGO density of atelectatic-inflammatory nature with accompanying fibrosis. For this reason, the patient was consulted by an oncologist and then referred to a thoracic surgeon - where after consultation, the date of bronchoscopy was scheduled and laboratory tests were ordered Concomitant product details were not provided. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Translation Document received on 26-MAY-2021.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1380474 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified (The patient was taking heart medications); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Possibly thrombosis; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Possibly thrombosis) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Heart disease, unspecified (The patient was taking heart medications). On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced THROMBOSIS (Possibly thrombosis) (seriousness criteria death and medically significant). The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was reported as heart medications (not otherwise specified). Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1385764 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Intracardiac thrombus, Physical examination
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PULMICORT; ELIQUIS; VIBEDEN; CRESTOR; AMLODIPINE
Current Illness: Cardiac thrombosis (Previously cardiac thrombosis (approximately 25 years ago))
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer (Due to Cardiac conduction disorders); Electroneurography (Examined for neuropathy in legs and feet)
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Physical examination; Result Unstructured Data: The patient was fit compared to his age
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cardiac thrombosis; Cardiac arrest; This regulatory authority case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (Cardiac thrombosis) and CARDIAC ARREST (Cardiac arrest) in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001176) for COVID-19 vaccination. The patient''s past medical history included Artificial cardiac pacemaker wearer (Due to Cardiac conduction disorders) in November 2019 and Electroneurography (Examined for neuropathy in legs and feet) on 16-Apr-2021. Concurrent medical conditions included Cardiac thrombosis (Previously cardiac thrombosis (approximately 25 years ago)). Concomitant products included BUDESONIDE (PULMICORT) from 21-Dec-2017 to an unknown date for Asthma prophylaxis, ROSUVASTATIN CALCIUM (CRESTOR) from 31-Oct-2019 to an unknown date for Hypercholesterolaemia, AMLODIPINE from 31-Oct-2019 to an unknown date for Hypertension, APIXABAN (ELIQUIS) from 30-Oct-2019 to an unknown date for Thrombosis prophylaxis, HYDROXOCOBALAMIN (VIBEDEN) from 14-Oct-2020 to an unknown date for Vitamin B12 deficiency. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (Cardiac thrombosis) (seriousness criteria death and medically significant) and CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 19-Apr-2021. The reported cause of death was Cardiac arrest and Cardiac thrombosis. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Physical examination: normal (normal) The patient was fit compared to his age. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although the patient''s history of cardiac thrombus confounds assessment. Event terms, onset dates and outcomes captured per reporting.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although the patient''s history of cardiac thrombus confounds assessment. Event terms, onset dates and outcomes captured per reporting.; Reported Cause(s) of Death: Cardiac arrest; Cardiac thrombosis


VAERS ID: 1385767 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-05-07
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Echocardiogram, International normalised ratio, Pericardial haemorrhage, Platelet count, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREVENAR 13
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Thorax X-ray; Test Result: Inconclusive ; Result Unstructured Data: Result: Not possible to detect lung embolism; Test Date: 20210508; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210508; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 5.2; Test Date: 20210507; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: 348
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: The patient has blood in the pericardium; Suspicion of lung embolism (not possible to verify); Hospitalised with difficulty breathing; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDIAL HAEMORRHAGE (The patient has blood in the pericardium), PULMONARY EMBOLISM (Suspicion of lung embolism (not possible to verify)) and DYSPNOEA (Hospitalised with difficulty breathing) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001654 and 3001176) for COVID-19 vaccination. Concurrent medical conditions included COPD. Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) from 17-Mar-2021 to an unknown date for Pneumococcal immunisation. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PERICARDIAL HAEMORRHAGE (The patient has blood in the pericardium) (seriousness criteria death, hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (Suspicion of lung embolism (not possible to verify)) (seriousness criteria death, hospitalization, medically significant and life threatening) and DYSPNOEA (Hospitalised with difficulty breathing) (seriousness criteria death, hospitalization and life threatening). The patient died on 09-May-2021. The reported cause of death was Pericardial haemorrhage, Lung embolism and hospitalised with difficulty breathing. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Platelet count: 348 (Inconclusive) 348. On 08-May-2021, Chest X-ray: inconclusive (Inconclusive) Result: Not possible to detect lung embolism. On 08-May-2021, Echocardiogram: inconclusive (Inconclusive) Inconclusive. On 08-May-2021, International normalised ratio: 5.2 (Inconclusive) 5.2. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Fibrin D dimer test was not performed. The patient was too weak to make a computerized tomogram scan of thorax. No treatment information was provided by the reporter. This is a case of death of a 64-year-old female patient, 24 days after receiving second dose of vaccine (Lot number 3001654). A possible confounding factor is the patient''s medical history of Chronic obstructive pulmonary disease (COPD). Very limited information regarding the clinical details pertaining to death and the concomitant medications was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death of a 64-year-old female patient, 24 days after receiving second dose of vaccine (Lot number 3001654). A possible confounding factor is the patient''s medical history of Chronic obstructive pulmonary disease (COPD). Very limited information regarding the clinical details pertaining to death and the concomitant medications was provided at this time. No further information is expected.; Reported Cause(s) of Death: Pericardial haemorrhage; Lung embolism; Hospitalised with difficulty breathing


VAERS ID: 1386893 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 62676IA / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 94-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 62676IA) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications nor treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable. Due to lack of information and unsuccessful follow-up, the causal relationship cannot be assessed between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is expected. Very limited information regarding the event has been provided at this time. No follow up is possible.; Sender''s Comments: Due to lack of information and unsuccessful follow-up, the causal relationship cannot be assessed between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is expected. Very limited information regarding the event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388757 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 24-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died on 07-May-2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1389389 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-24
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Colonoscopy, Multiple organ dysfunction syndrome, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELTROXIN; AMLODIPIN ACCORD; METFORMIN; LOSARTAN / HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; VITAMIN B NOS; TRAJENTA
Current Illness: Diarrhea (Long-term diarrhea diagnosed as Lymphocytic colitis); Lymphocytic colitis; Polymyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Colonoscopy; Result Unstructured Data: Lymphocytic colitis
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cardiac infarction; Multi organ failure; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac infarction) and MULTIPLE ORGAN DYSFUNCTION SYNDROME (Multi organ failure) in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3000489) for COVID-19 vaccination. Concurrent medical conditions included Lymphocytic colitis since 31-Mar-2021, Diarrhea (Long-term diarrhea diagnosed as Lymphocytic colitis) and Polymyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPIN ACCORD) from 18-Jan-2021 to an unknown date and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN / HYDROCHLOROTHIAZIDE) from 24-Apr-2018 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (ELTROXIN) from 17-Jun-2014 to an unknown date for Hypometabolism, METFORMIN from 10-Mar-2014 to an unknown date and LINAGLIPTIN (TRAJENTA) from 09-Oct-2014 to an unknown date for Type 2 diabetes mellitus, VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (Cardiac infarction) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (Multi organ failure) (seriousness criteria death and medically significant). The patient died on 04-May-2021. The reported cause of death was Myocardial infarct and Multi organ failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Colonoscopy: colonoscopy (abnormal) Lymphocytic colitis. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medication not reported. Company Comments Very limited information regarding the events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct; Multi organ failure


VAERS ID: 1389404 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-05-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Diarrhoea, Disorientation, Hyperglycaemia, Pain, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM ACCORD; TRAZODONA [TRAZODONE]; REXER FLAS; OMEPRAZOLE
Current Illness: Cognitive deterioration; Diabetes mellitus; Permanent atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Blood glucose; Result Unstructured Data: Hyperglycemia
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS (Distress respiratory), DISORIENTATION (Disorientation), HYPERGLYCAEMIA, DIARRHOEA (Diarrhea), PYREXIA (Fever) and PAIN (Ache) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001177 and 3001937) for COVID-19 vaccination. The patient''s past medical history included Cranioencephalic trauma in 2017. Concurrent medical conditions included Diabetes mellitus since 1997, Permanent atrial fibrillation and Cognitive deterioration since 2012. Concomitant products included LEVETIRACETAM (LEVETIRACETAM ACCORD), TRAZODONA [TRAZODONE], MIRTAZAPINE (REXER FLAS) and OMEPRAZOLE for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced RESPIRATORY DISTRESS (Distress respiratory) (seriousness criteria death and medically significant), DISORIENTATION (Disorientation) (seriousness criterion death), DIARRHOEA (Diarrhea) (seriousness criterion death), PYREXIA (Fever) (seriousness criterion death) and PAIN (Ache) (seriousness criterion death). On 14-May-2021, the patient experienced HYPERGLYCAEMIA (seriousness criterion death). The patient died on 20-May-2021. The reported cause of death was Disorientation, Distress respiratory and Hyperglycaemia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood glucose: high (High) Hyperglycemia. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Disorientation; Distress respiratory; Hyperglycaemia


