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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: 1418568 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / 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: 2021-04-19
   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: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

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 male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001657) for COVID-19 vaccination. The patient''s past medical history included Atrial fibrillation, Disease coronary artery and Cardiac failure. On 18-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 19-Apr-2021. The reported cause of death was mort subite. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter. This is a case of sudden death of a 74-year-old male patient, and 2 days after receiving first dose of vaccine (Lot number 3001657). The possible confounding factors are the patient''s medical history of Atrial fibrillation, Coronary artery disease and Cardiac failure. Very limited information regarding concomitant medications, and the clinical details pertaining to death and cause of death was provided at this time. No further information is expected. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021068671.; Sender''s Comments: This is a case of sudden death of a 74-year-old male patient, and 2 days after receiving first dose of vaccine (Lot number 3001657). The possible confounding factors are the patient''s medical history of Atrial fibrillation, Coronary artery disease and Cardiac failure. Very limited information regarding concomitant medications, and the clinical details pertaining to death and cause of death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Mort subite


VAERS ID: 1418579 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Chronic alcoholism; Pneumopathy; Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Embolism pulmonary; Ischemic stroke; This regulatory authority case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Embolism pulmonary) and ISCHAEMIC STROKE (Ischemic stroke) in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Chronic alcoholism, Tabaquism, Pneumopathy in 2020 and AFib. On 22-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 25-May-2021, the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criteria death and medically significant) and ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 26-May-2021. The reported cause of death was avc. 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 concomitant medications were not provided. The treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Company Comment: This is a case of death in a 54 -years-old male subject with no reported medical hx, who died on the 04 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 54 -years-old male subject with no reported medical hx, who died on the 04 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: AVC


VAERS ID: 1418591 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CACIT VITAMINE D3 1000 mg/880 MONOPROST 50 microgrammes/ml, ; LACTULOSE; HYDROCHLOROTHIAZIDE; KARDEGIC 75 mg, ; CARDENSIEL 1,25 mg, ; IRBESARTAN; STAGID 700 mg,
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Double thrombose pulmonaire; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Double thrombose pulmonaire) in a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension arterial. Concomitant products included CACIT VITAMINE D3 1000 mg/880 UI, LATANOPROST (MONOPROST 50 microgrammes/ml), LACTULOSE, HYDROCHLOROTHIAZIDE, KARDEGIC 75 mg, , CARDENSIEL 1,25 mg, comprim? pellicul?, IRBESARTAN and STAGID 700 mg, comprim? s?cable for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PULMONARY THROMBOSIS (Double thrombose pulmonaire) (seriousness criteria death and medically significant). The patient died on 12-May-2021. The reported cause of death was Pulmonary thrombosis. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Angiogram: embolie pulmonaire (Inconclusive) embolie pulmonaire proximale bilat?rale avec signes de gravit?. Treatment information was not provided. On an unknown date, the patient had a COVID-19 PCR test that was negative. Very limited information regarding the event has been provided at this time. Further information is not expected. Sender''s Case Number: FR-AFSSAPS-2021065147. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15 Jun 2021. Updated the date of death, added medical history, concomitant medications, batch number, the start and end date of event.; 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: Pulmonary thrombosis


VAERS ID: 1419198 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPON; DIAMICRON; LOBIVON; ORIZAL
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Death; Arrest respiratory; Hypertensive heart disease; Arrest cardiac; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), RESPIRATORY ARREST (Arrest respiratory), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) and CARDIAC ARREST (Arrest cardiac) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included PARACETAMOL (DEPON), GLICLAZIDE (DIAMICRON), NEBIVOLOL HYDROCHLORIDE (LOBIVON) and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (ORIZAL) for an unknown indication. On 06-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 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 08-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), RESPIRATORY ARREST (Arrest respiratory) (seriousness criteria death and medically significant), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) (seriousness criteria death and medically significant) and CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Arrest cardiac, Arrest respiratory and Hypertensive heart disease. An autopsy was not performed. No treatment information was provided. Action taken with Moderna Covid vaccine was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Concomitant medication has been added; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Arrest cardiac; Arrest respiratory; Hypertensive heart disease


VAERS ID: 1419338 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186-05 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of UNRESPONSIVE TO STIMULI in a 94-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002186-05) for COVID-19 vaccination. The patient''s past medical history included Hematoma subdural since an unknown date. Concurrent medical conditions included Alzheimer''s disease. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced UNRESPONSIVE TO STIMULI (seriousness criterion death). The patient died on 20-May-2021. The reported cause of death was Unresponsive to stimuli. 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 products were reported. No treatment information was provided. Very limited information regarding the death 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. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received does not contain any new information; Sender''s Comments: Very limited information regarding the death 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: Unresponsive to stimuli


VAERS ID: 1419673 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001942 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGINE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; THERALEN; KEPPRA [LEVETIRACETAM]; CIRCADIN; MIRTAZAPINE; LORATADINE
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 33-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001942) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy. Concomitant products included LAMOTRIGINE, MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), ALIMEMAZINE TARTRATE (THERALEN), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), MELATONIN (CIRCADIN), MIRTAZAPINE and LORATADINE for an unknown indication. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on May 2021 The patient died in May 2021. The cause of death was not reported. It is unknown if an autopsy was performed. Treatment information was not provided. Company Comment: This is a case of death not otherwise specified in a 33-year-old male patient with a medical history of epilepsy on antiepileptic therapy, that occurred on an unknown number of days after receiving second dose of vaccine (Lot number 3001942). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translated document contains no significant information.; Sender''s Comments: This is a case of death not otherwise specified in a 33-year-old male patient with a medical history of epilepsy on antiepileptic therapy, that occurred on an unknown number of days after receiving second dose of vaccine (Lot number 3001942). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1419997 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-06-23
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: 2021-06-09
   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.MOD20212

Write-up: Death; This spontaneous 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 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 09-Jun-2021 The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. Company comment: Very limited information regarding this event has been provided at this time. Details regarding the vaccine, cause of death is required for further assessment; Sender''s Comments: Very limited information regarding this event has been provided at this time. Details regarding the vaccine, cause of death is required for further assessment; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1420106 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Obstructive airways disorder
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad)

Life Threatening? Yes
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: BUVENTOL
Current Illness: Asthma; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Opioid abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of OBSTRUCTIVE AIRWAYS DISORDER in a 44-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Opioid abuse. Concurrent medical conditions included Asthma and Chronic obstructive pulmonary disease. Concomitant products included SALBUTAMOL SULFATE (BUVENTOL) for an unknown indication. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced OBSTRUCTIVE AIRWAYS DISORDER (seriousness criteria death, hospitalization and life threatening). The reported cause of death was Airways obstruction. 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 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translation received on 18-Jun-2021.Description to be coded was updated(Severe obstruction).; Sender''s Comments: This is a case of death in a 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time.; Reported Cause(s) of Death: Airways obstruction


