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

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

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1262005 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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:
Current Illness: Hyperlipidaemia; Hypertension arterial; Type 2 diabetes mellitus (Diabetes mellitus Typ 2)
Preexisting Conditions: Comments: Diabetes mellitus Typ 2, art. Hypertonie
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: Arteria Basilarisverschluss; This regulatory authority case was reported by a physician and describes the occurrence of BASILAR ARTERY OCCLUSION (Arteria Basilarisverschluss) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. Diabetes mellitus Typ 2, art. Hypertonie. Concurrent medical conditions included Hyperlipidaemia, Type 2 diabetes mellitus (Diabetes mellitus Typ 2) and Hypertension arterial (art. Hypertonie). On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form once a day. On 01-Apr-2021, the patient experienced BASILAR ARTERY OCCLUSION (Arteria Basilarisverschluss) (seriousness criterion death). The patient died on 01-Apr-2021. The reported cause of death was Basilar artery occlusion. 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 event has been provided at this time and a causal relationship cannot be excluded, although the elderly patient had a number of underlying conditions that could have contributed to the arterial occlusion and death.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded, although the elderly patient had a number of underlying conditions that could have contributed to the arterial occlusion and death; Reported Cause(s) of Death: Basilar artery occlusion


VAERS ID: 1262015 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 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: 2021-04-01
   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:
Current Illness: Arterial hypertension; Fibrosis lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Fibrosis lung since an unknown date and Arterial hypertension since an unknown date. On 23-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 01-Apr-2021. The reported cause of death was Sudden death. 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. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; 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: Sudden death


VAERS ID: 1262028 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arterial haemorrhage, Hypovolaemic shock
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Dehydration (narrow)

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: ENALAPRIL; CARVEDILOL
Current Illness: Duchenne muscular dystrophy; Endotracheal intubation; Percutaneous endoscopic gastrostomy; Respiration failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: IN SHOCK; This regulatory authority case was reported by a physician and describes the occurrence of ARTERIAL HAEMORRHAGE, IN SHOCK and HYPOVOLAEMIC SHOCK, in a 26-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. Concurrent medical conditions included Endotracheal intubation, Respiration failure, Percutaneous endoscopic gastrostomy and Duchenne muscular dystrophy. Concomitant products included ENALAPRIL and CARVEDILOL for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 10-Apr-2021, the patient experienced ARTERIAL HAEMORRHAGE (IN SHOCK) (seriousness criterion death) and HYPOVOLAEMIC SHOCK (IN SHOCK) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was Hypovolaemic shock and Arterial haemorrhage. It is unknown if an autopsy was performed. 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 treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. There is also limited information with regards the conditions captured as history / current conditions and it is unclear if any of these are associated with the recorded events; Reported Cause(s) of Death: Hypovolaemic shock; Arterial haemorrhage


VAERS ID: 1262030 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE - TABLETS; BENDROFLUAZIDE; ATENOLOL; VALSARTAN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTMODERNATX, INC.MOD20210

Write-up: cardiogenic shock; myocardial infarction; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock) and MYOCARDIAL INFARCTION (myocardial infarction) in a 76-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE (AMLODIPINE - TABLETS), BENDROFLUMETHIAZIDE (BENDROFLUAZIDE), ATENOLOL and VALSARTAN for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criterion death) and MYOCARDIAL INFARCTION (myocardial infarction) (seriousness criterion death). The reported cause of death was Cardiogenic shock and Myocardial infarction. It is unknown if an autopsy was performed. Treatment information was not provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is not clear if the sender''s comment of "side-effects are unexpected" was a specific statement that the captured events were not related so as reported causality retained as not provided.; Reporter''s Comments: Side-effects are unexpected. challenge; compatible Re-challenge: RO De-challenge; inconclusive Signs and symptoms: compatible Lab test: L0 Alternate explanation: present Outcome I 1 uncertain.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is not clear if the sender''s comment of "side-effects are unexpected" was a specific statement that the captured events were not related so as reported causality retained as not provided.; Reported Cause(s) of Death: Cardiogenic shock; Myocardial infarction


VAERS ID: 1262034 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Myalgia, Nausea, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Comments: No medical history information reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Unknown cause of death; Nausea; Generalized joint pain; Neuralgia; Fatigue; Myalgia; Headache; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death), NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history information reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Apr-2021, the patient experienced NEURALGIA (Neuralgia) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MYALGIA (Myalgia) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced ARTHRALGIA (Generalized joint pain) (seriousness criterion medically significant). On 04-Apr-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment: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: 1266191 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   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: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Sudden death; This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Sudden death) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. 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) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Limited information regarding the death of this elderly man has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1266206 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
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: 2021-04-05
   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: EUTIROX; ATENOLOLO EG; LASIX [FUROSEMIDE]; COAPROVEL; HUMALOG
Current Illness: Artificial cardiac pacemaker wearer; Diabetes mellitus; Hypertension; Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypertension, Hyperthyroidism and Artificial cardiac pacemaker wearer. Concomitant products included LEVOTHYROXINE SODIUM (EUTIROX), ATENOLOL (ATENOLOLO EG), FUROSEMIDE (LASIX [FUROSEMIDE]), HYDROCHLOROTHIAZIDE, IRBESARTAN (COAPROVEL) and INSULIN LISPRO (HUMALOG) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 05-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. Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided. Company comment:Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Minor change to name of Concomitant medication from Lasix vials to Lasix tablets; 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: Unknown cause of death