VAERS ID: 1390065 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-05
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Emphysema; Myocardial infarction; Pulmonary edema
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Myocardial Infarction; Death; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial Infarction) and DEATH (Death) in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001940 and 3001414) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis, Myocardial infarction, Emphysema and Pulmonary edema. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 04-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 05-May-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial Infarction) (seriousness criteria death and medically significant) and DEATH (Death) (seriousness criteria death and medically significant). The patient died on 05-May-2021. The reported cause of death was Myocardial infarction. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Myocardial Infarction) and DEATH (Death) to be unlikely related. Treatment and Concomitant medicines were not provided, Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Very limited information regarding this event has been provided at this time. No further information in expected. Patient?s cardiovascular risk factors are co-suspect for the events.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information in expected. Patient?s cardiovascular risk factors are co-suspect for the events.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1390134 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 8
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: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 12-May-2021, the patient experienced PNEUMONIA (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was Bilateral pneumonia. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: The Follow up document was received on 4th June 2021 and had significant data. The patient''s death date and vaccination date was updated. On 07-Jun-2021: The follow up document was received on 7 June 2021 and had No New information.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Bilateral pneumonia


VAERS ID: 1390140 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-14
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperpyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: iperpiressia scarsamente responsiva a terapia antipiretica; This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA (iperpiressia scarsamente responsiva a terapia antipiretica) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter in total. On 14-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPERPYREXIA (iperpiressia scarsamente responsiva a terapia antipiretica) (seriousness criteria death and medically significant). The patient died on 14-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment product information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1390564 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Leg amputation, Postoperative wound complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: A few days after the second dose, the family found that the surgical wound had stopped healing; Amputation above knee; This regulatory authority case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND COMPLICATION (A few days after the second dose, the family found that the surgical wound had stopped healing) and LEG AMPUTATION (Amputation above knee) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced LEG AMPUTATION (Amputation above knee) (seriousness criteria death and hospitalization prolonged). On an unknown date, the patient experienced POSTOPERATIVE WOUND COMPLICATION (A few days after the second dose, the family found that the surgical wound had stopped healing) (seriousness criteria death and hospitalization prolonged). The patient died on 29-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information provided. Company comment: Very limited information has been provided at this time. No further information is expected. This case was linked to PL-URPL-DML-MLP.4401.2.307.2021 (E2B Linked Report).; Sender''s Comments: Very limited information has been provided at this time. No further information is expected. PL-URPL-DML-MLP.4401.2.307.2021:; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1390640 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature, Fatigue, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: Body temperature; Result Unstructured Data: Fever- 38.3?C; Test Name: SARS-CoV-2 IgG antibody test; Test Result: Positive ; Result Unstructured Data: After death; Test Name: SARS-CoV-2 IgM antibody test; Test Result: Negative ; Result Unstructured Data: After death; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: After death; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210224; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA, FATIGUE and PYREXIA in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The patient''s past medical history included Pacemaker insertion (cardiac) on 09-Dec-2014. On 16-Feb-2021 at 11:13 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ASTHENIA (seriousness criterion death), FATIGUE (seriousness criterion death) and PYREXIA (seriousness criterion death). The patient died on 17-Feb-2021. The reported cause of death was Weakness generalised, Fatigue and Fever. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-Feb-2021, Body temperature: 38.3 (High) Fever- 38.3?C. On 24-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) After death and negative (Negative) After death. On an unknown date, SARS-CoV-2 test: negative (Negative) After death. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ASTHENIA, FATIGUE and PYREXIA to be possibly related. Relevant concomitant medications was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of sudden death in a 79-year-old female with hx of Pacemaker insertion, who developed asthenia, fatigue and pyrexia on the day of vaccination and died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reporter''s Comments: Tha causality was assessed as possible.; Sender''s Comments: This is a case of sudden death in a 79-year-old female with hx of Pacemaker insertion, who developed asthenia, fatigue and pyrexia on the day of vaccination and died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Weakness generalised; fatigue; fever


VAERS ID: 1391232 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-24
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Chest X-ray, Computerised tomogram head, Platelet count, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Blood test; Test Result: Inconclusive ; Result Unstructured Data: No information available; Test Date: 20210427; Test Name: Thorax X-ray; Test Result: Inconclusive ; Result Unstructured Data: No information available; Test Date: 20210427; Test Name: CT brain scan; Result Unstructured Data: Classic bleeding; Test Date: 20210427; Test Name: Thrombocyte count; Result Unstructured Data: Normal; Test Date: 20210508; Test Name: Thrombocyte count; Result Unstructured Data: Normal
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cerebral hemorrhage with irreparable brain damage; Subdural hematoma; This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral hemorrhage with irreparable brain damage) and SUBDURAL HAEMATOMA (Subdural hematoma) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 300042722 and 3001531) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral hemorrhage with irreparable brain damage) (seriousness criteria death, medically significant and life threatening) and SUBDURAL HAEMATOMA (Subdural hematoma) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was Subdural hematoma, Brain injury and Cerebral hemorrhage. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood test: inconclusive (Inconclusive) No information available. On 27-Apr-2021, Chest X-ray: inconclusive (Inconclusive) No information available. On 27-Apr-2021, Computerised tomogram head: abnormal (abnormal) Classic bleeding. On 27-Apr-2021, Platelet count: normal (normal) Normal. On 08-May-2021, Platelet count: normal (normal) Normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication and treatment drug reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Subdural hematoma; Brain injury; Cerebral hemorrhage


VAERS ID: 1391233 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-05-08
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac function test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN HEXAL; LERCANIDIPINE ORION; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]
Current Illness: Living in nursing home (The patient was a resident of a group home); Pulse increased
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Developmental delay (The patient was developmental delayed)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Cardiac function test; Result Unstructured Data: Everything looked fine
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Sudden death, cause unknown; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death, cause unknown) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 301176 and 300042722) for COVID-19 vaccination. The patient''s past medical history included Depression and Developmental delay (The patient was developmental delayed). Concurrent medical conditions included Living in nursing home (The patient was a resident of a group home) and Pulse increased. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALIN HEXAL) from 03-Oct-2012 to an unknown date for Anxiety, LERCANIDIPINE HYDROCHLORIDE (LERCANIDIPINE ORION) from 12-Mar-2021 to an unknown date for Hypertension, CYANOCOBALAMIN-TANNIN COMPLEX (BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]) from 27-Mar-2019 to an unknown date for Vitamin B12 deficiency. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. The patient died on 08-May-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Cardiac function test: normal (normal) Everything looked fine. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. It was reported that patient had a zest for life. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable. This is a case of death in a 59-year-old male subject with a history of Depression and Developmental delay who died 30 days after receiving second dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information received on 07 Jun 2021, information regarding cause of death was added.; Sender''s Comments: This is a case of death in a 59-year-old male subject with a history of Depression and Developmental delay who died 30 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Death from natural causes


