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From the 1/14/2022 release of VAERS data:

Found 5,438 cases where Vaccine is COVID19 and Manufacturer is MODERNA and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1312437 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-04-25
   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: PREGABALINE; PANTOPRAZOLE; OXYCODONE; CLOZAPINE; SINEMET
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: asystolie; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (asystole) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included PREGABALINE, PANTOPRAZOLE, OXYCODONE, CLOZAPINE and CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for an unknown indication. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CARDIAC ARREST (asystole) (seriousness criterion death). The patient died on 25-Apr-2021. The reported cause of death was sudden death, asystole. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Limited information regarding the event or the patient''s medical history has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the event or the patient''s medical history has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: sudden death, asystole.


VAERS ID: 1313396 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042450 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), 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: 2021-01-24
   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: Artificial cardiac pacemaker user; Cardiomyopathy (Coronary and chronic valvular cardiomyopathy); Dementia (Severe dementia since 2014 Moderate dementia since 2011)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block second degree
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; convulsions; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and SEIZURE (convulsions) in a 96-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042450) for COVID-19 vaccination. The patient''s past medical history included Atrioventricular block second degree in 1995. Concurrent medical conditions included Cardiomyopathy (Coronary and chronic valvular cardiomyopathy), Dementia (Severe dementia since 2014 Moderate dementia since 2011) since 2011 and Artificial cardiac pacemaker user since 04-Oct-1995. On 21-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jan-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant). The patient died on 24-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE (convulsions) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment medication was provided. Company Comment: This is a case of death in a 96-year-old female subject with unknown medical history of Atrioventricular block second degree with cardiac pacemaker, Coronary and chronic valvular cardiomyopathy and Severe dementia, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translation received. NNI; Sender''s Comments: This is a case of death in a 96-year-old female subject with unknown medical history of Atrioventricular block second degree with cardiac pacemaker, Coronary and chronic valvular cardiomyopathy and Severe dementia, who died 3 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: 1313406 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 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: AMIODARONE; BISOPROLOL MEPHA; ELIQUIS; Fentanyl transdermal system; PREGABALINUM; TORASEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Atrial fibrillation; Blood pressure high; Hypertension; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This case was received via a regulatory authority (Reference number: 14776) on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in an 85-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. The patient''s past medical history included Blood pressure high, Atrial fibrillation, Stroke, Aortic valve insufficiency and Hypertension. Concomitant products included AMIODARONE, BISOPROLOL FUMARATE (BISOPROLOL MEPHA), APIXABAN (ELIQUIS), Fentanyl (Fentanyl transdermal system), PREGABALIN (PREGABALINUM) and TORASEMIDE for an unknown indication. On 19-Apr-2021 at 8:20 AM, 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. 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 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Tod) to be unlikely related. No treatment information was reported by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable. This is a case of death in a 85-year-old female subject with a medical history of Hypertension, Atrial fibrillation, Aortic valve insufficiency and Stroke, who died next day after receiving the second dose of vaccine. Based on reporter''s causality, the patient''s age and comorbid risk factors the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant Translated information regarding case narrative, reporter''s and sender''s comments, medical history, suspect and concomitant medication dosing, causality. Sender''s Comments: This is a case of death in a 85-year-old female subject with a medical history of Hypertension, Atrial fibrillation, Aortic valve insufficiency and Stroke, who died next day after receiving the second dose of vaccine. Based on reporter''s causality, the patient''s age and comorbid risk factors the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1313435 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dyspnoea, Headache, Limb discomfort, Productive cough
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Hypertension
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 an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Unknown cause of death), PRODUCTIVE COUGH, LIMB DISCOMFORT, HEADACHE and DYSPNOEA in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and. On 16-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCTIVE COUGH (seriousness criterion medically, LIMB DISCOMFORT (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant) and DYSPNOEA (seriousness criterion medically significant). The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCTIVE COUGH, LIMB DISCOMFORT, HEADACHE and DYSPNOEA had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication or treatment were provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1316341 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Haemorrhagic stroke, Magnetic resonance imaging head, Pyramidal tract syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021-04-17
   Days after onset: 8
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: ROSUVASTATIN; EXELON [RIVASTIGMINE]
Current Illness: Dementia vascular
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Encephalopathy
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Test Result: Inconclusive ; Result Unstructured Data: Bleeding in basal ganglia; Test Name: MRI brain; Test Result: Inconclusive ; Result Unstructured Data: Bleeding in basal ganglia
CDC Split Type: GRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; Pyramidal tract syndrome; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) and PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Encephalopathy and Dyslipidaemia. Concurrent medical conditions included Dementia vascular. Concomitant products included ROSUVASTATIN from 01-Apr-2015 to an unknown date and RIVASTIGMINE (EXELON [RIVASTIGMINE]) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criteria death, hospitalization prolonged and medically significant) and PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) (seriousness criterion hospitalization prolonged). The patient died on 17-Apr-2021. The reported cause of death was Pyramidal tract syndrome and Haemorrhagic stroke. It is unknown if an autopsy was performed. At the time of death, PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: bleeding in basal ganglia (Inconclusive) Bleeding in basal ganglia. On an unknown date, Magnetic resonance imaging head: bleeding in basal ganglia (Inconclusive) Bleeding in basal ganglia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: This is a case of death in a 71-year-old female subject with a medical history of Dementia vascular, Encephalopathy and Dyslipidemia, who died 11 days after receiving the vaccine. Based on information received and patient''s risk factors from the medical history, the event/death is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 71-year-old female subject with a medical history of Dementia vascular, Encephalopathy and Dyslipidemia, who died 11 days after receiving the vaccine. Based on information received and patient''s risk factors from the medical history, the event/death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Pyramidal tract syndrome; Haemorrhagic stroke


VAERS ID: 1316482 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration, Hypotonia, Respiratory rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: FIMODERNATX, INC.MOD20211

Write-up: Death; Breathing rate increased; Flaccidity; General physical health deterioration; Vomiting; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), RESPIRATORY RATE INCREASED (Breathing rate increased), HYPOTONIA (Flaccidity), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) and VOMITING (Vomiting) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Death) (seriousness criterion death), RESPIRATORY RATE INCREASED (Breathing rate increased) (seriousness criterion medically significant), HYPOTONIA (Flaccidity) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 21-Apr-2021, RESPIRATORY RATE INCREASED (Breathing rate increased), HYPOTONIA (Flaccidity), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) and VOMITING (Vomiting) outcome was unknown. The patient died on 21-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. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment: This is a case of death in a 80-year-old male subject with unknown medical history, who died one day 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 80-year-old male subject with unknown medical history, who died one day 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: 1318143 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-14
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: 2021-04-19
   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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: death; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 19-Apr-2021 The patient died on 19-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. A patient of an unknown age and gender who received mRNA-1273 died on an unknown days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Based on the current case data, this case has been classified as invalid. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A patient of an unknown age and gender who received mRNA-1273 died on an unknown days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Based on the current case data, this case has been classified as invalid. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1319043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Unevaluable event; This regulatory authority case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion death). The patient died on 08-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. On unknown date, patient had a negative COVID-19 virus test. Company Comment: A male patient of an unknown age who received mRNA-1273 died 3 days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A male patient of an unknown age who received mRNA-1273 died 3 days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1319089 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G267614A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: BISOCARD; VALSOCARD HCT; XANAX SR; SCIPPA; MILURIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Bronchitis; Hypertension; Obesity; Panic disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: Blood pressure; Result Unstructured Data: 125/70 mmHg; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: 35.8 degrees Celsius; Test Date: 20210403; Test Name: Pulse rate; Result Unstructured Data: 80/min; Test Date: 20210403; Test Name: Oxygen saturation; Test Result: 96 %; Result Unstructured Data: 96%
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G267614A) for COVID-19 vaccination. The patient''s past medical history included Arrhythmia, Obesity, Panic disorder, Hypertension and Bronchitis. Previously administered products included for Bronchitis: Zinnat. Concomitant products included BISOPROLOL FUMARATE (BISOCARD), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSOCARD HCT), ALPRAZOLAM (XANAX SR), ESCITALOPRAM OXALATE (SCIPPA) and ALLOPURINOL (MILURIT) for an unknown indication. On 03-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 03-Apr-2021 The patient died on 03-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 03-Apr-2021, Blood pressure measurement: 125/70 mmHg 125/70 mmHg. On 03-Apr-2021, Body temperature: 35.8 35.8 degrees Celsius. On 03-Apr-2021, Heart rate: 80 80/min. On 03-Apr-2021, Oxygen saturation: 96 % 96%. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 was Not applicable. The cause of Death is not reported. The patient died approximately 6 hours after vaccination with COVID-19 Vaccine Moderna. There is no information about the cause of death or whether autopsy was done. The causal relationship between the reported death and the vaccine is unassessable. The case is serious due to fatal outcome.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1319628 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001937 / 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: 2021-04-16
   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: Churg Strauss syndrome; COPD; Trigeminal neuralgia (Autopsy asked for, but no performed at the time of the report.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20211