VAERS ID: 1269866 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / 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: LORMETAZEPAM; FUROSEMIDE; METFORMIN; CONGESCOR; SOLDESAM; PANTOPRAZOLE; CARDIOASPIRIN
Current Illness: Antiinflammatory therapy; Anxiety; Cardiac failure; Cardiomyopathy; Chronic gastritis; Diabetes; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included Antiinflammatory therapy since an unknown date. Concurrent medical conditions included Cardiomyopathy, Chronic gastritis, Cardiac failure, Diabetes, Hypertension arterial and Anxiety. Concomitant products included DEXAMETHASONE SODIUM PHOSPHATE (SOLDESAM) from 07-Apr-2021 to an unknown date for Antiinflammatory therapy, LORMETAZEPAM from 07-Apr-2021 to an unknown date for Anxiety, BISOPROLOL FUMARATE (CONGESCOR) from 07-Apr-2021 to an unknown date for Cardiac failure, ACETYLSALICYLIC ACID (CARDIOASPIRIN) from 07-Apr-2021 to an unknown date for Cardiomyopathy, PANTOPRAZOLE from 07-Apr-2021 to an unknown date for Chronic gastritis, METFORMIN from 07-Apr-2021 to an unknown date for Diabetes, FUROSEMIDE from 07-Apr-2021 to an unknown date for Hypertension arterial. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. 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 medications were not 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: 1269867 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Gaze palsy, Heart rate, Oxygen saturation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: TARGINIQ; DICLOREUM [DICLOFENAC]; OXATOMIDE
Current Illness:
Preexisting Conditions: Comments: Relevant medical history still needs to be translated
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: 110/80; Test Date: 20210409; Test Name: heart rate; Test Date: 20210409; Test Name: SO2; Result Unstructured Data: 100 %
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; BP 110/80 P 100 SO2 100% This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), GAZE PALSY and SEIZURE. BP 110/80 P 100 SO2 100% in a 68-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001655) for COVID-19 vaccination. Relevant medical history still needs to be translated. Concomitant products included NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE (TARGINIQ), DICLOFENAC (DICLOREUM [DICLOFENAC]) and OXATOMIDE for an unknown indication. On 09-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 GAZE PALSY (seriousness criterion medically significant) and SEIZURE (seriousness criterion medically significant). On 11-Apr-2021, GAZE PALSY and SEIZURE outcome was unknown. The patient died on 11-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 09-Apr-2021, Blood pressure measurement: 110/80 110/80. On 09-Apr-2021, Heart rate: 100. On 09-Apr-2021, Oxygen saturation: 100 % 100 %. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Death event added, the outcome were changed for other than death event.; Reporter''s ; Sender''s Comments: Limited translated 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: 1276136 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-04-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-01
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: 2021-04-12
   Days after onset: 11
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: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Cardiac failure aggravated; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure aggravated) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiac failure. Previously administered products included for an unreported indication: COVID-19 VACCINE (Moderna COVID-19 Vaccine) on 02-Mar-2021. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC FAILURE (Cardiac failure aggravated) (seriousness criteria death and hospitalization). The patient died on 12-Apr-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. The outcome of the event was fatal ,so the action taken for the second dose of Moderna COVID -19 vaccine was not applicable. Company comment: Very limited information regarding this event of aggravated Cardiac Failure has been provided at this time. Further information cannot be obtained as the reporter did not allow further contact.; Sender''s Comments: Very limited information regarding this event of aggravated Cardiac Failure has been provided at this time. Further information cannot be obtained as the reporter did not allow further contact.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1276139 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: SEROQUEL; PROMETHAZINE - CODEINE [CITRIC ACID;CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE;SODIUM CITRATE ACID; HALOPERIDOL 1A PHARMA; METFORMINE [METFORMIN]; ACETYLSALICYLZUUR; COLECALCIFEROL; SIMVASTATINE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemia myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Malaise; Neck discomfort; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck discomfort) and MALAISE (Malaise) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included Ischaemia myocardial. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CITRIC ACID, CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, SODIUM CITRATE ACID, SULFOGAIACOL (PROMETHAZINE - CODEINE [CITRIC ACID;CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE;SODIUM CITRATE ACID;SULFOGAIACOL]), HALOPERIDOL (HALOPERIDOL 1A PHARMA), METFORMINE [METFORMIN], ACETYLSALICYLZUUR, COLECALCIFEROL, SIMVASTATINE and LORAZEPAM for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck discomfort) (seriousness criterion death) and MALAISE (Malaise) (seriousness criterion death). The patient died on 30-Mar-2021. The reported cause of death was Sudden death, Pulmonary congestion, Congestive hepatopathy and Arrhythmia. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment of these events were not reported. Reporter did not allow further contact; Reported Cause(s) of Death: Sudden death; Pulmonary congestion; Congestive hepatopathy; Arrhythmia