VAERS ID: 1392262 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Myeloproliferative neoplasm
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Coronary heart disease; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Antigentest; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210420; Test Name: PCR Test; Test Result: Positive ; Result Unstructured Data: positive; Ct value = 13 SARS-COV2 lineage B.1.1.7
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: COVID-19; Vaccination failure; inappropriate schedule of vaccination; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Myeloproliferative neoplasm since an unknown date, Adipositas, Hypertension arterial and Coronary heart disease. On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination). On 20-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination) outcome was unknown. The patient died on 24-Apr-2021. The reported cause of death was Respiratory failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive) positive and positive (Positive) positive; Ct value = 13 SARS-COV2 lineage B.1.1.7. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company Comments: This case concerns a 74-year-old female patient who experienced inappropriate schedule of vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient had significant underlying co-morbidities to include neoplastic disease in addition to advancing age. Based in biological implausibility, causal relationship between the reported events and product use is unlikely.; Sender''s Comments: This case concerns a 74-year-old female patient who experienced inappropriate schedule of vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient had significant underlying co-morbidities to include neoplastic disease in addition to advancing age. Based in biological implausibility, causal relationship between the reported events and product use is unlikely.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1392315 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Death, Headache
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; SIMCORA; CONCOR; CALCIMAGONA D3; BECOZYM-F; LEXOTANIL
Current Illness: Adiposis; Arterial hypertension; Nicotine abuse
Preexisting Conditions: Medical History/Concurrent Conditions: Breast ductal carcinoma (no recurrence until 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: heart failure; Death NOS; headache; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) and CARDIAC FAILURE (heart failure) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 300042460 and 300042723) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Breast ductal carcinoma (no recurrence until 2020) in 2010. Concurrent medical conditions included Arterial hypertension, Adiposis and Nicotine abuse. Concomitant products included LISINOPRIL, SIMVASTATIN (SIMCORA), BISOPROLOL FUMARATE (CONCOR), CALCIUM CARBONATE, COLECALCIFEROL (CALCIMAGONA D3), NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (BECOZYM-F) and BROMAZEPAM (LEXOTANIL) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion death). The patient died on 02-Mar-2021. The reported cause of death was Acute heart failure. It is unknown if an autopsy was performed. At the time of death, HEADACHE (headache) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death NOS) to be unlikely related. No further causality assessments were provided for CARDIAC FAILURE (heart failure) and HEADACHE (headache). The patient developed headache 3 hours after the first dose of vaccine. It was reported that the patient died Half an hour to two hours before legal inspection. Action taken with mRNA-1273 in response to the event was Not Applicable Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events: headache and heart failure, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Regarding the Event "Death", based on reporter''s causality (and medical history) the event is assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-166506 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Translation document received on 01JUN2021: Concomitant medication dosage details were updated and inspecting physicians notes in narrative.; Reporter''s Comments: Death occurred 4.5 days after the second vaccination of the Moderna Covid-19 vaccine, in an 80-year-old polymorbid patient with several cardiovascular risk factors (smoking, overweight, hypertension and previous breast cancer). The monographs for the Moderna Covid-19 vaccine, do not list sudden death following the administration of the vaccine under possible adverse events. In the immediate aftermath of the two administrations, the patient showed no signs compatible with an allergic reaction and with the exception of a headache reported following the first administration, no adverse reactions were observed. The medical examiner believes possible cause of death was cardiac arrest due to natural causes ("Natural internal event"). There is no objective, laboratory or imaging evidence, let alone autopsy evidence to support a causal link between administration of the vaccine and the death. Therefore, considering the health status of the patient and her age, in spite of the temporal link between the administration of the vaccine and the event, based on the current state of knowledge we consider the causal role of the vaccine with the death of the patient unlikely.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1392318 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACIDE FOLIQUE; METFIN; CONDROSULF; TOPIRAMATO; OLANZAPINA; REDORMIN [HUMULUS LUPULUS HOPS;VALERIANA OFFICINALIS ROOT]; STILNOX; TEMESTA [LORAZEPAM]; TRANXILIUM; PARONEX; SYMFONA [GINKGO BILOBA ACETONE EXTRACT]; BENERVA; CALCIMAGON D3; LACRY
Current Illness: Chronic depression; Deaf; Diabetes; Epilepsy; Hypercholesterolemia; Hypertensive cardiomyopathy; Mental retardation
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse chronic; Cholecystectomy; Deep vein thrombosis; Encephalopathy chronic; Equilibrium trouble; Facial paresis; Fall; Head injury; Head injury; Hernia inguinal; Hypernatremia; Pulmonary embolism; Rhabdomyolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 66-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Head injury on 12-Mar-2021, Folate deficiency, Head injury in 1965, Fal, Equilibrium trouble, Encephalopathy chronic, Alcohol abuse chronic, Facial paresis in 1979, Cholecystectomy in 2012, Hypernatremia on 23-Jul-2019, Deep vein thrombosis in 2012, Hernia inguinal, Pulmonary embolism in 2020 and Rhabdomyolysis. Concurrent medical conditions included Epilepsy, Hypertensive cardiomyopathy, Diabetes, Mental retardation since 1965, Hypercholesterolemia since 1965, Deaf since 1979 and Chronic depression. Concomitant products included FOLIC ACID (ACIDE FOLIQUE) from 13-Mar-2021 to 13-Apr-2021, METFORMIN HYDROCHLORIDE (METFIN), CHONDROITIN SULFATE SODIUM (CONDROSULF), TOPIRAMATE (TOPIRAMATO), OLANZAPINE (OLANZAPINA), HUMULUS LUPULUS HOPS, VALERIANA OFFICINALIS ROOT (REDORMIN [HUMULUS LUPULUS HOPS;VALERIANA OFFICINALIS ROOT]), ZOLPIDEM TARTRATE (STILNOX), LORAZEPAM (TEMESTA [LORAZEPAM]), CLORAZEPATE DIPOTASSIUM (TRANXILIUM), PAROXETINE HYDROCHLORIDE (PARONEX), GINKGO BILOBA ACETONE EXTRACT (SYMFONA [GINKGO BILOBA ACETONE EXTRACT]), THIAMINE HYDROCHLORIDE (BENERVA), CALCIUM CARBONATE, COLECALCIFEROL (CALCIMAGON D3), GLYCEROL, HYALURONATE SODIUM, POLYACRYLATE SODIUM (LACRYCON [GLYCEROL;HYALURONATE SODIUM;POLYACRYLATE SODIUM]), PARACETAMOL (DAFALGAN) and MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) for an unknown indication. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 02-May-2021 The patient died on 02-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Nevertheless, concomitant diseases and medications could be potentially confounders/co-suspects.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Nevertheless, concomitant diseases and medications could be potentially confounders/co-suspects.; Reported Cause(s) of Death: unknown casue of death


VAERS ID: 1392321 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-07
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Lymphocyte count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; XARELTO; TORASEMID; SPIRICORT; MALTOFER [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]; KCL; PANTOPRAZOLE; LAXOBERON
Current Illness: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cholecystolithiasis; Gastroesophageal reflux; Glaucoma; Hernia hiatal; Hypertension arterial; Hypertensive cardiomyopathy (tendency towards hypokalemia; on diuretic therapy); Hypokalemia; Intertrigo; Lymphopenia (relative lymphopaenia); Macrocytosis; Myocardial infarction; Obesity (BMI 44 Kg/m2); Polymyalgia rheumatica; Polytrauma
Allergies:
Diagnostic Lab Data: Test Name: Absolute lymphocyte count; Result Unstructured Data: 19.8%; Test Date: 2018; Test Name: Absolute lymphocyte count; Result Unstructured Data: 14.5% decreased; Test Date: 2019; Test Name: Absolute lymphocyte count; Result Unstructured Data: 15.6% decreased
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: (Found Dead); This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found Dead)) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cholecystolithiasis, Gastroesophageal reflux, Polytrauma in 2016, Glaucoma, Hernia hiatal, Macrocytosis, Intertrigo, Obesity (BMI 44 Kg/m2), Hypokalemia , Hypertensive cardiomyopathy (tendency towards hypokalemia; on diuretic therapy), Myocardial infarction in 2014, Hypertension arterial, Atrial fibrillation, Polymyalgia rheumatica and Lymphopenia (relative lymphopaenia) in 2018. Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN, RIVAROXABAN (XARELTO), TORASEMIDE (TORASEMID), PREDNISOLONE (SPIRICORT), FERRIC HYDROXIDE POLYMALTOSE COMPLEX (MALTOFER [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]), POTASSIUM CHLORIDE (KCL), PANTOPRAZOLE and SODIUM PICOSULFATE (LAXOBERON) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 07-May-2021 The patient died on 07-May-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2018, Lymphocyte count: 14.5 (Low) 14.5% decreased. In 2019, Lymphocyte count: 15.6 (Low) 15.6% decreased. On an unknown date, Lymphocyte count: 19.8 (normal) 19.8%. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH . (Found Dead)) to be unlikely related. Sender''s Comment: 88-year-old obese polymorbid patient, under multiple chronic therapies?. Death following the second dose of mRNA Covid-19 vaccines in elderly and fragile patients is not reported in the monographs for vaccines, nor in international literature. In light of the available data and considering the patient''s comorbidities (known heart disease, high blood pressure and multiple medications), the causal link between death and the vaccine is considered unlikely (non-causal temporal correlation). However, this view regarding the causal link cannot entirely rule out the vaccine''s contribution. The hypothesis could be an immune reaction following the vaccine with a deterioration in the general conditions of a polymorbid patient (known lymphopaenia revealed in tests carried out before the event since 2018). Treatment information was not applicable. The patient was polymorbid patient, under multiple chronic therapies. The diagnostic tests not carried out. This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Translation document attached: updated with autopsy information and senders comment.; Sender''s Comments: This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1393617 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-25
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness: COPD; Hypertension; Ischemic heart disease (IHD)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: Unexpected death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Unexpected death) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 immunisation. Concurrent medical conditions included Hypertension, Ischemic heart disease (IHD) and COPD. Concomitant products included AMLODIPINE from 12-Feb-2021 to 25-Apr-2021 for Hypertension. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 25-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 75-year-old male subject with a history of Hypertension, Ischemic Heart Disease and COPD, who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 75-year-old male subject with a history of Hypertension, Ischemic Heart Disease and COPD, who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1393636 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Confusional state, Death, International normalised ratio, Multiple organ dysfunction syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; KCL-RETARD; CARDICOR; ANAGRELIDE HYDROCHLORIDE; COUMADIN; DEFERASIROX
Current Illness: AFib
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: C-reactive protein; Result Unstructured Data: Reported as abnormal; Test Date: 20210505; Test Name: INR; Result Unstructured Data: Reported as abnormal
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME, CONFUSIONAL STATE and DEATH (Death) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included AFib. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE (KCL-RETARD), BISOPROLOL FUMARATE (CARDICOR), ANAGRELIDE HYDROCHLORIDE, WARFARIN SODIUM (COUMADIN) and DEFERASIROX for an unknown indication. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 05-May-2021, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (seriousness criterion death) and CONFUSIONAL STATE (seriousness criterion death). The patient died on 06-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, C-reactive protein: abnormal (abnormal) Reported as abnormal. On 05-May-2021, International normalised ratio: abnormal (abnormal) Reported as abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Lab data included Activated partial thromboplastin time, Blood potassium, Chest X-ray, Computerised tomogram head, Haemoglobin and Procalcitonin. No results provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up document had no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.; Reported Cause(s) of Death: Unknown