VAERS ID: 1420953 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Death, Loss of consciousness, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: SINTROM; LISITRIL; METO ZEROK; PANTOPRAZOL NYCOMED; VICTOZA; TRESIBA; INSULIN HUMAN; TAMBOCOR; LYRICA; GLUCAGEN HYPOKIT; TEMESTA EXPIDET; NITROLINGUAL
Current Illness: Albuminuria (chronic relevant albuminuria (ACR 45.7 mg/mmol in 12/2019 (absolute albuminuria 915 mg/l in 2/2014)); Blood pressure high (Hypertensive heart disease with high blood pressure treated since 2003 and possibly ischemic with); Diabetic foot (diabetic foot with lesions in toes I bilaterally and mal perforans dig IV on the right, absence of relevant macroangiopathy (valid wrists up to periphery in 1/2020)); Diabetic maculopathy (OS diabetic maculopathy without edema); Diabetic polyneuropathy (diabetic polyneuropathy with status post therapy with Lyrica, pallesthesia); Diabetic retinopathy (initial diabetic retinopathy in 2/2020 with:); Fluorescein angiography normal; Gonalgia (AIS Duplex of 1/2017: Recurrence on left gonalgia proximal thigh perforating veins since 10/2016 w/on: or clinically lateral compartment arthritis and patellar ligament insertion on Quadriceps muscle shortening); Paroxysmal atrial fibrillation (currently symptoms suspect paroxysmal AF or intermittent tachycardic AF with BB and ACO. first diagnosis with paroxysmal AF in 2002 or coronarography 11/2008: normal or TTE 2008: mild IVS, moderate biatrial enlargement, examination otherwise normal); Type II diabetes mellitus (Metabolic syndrome with: or type II diabetes mellitus (diagnosed 2003) with insulin with)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Asthma NOS (Subclinical asthma with: or status post parainfective exacerbation in 10/2012 status post bilateral central pulmonary embolism with DVT of the left lower limb and discontinuation of ACO in 1/2014 with: or TTE of 1/2014: pulmonary hypertension (55 mmHg) on EP); Atrial fibrillation; Cardiomyopathy; Crossectomy (status post crossectomy and stripping of the left great saphenous vein in 1990 with:); Diabetes mellitus; Electrical cardioversion (status post electrical conversion 2008 status post tachycardization within EPs in 01/2014); Hypercholesteremia (hypercholesterolemia or adiposity (BMI 37 kg/m2) of the abdominal type or non-alcoholic fatty liver disease of the NASH type C4s chronic venous insufficiency (CEAP) on the right (C3a) on the left with:); Metabolic syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38 degree Celsius
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Death; Fell unconscious; Fever; Myalgia; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), PYREXIA (Fever), MYALGIA (Myalgia) and LOSS OF CONSCIOUSNESS (Fell unconscious) in a 67-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiomyopathy on 20-May-2021, Arterial hypertension on 20-May-2021, Atrial fibrillation on 20-May-2021, Metabolic syndrome on 20-May-2021, Diabetes mellitus on 20-May-2021, Hypercholesteremia (hypercholesterolemia or adiposity (BMI 37 kg/m2) of the abdominal type or non-alcoholic fatty liver disease of the NASH type C4s chronic venous insufficiency (CEAP) on the right (C3a) on the left with:) on 20-May-2021, Asthma NOS (Subclinical asthma with: or status post parainfective exacerbation in 10/2012 status post bilateral central pulmonary embolism with DVT of the left lower limb and discontinuation of ACO in 1/2014 with: or TTE of 1/2014: pulmonary hypertension (55 mmHg) on EP) on 20-May-2021, Electrical cardioversion (status post electrical conversion 2008 status post tachycardization within EPs in 01/2014) in 2008 and Crossectomy (status post crossectomy and stripping of the left great saphenous vein in 1990 with:). Previously administered products included for Product used for unknown indication: Tambocor. Past adverse reactions to the above products included No adverse event with Tambocor. Concurrent medical conditions included Blood pressure high (Hypertensive heart disease with high blood pressure treated since 2003 and possibly ischemic with) since 2003, Paroxysmal atrial fibrillation (currently symptoms suspect paroxysmal AF or intermittent tachycardic AF with BB and ACO. first diagnosis with paroxysmal AF in 2002 or coronarography 11/2008: normal or TTE 2008: mild IVS, moderate biatrial enlargement, examination otherwise normal), Type II diabetes mellitus (Metabolic syndrome with: or type II diabetes mellitus (diagnosed 2003) with insulin with) since 2003, Diabetic polyneuropathy (diabetic polyneuropathy with status post therapy with Lyrica, pallesthesia), Diabetic foot (diabetic foot with lesions in toes I bilaterally and mal perforans dig IV on the right, absence of relevant macroangiopathy (valid wrists up to periphery in 1/2020)), Albuminuria (chronic relevant albuminuria (ACR 45.7 mg/mmol in 12/2019 (absolute albuminuria 915 mg/l in 2/2014)), Diabetic retinopathy (initial diabetic retinopathy in 2/2020 with:) since February 2020, Fluorescein angiography normal since February 2020, Diabetic maculopathy (OS diabetic maculopathy without edema) and Gonalgia (AIS Duplex of 1/2017: Recurrence on left gonalgia proximal thigh perforating veins since 10/2016 w/on: or clinically lateral compartment arthritis and patellar ligament insertion on Quadriceps muscle shortening) since January 2017. Concomitant products included GLYCERYL TRINITRATE (NITROLINGUAL) for Chest pain, ACENOCOUMAROL (SINTROM), LISINOPRIL (LISITRIL), METOPROLOL SUCCINATE (METO ZEROK), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOL NYCOMED), LIRAGLUTIDE (VICTOZA), INSULIN DEGLUDEC (TRESIBA), INSULIN HUMAN, FLECAINIDE ACETATE (TAMBOCOR), PREGABALIN (LYRICA), GLUCAGON HYDROCHLORIDE (GLUCAGEN HYPOKIT) and LORAZEPAM (TEMESTA EXPIDET) for an unknown indication. On 19-May-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PYREXIA (Fever) (seriousness criteria death and medically significant) and MYALGIA (Myalgia) (seriousness criteria death and medically significant). On 20-May-2021, the patient experienced DEATH (Death) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Fell unconscious) (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was rhythm disturbance in the context of myocardial ischemia. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Body temperature: 38 (Inconclusive) 38 degree Celsius. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (Fever) and MYALGIA (Myalgia) to be probably related and DEATH (Death) to be unlikely related. No further causality assessment was provided for LOSS OF CONSCIOUSNESS (Fell unconscious). Patient was suffering from ischemic heart disease and it was on progress. After vaccination patent had a temperature of 38?C and while try to get up from bed patient fall unconscious and when 144 alerted patient found asystole. All the resuscitative maneuvers went vain No laboratory data was given. No treatment information was given. Based on reporter''s causality and multiple comorbidities, the event of death is assessed as unlikely related to mRNA-1273. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events of pyrexia and myalgia, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added medical histories and lab tests. Updated the dose information.; Sender''s Comments: Based on reporter''s causality and multiple comorbidities, the event of death is assessed as unlikely related to mRNA-1273. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events of pyrexia and myalgia, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Rhythm disturbance in the context of myocardial ischemia


VAERS ID: 1420977 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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; Asthma bronchial; Closed femur fracture
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100092398

Write-up: Condition worsened; Acute heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) and CONDITION AGGRAVATED (Condition worsened) in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Closed femur fracture, Arterial hypertension and Asthma bronchial. On 17-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criteria death and medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition worsened) (seriousness criterion death). The patient died on 27-Apr-2021. The reported cause of death was Acute heart failure. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. No Treatment information was provided.; Sender''s Comments: This is a case of sudden death in an 81-year-old female with hx of Closed femur fracture, who died of Cardiac failure acute 10 days after receiving a dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1421009 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
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: 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: Aneurysm of aorta; Aortic valve stenosis; Infarct myocardial
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 54-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Prophylactic vaccination: COVID-19 Vaccine COVID-19 Vaccine AstraZeneca suspension for injectionCOVID-19 Vaccine AstraZeneca. Concurrent medical conditions included Aortic valve stenosis, Infarct myocardial since 2020, Aneurysm of aorta and Asthma. On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medication was not reported. No treatment medication was not reported This is a case of sudden death in a 54-year-old male with medicatl history of aortic valve stenosis, infarct myocardial, asthma and aneurysm of aorta, who died after receiving second dose of vaccine. Autopsy results were not provided. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 54-year-old male with medicatl history of aortic valve stenosis, infarct myocardial, asthma and aneurysm of aorta, who died after receiving second dose of vaccine. Autopsy results were not provided. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1421010 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
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: 2021-05-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Cardiac arrhythmia; Diabetes mellitus, antepartum
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM and THROMBOSIS in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in January 2021. Concurrent medical conditions included Arterial hypertension, Diabetes mellitus, antepartum and Cardiac arrhythmia. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant) and THROMBOSIS (seriousness criterion medically significant). The patient died on 12-May-2021. The reported cause of death was Lung embolism. An autopsy was performed, but no results were provided. At the time of death, THROMBOSIS had not resolved. No concomitant medications were provided. No treatment was reported for the events. Action taken with the suspect product was not applicable. This is a case of an 80-year-old female patient with a history of arterial hypertension, diabetes mellitus, and cardiac arrhythmia who experienced thrombosis and lung embolism which resulted in fatal outcome three weeks following second dose of the vaccine. An autopsy was performed, but no results were provided. Very limited information has been provided at this time. Causality is confounded with patient''s advanced age and reported medical history.; Sender''s Comments: This is a case of an 80-year-old female patient with a history of arterial hypertension, diabetes melitus, and cardiac arrhytmia who experienced thrombosis and lung embolism which resulted in fatal outcome three weeks following second dose of the vaccine. An autopsy was performed, but no results were provided. Very limited information has been provided at this time. Causality is confouded with patient''s advanced age and reported medical history.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1421852 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100100886