VAERS ID: 1276142 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-13
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiopulmonary failure, Crepitations, Dyspnoea, Haemoptysis, Hypoxia, Oxygen saturation, Productive cough, Pyrexia, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

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: MELATONINE; QUETIAPINE; OXAZEPAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history provided
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: body temperature; Result Unstructured Data: 38 tot 40.5 Celcius; Test Date: 20210413; Test Name: SaO2 69%; Test Result: 69 %; Result Unstructured Data: 69%; Test Date: 20210413; Test Name: sputum; Result Unstructured Data: bloody
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: sputum; SaO2 69%; 38 tot 40.5 Celcius; Pulm: over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIOPULMONARY FAILURE, HAEMOPTYSIS (sputum), HYPOXIA (SaO2 69%), PYREXIA (: 38 tot 40.5 Celcius), UNRESPONSIVE TO STIMULI , CREPITATIONS (Pulm: over) and DYSPNOEA in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No relevant medical history provided. Concomitant products included MELATONINE, QUETIAPINE, OXAZEPAM and PARACETAMOL for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CARDIOPULMONARY FAILURE (seriousness criterion death), HAEMOPTYSIS (sputum) (seriousness criterion death), HYPOXIA (SaO2 69%) (seriousness criterion death), PYREXIA (38 tot 40.5 Celcius) (seriousness criterion death), UNRESPONSIVE TO STIMULI (seriousness criterion death), CREPITATIONS (Pulm: over) (seriousness criterion death) and DYSPNOEA (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was: It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 38 tot 40.5 celcius (abnormal) 38 tot 40.5 Celcius. On 13-Apr-2021, Oxygen saturation: 69 % (abnormal) 69%. On 13-Apr-2021, Productive cough: bloody (abnormal) bloody. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.; Sender''s Comments: This is a case of sudden death in a 86-year-old male patient with an unknown medical history died of cardiopulmonary failure 1 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death:


VAERS ID: 1281131 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATOZET; ASPIRIN CARDIO; ENTRESTO; CARVEDILOLUM
Current Illness: Heart attack; Heart insufficiency; Hypercholesterolaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Cardiac values; Result Unstructured Data: normal; Test Date: 202103; Test Name: Neurological tests; Test Result: Negative ; Result Unstructured Data: After 24 hours of sedation; Test Date: 202103; Test Name: Saturation values; Result Unstructured Data: Low saturation % levels
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; Ventricular fibrillation; Cardio-respiratory arrest; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), VENTRICULAR FIBRILLATION (Ventricular fibrillation) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in an 84-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included Heart attack since 1998, Hypercholesterolaemia since 1998 and Heart insufficiency since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO) for Acute myocardial infarction, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and CARVEDILOLUM for Cardiac insufficiency, ATORVASTATIN CALCIUM, EZETIMIBE (ATOZET) for Hypercholesteraemia. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria medically significant and life threatening) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria medically significant and life threatening). On 09-Mar-2021, VENTRICULAR FIBRILLATION (Ventricular fibrillation) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) had not resolved. The patient died on 09-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemodynamic test: normal (normal) normal. In March 2021, Neurological examination: negative (Negative) After 24 hours of sedation. In March 2021, Oxygen saturation (95-100): low% (Low) Low saturation % levels. Treatment of the events included resuscitation which was successful. It was reported that following ventricular fibrillation and cardio-respiratory arrest, the patient suffered cerebral anoxia with brain damage and neurological deficits. Although cardiac values were good per the reporter, low saturation levels were observed and the patient died after 5 days. This is a case of sudden death in a 84-year-old male patient with a history of Heart attack, Hypercholesterolaemia and Heart insufficiency, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Translation received, diagnostic information was added as well as details pertaining to the fatal events.; Sender''s Comments: This is a case of sudden death in a 84-year-old male patient with a history of Heart attack, Hypercholesterolaemia and Heart insufficiency, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1283622 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Sudden death, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; Tonic clonic jerking; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) in a 50-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 Epilepsy. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criterion death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) (seriousness criterion medically significant) and PYREXIA (Pyrexia) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. At the time of death, TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided 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. Pyrexia retained as serious / MS per assessment included in Authority report. It is not clear if the vaccine dose administered prior to the events was the first or second dose.; Reported Cause(s) of Death: sudden death