VAERS ID: 1393968 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIOFOR; FORXIGA; ASPIRIN [ACETYLSALICYLIC ACID]; ATORIS
Current Illness: Hypertension arterial; Peripheral arterial occlusive disease (PAOB with left AIC stenosis); Stenosis (left AIC stenosis); Type II diabetes mellitus (on per os therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Test Result: Inconclusive ; Result Unstructured Data: without a clear cause on coronary angiography; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: In ECG after ROSC STEMI of the lower wall, on coronary angiography without substrate
CDC Split Type: SIMODERNATX, INC.MOD20212

Write-up: Heart arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Heart arrest) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Peripheral arterial occlusive disease (PAOB with left AIC stenosis), Hypertension arterial, Type II diabetes mellitus (on per os therapy) and Stenosis (left AIC stenosis). Concomitant products included METFORMIN HYDROCHLORIDE (SIOFOR), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA), ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (ATORIS) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: inconclusive (Inconclusive) without a clear cause on coronary angiography. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) In ECG after ROSC STEMI of the lower wall, on coronary angiography without substrate. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This is a case of sudden death in a 72-year-old male with hx of Peripheral arterial occlusive disease, Hypertension arterial, Type II diabetes mellitus and Stenosis, who died of Cardiac Arrest, 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 72-year-old male with hx of Peripheral arterial occlusive disease, Hypertension arterial, Type II diabetes mellitus and Stenosis, who died of Cardiac Arrest, 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1396138 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRANXENE; BISOPROLOL; METFORMINE [METFORMIN]; AMLOR; UNI DIAMICRON; ESTIVAN
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: asystolie; Cardiovasculair probleem; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (asystolie) and CARDIOVASCULAR DISORDER (Cardiovasculair probleem) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus. Concomitant products included CLORAZEPATE DIPOTASSIUM (TRANXENE), BISOPROLOL, METFORMINE [METFORMIN], AMLODIPINE BESILATE (AMLOR), GLICLAZIDE (UNI DIAMICRON) and EBASTINE (ESTIVAN) for an unknown indication. On 20-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced CARDIAC ARREST (asystolie) (seriousness criteria death and medically significant) and CARDIOVASCULAR DISORDER (Cardiovasculair probleem) (seriousness criterion death). The patient died on 22-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided.; Reporter''s Comments: Treatment - Evolution of the ADR - Overleden Examinations - reanimatie; Sender''s Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. However, the patient''s history of diabetes is a risk factor and confounds causality assessment.; Reported Cause(s) of Death: Death


VAERS ID: 1396162 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pH, Cardio-respiratory arrest, Coma scale, Fall, Fibrin D dimer, Loss of consciousness, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUMET; GLIMEPIRIDE; ENALAPRIL; DICLOFENAC; Diprosone
Current Illness: Arterial hypertension; Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space.); Dehydration (Low water intake, in the last 7-10 days.); Diabetic retinopathy; Polyarthralgia; Somnolence (During the last 7-10 days, patient was drowsy.); Treatment nonadherence (Problems with medication compliance.); Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Blood glucose; Result Unstructured Data: 40mmol/L; Test Date: 20210515; Test Name: Lactate; Result Unstructured Data: 18 mmol /L; Test Date: 20210515; Test Name: Arterial blood pH; Result Unstructured Data: 6.67; Test Date: 20210515; Test Name: Glasgow coma scale; Test Result: Inconclusive ; Result Unstructured Data: Neurological evaluation she has a coma scale score of 3/15, pupils were in reactive mydriasis, without corneal reflex and with swallowing reflex.; Test Date: 20210515; Test Name: Fibrin D dimer; Result Unstructured Data: 10000 nanogram per milliliter
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Cardiorespiratory arrest; Pulmonary embolism; fall with head trauma; loses consciousness; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest), PULMONARY EMBOLISM (Pulmonary embolism) and LOSS OF CONSCIOUSNESS (loses consciousness) in a 78-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002186) for SARS-CoV-2 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type II diabetes mellitus, Diabetic retinopathy, Arterial hypertension, Polyarthralgia, Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space.), Treatment nonadherence (Problems with medication compliance.), Somnolence (During the last 7-10 days, patient was drowsy.) since May 2021 and Dehydration (Low water intake, in the last 7-10 days.) since May 2021. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIMEPIRIDE, ENALAPRIL, DICLOFENAC and Betamethasone dipropionate (Diprosone) for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest) (seriousness criteria death and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness) (seriousness criterion medically significant). On 15-May-2021, FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness) had resolved. The patient died on 16-May-2021. The reported cause of death was cardio-respiratory arrest and pulmonary embolism. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood glucose (4.1-6): 40 (High) 40mmol/L. On 15-May-2021, Blood lactic acid (0.4-1.9): 18 (High) 18 mmol /L. On 15-May-2021, Blood pH (7.35-7.45): 6.67 (Low) 6.67. On 15-May-2021, Coma scale: 3/15 (Inconclusive) Neurological evaluation she has a coma scale score of 3/15, pupils were in reactive mydriasis, without corneal reflex and with swallowing reflex.. On 15-May-2021, Fibrin D dimer (Unknown-500): 10000 (High) 10000 nanogram per milliliter. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest) and PULMONARY EMBOLISM (Pulmonary embolism) to be possibly related. No further causality assessments were provided for FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness). On 15-May-2021, the patient had a fall, with head trauma, with loss of consciousness. When the ambulance arrived, she was in cardiorespiratory arrest and was resuscitated. She had a cardiorespiratory arrest at the emergency room and regained spontaneous circulation. She has echocardiographic signs of pulmonary embolism, without radiological confirmation. Neurological evaluation was done. Treatment medications were not reported. Company comment: This is a case of sudden death in a 78-year-old female patient with a history of Type II diabetes mellitus, Diabetic retinopathy, Arterial hypertension, Polyarthralgia, Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Translation uploaded; added 2 new events and lab findings; Reported Cause(s) of Death: Cardio-respiratory arrest; Pulmonary embolism