Write-up: Anorexia; This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE (Anorexia) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DECREASED APPETITE (Anorexia) (seriousness criterion death). 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) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day 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: 1421877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death unexplained) in an adult male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy. On 28-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-May-2021 The patient died on 29-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. This is a case of sudden death in a male subject of Unknown age with a hx of Epilepsy, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a male subject of Unknown age with a hx of Epilepsy, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1422730 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete, Chest pain, Dyspnoea, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: Primary hypertension (Well controlled)
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumor NOS (Patient was in remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: AV block complete; Syncope; Shortness of breath; Profusely sweating; Mild chest pain; This regulatory authority case was reported by a physician and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (AV block complete), SYNCOPE (Syncope), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profusely sweating) and CHEST PAIN (Mild chest pain) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Brain tumor NOS (Patient was in remission) in 2014. Concurrent medical conditions included Primary hypertension (Well controlled). On 02-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (AV block complete) (seriousness criteria death and medically significant), SYNCOPE (Syncope) (seriousness criteria death and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria death and medically significant), HYPERHIDROSIS (Profusely sweating) (seriousness criteria death and medically significant) and CHEST PAIN (Mild chest pain) (seriousness criteria death and medically significant). The patient died on 03-Jun-2021. The reported cause of death was AV block complete. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided. Company comment: This is a case of sudden death in a 70-year-old female subject with hx of primary hypertension and history o brain tumor (currently in remission) who died 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 70-year-old female subject with hx of primary hypertension and history o brain tumor (currently in remission) who died 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: AV block complete


VAERS ID: 1422882 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Blood test, C-reactive protein, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Confusional state, Headache, Injection site pain, Magnetic resonance imaging, Magnetic resonance imaging head, Malaise, Neurological symptom, Polyomavirus test, SARS-CoV-2 test, Sepsis, Single photon emission computerised tomogram, Ultrasound abdomen
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 36
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: NATRIUM HYDROGENCARBONATE; INSULIN ISOPHANE; CEFTRIAXON; SEVELAMEERCARBONAAT SANDOZ; LEVOTHYROXINE; AIROMIR [SALBUTAMOL]; ALFACALCIDOL; SERETIDE; SPIRIVA; ESOMEPRAZOL [ESOMEPRAZOLE]; ACETYLSALICYLZUUR; CODEINE; CINACALCET; ROSUVASTATINE [RO
Current Illness: Atherosclerosis of renal artery; Chronic renal insufficiency ; Cirrhosis liver; COPD (Gold II); Dialysis (dialysis patient); Hepatic steatosis; Hypercholesterolaemia; Hypertension; Iliac artery disease; Superficial femoral arterial stenosis; Type II diabetes mellitus; Vascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Abscess drainage - drainage; Appendicitis perforated; Drug-eluting stent placement (CX and LAD); Percutaneous coronary intervention (Drug eluting stent placement)
Allergies:
Diagnostic Lab Data: Test Date: 2008; Test Name: CAG; Test Result: Inconclusive ; Result Unstructured Data: CAGTest Date: 202104; Test Name: Lab onderzoek; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: X Thorax; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: CT ; Test Result: Inconclusive ; Result Unstructured Data: Blanco-CT . Test Date: 2014; Test Name: CT thorax; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210506; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 100 (hoogste meting tijdens opname); Test Date: 2008; Test Name: MRI rechter a iliaca communis; Test Result: Inconclusive ; Result Unstructured Data: significant letsel; Test Date: 202104; Test Name: MRI ; Test Result: Inconclusive ; Result Unstructured Data: CT-scan DD 23/4/2021. ; Test Date: 202104; Test Name: BK virus; Test Result: Inconclusive ; Result Unstructured Data: BK virus negative; Test Date: 202104; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 2008; Test Name: SPECT scan; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: Echo abdomen; Test Result: Inconclusive ; Result Unstructured Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis eci), NEUROLOGICAL SYMPTOM , CONFUSIONAL STATE , MALAISE and HEADACHE in a 69-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. Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication. The patient''s past medical history included Appendicitis perforated in 2010, Percutaneous coronary intervention (Drug eluting stent placement) in 2008, Abscess drainage transrectaal), Dialysis (dialysis patient) since an unknown date and Drug-eluting stent placement (CX and LAD) in 2008. Concurrent medical conditions included Hypercholesterolaemia since 2004, Cirrhosis liver, Hypertension since 2004, Type II diabetes mellitus since 2004, Chronic renal insufficiency , Atherosclerosis of renal artery, Vascular disorder , Iliac artery disease since 2008, COPD (Gold II) since 2008, Hepatic steatosis and Superficial femoral arterial stenosis since 2008. Concomitant products included SODIUM BICARBONATE (NATRIUM HYDROGENCARBONATE), INSULIN ISOPHANE BOVINE (INSULIN ISOPHANE), CEFTRIAXONE SODIUM (CEFTRIAXON), SEVELAMER CARBONATE , LEVOTHYROXINE, SALBUTAMOL (AIROMIR [SALBUTAMOL]), ALFACALCIDOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ESOMEPRAZOL [ESOMEPRAZOLE], ACETYLSALICYLZUUR, CODEINE, CINACALCET, ROSUVASTATINE [ROSUVASTATIN] and METOPROLOL for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced NEUROLOGICAL SYMPTOM (seriousness criteria death and hospitalization), CONFUSIONAL STATE (seriousness criteria death and hospitalization), MALAISE (seriousness criterion death), HEADACHE (Hoofdpijn) (seriousness criterion death) and INJECTION SITE PAIN. In April 2021, the patient experienced SEPSIS (Sepsis eci) (seriousness criteria death and medically significant). The patient died on 07-May-2021. The reported cause of death was sepsis. It is unknown if an autopsy was performed. At the time of death, INJECTION SITE PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2008, Angiocardiogram: unknown (Inconclusive) CAG SPECT-scan. In 2008, Magnetic resonance imaging: unknown (Inconclusive) In 2008, Single photon emission computerised tomogram: unknown (Inconclusive) In 2014, Computerised tomogram thorax: unknown (Inconclusive) unknown. In April 2021, Blood test: unknown (Inconclusive) In April 2021, Chest X-ray: unknown (Inconclusive) In April 2021, Computerised tomogram head: unknown (Inconclusive) In April 2021, Magnetic resonance imaging head: unknown (Inconclusive) CT-scan DD 23/4/2021. In April 2021, Polyomavirus test: unknown (Inconclusive) BK virus negative. In April 2021, SARS-CoV-2 test: negative (Negative) negative. In April 2021, Ultrasound abdomen: unknown (Inconclusive) On 06-May-2021, C-reactive protein: unknown (Inconclusive) 100 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 events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Reported Cause(s) of Death: MRI-scan


VAERS ID: 1422895 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001937 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Administration site erythema, Asphyxia, Autopsy, C-reactive protein, Vaccination site discomfort, Vaccination site pain, White blood cell count
SMQs:, Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: NEURONTIN; MAVENCLAD
Current Illness: Multiple sclerosis; Trigeminal neuralgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Autopsy; Result Unstructured Data: Found residue of food in airways. Suspected cause of death is obstruction of airways with following asphyxia and death.; Test Date: 20210422; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 9 mg/L; Test Date: 20210422; Test Name: White blood cell count; Result Unstructured Data: 0.3
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Asphyxia; Erythema; This regulatory authority case was reported by a physician and describes the occurrence of ASPHYXIA (Asphyxia) in a 66-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001937) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis and Trigeminal neuralgia. Concomitant products included CLADRIBINE (MAVENCLAD) from 11-Feb-2021 to an unknown date for Multiple sclerosis, GABAPENTIN (NEURONTIN) from 14-Apr-2021 to an unknown date for Trigeminal neuralgia. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema). On 28-Apr-2021, the patient experienced ASPHYXIA (Asphyxia) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Asphyxia. An autopsy was performed. At the time of death, VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Autopsy: asphyxia (abnormal) Found residue of food in airways. Suspected cause of death is obstruction of airways with following asphyxia and death. On 22-Apr-2021, C-reactive protein: 9 (Inconclusive) 9 mg/L. On 22-Apr-2021, White blood cell count: 0.3 (Low) 0.3. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) to be probably related. No further causality assessment was provided for ASPHYXIA (Asphyxia). No treatment information was provided. For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": 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. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": 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. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: ASPHYXIA