VAERS ID: 1287225 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure
SMQs:, 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), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: Respiratory insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Acute on chronic respiratory failure; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute on chronic respiratory failure) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Respiratory insufficiency. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ACUTE RESPIRATORY FAILURE (Acute on chronic respiratory failure) (seriousness criterion death). The patient died on 03-Apr-2021. The reported cause of death. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death:


VAERS ID: 1287520 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / -

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: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aneurysm ruptured; Aphasia; Cerebral hemorrhage
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death sudden; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Death sudden) 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 Dysphagia in 2017. Concurrent medical conditions included Cerebral hemorrhage since 2017, Aneurysm ruptured since 2017 and Aphasia since 2017. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form in total. The patient died on 12-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 Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information included. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Translated Document added. NNI; Sender''s Comments: This case of death concerns an 87-year-old, female patient who experienced sudden death after the administration of mRNA-1273 (Lot number: unknown). Although a temporal association exist, very limited information regarding this event have been provided at this time. Patient''s medical history and autopsy report is lacking. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1288585 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-05
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: 2021-03-18
   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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: mogelijk overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (mogelijk overlijden) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 01-Mar-2021. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. Death occurred on 18-Mar-2021 The patient died on 18-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. Conflictingly date of death also reported as 30 Mar 2021.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information can''t be requested.; Reported Cause(s) of Death: niet meer aanspreekbaar, somnolent en hierop overleden


VAERS ID: 1294958 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-08
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood urea, C-reactive protein, Dyspnoea, Fibrin D dimer, Nausea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arthrosis (of big joints); Gastroesophageal reflux; Hypertension arterial; Hyperuricemia; Osteoporosis; Vasculitis (Renal and pulmonary involvement)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 182 micromole per litre; Test Date: 20210412; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 2.9 millimole per liter; Test Date: 20210412; Test Name: Urea; Test Result: Inconclusive ; Result Unstructured Data: 7.9 millimole per liter; Test Date: 20210412; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 83 milligram per liter; Test Date: 20210412; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 6.51 milligram per liter
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: Pulmonary embolism; Breathlessness; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DYSPNOEA (Breathlessness) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3001531) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperuricemia, Gastroesophageal reflux, Vasculitis (Renal and pulmonary involvement), Hypertension arterial, Arthrosis (of big joints) and Osteoporosis. On 08-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant) and NAUSEA. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 13-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was not performed. At the time of death, DYSPNOEA (Breathlessness) and NAUSEA had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood creatinine: 182 (Inconclusive) 182 micromole per litre. On 12-Apr-2021, Blood potassium: 2.9 (Inconclusive) 2.9 millimole per liter. On 12-Apr-2021, Blood urea: 7.9 (Inconclusive) 7.9 millimole per liter. On 12-Apr-2021, C-reactive protein: 83 (Inconclusive) 83 milligram per liter. On 12-Apr-2021, Fibrin D dimer: 6.51 (Inconclusive) 6.51 milligram per liter. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. 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: Pulmonary embolism


VAERS ID: 1295004 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA XHBVC439AB / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: ISOSORBIDE MONONITRAAT RETARD RPH; RENVELA; FUROSEMIDE; NOVOMIX; ARANESP; BISOPROLOL [BISOPROLOL FUMARATE]; LOSARTAN; ADIRO AP; CARDURA; AKOSTOL; ALOPURINOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Sudden death; Fever; General malaise; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. xhbvc439ab) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRAAT RETARD RPH) from 16-Mar-2019 to an unknown date for Cardiac ischaemia, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) from 05-Mar-2013 to an unknown date for Diabetes with renal manifestations, BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]) from 12-May-2017 to an unknown date for Dyspnea, LOSARTAN from 08-Aug-2018 to an unknown date for Hypertension arterial, SEVELAMER CARBONATE (RENVELA) from 21-Nov-2013 to an unknown date and FUROSEMIDE from 11-May-2013 to an unknown date for Nephropathy, ACETYLSALICYLIC ACID (ADIRO AP) from 09-Jun-2017 to an unknown date and ACOTIAMIDE HYDROCHLORIDE (AKOSTOL) from 15-May-2019 to an unknown date for Peripheral vascular disease, unspecified, DARBEPOETIN ALFA (ARANESP) from 10-Sep-2020 to an unknown date for Peritoneal dialysis, DOXAZOSIN MESILATE (CARDURA) from 15-Jan-2021 to an unknown date and ALOPURINOL from 15-Jun-2012 to an unknown date 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 PYREXIA (Fever) and MALAISE (General malaise). On 10-Apr-2021, PYREXIA (Fever) and MALAISE (General malaise) had not resolved. The patient died on 10-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 treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1295028 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Death, Hypotension, Influenza like illness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: End stage renal disease (ESRD); Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: syndrome grippal; fibrillation; Hypotension; death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (fibrillation), HYPOTENSION (Hypotension) and INFLUENZA LIKE ILLNESS (syndrome grippal) in an 86-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 Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD). On 15-Mar-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. In March 2021, the patient experienced ATRIAL FIBRILLATION (fibrillation) (seriousness criteria death, hospitalization and medically significant) and HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization). On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (syndrome grippal) (seriousness criteria death and hospitalization). The patient died on 02-Apr-2021. The reported cause of death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. The action taken for mRNA-1273 was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: The date of death of and event hypotension was added.; 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 confirmed. Cause and dates of hospitalization not specified.