Write-up: SUDDEN DEATH; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (SUDDEN DEATH) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001937) for COVID-19 vaccination. Concurrent medical conditions included COPD, Trigeminal neuralgia (Autopsy asked for, but no performed at the time of the report.) and Churg Strauss syndrome. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 16-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (SUDDEN DEATH) to be possibly related. No Concomitant medications were reported by the reporter. Treatment medications were not reported. Action taken with mRNA-1273 in response to the drug was not applicable. The reporter (29 years old physician) was asked in the feedback to provide an update on the autopsy result when they are available. Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided. Awaiting translation; Reporter''s Comments: .; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided. Awaiting translation; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1324815 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, 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: 2021-04-11
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Haemorrhage brain; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Haemorrhage brain) in an 80-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (Haemorrhage brain) (seriousness criteria death and medically significant). The patient was treated with Surgery (Brain surgery) for Cerebral haemorrhage. The patient died on 11-Apr-2021. The reported cause of death was Haemorrhage brain. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The reporter mentioned the patient underwent brain surgery for treatment of the event, stating "Brain surgery - successful for the first bleed, not the second." Very limited information regarding this event has been provided at this time for a causal assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time for a causal assessment.; Reported Cause(s) of Death: Haemorrhage brain


VAERS ID: 1325108 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
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: GBMODERNATX, INC.MOD20211

Write-up: rabies; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of RABIES (rabies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RABIES (rabies) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant medications were not reported. Treatment information was not reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown) dosage form. On an unknown date, the patient experienced RABIES (rabies) (seriousness criterion death). For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to event was not applicable. Very limited information regarding this event has been provided at this time. This case lacks information regarding the exact time to onset of the event, time to death, patient information, and clinical context.; Sender''s Comments: Very limited information regarding this event has been provided at this time. This case lacks information regarding the exact time to onset of the event, time to death, patient information, and clinical context.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1325163 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: INSULIN
Current Illness: Diabetes mellitus (Diabetes mellitus)
Preexisting Conditions: Comments: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRMODERNATX, INC.MOD20211

Write-up: Nemam podataka da li je bilo kakve neposredne reakcije; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Nemam podataka da li je bilo kakve neposredne reakcije) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. UNK) for COVID-19 vaccination. Diabetes mellitus. Concurrent medical conditions included Diabetes mellitus (Diabetes mellitus). Concomitant products included INSULIN for Diabetes mellitus. On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter once a day. Death occurred on 08-Apr-2021 The patient died on 08-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 reported by the reporter. Company Comment : This is a case of death in a 59-year-old male subject with a medical history of DM, who died 8 days after receiving the 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 59-year-old male subject with a medical history of DM, who died 8 days after receiving the 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: 1325297 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA in a 99-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiomyopathy NOS. On 16-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 17-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DYSPNOEA (seriousness criterion death). 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 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up (translation) report received on 06MAY2021 included no new information.; Sender''s Comments: This is a case of death in a 99-year-old female subject with a medical history of Cardiomyopathy NOS, who died 4 days after receiving the first dose of vaccine. Based on information received, patient''s age and cardiomyopathy with recurrent respiratory crisis, the event is assessed as unlikely related to mRNA-1273..; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1325300 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Erythema, Hyperhidrosis, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: AFib; Cardiac failure (HA class IV); Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: cardio-circulatory conditions worsened; This regulatory authority case was reported by a physician and describes the occurrence of CARDIOVASCULAR DISORDER (cardio-circulatory conditions worsened) in an 88-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cardiac failure (HA class IV), AFib and Parkinson''s disease. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIOVASCULAR DISORDER (cardio-circulatory conditions worsened) (seriousness criterion death). On 21-Apr-2021, the patient experienced ERYTHEMA, HYPERHIDROSIS , VOMITING and PYREXIA. The patient died on 21-Apr-2021. The reported cause of death was Cardiovascular disorder. An autopsy was not performed. At the time of death, ERYTHEMA , HYPERHIDROSIS , VOMITING and PYREXIA outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Immediately after the vaccination, the patient''s cardio-circulatory conditions worsened, which led to death. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was not applicable as the patient died. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Cause of death added and narrative updated. On 07-May-2021: No new information. On 10-May-2021: Autopsy done was updated to no On 11-May-2021: No new information.; Sender''s Comments: This is a case of death in a 88-year-old female subject with a medical history of Cardiac failure (HA class IV), A Fib and Parkinson''s disease, who died one day after receiving the first dose of vaccine. Although a temporal association exists, based on reporter''s causality, patient''s age and Cardiac failure (HA class IV), the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1326092 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655-01 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Pleural effusion, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 2021-04-29
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION and COVID-19 PNEUMONIA in a 95-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655-01) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 18-Apr-2021, the patient experienced PLEURAL EFFUSION (seriousness criterion death) and COVID-19 PNEUMONIA (seriousness criterion death). The patient died on 29-Apr-2021. The reported cause of death was Effusion pleural and COVID-19 pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided by the reporter. Covid infection between the first and second dose: positive covid-19 molecular test. Onset of bronchopneumonia with pleural effusion due to covid-19 in a patient who was vaccinated at home on 08 April 2021. The patient was hospitalized due to effusion pleural and COVID-19 pneumonia. Treatment of the events was not reported. ADRs transferred to the a regulatory authorities on 22 Apri 2021. The reporter was asked to edit the profile. 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. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translation uploaded. On 14-May-2021: Updated outcome of events from not resolved to fatal. Added serious criteria of events to death, added death details.; 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: Effusion pleural; COVID-19 pneumonia


VAERS ID: 1326382 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Coronary artery occlusion
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: GLUCOPHAGE; MOXONIDINE; COAPROVEL; ROSUVASTATIN; ASAFLOW; EZETROL; AMLOR; KREDEX; NOVOMIX; PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness: Coronary heart disease; Diabetes (requiring insulin); Esophagitis; Hypertension; Hypothyroidism; Renal disease
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery (Double bypass); Infarction; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Coronary artery occlusion; Cardiovascular disorder; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CORONARY ARTERY OCCLUSION and CARDIOVASCULAR DISORDER in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Infarction, Bypass surgery (Double bypass) and Pacemaker insertion (cardiac). Concurrent medical conditions included Coronary heart disease, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis. Concomitant products included METFORMIN HYDROCHLORIDE (GLUCOPHAGE), MOXONIDINE, HYDROCHLOROTHIAZIDE, IRBESARTAN (COAPROVEL), ROSUVASTATIN, ACETYLSALICYLIC ACID (ASAFLOW), EZETIMIBE (EZETROL), AMLODIPINE BESILATE (AMLOR), CARVEDILOL (KREDEX), INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication. On 14-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) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced CORONARY ARTERY OCCLUSION (seriousness criterion death) and CARDIOVASCULAR DISORDER (seriousness criterion death). The patient died on 20-Apr-2021. The reported cause of death was Coronary occlusion. 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 treatment information was provided. Company Comment: This is a case of death in a 85-year-old male subject with a medical history of Coronary heart disease with CABG and Pacemaker insertion, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis, who died 6 days after receiving the second dose of vaccine. Based on the reports causality that coronary occlusion led to the death of the patient, the death is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up report received on 10MAY2021 included medical history and cause of death information. On 10-May-2021: Additional information added included no new information; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Coronary heart disease with CABG and Pacemaker insertion, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis, who died 6 days after receiving the second dose of vaccine. Based on the reports causality that coronary occlusion led to the death of the patient, the death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Coronary occlusion


VAERS ID: 1326422 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000 4273 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: TEMESTA EXPIDET; PARACETAMOL SANDOZ; NOVALGIN [METAMIZOLE SODIUM]; MEFENAMIC ACID; VITARUBIN [HYDROXOCOBALAMIN ACETATE]; TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral insufficiency (Unknown date of diagnosis)
Allergies:
Diagnostic Lab Data: Test Date: 20191210; Test Name: Blood creatinine; Result Unstructured Data: 86 micromole per litre
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 96-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000 4273) for COVID-19 immunisation. The patient''s past medical history included Mitral insufficiency (Unknown date of diagnosis). Concomitant products included LORAZEPAM (TEMESTA EXPIDET), PARACETAMOL (PARACETAMOL SANDOZ), METAMIZOLE SODIUM (NOVALGIN [METAMIZOLE SODIUM]), MEFENAMIC ACID, HYDROXOCOBALAMIN ACETATE (VITARUBIN [HYDROXOCOBALAMIN ACETATE]) and MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS (TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDROUS]) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 15-Feb-2021 The patient died on 15-Feb-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 10-Dec-2019, Blood creatinine: 86 micromole per litre (normal) 86 micromole per litre. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be unlikely related. No treatment information was provided. As patient died, action taken with respect to mRNA-1273 was not applicable. This is a case of death in a 96-year-old male subject with a medical history of Mitral insufficiency, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021 contains no new information.; Sender''s Comments: This is a case of death in a 96-year-old male subject with a medical history of Mitral insufficiency, who died one day 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: 1329626 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
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: 2021-04-15
   Days after onset: 5
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: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Atrial fibrillation. On 07-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 10-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (seriousness criteria death, hospitalization and medically significant). The patient died on 15-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a case of death in a 81-year-old female subject with a medical history of Atrial fibrillation, who died 8 days after receiving the second 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 81-year-old female subject with a medical history of Atrial fibrillation, who died 8 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Stroke