VAERS ID: 1396257 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002335 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Psychosis
Preexisting Conditions: Medical History/Concurrent Conditions: Polydypsia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002335) for COVID-19 vaccination. The patient''s past medical history included Polydypsia. Concurrent medical conditions included Psychosis. On 22-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 23-May-2021 The patient died on 23-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were provided. No concomitant medication were provided. Action taken with mRNA-1273 in response to the event was not applicable Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Sender''s Comments: This a report of dead one day after the second dose of the product in a psychotic patient. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death:


VAERS ID: 1397950 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Brain oedema, Cardio-respiratory arrest, Death, Fatigue, Hypoxic-ischaemic encephalopathy, Myocardial infarction, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Heart attack; cardiopulmonary arrest; cerebral edema; hypoxic-ischemic encephalopathy; Death; Abdominal pain; Exhaustion; Hand pain; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), MYOCARDIAL INFARCTION (Heart attack), ABDOMINAL PAIN (Abdominal pain), FATIGUE (Exhaustion), PAIN IN EXTREMITY (Hand pain), CARDIO-RESPIRATORY ARREST (cardiopulmonary arrest), BRAIN OEDEMA (cerebral edema) and HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (hypoxic-ischemic encephalopathy) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced CARDIO-RESPIRATORY ARREST (cardiopulmonary arrest) (seriousness criteria death and medically significant), BRAIN OEDEMA (cerebral edema) (seriousness criteria death and medically significant) and HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (hypoxic-ischemic encephalopathy) (seriousness criteria death and medically significant). On 16-Mar-2021, ABDOMINAL PAIN (Abdominal pain), FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Hand pain) had resolved. The patient died on 06-Apr-2021. The reported cause of death was Cardiopulmonary arrest, Cerebral edema, Myocardial infarction and Hypoxic-ischemic encephalopathy. An autopsy was performed, but no results were provided. At the time of death, MYOCARDIAL INFARCTION (Heart attack) had not resolved. Concomitant product was not provided by the reporter. Treatment information was not provided. This is a case of death in a 75 -years-old female subject with no reported medical hx, who died on the 34 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 75 -years-old female subject with no reported medical hx, who died on the 34 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Cardiopulmonary arrest; Cerebral edema; Myocardial infarction; Hypoxic-ischemic encephalopathy


VAERS ID: 1397952 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agnosia, Aphasia, Blood pressure measurement, Computerised tomogram, Haemorrhage intracranial, Hemiplegia, Hypertensive crisis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No Medical history was reported. No previous bleeding tendency.
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Her lifetime value were around 110/70 mmHg.; Test Name: Blood Pressure; Result Unstructured Data: Her lifetime value were around 110/70 mmHg.; Test Name: Computerized tomography scan; Result Unstructured Data: Intracranial hemorrhage in the left basal ganglia.
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Hypertensive crisis; Intracranial hemorrhage; collapsed; Right hemiplegia; Aphasia; Agnosia; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERTENSIVE CRISIS (Hypertensive crisis), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage), LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical history was reported. No previous bleeding tendency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (Hypertensive crisis) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (collapsed) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right hemiplegia) (seriousness criteria hospitalization and medically significant), APHASIA (Aphasia) (seriousness criterion hospitalization) and AGNOSIA (Agnosia) (seriousness criterion hospitalization). The patient was treated with CLONIDINE HYDROCHLORIDE (intravenous) for Adverse event, at a dose of 0.15 mg and FUROSEMIDE (intravenous) for Adverse event, at a dose of 20 mg. The patient died on an unknown date. The reported cause of death was Hypertensive crisis and Intracranial hemorrhage. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 210/110 mmHg (High) Her lifetime value were around 110/70 mmHg. and 180/100 mmHg (High) Her lifetime value were around 110/70 mmHg.. On an unknown date, Computerised tomogram: intracranial hemorrhage (abnormal) Intracranial hemorrhage in the left basal ganglia.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERTENSIVE CRISIS (Hypertensive crisis), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage), LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) to be possibly related. Patient had no history of thrombocytopenia or any other abnormal blood test. Patient was not taking any previous medication at the time of vaccination. On an unspecified date, the patient Blood pressure remained over 180/100 mmHg, despite treatment during hospitalization. On an unspecified date, 9 days after the event onset patient passed away without any improvement. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Hypertensive crisis; intracranial hemorrhage


VAERS ID: 1397968 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-12
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTACLAST; COVERCARD; ATORVASTATIN; ACETYLSALICYLIC ACID; BENFOGAMMA; TRAMADOLOR; CARVOL; APO-FAMOTIDIN; FRONTIN
Current Illness: Angiopathy; Stroke
Preexisting Conditions: Medical History/Concurrent Conditions: Gangrene
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Gangrene in March 2020. Concurrent medical conditions included Stroke since 2019 and Angiopathy. Concomitant products included CILOSTAZOL (ANTACLAST), AMLODIPINE BESILATE, PERINDOPRIL ARGININE (COVERCARD), ATORVASTATIN, ACETYLSALICYLIC ACID, BENFOTIAMINE (BENFOGAMMA), TRAMADOL HYDROCHLORIDE (TRAMADOLOR), CARVEDILOL (CARVOL), FAMOTIDINE (APO-FAMOTIDIN) and ALPRAZOLAM (FRONTIN) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. Death occurred on 12-May-2021 The patient died on 12-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. Treatment information was not provided by the reporter.; Sender''s Comments: As the patient had ongoing vascular diseases and suffered from strokes before, the causal relationship is unlikely between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1398051 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anuria, Asthenia, Dyspnoea, Oxygen saturation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Oxygen saturation; Result Unstructured Data: Low
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.), DYSPNOEA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) and ANURIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 13-May-2021, the patient experienced ASTHENIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criterion death), DYSPNOEA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criterion death) and ANURIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criteria death and medically significant). The patient died on 14-May-2021. The reported cause of death was Oligoanuria, Dyspnea and Asthenia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Oxygen saturation: low (Low) Low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Oligoanuria; Dyspnea; Asthenia


VAERS ID: 1398053 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and LOSS OF CONSCIOUSNESS in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-May-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and LOSS OF CONSCIOUSNESS (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was . It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: HA Report Added; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Reported Cause(s) of Death:


VAERS ID: 1398073 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Food refusal, Hyperglycaemia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Senile dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of VOMITING, FOOD REFUSAL, HYPERGLYCAEMIA, ASTHENIA and PYREXIA in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus and Senile dementia. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 09-May-2021, the patient experienced VOMITING (seriousness criterion death), FOOD REFUSAL (seriousness criterion death), HYPERGLYCAEMIA (seriousness criterion death), ASTHENIA (seriousness criterion death) and PYREXIA (seriousness criterion death). The patient died on 30-May-2021. The reported cause of death was Vomiting, Food refusal, Hyperglycaemia, Asthenia and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Vomiting; Food refusal; Hyperglycaemia; Asthenia; Fever


VAERS ID: 1398350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EFTERS?KS / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischemic attack (Tidigare biverkning av COVID-19 Vaccin Moderna)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: ISCHEMISK STROKE; This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (ISCHEMISK STROKE) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. EFTERS?KS) for COVID-19 vaccination. The patient''s past medical history included Transient ischemic attack (Tidigare biverkning av COVID-19 Vaccin Moderna) on 30-Mar-2021. In May 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced ISCHAEMIC STROKE (ISCHEMISK STROKE) (seriousness criteria death, hospitalization prolonged and medically significant). The reported cause of death was Ischaemic stroke. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. This is a case of sudden death in a 71-year-old male patient with a history of Transient ischemic attack, who died of ischaemic stroke after receiving first dose of vaccine. Very limited information has been provided at this time. This case was linked to SE-MPA-2021-025230 (E2B Linked Report).; Sender''s Comments: This is a case of sudden death in a 71-year-old male patient with a history of Transient ischemic attack, who died of ischaemic stroke after receiving first dose of vaccine. Very limited information has been provided at this time. SE-MPA-2021-025230:; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1400457 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia viral, Viral myocarditis
SMQs:, Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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: Arthritis rheumatoid; Bechterew''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21188165