VAERS ID: 1296874 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Nausea, Ventricular fibrillation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Flu-like illness; Vomiting; Nausea; Ventricular fibrillation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criterion death). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like illness), VOMITING (Vomiting) and NAUSEA (Nausea). The patient died on 17-Apr-2021. The reported cause of death was Ventricular fibrillation. It is unknown if an autopsy was performed. At the time of death, INFLUENZA LIKE ILLNESS (Flu-like illness), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Company Comment: This is a case of death in a 50-year-old female subject with unknown medical history, who died 2 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 50-year-old female subject with unknown medical history, who died 2 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: Ventricular fibrillation


VAERS ID: 1298719 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic aneurysm rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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:
Current Illness: Abdominal aortic aneurysm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Aortic aneurysm rupture; This regulatory authority case was reported by a physician and describes the occurrence of AORTIC ANEURYSM RUPTURE (Aortic aneurysm rupture) in a 95-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. Concurrent medical conditions included Abdominal aortic aneurysm. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced AORTIC ANEURYSM RUPTURE (Aortic aneurysm rupture) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Aortic aneurysm rupture. 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. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported. No treatment information was provided. Company Comment: This is a case of death in a 95-year-old female subject with a medical history of Abdominal aortic aneurysm, who died in the same month after receiving the first dose of vaccine. Based on information received, death was due to Aortic aneurysm rupture, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 95-year-old female subject with a medical history of Abdominal aortic aneurysm, who died in the same month after receiving the first dose of vaccine. Based on information received, death was due to Aortic aneurysm rupture, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Aortic aneurysm rupture


VAERS ID: 1301855 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-05
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / 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: 2021-04-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Chronic bronchitis. On 16-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 06-Apr-2021. The reported cause of death was myocardial infarction of the inferior wall. An autopsy was not performed. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.; Sender''s Comments: An autopsy report was not provided but a diagnosis of cardiac arrest was provided. Llimited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Myocardial infarction of the inferior wall


VAERS ID: 1301862 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 2021-04-14
   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: Heart failure; Hypertension; Hypothyroidism; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, 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) and DEPRESSED LEVEL OF CONSCIOUSNESS in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Heart failure, Hypertension and Type II diabetes mellitus. On 13-Apr-2021, the patient received first 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 DEATH (Unknown cause of death) (seriousness criterion death) and DEPRESSED LEVEL OF CONSCIOUSNESS (seriousness criterion death). The patient died on 14-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. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021039777 Company comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Reported Cause(s) of Death


VAERS ID: 1301881 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-02-18
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: Angiopathy; Diabetes mellitus insulin-dependent; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Lung embolism; This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Lung embolism) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Diabetes mellitus insulin-dependent and Angiopathy. On 16-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 13-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 18-Feb-2021, the patient experienced PULMONARY EMBOLISM (Lung embolism) (seriousness criterion death). The patient died on 18-Feb-2021. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided Treatment for the events were not provided Company comment: This is a case of death in a 85-year-old female subject with a medical history of HTN, DM, and angiopathy, who died 5 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 85-year-old female subject with a medical history of HTN, DM, and angiopathy, who died 5 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: Lung embolism


VAERS ID: 1304048 (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: 2021-05-10
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: Atrial fibrillation; Dyspnoea; Shooting pain
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); COVID-19; Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia and 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 in November 2020 and Alcohol abuse (No alcohol in a year.) in 2020. Concurrent medical conditions included Dyspnoea since November 2020, Shooting pain since December 2020 and Atrial fibrillation. Concomitant products included Simvastatin from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM 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 not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) normal. On 09-Apr-2021, C-reactive protein: 18 (High) 18. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia and units not specified). On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. 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. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated.; 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: 1304250 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, Dyspnoea, Hypoxia, Tryptase
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MASDIL; EUCREAS; TORASEMID; SEGURIL; PRAVASTATINA [PRAVASTATIN]; ELIQUIS; DIOVAN
Current Illness: Atrial fibrillation; Chronic kidney disease; Hypertension; Hypertrophic cardiomyopathy; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Blood tryptase; Result Unstructured Data: 30.8 microgram per litre; Test Date: 20210410; Test Name: Blood tryptase; Result Unstructured Data: 33.5 microgram per litre
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: Anaphylactic shock; Hypoxia; Dyspnea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), HYPOXIA (Hypoxia) and DYSPNOEA (Dyspnea) in an 85-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 Cardiovascular disease, unspecified Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Chronic kidney disease , Atrial fibrillation and Hypertrophic cardiomyopathy. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, METFORMIN HYDROCHLORIDE, VILDAGLIPTIN (EUCREAS) for Diabetes mellitus, VALSARTAN (DIOVAN) for Hypertension, DILTIAZEM HYDROCHLORIDE (MASDIL), TORASEMIDE (TORASEMID), FUROSEMIDE (SEGURIL) and PRAVASTATINA [PRAVASTATIN] for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death and hospitalization), HYPOXIA (Hypoxia) (seriousness criteria death and hospitalization) and DYSPNOEA (Dyspnea) (seriousness criteria death and hospitalization). The patient died on 11-Apr-2021. The reported cause of death was Anaphylactic shock, Dyspnea and Hypoxia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Tryptase: 30.8 microgram per litre abnormal. On 10-Apr-2021, Tryptase: 33.5 microgram per litre abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.; Reported Cause(s) of Death: Anaphylactic shock; Dyspnea; Hypoxia