VAERS ID: 1331563 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 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: 2021-04-20
   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: Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Ischaemic heart disease. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 20-Apr-2021. The reported cause of death was mort subite. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The action taken with mRNA-1273 was not applicable. Company Comment: This is a case of death in a 90-year-old male subject with a medical history of Ischaemic heart disease, who died 10 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 90-year-old male subject with a medical history of Ischaemic heart disease, who died 10 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: Mort subite


VAERS ID: 1332294 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: CRESTASTATIN; NEBIVOLOL STREULI
Current Illness: Arterial hypertension; Hypercholesteraemia; Hypertonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; unconsciousness; malaise; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), MALAISE (malaise) and LOSS OF CONSCIOUSNESS (unconsciousness) in a 76-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001530) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension, Hypercholesteraemia and Hypertonia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTASTATIN) from 09-Feb-2021 to 11-Apr-2021 and NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL STREULI) from an unknown date to 11-Apr-2021 for an unknown indication. On 08-Apr-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MALAISE (malaise) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced DEATH (Death) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (unconsciousness) (seriousness criterion medically significant). The patient died on 11-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, MALAISE (malaise) outcome was unknown and LOSS OF CONSCIOUSNESS (unconsciousness) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) and MALAISE (malaise) to be unlikely related and LOSS OF CONSCIOUSNESS (unconsciousness) to be not related. On 08 Apr 2021, the patient received moderna vaccine and experienced malaise alone after 3 hours. On 11 Apr 2021,while the patient went to the fridge experienced unconsciousness and unsuccessful resuscitation. The death was reported as completely unexpected by the treating physician No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 76-year-old male subject with a medical history of hypertension, Hypercholesteraemia and Hypertonia, who died 3 days after receiving the vaccine. Autopsy was not performed, based on the reporters acute cardiovascular event could have led to the patient''s death the causality to the vaccine is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received on 13 May 2021.Translation uploaded.Added medical history.; Sender''s Comments: This is a case of death in a 76-year-old male subject with a medical history of hypertension, Hypercholesteraemia and Hypertonia, who died 3 days after receiving the vaccine. Autopsy was not performed, based on the reporters acute cardiovascular event could have led to the patient''s death the causality to the vaccine is assessed as unlikely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1332307 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insulin-requiring type 2 diabetes mellitus; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Death NOS; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Insulin-requiring type 2 diabetes mellitus and Ischaemic heart disease. On 15-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 25-Mar-2021 The patient died on 25-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 did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021044924 Limited information regarding the death, including the cause of death, has been provided at this time and a causal relationship cannot be excluded. The patient''s underlying conditions may have contributed to their death; Sender''s Comments: Limited information regarding the death, including the cause of death, has been provided at this time and a causal relationship cannot be excluded. The patient''s underlying conditions may have contributed to their death; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1333061 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aneurysm ruptured, Blood pressure measurement, C-reactive protein, Fatigue, Glomerular filtration rate, Headache, Nausea, Procalcitonin, Pyrexia, Subarachnoid haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATACAND; ASPIRIN CARDIO; CALCIMAGON; ZANIDIP; TORASEMID; NEPHROTRANS
Current Illness: Arterial hypertension; Chronic renal insufficiency; Ischaemic heart disease; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: Blood pressure; Result Unstructured Data: 197/68; Test Date: 20210403; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 7.43 mmol/L; Test Date: 20210406; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 167 mg/L; Test Date: 20210406; Test Name: Estimated glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: 7 ml/min/1.73m2; Test Date: 20210406; Test Name: Procalcitonin; Test Result: Inconclusive ; Result Unstructured Data: 2.26 microgram per litre
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: aneurysm rupture; headache; fever; Fatigue; Nausea; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SUBARACHNOID HAEMORRHAGE, ANEURYSM RUPTURED (aneurysm rupture), HEADACHE (headache), PYREXIA (fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 30042460) for COVID-19 vaccination. The patient''s past medical history included Acute myocardial infarction and Stroke. Concurrent medical conditions included Arterial hypertension, Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy. Concomitant products included CANDESARTAN CILEXETIL (ATACAND), ACETYLSALICYLIC ACID (ASPIRIN CARDIO) from 03-Apr-2021 to an unknown date, CALCIUM (CALCIMAGON [CALCIUM]), LERCANIDIPINE HYDROCHLORIDE (ZANIDIP), TORASEMIDE (TORASEMID) and SODIUM BICARBONATE (NEPHROTRANS) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (headache) (seriousness criteria medically significant and life threatening), PYREXIA (fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Apr-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (seriousness criteria death and medically significant) and ANEURYSM RUPTURED (aneurysm rupture) (seriousness criteria death and medically significant). On 17-Apr-2021, PYREXIA (fever) and FATIGUE (Fatigue) outcome was unknown. 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, HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, C-reactive protein: 7.43 mmol/l (Inconclusive) 7.43 mmol/L. On 06-Apr-2021, C-reactive protein: 167 mg/l (Inconclusive) 167 mg/L. On 06-Apr-2021, Glomerular filtration rate: 7 ml/min/1.73m2 (Inconclusive) 7 ml/min/1.73m2. On 06-Apr-2021, Procalcitonin: 2.26 (Inconclusive) 2.26 microgram per litre. On 08-Apr-2021, Blood pressure measurement: 197/68 (High) 197/68. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered HEADACHE (headache), PYREXIA (fever), FATIGUE (Fatigue) and NAUSEA (Nausea) to be probably related and SUBARACHNOID HAEMORRHAGE and ANEURYSM RUPTURED (aneurysm rupture) to be unlikely related. No treatment medications were reported. This is a case of death in a 78-year-old female subject with a medical history of Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy, who died 17 days after receiving the first dose of vaccine. Although a temporal association exists, based on the current available information, that the aneurysm rupture leading to subarachnoid hemorrhage and death, the events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: MAH causality and narrative updated according to the company comment. Serious criteria for some events changed.; Sender''s Comments: This is a case of death in a 78-year-old female subject with a medical history of Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy, who died 17 days after receiving the first dose of vaccine. Although a temporal association exists, based on the current available information, that the aneurysm rupture leading to subarachnoid hemorrhage and death, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1333063 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-09
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apraxia, Death, General physical health deterioration, Hypokinesia, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 31
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 (Reported no significant symptoms, no complications and with favorable progress.); Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Inability to swallow; Inability to move spontaneously; Gradual decline in her general conditions; Death; multiple epileptic Seizure; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), SEIZURE (multiple epileptic Seizure), APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) in an 87-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Dementia in 2020 and COVID-19 (Reported no significant symptoms, no complications and with favorable progress.) in 2020. On 29-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SEIZURE (multiple epileptic Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced APRAXIA (Inability to swallow) (seriousness criterion medically significant), HYPOKINESIA (Inability to move spontaneously) (seriousness criterion medically significant) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, SEIZURE (multiple epileptic Seizure) had not resolved and APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) outcome was unknown. Patient experienced multiple epileptic seizures within a 24-hour period an event that to a gradual decline in her general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair). Swallowing was compromised to the point that would not eat anything other than blended food. Following the gradual decline, palliative care was set up. No investigations of any kind were carried out by the medical staff. Concomitant product use was not provided by the reporter. This case concerns an 87-year-old woman, residing in a care home for elderly people, known to have dementia and previous COVID-19 disease in 2020, with no significant symptoms, no complications and with favourable progress. Usual pharmacotherapy unknown. No known allergies. On 29-Jan-2021, the woman was vaccinated with the first dose of the Moderna Covid-19 vaccine. No adverse reactions were reported. Approximately one month later, on 05-Mar-2021, the woman was vaccinated with the second dose of the Moderna Covid-19 vaccine. On 09-Mar-2021, the woman experienced multiple epileptic seizures within a 24-hour period, an event that to a gradual decline in here general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair). Swallowing was compromised to the point that would not eat anything other than blended food. Following the gradual decline, palliative care was set up. The patient was confirmed deceased on 10-Apr-2021. No investigations of any kind were carried out by the medical staff. Action taken with m-RNA-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 events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Translation received. Narrative updated.; 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1333066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Cardiac death, Chills, Fatigue, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: BISOPROLOL; XARELTO; PERINDOPRIL; ATORVASTAX; XENALON
Current Illness: Atrial fibrillation; Drug allergy (Allergy to Acemetacin); Heart failure; Hypercholesterolemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: found unconscious; cardiac death; considerable exhaustion; severe pain in the lower abdomen; chills; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC DEATH (cardiac death) and LOSS OF CONSCIOUSNESS (found unconscious) in a 79-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 Atrial fibrillation, Hypertension, Hypercholesterolemia, Heart failure and Drug allergy (Allergy to Acemetacin). Concomitant products included BISOPROLOL from 29-Sep-2020 to an unknown date, RIVAROXABAN (XARELTO) from 26-Mar-2015 to an unknown date, PERINDOPRIL from 26-Mar-2014 to an unknown date, ATORVASTATIN CALCIUM (ATORVASTAX) from 29-Apr-2014 to an unknown date and SPIRONOLACTONE (XENALON) from 25-Jan-2019 to an unknown date for an unknown indication. In March 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 03-Apr-2021, the patient experienced CHILLS (chills). On 04-Apr-2021, the patient experienced ABDOMINAL PAIN LOWER (severe pain in the lower abdomen). On 05-Apr-2021, the patient experienced CARDIAC DEATH (cardiac death) (seriousness criterion death) and FATIGUE (considerable exhaustion). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (found unconscious) (seriousness criterion medically significant). On 05-Apr-2021, LOSS OF CONSCIOUSNESS (found unconscious) outcome was unknown. The patient died on 05-Apr-2021. The reported cause of death was suspected sudden cardiac death. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN LOWER (severe pain in the lower abdomen), CHILLS (chills) and FATIGUE (considerable exhaustion) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC DEATH (cardiac death) to be unlikely related. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (found unconscious), ABDOMINAL PAIN LOWER (severe pain in the lower abdomen), CHILLS (chills) and FATIGUE (considerable exhaustion). Follow-up received on 13-May-2021 was significant and included the appended translation document and additional information based on the narrative was updated. On an unspecified date, it was reported that the patient developed severe pain in the lower abdomen two days after the second dose of covid-19 vaccine and made an emergency medical visit. No treatment information was provided, but it was reported that "nothing in particular" was found. It was reported that the pain improved, but the patient experienced considerable exhaustion. On an unspecified date, three days after the vaccination, it was reported that the patient was found unconscious and resuscitation was unsuccessful. Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded, although the patient''s concurrent conditions were likely related to their death. Awaiting translation for additional information. Sender''s Comment: Sudden cardiac death in a 79-year-old patient known to have heart disease 3 days after the second injection of the Moderna covid-19 vaccine. The countries monograph for the Moderna covid-19 vaccine does not list cases of death under the side effects (1). The database, in the Moderna covid-19 vaccine monograph (2), out of 49,811 reports, lists 1441 cases of death. In light of the literature data and information available to us, considering the cardiological comorbidities of the patient, despite the close temporal link, we consider a link between the sudden cardiac death and the Moderna covid-19 vaccine as unlikely. This view on causality cannot, however, entirely rule out the role/contribution of the vaccine. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided, although the patient''s concurrent conditions were possibly related to their death. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Translated document received on 13 MAY 2021 with no new information; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided, although the patient''s concurrent conditions were possibly related to their death. .; Reported Cause(s) of Death: Suspected sudden cardiac death