Write-up: Death; Viral myocarditis; Pneumonia viral; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), VIRAL MYOCARDITIS (Viral myocarditis) and PNEUMONIA VIRAL (Pneumonia viral) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA on 18-Jan-2021. Past adverse reactions to the above products included Drug intolerance NOS with COVID-19 VACCINE ASTRAZENECA. Concurrent medical conditions included Bechterew''s disease and Arthritis rheumatoid. On 15-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) Unknown. On 17-Feb-2021, the patient experienced VIRAL MYOCARDITIS (Viral myocarditis) (seriousness criteria death and medically significant) and PNEUMONIA VIRAL (Pneumonia viral) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Viral myocarditis and Pneumonia viral. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product details not provided Treatment details was not provided Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the serious events, a causal relationship cannot be excluded. The event death was consistent with the reported cause of death in the case.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the serious events, a causal relationship cannot be excluded. The event death was consistent with the reported cause of death in the case.; Autopsy-determined Cause(s) of Death: Viral myocarditis; Pneumonia viral


VAERS ID: 1400469 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 2
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: COVID-19 (with severe (Acute respiratory distress syndrome) ARDS.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100079088

Write-up: Brain death; Arrest cardiac; This regulatory authority case was reported by a physician and describes the occurrence of BRAIN DEATH (Brain death) and CARDIAC ARREST (Arrest cardiac) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (with severe (Acute respiratory distress syndrome) ARDS.) in January 2021. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 23-May-2021. The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided No treatment product information was provided. For medical history COVID-19, the patient was treated with extracorporeal membrane oxygenation (ECMO) following ?Reha'' (rehabilitation). Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Translation uploaded as initial_additional SD1: updated with medical history.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1400679 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-12
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Coombs direct test
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATINA ABEX; ADVAGRAF; SINTROM; FUROSEMIDA KERN PHARMA; OLMETEC; REVOLADE; ZYLORIC; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV
Current Illness: Atrial fibrillation; Autoimmune thrombocytopenia; Hypercholesteremia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Cardiac transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Coombs direct test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Autoimmune hemolytic anemia; This regulatory authority case was reported by a physician and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) in a 47-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. Co-suspect product included non-company product AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV) for Tooth infection. The patient''s past medical history included Acute myocardial infarction in 2001 and Cardiac transplant in December 2011. Concurrent medical conditions included Hypercholesteremia, Atrial fibrillation, Autoimmune thrombocytopenia and Hypertension arterial. Concomitant products included ELTROMBOPAG OLAMINE (REVOLADE) for Autoimmune thrombocytopenia, ATORVASTATIN CALCIUM (ATORVASTATINA ABEX) from 18-Jun-2012 to an unknown date, TACROLIMUS (ADVAGRAF) from 04-Jun-2012 to an unknown date, ACENOCOUMAROL (SINTROM) from 06-Jun-2012 to an unknown date, FUROSEMIDE (FUROSEMIDA KERN PHARMA) from 03-Jun-2012 to an unknown date, OLMESARTAN MEDOXOMIL (OLMETEC) from 06-Oct-2015 to an unknown date, ALLOPURINOL (ZYLORIC) from 27-Jul-2012 to an unknown date and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) from 17-Apr-2019 to an unknown date for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 21-Apr-2021, the patient started AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV) (Oral) 750 milligram every eight hours. On 08-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 12-May-2021, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) (seriousness criteria death, hospitalization and medically significant). The patient died on 01-Jun-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Coombs direct test: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Outcome of the Event reported as Fatal , Death date updated .; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the serious event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1400771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal death) in a 22-week-old male infant exposed to mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Vaccine exposure during pregnancy. No Medical History information was reported. On 09-May-2021, the mother received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the infant was diagnosed with FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The infant died on 20-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intra-uterine), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company Comment : Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case Sender''s (Case) Safety Report Unique Identifier : FR-AFSSAPS-2021061999; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1400790 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Dyspnea; Asthenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Dyspnea) in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Dyspnea) (seriousness criteria death and life threatening) and ASTHENIA (Asthenia). The patient died on 15-Apr-2021. The reported cause of death was d?compensation respiratoire aigue. It is unknown if an autopsy was performed. At the time of death, ASTHENIA (Asthenia) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. This is a case of sudden death in a 84-year-old male patient with a history of diabetes, who died of dyspnea 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Senders case reference number is FR-AFSSAPS-2021062650.; Sender''s Comments: This is a case of sudden death in a 84-year-old male patient with a history of diabetes, who died of dyspnea 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: D?compensation respiratoire aigue


VAERS ID: 1400977 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Depression. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 17-May-2021 The patient died on 17-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Death is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 6 days. Based on the above, lacking detailed information, causality is not assessable. The case is serious because the patient died. Further information is expected. Death is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 6 days. Based on the above, lacking detailed information, causality is not assessable. The case is serious because the patient died. Further information is expected.; Sender''s Comments: This is a case of sudden death in a 34-year-old Male with a history of depression, who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1400978 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Colonoscopy, Death, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; COVEREX AS KOMB; MILURIT; TALLITON; FUROSEMIDE; COVEREX AS; DOXAZOSIN
Current Illness: Aortic stenosis; Chronic renal insufficiency; Heart failure with reduced ejection fraction; Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis (NOS); Colonoscopy (Results: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.); Diverticula of colon
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Colonoscopy; Result Unstructured Data: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.; Test Date: 2021; Test Name: PCR; Test Result: Negative ; Result Unstructured Data: Negative for COVID-19; Test Date: 2021; Test Name: Antigen Test; Test Result: Negative ; Result Unstructured Data: Negative for COVID-19
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: hal?l; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (hal?l) in an 88-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Colitis (NOS), Diverticula of colon and Colonoscopy (Results: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.). Concurrent medical conditions included Heart failure with reduced ejection fraction, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), INDAPAMIDE, PERINDOPRIL ARGININE (COVEREX AS KOMB), ALLOPURINOL (MILURIT), CARVEDILOL (TALLITON), FUROSEMIDE, PERINDOPRIL ARGININE (COVEREX AS) and DOXAZOSIN for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 28-Apr-2021 The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: diverticulosis (abnormal) Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.. In 2021, Polymerase chain reaction: negative (Negative) Negative for COVID-19. In 2021, SARS-CoV-2 test: negative (Negative) Negative for COVID-19. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (hal?l) to be unlikely related. Treatment information was not provided. The health professional assessed the causal relationship was unlikely between the suspected drug- Moderna COVID-19 vaccine and the adverse event. This is a case of death in a 88-year-old female subject with a history of Heart failure, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis who died 28 days after receiving first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 88-year-old female subject with a history of Heart failure, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis who died 28 days after receiving first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1401023 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-12
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITTICO; OLMESARTAN; XADAGO; AMLODIPINA ALTER; NEUPRO; DITROPAN; MADOPAR; CARDIOASPIRIN
Current Illness: Blindness (Blindness in the right eye.); Essential hypertension, unspecified; Incontinence of urine; Osteoarthrosis, generalized, involving unspecified site; Paralysis agitans
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C (Hepatitis C carrier.); Lumbosacral disc herniation (Lumbar intervertebral disc hernia with no myelopathy.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: myocardial infarction; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction) in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042698) for COVID-19 vaccination. The patient''s past medical history included Lumbosacral disc herniation (Lumbar intervertebral disc hernia with no myelopathy.) and Hepatitis C (Hepatitis C carrier.). Concurrent medical conditions included Incontinence of urine, Osteoarthrosis, generalized, involving unspecified site, Essential hypertension, unspecified, Paralysis agitans and Blindness (Blindness in the right eye.). Concomitant products included TRAZODONE HYDROCHLORIDE (TRITTICO), OLMESARTAN, SAFINAMIDE MESILATE (XADAGO), AMLODIPINE (AMLODIPINA ALTER), ROTIGOTINE (NEUPRO), OXYBUTYNIN HYDROCHLORIDE (DITROPAN), BENSERAZIDE HYDROCHLORIDE, LEVODOPA (MADOPAR) and ACETYLSALICYLIC ACID (CARDIOASPIRIN) for an unknown indication. On 18-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 12-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (myocardial infarction) (seriousness criteria death and medically significant). The patient died on 13-Mar-2021. The reported cause of death was Infarct myocardial. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication was reported. Very limited information regarding this event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Translation source received on 04-Jun-2021 contain non-significant information: Relevant Medical history comments were updated. Formulation details for concomitant medications was updated. On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains no new information.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1401419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-17
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: General physical condition decreased; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Death; General physical health deterioration; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included General physical condition decreased. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 17-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration). The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) outcome was unknown. Company Comment: This case concerns a 75-year-old male patient who received mRNA-1273 and experienced general physical condition decreased shortly after taking the vaccine and died 3 days later, Although, there exist a very strong tempal association. there is still not enough information to assess the causal relationship to product use without the exact cause of death. However, causal relationship between the product administration and general health deterioration cannot be excluded.; Sender''s Comments: This case concerns a 75-year-old male patient who received mRNA-1273 and experienced general physical condition decreased shortly after taking the vaccine and died 3 days later, Although, there exist a very strong tempal association. there is still not enough information to assess the causal relationship to product use without the exact cause of death. However, causal relationship between the product administration and general health deterioration cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1401422 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Bone pain, Epistaxis, Fatigue, Malaise, Myalgia, Myeloid leukaemia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Koorts: 37.5 tot 38 graden Celsius
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Myeloid leukaemia; Myalgia; Generalized joint pain; Fatigue; Bone pain; Malaise; Nose bleed; This regulatory authority case was reported by an other and describes the occurrence of BONE PAIN (Bone pain), MALAISE (Malaise), EPISTAXIS (Nose bleed), MYELOID LEUKAEMIA (Myeloid leukaemia), MYALGIA (Myalgia), ARTHRALGIA (Generalized joint pain) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criterion death), MALAISE (Malaise) (seriousness criterion death), EPISTAXIS (Nose bleed) (seriousness criterion death), MYALGIA (Myalgia) (seriousness criterion death), ARTHRALGIA (Generalized joint pain) (seriousness criterion death) and FATIGUE (Fatigue) (seriousness criterion death). On an unknown date, the patient experienced MYELOID LEUKAEMIA (Myeloid leukaemia) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was meyeloide leukemie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: increased Koorts: 37.5 tot 38 graden Celsius. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant information was not provided. Treatment information of the patient was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Meyeloide leukemie