VAERS ID: 1304251 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 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? Yes
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Arterial bypass operation; Bladder cancer; Chronic lymphoid leukaemia; Ischaemic cardiomyopathy; Peripheral arterial occlusive disease; Prostatitis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer, Aortic valve calcification, Arterial bypass operation, Prostatitis, Chronic lymphoid leukaemia, Peripheral arterial occlusive disease, Type 2 diabetes mellitus and Ischaemic cardiomyopathy. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. 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. Action taken with the mRNA-1273 was not applicable. Company Comment: 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: Unknown cause of death


VAERS ID: 1306269 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 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: 2021-04-22
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; Bipolar disorder
Preexisting Conditions:
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 an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension and Bipolar disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was Haemorrhagic stroke. An autopsy was not performed. 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. No concomitant medications and treatment information were provided.; 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: Haemorrhagic stroke


VAERS ID: 1306415 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-19
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Pulse absent
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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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: 2021-04-19
   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: Arterial hypertension; Blood pressure high; Treatment noncompliance
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma; Hernia repair (scrotal hernia surgery); Scrotal hernia; Traumatic brain injury; Comments: art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Pulse rate; Test Result: Negative ; Result Unstructured Data: Pulse absent
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS and PULSE ABSENT in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance. The patient''s past medical history included Scrotal hernia, Cranioencephalic trauma, Traumatic brain injury and Hernia repair (scrotal hernia surgery). Concurrent medical conditions included Arterial hypertension, Blood pressure high and Treatment noncompliance. On 12-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion death) and PULSE ABSENT (seriousness criterion death). The patient died on 19-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 19-Apr-2021, Heart rate: pulse absent (Negative) Pulse absent. 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: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second 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 29-Apr-2021: Translation received. On 05-May-2021: Dose 1 added.; Sender''s Comments: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 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: Unknown cause of death


VAERS ID: 1306453 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 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: 2021-04-08
   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: PANTOPRAZOL [PANTOPRAZOLE]; SOLIAN; D-CURE; GLUCOPHAGE; APOCARD RETARD; BISOPROLOL [BISOPROLOL FUMARATE]; ZYPREXA VELOTAB; FOLAVIT; L-THYROXINE [LEVOTHYROXINE]; PROTHIADEN
Current Illness: Cardiac failure; Diabetes; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac failure and Psychiatric disorder NOS. Concomitant products included PANTOPRAZOL [PANTOPRAZOLE], AMISULPRIDE (SOLIAN), COLECALCIFEROL (D-CURE), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), FLECAINIDE ACETATE (APOCARD RETARD), BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]), OLANZAPINE (ZYPREXA VELOTAB), FOLIC ACID (FOLAVIT), L-THYROXINE [LEVOTHYROXINE] and DOSULEPIN HYDROCHLORIDE (PROTHIADEN) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications included MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Description: The patient had not reported any complaints during the day or signs after vaccination. The patient fell down in her room and must have died right away. She was hanging stockings on a heater, the position of the body clearly showed that she had fallen down and had not moved. The patient did not receive any treatment. Action taken with the drug in response to events was not applicable. Company comment:This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 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 30-Apr-2021: Translation received included medical history information.; Sender''s Comments: This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 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: 1306512 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 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: 2021-03-31
   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: Cardiac failure; Coronary heart disease; Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, 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 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. Concurrent medical conditions included Dialysis, Cardiac failure and Coronary heart disease. On 24-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 MYOCARDIAL INFARCTION seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION to be unlikely related. The concomitant medications were not reported. The patient was resuscitated and later died at the hospital. The relationship to the vaccine was considered unlikely because the patient had severe heart disease. The action taken with mRNA 1273 with the event was not applicable. Company comment: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received. Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1308645 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / 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: 2021-04-10
   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: CARDIRENE; ENALAPRIL IDROCLOROTIAZIDE EG; COLECALCIFEROL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Cerebrovascular accident; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history was provided by the reporter. On 01-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible. Senders case reference number is IT-MINISAL02-714401. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Stop date of the event and date of death was updated.; Sender''s Comments: This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, 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: stroke