VAERS ID: 1333071 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, COVID-19 pneumonia, Heart rate, Influenza like illness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 19
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: Arterial hypertension (for 30 years); Benign prostatic hyperplasia; Ischemic heart disease (for 30 years); Large intestine carcinoma; Parkinson''s syndrome; Type II diabetes mellitus (for 30 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Skin malignant melanoma excision (on the back)
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 202104; Test Name: Heart rate; Result Unstructured Data: normal
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (oboustrann� covid-19 pneumonie) in a 96-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 Skin malignant melanoma excision (on the back) and Cholecystectomy. Concurrent medical conditions included Parkinson''s syndrome, Benign prostatic hyperplasia, Large intestine carcinoma since 2019, Arterial hypertension (for 30 years), Type II diabetes mellitus (for 30 years) and Ischemic heart disease (for 30 years). On 02-Apr-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 INFLUENZA LIKE ILLNESS. On 15-Apr-2021, the patient experienced COVID-19 PNEUMONIA (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced PYREXIA. The patient died on 21-Apr-2021. The reported cause of death was COVID-19 pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive Positive. In April 2021, Blood pressure measurement: normal normal. In April 2021, Heart rate: normal normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment for the events were not provided. No Concomitant medications were provided Company comment: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. This case was linked to CZ-CZSUKL-21004569 (E2B Linked Report).; Sender''s Comments: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. CZ-CZSUKL-21004569:; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1333099 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDROL; APO-FAMOTIDIN; XETER; SALAZOPYRIN
Current Illness: Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: GERD; Hypercholesteraemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of FATIGUE and ASTHENIA in a 56-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 GERD and Hypercholesteraemia. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included FAMOTIDINE (APO-FAMOTIDIN) for GERD, ROSUVASTATIN CALCIUM (XETER) from 02-Feb-2021 to an unknown date for Hypercholesteraemia, methylprednisolone (MEDROL) and SULFASALAZINE (SALAZOPYRIN) for Rheumatoid arthritis. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 03-Apr-2021, the patient experienced FATIGUE (seriousness criterion death) and ASTHENIA (seriousness criterion death). The patient died on 12-Apr-2021. The reported cause of death was Fatigue and Weakness. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered FATIGUE and ASTHENIA to be possibly related. No treatment information was provided. This is a case of death in a 56-year-old female subject with a medical history of GERD, Hypercholesteraemia and Rheumatoid arthritis, who died 10 days after receiving the 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 56-year-old female subject with a medical history of GERD, Hypercholesteraemia and Rheumatoid arthritis, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Fatigue; weakness


VAERS ID: 1333104 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oxygen saturation, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease Parkinson''s; Hypercholesterolaemia; Hypertension; Lung neoplasm surgery; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Oxygen saturation
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of TACHYCARDIA in a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Hypercholesterolaemia, Disease Parkinson''s, Hypertension, Lung neoplasm surgery and Radiotherapy. Previously administered products included for an unreported indication: ATORVASTATINA EG, NITROGLICERINA ZENTIVA, AXAGON [ESOMEPRAZOLE MAGNESIUM], LEXOTAN, DIURESIX [TORASEMIDE], TARGIN, ESKIM and PLAVIX. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TACHYCARDIA (seriousness criterion death) and VOMITING. The patient died on 02-Apr-2021. The reported cause of death was Vomiting, Oxygen saturation low and Tachycardia. It is unknown if an autopsy was performed. At the time of death, VOMITING, outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Oxygen saturation: low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant product use was not 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 events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: FU added On 10-May-2021: Vaccine Dose number added; Reported Cause(s) of Death: Vomiting; Oxygen saturation low; Tachycardia


VAERS ID: 1333110 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: APROVEL; DOXAZOSIN; CATAPRESAN TTS-2; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; PROGRAF; DIDROGYL; EUTIROX; PANTOPRAZOLE; ACARBOSE; METFORMIN; MEDROL [METHYLPREDNISOLONE]; ROCALTROL
Current Illness: Diabetes; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: (8 APRILE 2021 1^ DOSE) (8 APRILE 2021 1^ DOSE); This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN ((8 APRILE 2021 1^ DOSE)) and MYALGIA ((8 APRILE 2021 1^ DOSE) ) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Renal transplant. Concurrent medical conditions included Diabetes, Hypertension arterial and Hypothyroidism. Concomitant products included ACARBOSE and METFORMIN for Diabetes, IRBESARTAN (APROVEL), DOXAZOSIN and CLONIDINE (CATAPRESAN TTS-2) for Hypertension arterial, LEVOTHYROXINE SODIUM (EUTIROX) for Hypothyroidism, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), TACROLIMUS (PROGRAF) and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Renal transplant, CALCIFEDIOL (DIDROGYL), PANTOPRAZOLE and CALCITRIOL (ROCALTROL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CHEST PAIN ((8 APRILE 2021 1^ DOSE)) (seriousness criterion death) and MYALGIA ((8 APRILE 2021 1^ DOSE)) (seriousness criterion death). The patient died on 17-Apr-2021. The reported cause of death was Pain retrosternal and Pain muscle. 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. Action taken with mRNA-1273 with respect to the events was not applicable. This is a case of death in a 63-year-old female subject with a medical history of Renal transplant, Diabetes, Hypertension arterial and Hypothyroidism, who died 9 days after receiving the first dose of vaccine. Very limited information has been provided at this time. Death report is not available. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old female subject with a medical history of Renal transplant, Diabetes, Hypertension arterial and Hypothyroidism, who died 9 days after receiving the first dose of vaccine. Very limited information has been provided at this time. Death report is not available. No follow up is possible.; Reported Cause(s) of Death: pain retrosternal; pain muscle