VAERS ID: 1424979 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943-65 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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: DELTACORTENE; XARELTO; DUROGESIC; LANSOPRAZOLE; ESIDREX; ALLOPURINOL; LASIX [FUROSEMIDE]; FERRO GRAD C
Current Illness: Aortic valve stenosis; Atrial fibrillation; Chronic anemia; Chronic ischemic heart disease, unspecified; Decompensation cardiac; Dyspnoea; Kyphosis; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and CARDIAC FAILURE in a 91-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943-65) for COVID-19 vaccination. The patient''s past medical history included Inguinal hernia and Benign prostatic hypertrophy. Concurrent medical conditions included Decompensation cardiac since 01-Apr-2016, Atrial fibrillation, Aortic valve stenosis, Polymyalgia rheumatica, Dyspnoea, Kyphosis, Chronic anemia and Chronic ischemic heart disease, unspecified. Concomitant products included PREDNISONE (DELTACORTENE), RIVAROXABAN (XARELTO), FENTANYL (DUROGESIC), LANSOPRAZOLE, HYDROCHLOROTHIAZIDE (ESIDREX), ALLOPURINOL, FUROSEMIDE (LASIX [FUROSEMIDE]) and ASCORBIC ACID, FERROUS SULFATE (FERRO GRAD C) for an unknown indication. On 15-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 17-May-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and CARDIAC FAILURE (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was Standstill cardiac 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. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added other medical relevant history. Added concomitant medicines.; 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: Standstill cardiac; Decompensation cardiac


VAERS ID: 1425711 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002336 / 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: SUDDEN DEATH; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (SUDDEN DEATH) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002336) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (SUDDEN DEATH) to be possibly related. No concomitant product use was provided. No treatment information was reported. This is a case of sudden death in a 64-year old male subject, who died 6 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 64-year old male subject, who died 6 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1428705 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001939 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hemiparesis, Hypertension, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 13
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; Joint pain
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Blood pressure; Result Unstructured Data: Increased; Test Date: 20210508; Test Name: Pulse rate; Result Unstructured Data: Rapid pulse
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: (209/120 Hgmm); (115/min); This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (hemiparesis), HYPERTENSION (209/120 Hgmm), HEART RATE INCREASED (115/min) and VACCINATION FAILURE in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001939) for COVID-19 vaccination. The patient''s past medical history included Hypertension and Joint pain. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-May-2021, the patient experienced HEMIPARESIS (hemiparesis) (seriousness criteria death, hospitalization and medically significant), HYPERTENSION (209/120 Hgmm) (seriousness criteria death and hospitalization) and HEART RATE INCREASED (115/min) (seriousness criteria death and hospitalization). On 21-May-2021, the patient experienced VACCINATION FAILURE (seriousness criteria death and hospitalization). The patient died on 21-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood pressure measurement: 209/120 mmhg (High) Increased. On 08-May-2021, Heart rate: 115 (High) Rapid pulse. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment details provided. This fatal case concerns a 66-year-old male with serious unexpected events of hemiparesis, hypertension, heart rate increased, and vaccination failure. Event latency 8 days after first dose mRNA-1273. Outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 66-year-old male with serious unexpected events of hemiparesis, hypertension, heart rate increased, and vaccination failure. Event latency 8 days after first dose mRNA-1273. Outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1430783 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-31
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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: Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Tod; Tod; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Tod) and CARDIAC FAILURE ACUTE (Tod) in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Coronary heart disease. On 01-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced DEATH (Tod) (seriousness criteria death and medically significant) and CARDIAC FAILURE ACUTE (Tod) (seriousness criteria death and medically significant). The patient died on 31-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 DEATH (Tod) and CARDIAC FAILURE ACUTE (Tod) to be unlikely related. No concomitant medications were reported. Treatment information was not provided. This fatal case concerns a 77-year-old male with serious unexpected events cardiac failure acute with outcome death. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 77-year-old male with serious unexpected events cardiac failure acute with outcome death. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1431597 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebral artery thrombosis, Cerebral infarction
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: GALANTAMINE; LOSATRIX; PLAVIX; NITROSID; PIOGLITAZONE; PARACETAMOL; SIMVASTATIN; ATENBLOCK; TRAJENTA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: Atrial fibrillation; Cerebral infarction; Middle cerebral artery thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021. This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL INFARCTION (Cerebral infarction) and CEREBRAL ARTERY THROMBOSIS (Middle cerebral artery thrombosis) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002186) for COVID-19 vaccination. No medical history was provided. Concomitant products included GALANTAMINE, LOSARTAN POTASSIUM (LOSATRIX), CLOPIDOGREL BISULFATE (PLAVIX), ISOSORBIDE DINITRATE (NITROSID), PIOGLITAZONE, PARACETAMOL, SIMVASTATIN, ATENOLOL (ATENBLOCK) and LINAGLIPTIN (TRAJENTA) for an unknown indication. On 28-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria death and medically significant), CEREBRAL INFARCTION (Cerebral infarction) (seriousness criteria death and medically significant) and CEREBRAL ARTERY THROMBOSIS (Middle cerebral artery thrombosis) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The reported cause of death was Cerebral infarction. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the events was not applicable since the patient died. This fatal case concerns an 86-year-old female with serious unexpected events of atrial fibrillation, cerebral infarction, and cerebral artery thrombosis. Event latency 2 days after first dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns an 86-year-old female with serious unexpected events of atrial fibrillation, cerebral infarction, and cerebral artery thrombosis. Event latency 2 days after first dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1431600 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Ileus paralytic, Intestinal ischaemia, Mesenteric artery thrombosis, Pseudomembranous colitis
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: death; Intestinal ischaemia; Mesenteric artery thrombosis; Pseudomembranous colitis; Paralytic ileus; This regulatory authority case was reported by a physician and describes the occurrence of INTESTINAL ISCHAEMIA (Intestinal ischaemia), MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis), PSEUDOMEMBRANOUS COLITIS (Pseudomembranous colitis), ILEUS PARALYTIC (Paralytic ileus) and DEATH (death) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INTESTINAL ISCHAEMIA (Intestinal ischaemia) (seriousness criteria death and medically significant), MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) (seriousness criteria death, medically significant and life threatening), PSEUDOMEMBRANOUS COLITIS (Pseudomembranous colitis) (seriousness criteria death and medically significant) and ILEUS PARALYTIC (Paralytic ileus) (seriousness criteria death and medically significant). The patient died on 22-May-2021. The reported cause of death was Intestinal ischaemia and Mesenteric artery thrombosis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. This is a case of sudden death in a 74-year-old male subject with no known Medical History , who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old male subject with no known Medical History , who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Intestinal ischaemia; Mesenteric artery thrombosis


VAERS ID: 1431781 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Myocarditis, 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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypothyreosis; Variant angina
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100100794

Write-up: Myocarditis; Cardiac arrest; Cardiac arrhythmia; Ventricular fibrillation; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), CARDIAC ARREST (Cardiac arrest), ARRHYTHMIA (Cardiac arrhythmia) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002620) for COVID-19 vaccination and Prophylactic vaccination. The patient''s past medical history included Gastritis. Concurrent medical conditions included Hypothyreosis and Variant angina. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death, hospitalization and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death, hospitalization and medically significant) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on 09-Jun-2021 due to ARRHYTHMIA, CARDIAC ARREST, MYOCARDITIS and VENTRICULAR FIBRILLATION. The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment included cardiopulmonary resuscitation for the cardiac arrest. The action taken with mRNA 1273 with the events was considered as not applicable. This is a case of death in a 65-year-old male patient, that occurred 1 day after receiving the second dose of vaccine (Lot number 3002620). Based on the provided information, the patient had cardiac arrest and expired. A possible confounding factor is the patient''s medical history of variant angina. No further information is expected.; Sender''s Comments: This is a case of death in a 65-year-old male patient, that occurred 1 day after receiving the second dose of vaccine (Lot number 3002620). Based on the provided information, the patient had cardiac arrest and expired. A possible confounding factor is the patient''s medical history of variant angina. No further information is expected.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1432262 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Sudden death
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: 2021-06-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST, SUDDEN DEATH and DEATH in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Cutaneous) 1 dosage form. On 08-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant), SUDDEN DEATH (seriousness criteria death and medically significant) and DEATH (seriousness criteria death and medically significant). The patient died on 08-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. Treatment information was not reported. This fatal case concerns a 53-year-old male with a serious unexpected event of cardiac arrest, sudden death, and death. Event latency 7 days after mRNA-1273. Case of death unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 53-year-old male with a serious unexpected event of cardiac arrest, sudden death, and death. Event latency 7 days after mRNA-1273. Case of death unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1433102 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: SORTIS; ANOPYRIN; TROMBEX; MILURIT; TRITACE; CORYOL [CARVEDILOL]; EZEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct (stents used); Myocardial infarct (bypasses used)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION and BACK PAIN in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 626761A) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct (bypasses used) from 2002 to 2016 and Myocardial infarct (stents used) in 2002. Concomitant products included CLOPIDOGREL BISULFATE (TROMBEX) for Anticoagulant therapy, ACETYLSALICYLIC ACID (ANOPYRIN) for Antiplatelet therapy, RAMIPRIL (TRITACE) for Arterial hypertension, ALLOPURINOL (MILURIT) for Gout, ATORVASTATIN CALCIUM (SORTIS) for Hypercholesterolaemia, EZETIMIBE (EZEN) for Hyperlipidemia, CARVEDILOL (CORYOL [CARVEDILOL]) for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced BACK PAIN (seriousness criterion life threatening). On 09-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death, medically significant and life threatening). The patient died on 09-Apr-2021. The reported cause of death was myocardial infarction. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment information was provided by the reporter. The patient consulted Cardiologist and was observed as everything was normal. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1433120 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-29
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Dizziness, Dyspnoea, Gait disturbance, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (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), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Chronic bronchitis; Hypothyroidism; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Cardiovascular collapse; Gait instability; Dyspnea; Light headedness; Nausea; This regulatory authority case was reported by a physician and describes the occurrence of CIRCULATORY COLLAPSE (Cardiovascular collapse), GAIT DISTURBANCE (Gait instability), DYSPNOEA (Dyspnea), DIZZINESS (Light headedness) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. Concurrent medical conditions included Hypothyroidism, Chronic bronchitis, Arterial hypertension and Obesity. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced GAIT DISTURBANCE (Gait instability) (seriousness criterion death), DYSPNOEA (Dyspnea) (seriousness criterion death), DIZZINESS (Light headedness) (seriousness criterion death) and NAUSEA (Nausea) (seriousness criterion death). On 01-May-2021, the patient experienced CIRCULATORY COLLAPSE (Cardiovascular collapse) (seriousness criteria death and medically significant). The patient died on 01-May-2021. The reported cause of death was Acute heart failure. An autopsy was performed. The autopsy-determined cause of death. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product were not provided/unknown. Treatment medication were not reported/unknown. Very limited information regarding these events have been provided at this time. No further information is expected at this time. Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Acute heart failure; Autopsy-determined Cause(s) of Death.