VAERS ID: 1403189 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-28
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100077669

Write-up: Pulmonary embolism; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Pulmonary embolism. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information was not provided. Company comment: Very limited information regarding this event has been provided at this time. Further information is not expected; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1403806 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESCOVY; TIVICAY; ATORVASTATIN +PHARMA
Current Illness: COPD (COPD); Nicotine abuse (chron. Nikotinkonsum); Osteoporosis (Osteoporose)
Preexisting Conditions: Medical History/Concurrent Conditions: Prostatic carcinoma (Prostata Ca in Remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben; This regulatory authority case was reported by a pharmacist and describes the occurrence of SUDDEN DEATH (Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Prostatic carcinoma (Prostata Ca in Remission), COPD (COPD), Nicotine abuse (chron. Nikotinkonsum) and Osteoporosis (Osteoporose). Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), DOLUTEGRAVIR SODIUM (TIVICAY) and ATORVASTATIN CALCIUM (ATORVASTATIN +PHARMA) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 28-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben) to be possibly related. No treatment information was reported The action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding the event of death has been provided at this time. No follow up is possible.; Sender''s Comments: Very limited information regarding the event of death has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1403917 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002330 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Laryngeal oedema; Cardio-respiratory arrest; This regulatory authority case was reported by a pharmacist and describes the occurrence of LARYNGEAL OEDEMA (Laryngeal oedema) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002330) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 24-May-2021, the patient experienced LARYNGEAL OEDEMA (Laryngeal oedema) (seriousness criteria death, hospitalization and medically significant) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death, hospitalization and medically significant). The patient died on 25-May-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment information provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1404530 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperplasia of prostate; Nephrosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Brain CT; Result Unstructured Data: Vascular encephalopathy; Test Date: 20210421; Test Name: Brain CT; Result Unstructured Data: Multi-focal, extensive bleeding left side; Test Date: 20210421; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: agyv?rz?s; This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (agyv?rz?s) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included Nephrosclerosis and Hyperplasia of prostate. Concurrent medical conditions included Hypertension. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 millimetre. On 21-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (agyv?rz?s) (seriousness criteria death and medically significant). The patient died on 23-Apr-2021. The reported cause of death was Cerebral hemorrhage. An autopsy was performed. The autopsy-determined cause of death was Cerebral hemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram head: abnormal (abnormal) Vascular encephalopathy and abnormal (abnormal) Multi-focal, extensive bleeding left side. On 21-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CEREBRAL HAEMORRHAGE (agyv?rz?s) to be unlikely related. No concomitant medication was reported. Company comment: Very limited information regarding the event has been provided. This a report of dead 19 days after receiving the product, in a 85-old hypertensive patient, whose concomitant medication was not provided. Autopsy showed cerebral haemorrage. Very limited information regarding the event has been provided for inferring causality. Regulatory authority determined causality was unlikely.; Reporter''s Comments: Cerebral hemorrhage is not expected after vaccination with COVID-19 Vaccine Moderna. TTO was 18 days. The causal relationship between the event and the vaccine is considered unlikely. The case is serious due to fatal outcome.; Sender''s Comments: Very limited information regarding the event has been provided. This a report of dead 19 days after receiving the product, in a 85-old hypertensive patient, whose concomitant medication was not provided. Autopsy showed cerebral haemorrage. Very limited information regarding the event has been provided for inferring causality. Regulatory authority determined causality was unlikely.; Reported Cause(s) of Death: Cerebral hemorrhage; Autopsy-determined Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1404541 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 20-May-2021 The patient died on 20-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medications and treatment information was not provided. Company Comment : Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1404612 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Urinary tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 6
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: ITMODERNATX, INC.MOD20212

Write-up: ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 04-May-2021, the patient experienced PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death and medically significant) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criterion death). The patient died on 10-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was unknown. Company Comment : Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.; Reported Cause(s) of Death: Unknown


VAERS ID: 1404726 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Urinary tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death, hospitalization and medically significant) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death and hospitalization). The patient was hospitalized on 05-May-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient died on 10-May-2021. The reported cause of death was Bronchial pneumonia and Urinary tract infection. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was unknown. Very limited information regarding this event/s has been provided at this time. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Translation received. Added start date of hospitalization.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.; Reported Cause(s) of Death: bronchial pneumonia; urinary tract infection


VAERS ID: 1405013 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 2
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: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Fatale hersenbloeding) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was Cerebral bleeding. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1408058 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; EZETROL; DOXAZOSIN; VIPDOMET
Current Illness: Alcohol abuse; Arterial hypertension; Diabetes mellitus; Ischemic cardiomyopathy; Metabolic syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic bypass; Hydrocephalus; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Asthenia; Fever; This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA (Asthenia) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac). Concurrent medical conditions included Ischemic cardiomyopathy, Arterial hypertension, Diabetes mellitus, Alcohol abuse and Metabolic syndrome. Concomitant products included EDOXABAN TOSILATE (LIXIANA), EZETIMIBE (EZETROL), DOXAZOSIN and ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE (VIPDOMET) for an unknown indication. On 21-May-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ASTHENIA (Asthenia) (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 22-May-2021. The reported cause of death was Asthenia and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered ASTHENIA (Asthenia) and PYREXIA (Fever) to be possibly related. No treatment information was provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This is a case of sudden death in a 74-year-old male patient with a history of Ischemic cardiomyopathy, Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac), who died 1 day after receiving last dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old male patient with a history of Ischemic cardiomyopathy, Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac), who died 1 day after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Asthenia; Fever