VAERS ID: 1333116 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-25
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Chest pain, Confusional state, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   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: Chronic kidney disease (Chronic renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Dyslipidemia; End ileostomy (under palliative care); Gastritis chronic; Hysterectomy; Ileocecal resection; Microvascular angina; Sigmoid diverticulitis; Syncope; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Aggravated chronic kidney disease; Thoracic pain; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), ACUTE KIDNEY INJURY (Aggravated chronic kidney disease), CONFUSIONAL STATE and CHEST PAIN (Thoracic pain) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Dyslipidemia, Arterial hypertension, Syncope, Type II diabetes mellitus, Microvascular angina, Gastritis chronic, COVID-19, Ileocecal resection, Sigmoid diverticulitis, End ileostomy (under palliative care) on 25-Mar-2021 and Hysterectomy. Concurrent medical conditions included Chronic kidney disease (Chronic renal insufficiency). On 25-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 25-Mar-2021, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml in total. On 25-Mar-2021, the patient experienced ACUTE KIDNEY INJURY (Aggravated chronic kidney disease) (seriousness criterion medically significant), CONFUSIONAL STATE (seriousness criterion medically significant) and CHEST PAIN (Thoracic pain) (seriousness criterion medically significant). The patient died on 06-Apr-2021. The reported cause of death was Chronic renal insufficiency. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Aggravated chronic kidney disease) and CONFUSIONAL STATE outcome was unknown and CHEST PAIN (Thoracic pain) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. It was reported that patient was already under palliative care due to kidney disease and having rejected dialysis. Per MR - End ileostomy removed from events and added to medical history. This is a case of death in a 87-year-old female subject with a medical history of ileostomy (under palliative care) and Chronic kidney disease, who died 12 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Company Comment: This is a case of death in a 87-year-old female subject with a medical history of HTN, DM, CKD, Syncope, Angina, Gastritis, Sigmoid diverticulitis with resection, Covid-19 and Hysterectomy, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Translated document received on 04 May 2021 has no new information. On 11-May-2021: Follow-up provide medical history and an additional event.; Reported Cause(s) of Death: Chronic renal insufficiency


VAERS ID: 1333122 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-13
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: HYDROXYCARBAMIDE CAPSULE 500MG / Brand name not specified; PANTOPRAZOL TABLET MSR 20MG / Brand name not specified; ACETYLSALICYLZUUR TABLET 80MG / Brand name not specified
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-May-2021 and was forwarded to Moderna on 12-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Unknown cause of death) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concomitant products included HYDROXYCARBAMIDE CAPSULE 500MG / Brand name not specified from 04-Mar-2021 to an unknown date, PANTOPRAZOL TABLET MSR 20MG / Brand name not specified and ACETYLSALICYLZUUR TABLET 80MG / Brand name not specified for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 13-Apr-2021 The patient died on 13-Apr-2021. The cause of death was not reported. An autopsy was not 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 death in a 70-year-old male subject with a possible medical history of chronic myelogenous leukemia (because of concomitant HYDROXYCARBAMIDE), who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: A follow up received on 13 May 2021 has no new information; Sender''s Comments: This is a case of death in a 70-year-old male subject with a possible medical history of chronic myelogenous leukemia (because of concomitant HYDROXYCARBAMIDE), who died 16 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: 1336219 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 2 - / OT

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

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

Write-up: Cerebral bleeding; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral bleeding) and FATIGUE (Tiredness) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. unknown and unknown) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (Tiredness) (seriousness criteria death and hospitalization). In April 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cerebral bleeding. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of death in a 92-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died approximately within a month after receiving the second 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 92-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died approximately within a month after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1336375 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
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: BEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of ARRHYTHMIA in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, 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 experienced ARRHYTHMIA (seriousness criteria death and medically significant). The patient died on 16-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 medications reported by investigator. Treatment of this event was not reported. This is a case of death in a 35-year-old female subject with unknown medical history, who died one day 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 35-year-old female subject with unknown medical history, who died one day 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: 1336380 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CNK: 4301081 / 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. CNK: 4301081) for COVID-19 vaccination. No Medical History information was reported. On 28-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. 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) (Unknown), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 in response to the event is not applicable. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death and patient''s history and concurrent conditions not provided confounded assessment; Reporter''s Comments: Treatment. Evolution of the ADR; 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. Cause of death and patient''s history and concurrent conditions not provided confounded assessment; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1338217 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, Chest X-ray, Death, Glycosylated haemoglobin, Infection, Pollakiuria, Ultrasound kidney, Urine albumin/creatinine ratio, Urogram, White blood cell count
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: 2021-04-08
   Days after onset: 37
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: Albuminuria; Confused; Diabetes (present through a longer period); Fall (Fell mutiple times during hospitalisation); Hypertension; Hyperthyroidism; Renal failure (kidney failure had been present for a longer period)
Preexisting Conditions: Medical History/Concurrent Conditions: Polio
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Elevating during hospitalisation from 214 �mol/L to 337 �mol/L; Test Name: Potassium; Result Unstructured Data: nothing abnormal; Test Name: Sodium; Result Unstructured Data: Nothing abnormal; Test Date: 20210407; Test Name: Thorax X-ray; Result Unstructured Data: small pleural accumulation, no obvious infiltrates; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Date: 20210405; Test Name: C-reactive protein; Result Unstructured Data: elevating to 225 mg/L; Test Name: HbA1C; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Name: Ultrasound kidney; Result Unstructured Data: No drainage obstruction; Test Name: Urine albumin/creatinine ratio; Test Result: Inconclusive ; Result Unstructured Data: No results were provided.; Test Name: CT Urography; Result Unstructured Data: Cholecystolithiasis, normal size kidney; Test Name: Leukocyte count; Test Result: Inconclusive ; Result Unstructured Data: Not convincingly decreasing during hospitalisation
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Kidney failure Can have been present through a longer period.; Death; Infection during hospitalisation increasing infection parameters; Frequent urination; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.), INFECTION (Infection during hospitalisation increasing infection parameters) and POLLAKIURIA (Frequent urination) in an 83-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 Polio. Concurrent medical conditions included Hyperthyroidism since 30-Mar-2021, Renal failure (kidney failure had been present for a longer period), Hypertension, Albuminuria since 30-Mar-2021, Fall (Fell mutiple times during hospitalisation), Diabetes (present through a longer period) and Confused since 30-Mar-2021. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced POLLAKIURIA (Frequent urination) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced INFECTION (Infection during hospitalisation increasing infection parameters) (seriousness criterion hospitalization). On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.) (seriousness criteria hospitalization and medically significant). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Kidney failure Can have been present through a longer period.), INFECTION (Infection during hospitalisation increasing infection parameters) and POLLAKIURIA (Frequent urination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, C-reactive protein: 225 (High) elevating to 225 mg/L. On 07-Apr-2021, Chest X-ray: abnormal (abnormal) small pleural accumulation, no obvious infiltrates. On an unknown date, Blood creatinine: 337 (High) Elevating during hospitalisation from 214 �mol/L to 337 �mol/L. On an unknown date, Blood potassium: normal (normal) nothing abnormal. On an unknown date, Blood sodium: normal (normal) Nothing abnormal. On an unknown date, C-reactive protein: unknown (Inconclusive) No results were provided.. On an unknown date, Glycosylated haemoglobin: unknown (Inconclusive) No results were provided.. On an unknown date, Ultrasound kidney: normal (normal) No drainage obstruction. On an unknown date, Urine albumin/creatinine ratio: unknown (Inconclusive) No results were provided.. On an unknown date, Urogram: abnormal (abnormal) Cholecystolithiasis, normal size kidney. On an unknown date, White blood cell count: unknown (Inconclusive) Not convincingly decreasing during hospitalisation. 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. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 83-year-old male subject with a medical history of HTN, DM and Hyperthyroidism, who died 21 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 83-year-old male subject with a medical history of HTN, DM and Hyperthyroidism, who died 21 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: Death