VAERS ID: 1434214 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection, Dyspnoea, Dyspnoea exertional, Fibrin D dimer, Malaise, Oxygen saturation, Pulmonary embolism, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 33
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: AMLODIPIN ACCORD; LOSARTAN MEDIC VALLEY; DURAPHAT
Current Illness: Aortic dissection (Small possibility of Aortic dissection (small OBS)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: Unknown; Test Date: 20210603; Test Name: Oxygen saturation; Test Result: Inconclusive 95 %; Result Unstructured Data: Oxygen saturation-95%; Test Date: 20210603; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: Unknown
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Acute unwell; Possible lung embolism with fatal ourcome; Hospitalised due to progressive dyspnoea through 4 weeks; Dyspnoea exertional; aortic dissection.; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Possible lung embolism with fatal ourcome), AORTIC DISSECTION (aortic dissection.), DYSPNOEA (Hospitalised due to progressive dyspnoea through 4 weeks), DYSPNOEA EXERTIONAL (Dyspnoea exertional) and MALAISE (Acute unwell) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Aortic dissection (Small possibility of Aortic dissection (small OBS)). Concomitant products included SODIUM FLUORIDE (DURAPHAT) from 20-May-2020 to an unknown date for Caries dental, AMLODIPINE BESILATE (AMLODIPIN ACCORD) from 08-Mar-2016 to an unknown date and LOSARTAN POTASSIUM (LOSARTAN MEDIC VALLEY) from 20-Feb-2018 to an unknown date for Hypertension. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (Possible lung embolism with fatal ourcome) (seriousness criteria death, hospitalization prolonged and medically significant), AORTIC DISSECTION (aortic dissection.) (seriousness criteria death and medically significant), DYSPNOEA (Hospitalised due to progressive dyspnoea through 4 weeks) (seriousness criteria death and hospitalization prolonged) and DYSPNOEA EXERTIONAL (Dyspnoea exertional) (seriousness criteria death and hospitalization prolonged). On 03-Jun-2021, the patient experienced MALAISE (Acute unwell) (seriousness criteria death and hospitalization prolonged). The patient died on 03-Jun-2021. The reported cause of death was Lung embolism and Aortic dissection. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Fibrin D dimer: unknown (Inconclusive) Unknown. On 03-Jun-2021, Oxygen saturation: 95 percent (Inconclusive) Oxygen saturation-95%. On 03-Jun-2021, Respiratory rate: unknown (Inconclusive) Unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Patients treatment product details was not provided by reporter. This fatal case concerns a 79-year-old male hospitalized with serious unexpected events of pulmonary embolism, aortic dissection, dyspnea, dyspnea exertional and malaise. Event latency x days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This fatal case concerns a 79-year-old male hospitalized with serious unexpected events of pulmonary embolism, aortic dissection, dyspnea, dyspnea exertional and malaise. Event latency x days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Lung embolism; Aortic dissection


VAERS ID: 1434339 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001939 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Myocardial ischaemia
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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATINA; ADIRO
Current Illness: Cardiovascular event prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST and MYOCARDIAL ISCHAEMIA in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001939) for COVID-19 vaccination. The patient''s past medical history included Angina pectoris. Concurrent medical conditions included Cardiovascular event prophylaxis. Concomitant products included ACETYLSALICYLIC ACID for Cardiovascular event prophylaxis, ATORVASTATINA [ATORVASTATIN] for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant) and MYOCARDIAL ISCHAEMIA (seriousness criteria death and medically significant). The patient died on 26-May-2021. The reported cause of death was respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter 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.; 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:


VAERS ID: 1434359 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LOSARTAN; SOMAC; BRILIQUE; BISOPROLOL; DIURAMIN; DISPERIN; SEPRAM; ATORVASTATIN
Current Illness:
Preexisting Conditions: Comments: No significant medical history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No significant medical history reported. Concomitant products included LOSARTAN from 04-Jan-2021 to an unknown date for Blood pressure high, TICAGRELOR (BRILIQUE) from 04-Jan-2021 to an unknown date and BISOPROLOL from 04-Jan-2021 to an unknown date for Coronary artery disease, Acetylsalicylic acid (DISPERIN) for Thrombosis prophylaxis, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC), AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (DIURAMIN), CITALOPRAM HYDROBROMIDE (SEPRAM) and ATORVASTATIN for an unknown indication. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Date of death was not reported . The action taken with mRNA-1273 was not applicable. This is a case of sudden death in a 63-year-old male subject on medications for high blood pressure, coronary artery disease, thrombosis prophylaxis, who died after receiving first dose of vaccine, the date of death is Unknown. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 63-year-old male subject on medications for high blood pressure, coronary artery disease, thrombosis prophylaxis, who died after receiving first dose of vaccine, the date of death is Unknown. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1434707 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Cardiovascular evaluation, Death, Disease progression, Echocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: ASPIRIN CARDIO; BELOC ZOK; OLMESARTAN MEPHA; TOREM [TORASEMIDE]; METOLAZON; EUTHYROX; ATORVASTATIN MEPHA; ACIDUM FOLICUM STREULI; ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]; ROCALTROL; HUMALOG; MAGNESIOCARD CITRON
Current Illness: Triple vessel disease; Type 1 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure); Diabetic nephropathy (Not histologically confirmed); Dialysis (worsening of kidney failure.); Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.); Hashimoto''s thyroiditis; Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23); Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome)
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Coronary angiography; Result Unstructured Data: triple vessel disease; Test Date: 2021; Test Name: Cardiological assessment; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes; Test Date: 2021; Test Name: Transthoracic echocardiography; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH and DISEASE PROGRESSION in a 55-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunization. The patient''s past medical history included Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23) on 23-Feb-2021, Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome), Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure), Diabetic nephropathy (Not histologically confirmed) in 1985, Hashimoto''s thyroiditis, Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.) from 22-Feb-2021 to 26-Feb-2021 and Dialysis (worsening of kidney failure.) on 12-Mar-2021. Concurrent medical conditions included Type 1 diabetes mellitus since 1973 and Triple vessel disease since 23-Feb-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), METOPROLOL SUCCINATE (BELOC ZOK), OLMESARTAN MEDOXOMIL (OLMESARTAN MEPHA), TORASEMIDE (TOREM [TORASEMIDE]), METOLAZONE (METOLAZON), LEVOTHYROXINE SODIUM (EUTHYROX), ATORVASTATIN CALCIUM (ATORVASTATIN MEPHA), FOLIC ACID (ACIDUM FOLICUM STREULI), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]), CALCITRIOL (ROCALTROL), INSULIN LISPRO (HUMALOG) and MAGNESIUM ASPARTATE HYDROCHLORIDE (MAGNESIOCARD CITRON) for an unknown indication. On 26-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 DISEASE PROGRESSION (seriousness criterion death). The patient died on 13-Mar-2021. The reported cause of death was Disease progression, Type 1 diabetes mellitus, dialysis-dependent kidney failure and Triple vessel disease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Angiocardiogram: abnormal (abnormal) triple vessel disease. In 2021, Cardiovascular evaluation: unknown (Inconclusive) LVEF of 65% without detectable changes. In 2021, Echocardiogram: unknown (Inconclusive) LVEF of 65% without detectable changes. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH and DISEASE PROGRESSION to be possibly related. It was reported that the patient was scheduled for a cardiac MRI (magnetic resonance imaging) on 09-Mar-2021, after which an aortic coronary bypass surgery was planned. It was reported that the rapid progression of the underlying diseases, after 22-Feb-2021, was presumed as the primary factor for the patient''s death. 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/s, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Translated document uploaded. Added additional causes of death (as per sender''s comments), medical history, lab data, frequency of con-meds, causality as reported.; 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/s, a causal relationship cannot be excluded; Reported Cause(s) of Death: Disease progression; type 1 diabetes mellitus; dialysis-dependent kidney failure; Triple vessel disease