VAERS ID: 1411117 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood sodium, C-reactive protein, Echocardiogram, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; DOLOPROCT [FLUOCORTOLONE PIVALATE;LIDOCAINE HYDROCHLORIDE]; CALCIUM OG D-VITAMIN; FURIX [FUROSEMIDE]; PANODIL; LANSOPRAZOL; GLYCEROL "OBA"; LACTULOSE "ORIFARM"; SPIRIX; HUSK PSYLLIUM FLOHSAMENSCHALEN; BRENTAN [MICONAZOLE NITRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (Aortic stenosis was diagnosed during hospitalization due to fainting on 27-28 May 2020); Dizziness; Falling (Tendencey to fall); Hyponatremia; Reduced general condition (Unexplained)
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Sodium; Result Unstructured Data: Hyponatraemia; Test Date: 20210416; Test Name: C-reactive protein; Result Unstructured Data: Severe increased CRP; Test Date: 202005; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: Mild aortic valve stenosis and normal EF; Test Date: 20210416; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: EF 55%, Normal right ventricle, mild valve pathology and hemodynamic mild pericardial effusion (fluid leakage).
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Acute pericarditis; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Acute pericarditis) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. Concurrent medical conditions included Hyponatremia on 01-Jan-2019, Reduced general condition (Unexplained), Aortic stenosis (Aortic stenosis was diagnosed during hospitalization due to fainting on 27-28 May 2020), Falling (Tendencey to fall) and Dizziness. Concomitant products included GLYCEROL (GLYCEROL "OBA") from 23-Feb-2021 to an unknown date and LACTULOSE (LACTULOSE "ORIFARM") from 14-Dec-2020 to an unknown date for Constipation, PLANTAGO OVATA HUSK (HUSK PSYLLIUM FLOHSAMENSCHALEN) from 14-Dec-2020 to an unknown date for Constipation chronic, FUROSEMIDE (FURIX [FUROSEMIDE]) from 19-Apr-2021 to an unknown date and SPIRONOLACTONE (SPIRIX) from 23-Apr-2021 to an unknown date for Diuretic therapy, LANSOPRAZOL from 02-Jul-2019 to 23-Apr-2021 for Esophageal acid reflux, MICONAZOLE NITRATE (BRENTAN [MICONAZOLE NITRATE]) from 12-Nov-2020 to 16-Apr-2021 for Fungal infection, FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE (DOLOPROCT [FLUOCORTOLONE PIVALATE;LIDOCAINE HYDROCHLORIDE]) from 26-Mar-2021 to an unknown date for Haemorrhoids, PARACETAMOL (PANODIL) from 10-Jan-2020 to an unknown date for Pain, ATORVASTATIN from 20-Apr-2021 to an unknown date for Thrombosis prophylaxis, CALCIUM, VITAMIN D SUBSTANCES (CALCIUM OG D-VITAMIN) for Vitamin D supplementation. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PERICARDITIS (Acute pericarditis) (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 15-May-2021. The reported cause of death was Acute pericarditis. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2020, Echocardiogram: unknown (Inconclusive) Mild aortic valve stenosis and normal EF. On 16-Apr-2021, Blood sodium: low (Low) Hyponatraemia. On 16-Apr-2021, C-reactive protein: high (High) Severe increased CRP. On 16-Apr-2021, Echocardiogram: unknown (Inconclusive) EF 55%, Normal right ventricle, mild valve pathology and hemodynamic mild pericardial effusion (fluid leakage).. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was given. This is a case of death in a 78-year-old male subject with a medical history of Aortic stenosis, who died 36 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No significant information for this follow up changing the previous causality assessment was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Translation received On 15-Jun-2021: laboratory data updated.; Sender''s Comments: This is a case of death in a 78-year-old male subject with a medical history of Aortic stenosis, who died 36 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No significant information for this follow up changing the previous causality assessment was reported.; Reported Cause(s) of Death: Acute pericarditis


VAERS ID: 1416158 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-13
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastric ulcer haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLATOR; VEROSPIRON; ASPIRIN PROTECT; CONCOR; DIAPREL; PERINDOPRIL ARGININE; METFOGAMMA
Current Illness: Diabetes mellitus; Dyspnoea on effort; Ischaemic cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Gastric ulcer haemorrhage; This regulatory authority case was reported by a physician and describes the occurrence of GASTRIC ULCER HAEMORRHAGE in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001940 and 3001650) for COVID-19 vaccination. Concurrent medical conditions included Dyspnoea on effort, Ischaemic cardiomyopathy and Diabetes mellitus. Concomitant products included AMLODIPINE BESILATE, ATORVASTATIN L-LYSINE (AMLATOR), SPIRONOLACTONE (VEROSPIRON), ACETYLSALICYLIC ACID (ASPIRIN PROTECT), BISOPROLOL FUMARATE (CONCOR), GLICLAZIDE (DIAPREL), PERINDOPRIL ARGININE and METFORMIN HYDROCHLORIDE (METFOGAMMA) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 04-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 13-May-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (seriousness criteria death and medically significant). The patient died on 24-May-2021. The reported cause of death was Gastric ulcer haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not provided. Gastric ulcer haemorrhage is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 9 days. Taking into account the presence of a gastric ulcer before the vaccination, and the runoff of the disease, causality between gastric ulcer haemorrhage and vaccination is unlikely. The case is serious because the patient died. No further information is expected.; Sender''s Comments: Gastric ulcer haemorrhage is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 9 days. Taking into account the presence of a gastric ulcer before the vaccination, and the runoff of the disease, causality between gastric ulcer haemorrhage and vaccination is unlikely. The case is serious because the patient died. No further information is expected.; Reported Cause(s) of Death: Gastric ulcer haemorrhage


VAERS ID: 1416160 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOCARD; ASACTAL; IRBESARTAN; MILURIT; MEZITAN; LECALPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Cardiac insufficiency; Dementia; Emphysema; Hypertension; Ischemic heart disease; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Patient was Covid 19 Negative.
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: DEATH; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis, Cardiac insufficiency, Dementia, Hypertension, Emphysema, Ischemic heart disease and Pulmonary embolism. Concomitant products included BISOPROLOL FUMARATE (BISOCARD), ACETYLSALICYLIC ACID (ASACTAL), IRBESARTAN, ALLOPURINOL (MILURIT), TRIMETAZIDINE HYDROCHLORIDE (MEZITAN) and LERCANIDIPINE HYDROCHLORIDE (LECALPIN) for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 16-May-2021 The patient died on 16-May-2021. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, SARS-CoV-2 test: unknown (Negative) Patient was Covid 19 Negative.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be unlikely related. Treatment information was not provided. This case concerns an 89-year-old female reported as hospitalization with a serious unexpected event of death associated with the patient''s primary diseases. Event latency 26 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender''s Comments: This case concerns an 89-year-old female reported as hospitalization with a serious unexpected event of death associated with the patient''s primary diseases. Event latency 26 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information is not expected.


VAERS ID: 1417055 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-04
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H20A / 1 UN / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carvedilol, Lovastatin, Furosemide, Protoxin.
Current Illness: Unknown.
Preexisting Conditions: Incontinence, HTN, GERD, Dyslipidemia, PAD/ PVD, OA.
Allergies: Unknown.
Diagnostic Lab Data: Unknown.
CDC Split Type:

Write-up: Died doe to unknown causes.


VAERS ID: 1418318 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIVA RESPIMAT; PARACETAMOL STADA; ACIDO ACETILSALICILICO MYLAN; PROLIA; BARNIX; DELTIUS; ZYLORIC; FOSTER NEXTHALER; VENTOLIN ACCUHALER; OMEPRAZOLE MYLAN [OMEPRAZOLE]; HYDREA
Current Illness: COPD; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Accident cerebrovascular; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Accident cerebrovascular) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial and COPD. Concomitant products included PARACETAMOL (PARACETAMOL STADA) for Ache, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT), BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTER NEXTHALER) and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for COPD, BARNIDIPINE HYDROCHLORIDE (BARNIX) for Hypertension arterial, DENOSUMAB (PROLIA) for Osteoporosis, OMEPRAZOLE (OMEPRAZOLE MYLAN [OMEPRAZOLE]) for Prophylaxis, ACETYLSALICYLIC ACID (ACIDO ACETILSALICILICO MYLAN) and HYDROXYCARBAMIDE (HYDREA) for Thrombocythemia, ALLOPURINOL (ZYLORIC) for Uric acid, COLECALCIFEROL (DELTIUS) for Vitamin D deficiency. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Subcutaneous) 1 dosage form. On 08-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Accident cerebrovascular) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Accident cerebrovascular. It is unknown if an autopsy was performed. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1418473 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke, Lymphocyte count increased
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer of lung
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma; Hypertension arterial; Hypertensive heart disease NOS
Allergies:
Diagnostic Lab Data: Test Name: Lymphocyte count increased; Result Unstructured Data: Increased for more than 2 years
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: accident vasculaire c?r?bral isch?mique; This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (accident vasculaire c?r?bral isch?mique) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial, Basal cell carcinoma and Hypertensive heart disease NOS. Concurrent medical conditions included Cancer of lung since 2021. On 10-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (accident vasculaire c?r?bral isch?mique) (seriousness criteria death, hospitalization and medically significant). The patient died on 15-May-2021. The reported cause of death was Ischemic stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lymphocyte count increased: increased (High) Increased for more than 2 years. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. Company Comment This case concerns an 82-year-old female with a serious unexpected event of ischaemic stroke with fatal outcome. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translation received on 17-jun-2021, updated with the lab data information.; Sender''s Comments: This case concerns an 82-year-old female with a serious unexpected event of ischaemic stroke with fatal outcome. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Ischemic stroke


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