VAERS ID: 1338219 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Dyspnoea, Hypokalaemia, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 5
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: LOSARSTAD; METOPROLOL; NORVASC; CENTYL MED
Current Illness: Aortic stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: acute coronary syndrome; Hypokalaemia; Oedema; Dyspnoea; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE CORONARY SYNDROME (acute coronary syndrome), HYPOKALAEMIA (Hypokalaemia), OEDEMA (Oedema) and DYSPNOEA (Dyspnoea) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. Concurrent medical conditions included Aortic stenosis. Concomitant products included LOSARTAN POTASSIUM (LOSARSTAD) from 29-Oct-2009 to an unknown date, METOPROLOL from 08-Nov-2010 to an unknown date, AMLODIPINE BESILATE (NORVASC) from 22-Jun-2018 to an unknown date and BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE (CENTYL MED) from 09-Sep-2014 to an unknown date for Hypertension. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ACUTE CORONARY SYNDROME (acute coronary syndrome) (seriousness criteria death, hospitalization, medically significant and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization and medically significant), OEDEMA (Oedema) (seriousness criterion hospitalization) and DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). The patient died on 10-Apr-2021. The reported cause of death was Acute coronary syndrome. An autopsy was performed, but no results were provided. At the time of death, HYPOKALAEMIA (Hypokalaemia), OEDEMA (Oedema) and DYSPNOEA (Dyspnoea) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 79-year-old male subject with unknown medical history of HTN, and Aortic stenosis, who died 14 days after receiving the first dose of vaccine. Based on information received, patient''s rage and risk factors for acute coronary syndrome, the events are assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 79-year-old male subject with unknown medical history of HTN, and Aortic stenosis, who died 14 days after receiving the first dose of vaccine. Based on information received, patient''s rage and risk factors for acute coronary syndrome, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute coronary syndrome


VAERS ID: 1339262 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary oedema, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (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 (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: PLAVIX; DROMOS; HUMALOG; ATORVASTATIN CALCIUM; METFORAL; ANTRA [OMEPRAZOLE MAGNESIUM]; NORVASC; KARVEA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA ; Diabetes mellitus; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021. The most recent information was received on 14-May-2021 and was forwarded to Moderna on 14-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE and DYSPNOEA in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The patient''s past medical history included CVA , Diabetes mellitus and Hypertensive heart disease Previously administered products included for an unreported indication: PREVENAR 13 on 18-Nov-2014 and FLUAD QUAD on 29-Oct-2020. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LEVOCARNITINE PROPIONATE HYDROCHLORIDE (DROMOS), INSULIN LISPRO (HUMALOG), ATORVASTATIN CALCIUM, METFORMIN HYDROCHLORIDE (METFORAL), OMEPRAZOLE MAGNESIUM (ANTRA [OMEPRAZOLE MAGNESIUM]), AMLODIPINE BESILATE (NORVASC) and IRBESARTAN (KARVEA) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 29-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 30-Apr-2021, the patient experienced RESPIRATORY FAILURE; PULMONARY OEDEMA (seriousness criterion death) and DYSPNOEA (seriousness criterion death). The patient died on 01-May-2021. The reported cause of death was Respiration failure, Oedema lung and Dyspnea. 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 medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14may2021 includes Patients medical history, Dose 1 start date, Concomitant medications , past drug history. On 18-May-2021: NNI; 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. All events conservatively retained as fatal / cause of death as SD Authority assessment shows them all as resulting in death although it is likely that dyspnea was a symptom of pulmonary edema which in turn resulted in respiratory failure.; Reported Cause(s) of Death: Respiration failure; Oedema lung; Dyspnea


VAERS ID: 1342802 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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:
Current Illness: Age-related macular degeneration; Glaucoma; Hypercholesteremia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Malaise; This regulatory authority case was reported by a physician and describes the occurrence of DEATH and MALAISE (Malaise) in a 75-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesteremia, Age-related macular degeneration and Glaucoma. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MALAISE (Malaise) (seriousness criterion medically significant). The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, MALAISE (Malaise) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MALAISE (Malaise) to be possibly related and DEATH to be unlikely related. No concomitant medications were reported. Treatment details was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear if the reported malaise was associated with the death of the patient and cause of death is not provided. Two dates of death reported in SD and later one retained; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear if the reported malaise was associated with the death of the patient and cause of death is not provided. Two dates of death reported in SD and later one retained; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1342830 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Oxygen saturation decreased
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (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:
Current Illness: Aortic valve stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100056376

Write-up: Acute dyspnea; Oxygen saturation decreased; Decompensation cardiac; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Acute dyspnea), OXYGEN SATURATION DECREASED (Oxygen saturation decreased) and CARDIAC FAILURE (Decompensation cardiac) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Aortic valve stenosis. 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 (Acute dyspnea) (seriousness criterion death), OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criterion death) and CARDIAC FAILURE (Decompensation cardiac) (seriousness criteria death and medically significant). The patient died on 28-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. Resuscitation was done on 28-apr-2021. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Events conservatively all retained as resulting in death per Authority assessment / reporting in SD although it is unknown if an autopsy was performed and the captured decreased oxygen saturation and dyspnea are likely effects of the also captured heart failure; 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. Events conservatively all retained as resulting in death per Authority assessment / reporting in SD although it is unknown if an autopsy was performed and the captured decreased oxygen saturation and dyspnea are likely effects of the also captured heart failure; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1344443 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Nasopharyngitis, Renal failure, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20211

Write-up: Confusional state; Renal failure; Urinary tract infection; Cold symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusional state), RENAL FAILURE (Renal failure), URINARY TRACT INFECTION (Urinary tract infection) and NASOPHARYNGITIS (Cold symptoms) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criteria death and medically significant), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion death) and NASOPHARYNGITIS (Cold symptoms) (seriousness criterion death). The patient died on 21-Apr-2021. The reported cause of death was Confusional state, Renal failure, Urinary tract infection and Cold symptoms. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the drug was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. All events conservatively retained as resulting in death as this is how they are assessed by the Authority although it is unknown if an autopsy was performed and events such as confusional state and cold symptoms are unlikely to be fatal in and of themselves; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. All events conservatively retained as resulting in death as this is how they are assessed by the Authority although it is unknown if an autopsy was performed and events such as confusional state and cold symptoms are unlikely to be fatal in and of themselves; Reported Cause(s) of Death: Confusional state; Renal failure; Urinary tract infection; Cold symptoms


VAERS ID: 1344568 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-18
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Retardation mental; Sleep apnea
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic gastritis; Anxiety; Enlarged prostate; Esophagitis; Volvulus of bowel
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Mesenteric ischemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of INTESTINAL ISCHAEMIA (Mesenteric ischemia) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Co-suspect products included non-company products TROPATEPINE HYDROCHLORIDE (LEPTICUR) for Parkinson''s syndrome and CYAMEMAZINE (TERCIAN [CYAMEMAZINE]) for Agitation. The patient''s past medical history included Alcoholic gastritis, Volvulus of bowel, Anxiety, Enlarged prostate and Esophagitis. Concurrent medical conditions included Retardation mental and Sleep apnea. On 18-Feb-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient started TROPATEPINE HYDROCHLORIDE (LEPTICUR) (unknown route) 10 milligram once a day. On an unknown date, the patient started CYAMEMAZINE (TERCIAN [CYAMEMAZINE]) (Oral) 1 dosage form. On 18-Apr-2021, the patient experienced INTESTINAL ISCHAEMIA (Mesenteric ischemia) (seriousness criteria death and medically significant). The patient died on 21-Apr-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. There is no treatment medication reported. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Intestinal ischemia captured as cause of death as per Authority assessment of event in SD although it is unknown if an autopsy occurred.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Intestinal ischemia captured as cause of death as per Authority assessment of event in SD although it is unknown if an autopsy occurred.


VAERS ID: 1345599 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Eusaprim forte 160 mg/800 mg; Movicol; AZOPT 10 mg/ml; Oxascand 5 mg; Mirtazapin Actavis 15 mg; Alvedon 500 mg; Dexametason Abcur 4 mg; Kalcipos-D 500 mg/400 IE; Alphagan 0,2 % (2 mg/ml); Innohep 4500 anti-Xa IE; Revlimid 25 mg; xalcom 50 m
Current Illness: Multiple myeloma; Plasmacytoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ILLNESS and DECREASED APPETITE in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002531) for COVID-19 vaccination. The patient''s past medical history included Plasmacytoma since an unknown date and Multiple myeloma since an unknown date. Concomitant products included sulfamethoxazole, trimethoprim (Eusaprim forte 160 mg/800 mg), macrogol, potassium chloride, sodium hydrogen carbonate, sodium chloride (Movicol), brinzolamide (AZOPT 10 mg/ml), oxazepam (Oxascand 5 mg), mirtazapine (Mirtazapin Actavis 15 mg), paracetamol (Alvedon 500 mg), dexamethasone (Dexametason Abcur 4 mg), calcium carbonate, cholecalciferol, calcium, Dry Vitamin D3 100 SD/S (Kalcipos-D 500 mg/400 IE), brimonidine tartrate, brimonidine (Alphagan 0,2 % (2 mg/ml), tinzaparin, tinzaparin sodium (Innohep 4500 anti-Xa IE), lenalidomide (Revlimid 25 mg), Timolol, combinations (xalcom 50 mikrogram/ml + 5 mg/ml) and codeine phosphate hemihydrate, codeine anhydrous, Paracetamol DC (PVP) 284N, paracetamol (Citodon 500 mg/30 mg) for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (seriousness criterion death) and DECREASED APPETITE (seriousness criterion death). The patient died in April 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 for the events were not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what the cause of death was and events of illness and decreased appetite conservatively retained as resulting in death as they were captured as doing so by the Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what the cause of death was and events of illness and decreased appetite conservatively retained as resulting in death as they were captured as doing so by the Authority; Reported Cause(s) of Death: unknown cause of death; Unknown cause of death