VAERS ID: 1435266 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-09
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 31946 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood creatinine, Blood glucose, C-reactive protein, Cardiac arrest, Fibrin D dimer, Lipase, Pulmonary embolism, Pulmonary infarction, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFIPREV [DIENOGEST;ETHINYLESTRADIOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary resuscitation; Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 106 INTERNATIONAL UNIT(S)-(UNDER 1000) 50/5; Test Date: 20210609; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 1.74 MILLIGRAM(S) 1.18/0.55; Test Date: 20210609; Test Name: Blood glucose; Test Result: 321 mg; Result Unstructured Data: 321; Test Date: 20210609; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 18.1 MILLIGRAM(S) 5/0; Test Date: 20210609; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 29.30 MILLIGRAM(S) 0.5/0; Test Date: 20210609; Test Name: Lipase; Test Result: Inconclusive ; Result Unstructured Data: 115 INTERNATIONAL UNIT(S)-(UNDER 100) 67/5; Test Date: 20210609; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: 878 NANOGRAM(S) 11.6/2.3
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 31946) for COVID-19 immunisation. No medical history was reported by the reporter. The patient''s past medical history included Cardiopulmonary resuscitation on 09-Jun-2021. Concomitant products included DIENOGEST, ETHINYLESTRADIOL (EFFIPREV [DIENOGEST;ETHINYLESTRADIOL]) for an unknown indication. On 15-May-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. On 09-Jun-2021, the patient experienced PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant). The patient died on 09-Jun-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 09-Jun-2021, Alanine aminotransferase: 106 (Inconclusive) 106 INTERNATIONAL UNIT(S)-(UNDER 1000) 50/5. On 09-Jun-2021, Blood creatinine: 1.74 (Inconclusive) 1.74 MILLIGRAM(S) 1.18/0.55. On 09-Jun-2021, Blood glucose (74-106 milligram): 321 milligram (abnormal) 321. On 09-Jun-2021, C-reactive protein: 18.1 (Inconclusive) 18.1 MILLIGRAM(S) 5/0. On 09-Jun-2021, Fibrin D dimer: 29.30 (Inconclusive) 29.30 MILLIGRAM(S) 0.5/0. On 09-Jun-2021, Lipase: 115 (Inconclusive) 115 INTERNATIONAL UNIT(S)-(UNDER 100) 67/5. On 09-Jun-2021, Troponin: 878 (Inconclusive) 878 NANOGRAM(S) 11.6/2.3. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. Patient was arrived emergency room at 11:24 AM patient was experienced lacking consciousness, pulse and absence of spontaneous breathing and pronounced extreme cyanosis and marble veined. No treatment information was provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. CT REPORTS AND COPIES OF BLOOD TESTS ARE AVAILABLE, CLINICAL DIARY FROM THE EMERGENCY ROOM AVAILABLE. REQUESTED TODAY DETAILED CLINICAL REPORT TO THE REPORTER This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Translation uploaded for initial SD containing narrative case summary and further information. On 18-Jun-2021: Follow-up received on 18-JUN-2021 Contains No new information. On 21-Jun-2021: Follow-up received on 21-JUN-2021 Contains No new information.; Sender''s Comments: This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1435291 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Cardiac arrest, Respiratory arrest, Terminal state
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
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: Carotid artery atheroma; Cerebral atrophy; Cognitive deterioration; Diabetes mellitus; Hypertensive cardiomyopathy; Hypoxic-ischaemic encephalopathy; Nephropathy; Peripheral obliterative arteriopathy; Retinopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Concurrent medical conditions included Carotid artery atheroma on 01-Jan-2015, Hypoxic-ischaemic encephalopathy on 11-Oct-2019, Nephropathy, Cerebral atrophy on 11-Oct-2019, Peripheral obliterative arteriopathy on 11-Jun-2021, Cognitive deterioration on 24-Jul-2019, Hypertensive cardiomyopathy on 25-Jun-2018, Diabetes mellitus on 01-Jan-2015 and Retinopathy. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. This is a case of a 72-year-old female patient with medical history of carotid artery atheroma, hypoxic-ischaemic encephalopathy, nephropathy, cerebral atrophy, peripheral obliterative arteriopathy, cognitive deterioration, hypertensive cardiomyopathy, diabetes mellitus and retinopathy who developed Terminal state, Abdominal pain upper, Cardiac arrest and Respiratory arrest. The patient died due to events and it is unknown if autopsy was performed. Very limited information regarding these events has been provided at this time. No further information is expected. The patient''s advanced age and underlying medical history confound causality.; Sender''s Comments: This is a case of a 72-year-old female patient with medical history of carotid artery atheroma, hypoxic-ischaemic encephalopathy, nephropathy, cerebral atrophy, peripheral obliterative arteriopathy, cognitive deterioration, hypertensive cardiomyopathy, diabetes mellitus and retinopathy who developed Terminal state, Abdominal pain upper, Cardiac arrest and Respiratory arrest. The patient died due to events and it is unknown if autopsy was performed. Very limited information regarding these events has been provided at this time. No further information is expected. The patient''s advanced age and underlying medical history confound causality.; Reported Cause(s) of Death: Arrest cardiac; Epigastralgia; Arrest respiratory


VAERS ID: 1435294 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea exertional, Gastrointestinal haemorrhage, Renal failure, Sepsis, Skin ulcer
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal haemorrhage (narrow), Pulmonary hypertension (broad), Ischaemic colitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 15
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: Atrial fibrillation; Decompensation cardiac; Implantable defibrillator user; Prostatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE, SEPSIS, RENAL FAILURE, DYSPNOEA EXERTIONAL and SKIN ULCER in a 73-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The patient''s past medical history included Implantable defibrillator user, Atrial fibrillation, Decompensation cardiac and Prostatic carcinoma. On 08-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (seriousness criteria death and medically significant), SEPSIS (seriousness criteria death and medically significant), RENAL FAILURE (seriousness criteria death and medically significant), DYSPNOEA EXERTIONAL (seriousness criterion death) and SKIN ULCER (seriousness criterion death). The patient died on 04-Jun-2021. The reported cause of death was gastrointestinal haemorrhage, sepsis, renal failure, dyspnoea exertional and skin ulcer. 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 medication use was not provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, 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: gastrointestinal haemorrhage, sepsis, renal failure, dyspnoea exertional and skin ulcer


VAERS ID: 1435443 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP040352

Write-up: Subarachnoid haemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) in a 94-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria death, hospitalization and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Subarachnoid haemorrhage. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. ? No treatment information was provided. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) but details about other factors were not obtained. Action taken with mRNA-1273 in response to the event was not applicable On 09-JUN-2021, in the morning, the patient was urgently admitted to the hospital due to loss of consciousness, and diagnosed with subarachnoid haemorrhage. The patient died at 22:00. 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: Subarachnoid haemorrhage


VAERS ID: 1435517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dizziness
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. The patient''s past medical history included Dizziness. On 10-May-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 03-Jun-2021 The patient died on 03-Jun-2021. 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. No concomitant drug was reported. No treatment information was 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.; 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.