VAERS ID: 1308656 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoptysis, Loss of consciousness, Oesophageal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (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: BENTELAN; PALEXIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP); Surgery (hernia operation); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: ch
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Oesophageal haemorrhage; Unconsciousness; Haemoptysis; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage), LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Co-suspect products included non-company products CABOZANTINIB S-MALATE (CABOMETYX) for an unknown indication and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) for Hypertension. The patient''s past medical history included Surgery (hernia operation) and Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP). Concomitant products included BETAMETHASONE SODIUM PHOSPHATE (BENTELAN) and TAPENTADOL HYDROCHLORIDE (PALEXIA) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On an unknown date, the patient started CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage form On an unknown date, CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage was changed to at an unspecified dose. and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) (unknown route) 20 milligram. On 02-Apr-2021, the patient experienced OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage) (seriousness criterion death), LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criterion medically significant) and HAEMOPTYSIS (Haemoptysis) (seriousness criterion medically significant). On 02-Apr-2021, LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) outcome was unknown. The patient died on 02-Apr-2021. The reported cause of death was Oesophageal haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. At 7:15 PM, the patient started vomiting blood . The blood came from his oesophagus.and shortly afterwards lost consciousness. Treatment provided included resuscitation and medical observation. No additional treatment was provided. The reporter did not provide any causality assessments. This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), 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 28-Apr-2021: Translation provided primary source reaction details. On 03-May-2021: No new information; Sender''s Comments: This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), 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: Oesophageal haemorrhage


VAERS ID: 1309017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: NITROFURANTOINE; RISPERIDON; AZITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Fever; Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 20-Apr-2020. Concomitant products included NITROFURANTOINE, RISPERIDONE (RISPERIDON) and AZITHROMYCIN for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). The patient died on 28-Feb-2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed; 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 confirmed; Reported Cause(s) of Death: Fever


VAERS ID: 1309029 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test
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), COVID-19 (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: ALLOPURINOL; FAMOTIDINE ACID REDUCER; TRAMADOL; CLONAZEPAM; ALFACALCIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident ("5 months ago"); COVID-19; Dialysis; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: Corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 83-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 Renal insufficiency, Dialysis, Cerebrovascular accident ("5 months ago") in December 2020, Renal insufficiency, Dialysis and COVID-19 on 02-Apr-2020. Concomitant products included ALLOPURINOL, FAMOTIDINE (FAMOTIDINE ACID REDUCER), TRAMADOL, CLONAZEPAM and ALFACALCIDOL 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. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2020, SARS-CoV-2 test positive: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: The follow-up received has NNI.; Sender''s Comments: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1309030 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: NLMODERNATX, INC.MOD20211

Write-up: pulmonary embolism; The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) and PULMONARY EMBOLISM (pulmonary embolism) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. 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 THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) (seriousness criterion death). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 07-Apr-2021. The reported cause of death was pulmonary embolism presumably from thrombotic. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received; The event verbatim changed for both the events and the stop date for the event thrombosis leg updated; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required.; Reported Cause(s) of Death: Pulmonary embolism presumably from thrombotic


VAERS ID: 1309055 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Haemorrhagic diathesis, Respiratory tract haemorrhage, Thrombocytopenia
SMQs:, Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: PLMODERNATX, INC.MOD20211

Write-up: Diathesis skin-mucosal; Respiratory tract bleeding; Failure heart; Acute thrombocytopenia; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding), THROMBOCYTOPENIA (Acute thrombocytopenia) and CARDIAC FAILURE (Failure heart) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Mar-2021, the patient experienced THROMBOCYTOPENIA (Acute thrombocytopenia) (seriousness criterion death). On 18-Mar-2021, the patient experienced HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal) (seriousness criterion death), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding) (seriousness criterion death) and CARDIAC FAILURE (Failure heart) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Respiratory tract bleeding, Heart failure, acute thrombocytopenia and diathesis skin-mucosal. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Cardiac failure, thrombocytopaenia (both immune and toxic thrombocytopaenia) and the associated dermatomucosal diathesis and respiratory tract bleeding are unexpected adverse reactions which are not listed in section 4.8 of the COVID-19 Vaccine Moderna Summary ofProduct Characteristics. A causal relationship between the administration of the Moderna vaccine and the occurrence of immune thrombocytopaenia cannot be ruled out or confirmed at the current stage of development. Based on the information in the report, although acute immune thrombocytopaenia was reported as an adverse reaction, the type of thrombocytopaenia has not been confirmed (immune thrombocytopaenia or toxic thrombocytopaenia was merely suspected). There is a temporal relationship between vaccine administration and the onset of thrombocytopaenia, but due to the reasons listed above, a causal relationship has not been established. No information is available on whether cardiac failure existed before the vaccination (an attempt to obtain information was unsuccessful); therefore, no temporal or causal relationships can be established. The reporting physician assessed the adverse reactions as severe (death). The regulatory authority classified the report as severe. This is a case of death in a 86-year-old female subject with unknown medical history, 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 03-May-2021: Translation received. Sender''s comments added.; Sender''s Comments: This is a case of death in a 86-year-old female subject with unknown medical history, 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: Respiratory tract bleeding; Heart failure; Acute thrombocytopenia; Diathesis skin-mucosal