VAERS ID: 1346247 (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: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: 2021-04-14
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Cardiac failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021. This regulatory authority case was reported by an other (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure) 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) (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 14-Apr-2021, the patient experienced CARDIAC FAILURE (Cardiac failure) (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. Treatment was none. Based on the current available information and temporal association between the use of the product and 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 event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1346303 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

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

Life Threatening? Yes
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: WARFARIN
Current Illness: Atrial fibrillation (Warfarin); Cardiomyopathy (Ischemic, ejection fraction of left ventricle under 25 %); Cerebral atrophy (Advanced, diffuse); Chronic ischemic heart disease, unspecified; Internal carotid artery stenosis (Severe, lateris sinistri)
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensated heart failure (Fluidothorax, chest drainage); Inferior myocardial infarction (Thrombolysis, coronarographically occlusion of ramus interventricularis anterior and arteria coronaria dextra); Subdural hematoma removal
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, 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 17-May-2021 and was forwarded to Moderna on 17-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) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Inferior myocardial infarction (Thrombolysis, coronarographically occlusion of ramus interventricularis anterior and arteria coronaria dextra) in 1999, Decompensated heart failure (Fluidothorax, chest drainage) in 2019 and Subdural hematoma removal on 30-Jan-2017. Concurrent medical conditions included Atrial fibrillation (Warfarin), Internal carotid artery stenosis (Severe, lateris sinistri), Cardiomyopathy (Ischemic, ejection fraction of left ventricle under 25 %), Cerebral atrophy (Advanced, diffuse) and Chronic ischemic heart disease, unspecified. Concomitant products included WARFARIN for Anticoagulant therapy. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 30-Apr-2021 The patient died on 30-Apr-2021. The reported cause of death was found dead in the morning. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the patient being found dead, a causal relationship cannot be excluded. Patient''s medical history suggests underlying pathophysiology likely played a role in their death and autopsy results not provided; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the patient being found dead, a causal relationship cannot be excluded. Patient''s medical history suggests underlying pathophysiology likely played a role in their death and autopsy results not provided; Reported Cause(s) of Death: Found dead in the morning


VAERS ID: 1348163 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Fatigue, Headache, Monoplegia, Pyrexia, Somnolence, Vertigo
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasilacton 20/100 mg; Kalioral; Pantoloc 40 mg; Folsan 5 mg; Hepamerz; Buronil 50 mg
Current Illness: Alcoholic steatohepatitis; Ascites; Depression; Disorder sleep; Gastritis (Gastritis); Hepatic encephalopathy (hepat.); Hypercholesteraemia; Hypertension arterial; Hypokalaemia; Lumbago (Lumbago)
Preexisting Conditions: Medical History/Concurrent Conditions: Bariatric surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: massive; This regulatory authority case was reported by a physician and describes the occurrence of CIRCULATORY COLLAPSE, the first episode of MONOPLEGIA and the second episode of MONOPLEGIA in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Depression since an unknown date, Gastritis (Gastritis) since an unknown date, Hepatic encephalopathy (hepat.) since an unknown date, Bariatric surgery, Ascites since an unknown date, Lumbago (Lumbago) since an unknown date, Disorder sleep since an unknown date, Hypertension arterial since an unknown date, Alcoholic steatohepatitis since an unknown date, Hypokalaemia since an unknown date and Hypercholesteraemia since an unknown date. Concomitant products included Lasilacton 20/100 mg for Ascites, Pantoloc 40 mg for Bariatric surgery and Gastritis, Buronil 50 mg for Disorder sleep, Kalioral for Hypokalaemia, Folsan 5 mg and Hepamerz for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced the first episode of MONOPLEGIA (seriousness criterion medically significant), the second episode of MONOPLEGIA (seriousness criterion medically significant), SOMNOLENCE, the first episode of VERTIGO, HEADACHE, FATIGUE and the first episode of PYREXIA. On 15-Apr-2021, the patient experienced the second episode of VERTIGO and the second episode of PYREXIA. 15-Apr-2021, the patient experienced HEADACHE (massive) and FATIGUE. On 15-Apr-2021 at 7:00 PM, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant). The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, last episode of MONOPLEGIA, SOMNOLENCE, HEADACHE and FATIGUE had resolved and last episode of VERTIGO, HEADACHE (massive), FATIGUE and the last episode of PYREXIA had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CIRCULATORY COLLAPSE, MONOPLEGIA, MONOPLEGIA, SOMNOLENCE, VERTIGO, VERTIGO, HEADACHE, HEADACHE (massive), FATIGUE, FATIGUE, PYREXIA and PYREXIA to be probably related. 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. This case was linked to AT-BASGAGES-2021-25397, AT-BASGAGES-2021-24979 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-MAY-2021 contains non-significant information. On 13-May-2021: Translation received on 19-MAY-2021 and does not contain any 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. AT-BASGAGES-2021-25397: AT-BASGAGES-2021-24979:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1348183 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021-04-18
   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: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Peripheral arterial occlusive disease. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 18-Apr-2021. The reported cause of death was accident. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not reported. Treatment information was not reported. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021048327; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Accident


VAERS ID: 1348571 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001940 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 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: Obstruction bowel
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Arresto cardiaco da causa indeterminato naturale.; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arresto cardiaco da causa indeterminato naturale.) in a 73-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001940) for COVID-19 immunisation. The patient''s past medical history included Obstruction bowel. On 01-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Arresto cardiaco da causa indeterminato naturale.) (seriousness criteria death and medically significant). The reported cause of death was Standstill cardiac. 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 medicines were reported. No treatment information were reported. Based on the current available information and temporal association between the use of the product and the cardiac arrest, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: NNI; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the cardiac arrest, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Standstill cardiac


VAERS ID: 1348575 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardiac failure, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: TIKLID; LETROZOLO AHCL; TOTALIP; GLURENOR; KARVEA; TILDIEM; NORVASC; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Acute pulmonary edema; Consciousness loss; Decompensation cardiac; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACUTE PULMONARY OEDEMA (Acute pulmonary edema), LOSS OF CONSCIOUSNESS (Consciousness loss) and CARDIAC FAILURE (Decompensation cardiac) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Aortic stenosis, Hypertension arterial and Type 2 diabetes mellitus. Concomitant products included TICLOPIDINE HYDROCHLORIDE (TIKLID), LETROZOLE (LETROZOLO AHCL), ATORVASTATIN CALCIUM (TOTALIP), GLIQUIDONE (GLURENOR), IRBESARTAN (KARVEA), DILTIAZEM HYDROCHLORIDE (TILDIEM), AMLODIPINE BESILATE (NORVASC) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication. On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Apr-2021, the patient experienced ACUTE PULMONARY OEDEMA (Acute pulmonary edema) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (Consciousness loss) (seriousness criteria death and medically significant) and CARDIAC FAILURE (Decompensation cardiac) (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Acute pulmonary edema, Consciousness loss and Decompensation cardiac. 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 information regarding treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Live follow up received on 18-May-2021: Added Medical history and concomitant medication.; 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. All events retained as being cause of death with fatal outcome per assessment / reporting by Authority in SD although it is not known if cause of death has been confirmed; Reported Cause(s) of Death: Acute pulmonary edema; Consciousness loss; Decompensation cardiac


VAERS ID: 1348948 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Interstitial lung disease, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (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: ALFUZOSIN STADA; CANDESARTAN SANDOZ; AMLODIPIN BLUEFISH; BISOPROLOL SANDOZ; ATORVASTATIN TEVA; ELIQUIS
Current Illness: Cough; Hypertension; Paroxysmal atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Respiratory failure; ; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) and INTERSTITIAL LUNG DISEASE in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Paroxysmal atrial fibrillation, Hypertension and Cough. Concomitant products included ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN STADA), CANDESARTAN CILEXETIL (CANDESARTAN SANDOZ), AMLODIPINE BESILATE (AMLODIPIN BLUEFISH), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), ATORVASTATIN CALCIUM (ATORVASTATIN TEVA) and APIXABAN (ELIQUIS) for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and INTERSTITIAL LUNG DISEASE (seriousness criteria death and medically significant). The reported cause of death was Respiratory failure and Interstitial lung disease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unknown if an autopsy was performed to confirm cause of death.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unknown if an autopsy was performed to confirm cause of death.; Reported Cause(s) of Death: Respiratory failure; Interstitial lung disease