VAERS ID: 1435748 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
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: 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: Benign prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: MASSIV CENTRAL LUNGEMBOLI; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (MASSIV CENTRAL LUNGEMBOLI) in a 76-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Benign prostatic hyperplasia since an unknown date. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (MASSIV CENTRAL LUNGEMBOLI) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Pulmonary embolism. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This is a case of fatal outcome with event of pulmonary embolism Cause of death was assessed as due to pulmonary embolism. 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: This is a case of fatal outcome with event of pulmonary embolism Cause of death was assessed as due to pulmonary embolism. 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.; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1439026 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Cardiac failure, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (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: LIXIANA; COSYREL; NEXIUM; FLEIDERINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma gastrointestinal; Hypertension arterial; Partial nephrectomy; Previous renal neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS, BEDRIDDEN, CARDIAC FAILURE and PARAESTHESIA in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The patient''s past medical history included Carcinoma gastrointestinal, Previous renal neoplasm, Hypertension arterial and Partial nephrectomy. Concomitant products included EDOXABAN TOSILATE (LIXIANA), BISOPROLOL FUMARATE, PERINDOPRIL ARGININE (COSYREL), NEXIUM and FLECAINIDE ACETATE (FLEIDERINA) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MUSCULAR WEAKNESS (seriousness criterion death), BEDRIDDEN (seriousness criterion death), CARDIAC FAILURE(seriousness criteria death and medically significant) and PARAESTHESIA (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was Paraesthesia hand, Decompensation cardiac, Bedridden and Hands weakness of. It is unknown if an autopsy was performed. No treatment medication was not reported. This is a case of death in a 67-year-old male subject with a history of Gastrointestinal Carcinoma, Renal neoplasia, Arterial Hypertension and Partial nephrectomy who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 67-year-old male subject with a history of Gastrointestinal Carcinoma, Renal neoplasia, Arterial Hypertension and Partial nephrectomy who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Paraesthesia hand; Decompensation cardiac; Bedridden; Hands weakness of


VAERS ID: 1439035 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral ischaemia, Platelet count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: Pneumonitis
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: Unknown
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PERIPHERAL ISCHAEMIA in a 93-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 Pneumonitis. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL ISCHAEMIA (seriousness criterion death). The patient died on 05-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 02-Apr-2021, Platelet count: unknown (Inconclusive) Unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. 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 24-Jun-2021: Additional information received 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1439379 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Fatal brain haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Fatal brain haemorrhage) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Ex-smoker. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Fatal brain haemorrhage) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was brain haemorrhage . An autopsy was not performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided. Follow-up received on 15-Jun-2021 included no new information This is a case of sudden death in a 51-year-old female subject with past history of smoking, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Translation received on 15-Jun-2021 does not contain any new information. On 22-Jun-2021: Follow up was found to be significant: Medical history and Autopsy result was updated.; Sender''s Comments: This is a case of sudden death in a 51-year-old female subject with past history of smoking, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1444272 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
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: 2021-04-11
   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: Bronchial carcinoma; Myelodysplastic syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Bronchial carcinoma and Myelodysplastic syndrome. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 11-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 medication information not reported. Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded. The translation of the source document has been requested. Sender''s (Case) Safety Report Unique Identifier number for this case is FR-AFSSAPS-2021076930; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded. The translation of the source document has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445162 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 53-year-old male patient 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 first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 2021 The patient died in 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 an unknown date, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445257 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis; Hypertension; Ischemic cardiomyopathy; Nephrosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in an 82-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. Concurrent medical conditions included Ischemic cardiomyopathy, Chronic bronchitis, Hypertension and Nephrosclerosis. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. No concomitants were provided by the reporter. No treatment information was provided by the reporter. As per autopsy, the event is related to patient''s primary diseases. As per reporter''s assessment, death is not related to the vaccine. This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Death


VAERS ID: 1445263 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: sudden collapse; sudden collapse and death; This regulatory authority case was reported by a physician and describes the occurrence of FALL (sudden collapse) and SUDDEN DEATH (sudden collapse and death) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 30-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 02-May-2021, the patient experienced FALL (sudden collapse) (seriousness criterion death) and SUDDEN DEATH (sudden collapse and death) (seriousness criterion death). The patient died on 02-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided/unknown. Treatment medication were not reported/unknown. This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445619 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-30
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebrovascular accident
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Stroke; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CARDIO-RESPIRATORY ARREST in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). On 05-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Irresuscitable cardio-respiratory arrest) (seriousness criterion death). The patient died on 05-Jun-2021. The reported cause of death was irresuscitable cardio-respiratory arrest and Stroke. An autopsy was not performed. No concomitant products were reported. No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable. Company comment: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received on 29-June-2021 included gender of patient is changed, medical history, death date and new event Irresuscitable cardio-respiratory arrest was added.; Reporter''s Comments: The medical assessor of the Competent Authority requested the investigation of the case at Regulatory Authority, to no result yet.; Sender''s Comments: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected.; Reported Cause(s) of Death: Irresuscitable cardio-respiratory arrest; stroke


VAERS ID: 1447573 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002919 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Pneumonia aspiration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hip fracture; Ischemic stroke; Pneumonia aspiration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Diarrhoea; Fever; Emesis; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (Emesis) in a 97-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002919) for COVID-19 vaccination. The patient''s past medical history included Ischemic stroke in 2014, Hip fracture in April 2021, COVID-19 and Pneumonia aspiration in May 2021. Concurrent medical conditions included Hypertension arterial. On 14-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion death), PYREXIA (Fever) (seriousness criterion death) and VOMITING (Emesis) (seriousness criterion death). The patient died on 16-Jun-2021. The reported cause of death was Fever, Diarrhoea, Pneumonia aspiration and Emesis. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment Medication information was provided. No concomitant medication information was provided. Action taken with mRNA-1273 was not applicable. Company Comment: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 29-Jun-2021 and does not contain any new information; Sender''s Comments: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Fever; Diarrhoea; Pneumonia aspiration; emesis


VAERS ID: 1447616 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-05-25
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (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: ENTRESTO; FUROSEMIDE; KALEORID; KARDEGIC; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Follicular lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Mesenteric ischaemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of INTESTINAL ISCHAEMIA (Mesenteric ischaemia) in a 77-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 and Follicular lymphoma. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FUROSEMIDE, POTASSIUM CHLORIDE (KALEORID), ACETYLSALICYLATE LYSINE (KARDEGIC) and BISOPROLOL for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced INTESTINAL ISCHAEMIA (Mesenteric ischaemia) (seriousness criteria death and medically significant). The reported cause of death was death due to mesenteric ischaemia. 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. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medication information were not reported. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021078084. 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. However, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon follow-up receipt: Follow-up information processed with initial report contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor.; Reported Cause(s) of Death: Death due to Mesenteric ischaemia


VAERS ID: 1449565 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain, Malaise, Myocarditis, Sudden cardiac death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: DEPEI202100110047