VAERS ID: 1309784 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular insufficiency, Coronary artery occlusion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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: DIAMICRON; SIMVASTATIN; JANUMET; FORXIGA
Current Illness: Hyperlipidaemia (Hyperlipid?mie); NIDDM (NIDDM)
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOVASCULAR INSUFFICIENCY and CORONARY ARTERY OCCLUSION in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. Concurrent medical conditions included NIDDM (NIDDM) and Hyperlipidaemia (Hyperlipid?mie). Concomitant products included GLICLAZIDE (DIAMICRON), SIMVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA) for an unknown indication. On 16-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 18-Apr-2021, the patient experienced CARDIOVASCULAR INSUFFICIENCY (seriousness criterion death) and CORONARY ARTERY OCCLUSION (seriousness criterion death). The patient died on 18-Apr-2021. The reported cause of death was Occlusion coronary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company comment:This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient autopsy info, Medical History, and Concomitant medication info added; Sender''s Comments: This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: Occlusion coronary


VAERS ID: 1309841 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-13
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acquired haemophilia, Gallbladder rupture, Haemobilia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gallbladder related disorders (narrow), Biliary tract disorders (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 27
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: ACETYLSALICYLIC ACID; ATORVASTATIN; SPIRONOLACTONE; BISOPROLOL FUMARATE; EZETIMIBE; Aldactone; CONCOR; Fludex; Triatec; ZANIDIP; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute blood loss anemia; Acute on chronic renal failure; Acute renal failure; Chronic renal failure; Coronary artery disease; Coronary artery disorder; Thrombopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Acquired haemophilia A with anti factor VIII; gall bladder hemorrhage; gallbladder perforation; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII), HAEMOBILIA (gall bladder hemorrhage) and GALLBLADDER RUPTURE (gallbladder perforation) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3000496 and 300042460) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure on 14-Mar-2021, Chronic renal failure, Acute blood loss anemia, Coronary artery disease, Acute on chronic renal failure on 14-Mar-2021, Thrombopenia and Coronary artery disorder. Concomitant products included ACETYLSALICYLIC ACID, ATORVASTATIN, SPIRONOLACTONE, BISOPROLOL FUMARATE, EZETIMIBE, Spironolactone (Aldactone), BISOPROLOL FUMARATE (CONCOR), Indapamide (Fludex), Ramipril (Triatec), LERCANIDIPINE HYDROCHLORIDE (ZANIDIP) and ALLOPURINOL (ZYLORIC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HAEMOBILIA (gall bladder hemorrhage) (seriousness criterion death) and GALLBLADDER RUPTURE (gallbladder perforation) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was gallbladder rupture and Gallbladder hemorrhage. It is unknown if an autopsy was performed. At the time of death, ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translated document received on 08 May 2021.Updated event death, death date and concomitant drug details.; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Gallbladder rupture; Gallbladder hemorrhage


VAERS ID: 1311562 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypotension, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: Bardet-Biedl syndrome; End stage renal disease (ESRD); Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Shock circulatory; Arterial hypotension; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Arterial hypotension) and SHOCK (Shock circulatory) in a 66-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 Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD) and Bardet-Biedl syndrome. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPOTENSION (Arterial hypotension) (seriousness criteria death and hospitalization). On 21-Mar-2021, the patient experienced SHOCK (Shock circulatory) (seriousness criteria death and hospitalization). The patient died on 21-Mar-2021. The reported cause of death was ?tat de choc avec hypoperfusion globale. An autopsy was not 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-2021040371. This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 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 29-Apr-2021: No new information On 04-May-2021: Follow up received on 04MAY2021 included an updated date of death (21MAR2021), no autopsy completed, and an updated start date of the event, shock, to 21MAR2021.; Sender''s Comments: This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 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: ?tat de choc avec hypoperfusion globale


VAERS ID: 1312402 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Malaise, Pallor
SMQs:, Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse event NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTMODERNATX, INC.MOD20211

Write-up: Death; Pale; Weakness; Feeling unwell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) 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 (Death), PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) in a 78-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 Adverse event NOS in 2005. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEATH (Death) (seriousness criterion death), PALLOR (Pale) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and MALAISE (Feeling unwell) (seriousness criterion medically significant). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death.; 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 reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death; Reported Cause(s) of Death: Unknown cause of death


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


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