VAERS ID: 1348968 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, 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: Medical History/Concurrent Conditions: Chronic disease (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKMODERNATX, INC.MOD20211

Write-up: Death; vaccination may have contributed to the overall deterioration in health; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and CONDITION AGGRAVATED (vaccination may have contributed to the overall deterioration in health) in an elderly patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Chronic disease (unspecified). On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and CONDITION AGGRAVATED (vaccination may have contributed to the overall deterioration in health) (seriousness criterion death). The reported cause of death was chronical diseases. An autopsy was performed. Not Provided The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment or concomitant products reported Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: chronical diseases


VAERS ID: 1351784 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-23
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram cerebral, 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: 2021-04-24
   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: Medical History/Concurrent Conditions: Hypertension arterial; Thrombosis venous superficial
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Angiogram cerebral; Result Unstructured Data
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial and Thrombosis venous superficial. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ISCHAEMIC STROKE (seriousness criteria death, hospitalization and medically significant). The patient died on 24-Apr-2021. The reported cause of death was Ischaemic stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Angiogram cerebral: abnormal (abnormal) For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were provided. Based on the current available information and temporal association between the use of the product and 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 event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: ischaemic stroke


VAERS ID: 1352455 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK LA / OT

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

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: Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture of humerus
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19; This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Fracture of humerus. Concurrent medical conditions included Ischaemic heart disease. On 30-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 17-Apr-2021. The reported cause of death was covid-19. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be unlikely related. Concomitant product use was not provided. This case concerns a 79year old male patient, with a medical history of Ischemic heart disease, who experienced a serious unexpected event of death (fatal) 18 days after receiving his unknown dose of mRNA-1273 vaccine. However, Very limited information has been provided at this time and require exact dates for further evaluation.; Sender''s Comments: This case concerns a 79year old male patient, with a medical history of Ischemic heart disease, who experienced a serious unexpected event of death(fatal) 18 days after receiving his unknown dose of mRNA-1273 vaccine. However, Very limited information has been provided at this time and require exact dates for further evaluation.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1353701 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 8
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: GLICLADA; UROXAL; COVERCARD PLUS; PENTOXYL-EP; ERGOTOP; FRONTIN; NEBIBETA; KALDYUM; FURON; KERBERAN; MYDETON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Stroke; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19 pneumonia; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 82-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 Stroke, Type II diabetes mellitus and Hypertension. Concomitant products included GLICLAZIDE (GLICLADA), Oxybutynin (UROXAL), AMLODIPINE BESILATE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERCARD PLUS), pentoxifylline (PENTOXYL-EP), nicergoline (ERGOTOP), ALPRAZOLAM (FRONTIN), NEBIVOLOL HYDROCHLORIDE (NEBIBETA), POTASSIUM CHLORIDE (KALDYUM), furosemide (FURON), CLOPIDOGREL BESYLATE (KERBERAN) and lidocaine, tolperisone (MYDETON) for an unknown indication. On 06-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 19-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death and hospitalization). The patient died on 27-Apr-2021. The reported cause of death was cardiovascular insufficiency caused by the infection, Asystole and COVID-19 pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. The patient died due to asystole, and cardiovascular insufficiency caused by the infection. Immunity does not develop within 13 days after vaccination. The causality between the vaccine and the event is unlikely. The case is serious due to fatal outcome. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18-may-2021 and contains no newinformation; Sender''s Comments: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. The patient died due to asystole, and cardiovascular insufficiency caused by the infection. Immunity does not develop within 13 days after vaccination. The causality between the vaccine and the event is unlikely. The case is serious due to fatal outcome.; Reported Cause(s) of Death: cardiovascular insufficiency caused by the infection; asystole; COVID-19 pneumonia


VAERS ID: 1353962 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: COVID-19; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was covid-19. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. Action taken with mRNA-1273 in response to the events was not applicable. ADR description - Covid; Sender''s Comments: Based on biological plausibility, the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 was consistent with infection in pandemic set up.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1354020 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, Computerised tomogram, SARS-CoV-2 test, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Invasive mechanical ventilation
Preexisting Conditions: Medical History/Concurrent Conditions: Asbestos exposure (ED 10/19); Coronary disease (Single vessel coronary disease); COVID-19 pneumonia (1st ARDS in COVID-19 pneumonia with bacterial superinfection.); Endotracheal intubation; Mechanical ventilation (invasive); Nicotine abuse (Nicotine use stopped, cumulative 30 pack years); Pleural thickening (discrete pleural thickening on the right after inhalative exposure to asbestos.); Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: 10010228; Result Unstructured Data: initially showed bipulmonary peripheral and peribronchovascular ground glass opacities, image morphologically and quantitatively consistent with mild pulmonary COVID case; Test Date: 20210326; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: ARDS in COVID- 19 pneumonia with bacterial superinfection
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA, ACUTE RESPIRATORY DISTRESS SYNDROME, SEPSIS, and VACCINATION FAILURE (COVID-19) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included COVID-19 pneumonia (1st ARDS in COVID-19 pneumonia with bacterial superinfection.) in October 2019, Nicotine abuse (Nicotine use stopped, cumulative 30 pack years), Asbestos exposure (ED 10/19) in October 2019, Coronary disease (Single vessel coronary disease), Pleural thickening (discrete pleural thickening on the right after inhalative exposure to asbestos.) in October 2019, Endotracheal intubation on 04-Apr-2021, Mechanical ventilation (invasive) on 04-Apr-2021, Tracheostomy on 09-Apr-2021 and Invasive mechanical ventilation from 04-Apr-2021 to 13-Apr-2021. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (seriousness criteria death and medically significant), ACUTE RESPIRATORY DISTRESS SYNDROME (seriousness criteria death and medically significant), SEPSIS (seriousness criteria death and medically significant), and VACCINATION FAILURE (COVID-19) (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was multiple organ dysfunction syndrome. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: (Positive) ARDS in COVID- 19 pneumonia with bacterial superinfection. On 30-Mar-2021, Computerised tomogram: (abnormal) initially showed bipulmonary peripheral and peribronchovascular ground glass opacities, image morphologically and quantitatively consistent with mild pulmonary COVID case. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 PNEUMONIA (COVID-19), ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS COVID-19), SEPSIS and VACCINATION FAILURE (COVID-19) to be unlikely related. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported. Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273. Treatment information included, invasive endotracheal ventilation (from 04/04/2021 until his death) and tracheostomy (on 04/09/2021), dexamethasone 6mg/d from 30 Mar 2021 to -09 Apr 2021, piperacillin-tazobactam 2x4.5g 05 Apr 2021 , 09 Apr 2021, meropenem 1g2x daily iv from 09 Apr 2021 -13 APR 2021, complex treatment due to multi-resistant organisms (COVID-19) from 30 Mar 2021 - 13 Apr 2021, was provided. Patient hospitalization was required on March 30th. Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 20-MAY 2021 contains translation document.; Sender''s Comments: Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Multiple organ dysfunction syndrome


VAERS ID: 1355427 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-27
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: 2021-04-29
   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:
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 a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. No Medical History information was reported. On 23-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) (unknown route) 1 dosage form. Death occurred on 29-Apr-2021 The patient died on 29-Apr-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. An autopsy was performed (results not provided). Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1355450 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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: 2021-04-23
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease Parkinson''s; Invasive cervix cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Invasive cervix cancer and Disease Parkinson''s. On 23-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 23-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 medication use was not reported. Treatment information was not reported. Very limited information regarding this event 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 event, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding this event 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 event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1355661 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-03-02
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: LISINOPRIL; SIMCORA; CONCOR; CALCIMAGONA D3; BECOZYM [VITAMIN B NOS]; LEXOTANIL; PROLIA
Current Illness: Adiposis; Arterial hypertension; Nicotine abuse
Preexisting Conditions: Medical History/Concurrent Conditions: Breast ductal carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Acute heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 300042723 and 300042460) for COVID-19 vaccination. The patient''s past medical history included Breast ductal carcinoma 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), VITAMIN B NOS (BECOZYM [VITAMIN B NOS]), BROMAZEPAM (LEXOTANIL) and DENOSUMAB (PROLIA) 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 02-Mar-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criteria death and medically significant). The patient died on 02-Mar-2021. The reported cause of death was Acute heart failure. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute heart failure) to be unlikely related. Teatment information not provided. Very limited information regarding this event has been provided at this time. However, patient''s underlying medical condition (arterial hypertension) remains a confounder. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. However, patient''s underlying medical condition (arterial hypertension) remains a confounder. Further information can''t be requested.; Reported Cause(s) of Death: Acute Heart Failure


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


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