Write-up: Ventricular fibrillation; Myocarditis; Sudden cardiac death; Breast pain; Malaise; This regulatory authority case was reported by a physician and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced BREAST PAIN (Breast pain) (seriousness criterion death) and MALAISE (Malaise) (seriousness criterion death). On 14-Jun-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death and medically significant), MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death and medically significant). The patient died on 14-Jun-2021. The reported cause of death was Sudden cardiac death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) to have an unknown relationship. Concomitant medication were not provided. Treatment medication 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. Company comment: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1449667 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-27
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Malaise, Product preparation issue
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), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Decompensation cardiac; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: General malaise; Arrest cardiac; Death; solution for haemodialysis; This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (General malaise), CARDIAC ARREST (Arrest cardiac), DEATH (Death) and PRODUCT PREPARATION ISSUE (solution for haemodialysis) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002543 and 3001941) for COVID-19 vaccination. The patient''s past medical history included Thoracic aortic aneurysm and Chronic respiratory failure. Concurrent medical conditions included Obesity and Decompensation cardiac since 20-Feb-2005. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form in total. On 27-May-2021, the patient experienced PRODUCT PREPARATION ISSUE (solution for haemodialysis) (seriousness criterion death). On 01-Jun-2021, the patient experienced MALAISE (General malaise) (seriousness criterion death), CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant) and DEATH (Death) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was not given No concomitant medication information was provided. Lab data included Hemoglobin test done on 01-06-2021. Action taken with mRNA-1273 in response to the event was not applicable. This is a report of death in a polymorbid 85 years old male, after second product dose. Concomitant medication was not provided. Autopsy was not provided. This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 01-07-2021 and does not contain any new information; Reporter''s Comments: paziente con pluripatologie (Scompenso Cardiaco, Insufficienza Respiratoria Cronica, Obesita, Aneurisma Aorta Toracica) deceduto per arresto cardiocircolatorio in data 01/06/2021 dopo somministrazione di Vaccino Moderna 2 dose lotto n 3002543 scad 22/11/2021 somministrato in data 27 Maggio 2021 (1 dose Moderna 22 Aprile 2021 h 16.15 lotto 3001941); Sender''s Comments: This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1449928 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-05-01
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a nurse and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 32-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) to be unlikely related. No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 was not applicable Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (translation) is expected; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (translation) is expected; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1449945 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-12
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMIODARONE; ATORVASTATIN; COVERSUM; DUODART; ELIQUIS; PANTOPRAZOLO; SPASMO URGENIN; SYMBICORT; DUPHALAC [LACTULOSE]; MYSOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Cirrhosis of liver; Orthostatic hypotension; Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Vaccination failure; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 and VACCINATION FAILURE (Vaccination failure) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EK9788) for COVID-19 vaccination. No medical history was reported. The patient''s past medical history included Orthostatic hypotension, Abdominal aortic aneurysm and Cirrhosis of liver. Concomitant products included PERINDOPRIL ERBUMINE (COVERSUM) for COVID-19 vaccination, AMIODARONE, ATORVASTATIN, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART), APIXABAN (ELIQUIS), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLO), ECHINACEA ANGUSTIFOLIA ROOT, SERENOA REPENS FRUIT, TROSPIUM CHLORIDE (SPASMO URGENIN), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LACTULOSE (DUPHALAC [LACTULOSE]) and PRIMIDONE (MYSOLIN) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced COVID-19 (seriousness criterion death). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). The patient died on 12-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 to be unlikely related and VACCINATION FAILURE (Vaccination failure) to have an unknown relationship. Treatment information was not provided. This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.; Sender''s Comments: "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"; Reported Cause(s) of Death: Unknown Cause of Death


VAERS ID: 1452864 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coronary artery thrombosis, Death, Ischaemic cardiomyopathy
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: LIPITOR
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: thrombosis in anterior descending branch of the left coronary artery; Death; Ischemic cardiomyopathy; This regulatory authority case was reported by a consumer and describes the occurrence of CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery), DEATH (Death) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 25-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery) (seriousness criteria death and medically significant), DEATH (Death) (seriousness criteria death and medically significant) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) (seriousness criteria death and medically significant). The patient died on 05-Jun-2021. The reported cause of death was atherosclerotic coronary lesions. An autopsy was performed, but no results were provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: atherosclerotic coronary lesions


VAERS ID: 1453068 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: LANSOX; CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Failure respiratory; Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Name: Desaturation; Result Unstructured Data: <85%
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No medical history was provided by the reporter. The patient''s past medical history included Failure respiratory. Concomitant products included LANSOPRAZOLE (LANSOX) and BISOPROLOL FUMARATE (CONGESCOR) for an unknown indication. On 19-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced CONDITION AGGRAVATED(seriousness criterion death). The patient died on 19-Jun-2021. The reported cause of death was Aggravation of existing disorder. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation decreased: <85% (abnormal) <85%. 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. Concomitant medication not reported. Treatment medication not reported. Very limited information regarding this patient''s death has been provided at this time.; Reporter''s Comments: Lansox 30 mg Congescor 2.5 Lasix 25; Sender''s Comments: Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Aggravation of existing disorder


VAERS ID: 1453799 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: d?c?s; Arr?t cardiaque; Malaise; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (d?c?s), CARDIAC ARREST (Arr?t cardiaque) and MALAISE (Malaise) 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 Smoker. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CARDIAC ARREST (Arr?t cardiaque) (seriousness criteria death and medically significant) and MALAISE (Malaise) (seriousness criterion death). The patient died on 05-May-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Company comment: Very limited information regarding the events has been provided at this time Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 2juL2021 contains translated source document; Sender''s Comments: Very limited information regarding the events has been provided at this time; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1455223 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-28
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatic vein thrombosis, Platelet count, Pulmonary embolism, Pyrexia, Raynaud's phenomenon, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Rectal cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 52000; Test Date: 20210613; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 370000
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Tromboembolia pulmonar; Thrombopenia; Trombosis de vena hep?tica; Raynaud; Fiebre; This regulatory authority case was reported by a physician and describes the occurrence of HEPATIC VEIN THROMBOSIS (Trombosis de vena hep?tica), PULMONARY EMBOLISM (Tromboembolia pulmonar), THROMBOCYTOPENIA (Thrombopenia), RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002183 and 3001532) for COVID-19 vaccination. The patient''s past medical history included Rectal cancer metastatic and COVID-19 (Covid-19) in September 2020. On 30-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RAYNAUD''S PHENOMENON (Raynaud) (seriousness criterion hospitalization) and PYREXIA (Fiebre) (seriousness criterion hospitalization). On 03-Jun-2021, the patient experienced HEPATIC VEIN THROMBOSIS (seriousness criteria death, hospitalization and medically significant) and THROMBOCYTOPENIA (Thrombopenia) (seriousness criteria hospitalization and medically significant). On 17-Jun-2021, the patient experienced PULMONARY EMBOLISM (Tromboembolia pulmonar) (seriousness criteria death, hospitalization and medically significant). On 13-Jun-2021, THROMBOCYTOPENIA (Thrombopenia) had resolved. In June 2021, RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) had resolved. The patient died on an unknown date. The reported cause of death was thrombosis and tromboembolia pulmonar. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Platelet count: 52000 cells per microlitre (Inconclusive) 52000. On 13-Jun-2021, Platelet count: 370000 cells per microlitre (Inconclusive) 370000. 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. Company comment Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) 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 rest of the events, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) 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 rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death; Tromboembolia pulmonar


VAERS ID: 1455899 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-01-21
Onset:2001-09-10
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 521458 / 1 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER NOT KNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-17
   Days after onset: 2014
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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Brain mass; This regulatory authority case was reported by a consumer and describes the occurrence of INTRACRANIAL MASS (Brain mass) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 521458) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2001, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2010, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 10-Sep-2001, the patient experienced INTRACRANIAL MASS (Brain mass) (seriousness criterion death). The patient died on 17-Mar-2007. The reported cause of death was Brain mass. 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 test: negative (Negative) Negative COVID-19 test. Company comment Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Brain mass


VAERS ID: 1457920 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-06-11
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002544 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Diarrhoea, Restlessness, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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 renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE, RESTLESSNESS, SOMNOLENCE and DIARRHOEA in a 95-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002544) for COVID-19 vaccination. The patient''s past medical history included Chronic renal impairment since an unknown date. On 26-Apr-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced DECREASED APPETITE (seriousness criterion death), RESTLESSNESS (seriousness criterion death), SOMNOLENCE (seriousness criterion death) and DIARRHOEA (seriousness criterion death). The patient died on 12-Jun-2021. The reported cause of death was Inappetence, Restlessness, Drowsiness and Diarrhea. 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 details were reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reporter''s Comments: Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reported Cause(s) of Death: Inappetence; Restlessness; Drowsiness; Diarrhea


VAERS ID: 1459314 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Psychiatric disorder NOS and Arterial hypertension. Previously administered products included for Product used for unknown indication: RISPERDAL. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 20-Jun-2021 The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021082913 Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translated document received on 06-Jul-2021, substance information of historical drug updated.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1462650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 01-Jan-2021 The patient died on 01-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided Company Comment: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Sender''s Comments: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1463936 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-29
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: Comments: Past medical history included "homocysteinurie."
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: beeld van asystolie; beeld van embool; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; op 29/06 plots onwel; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (overlijden), CARDIAC ARREST (beeld van asystolie), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies), EMBOLISM (beeld van embool), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) and MALAISE (op 29/06 plots onwel) in a 27-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Past medical history included "homocysteinurie.". On 25-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced DEATH (overlijden) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant) and MALAISE (op 29/06 plots onwel) (seriousness criterion death). On an unknown date, the patient experienced CARDIAC ARREST (beeld van asystolie) (seriousness criteria death and medically significant) and EMBOLISM (beeld van embool) (seriousness criteria death and medically significant). The patient died on 29-Jun-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 were provided. No treatment was reported for the events. Translation is pending. Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1466361 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-05-28
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: ASPIRIN CARDIO; PERINDOPRIL; AMIODARONE
Current Illness: Coronary disease (Date of diagnosis of stable coronary artery disease was unknown); Hypertension (Diagnosis date was unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Patient; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Patient .) in an 81-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001656 and 3000496) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Diagnosis date was unknown) and Coronary disease (Date of diagnosis of stable coronary artery disease was unknown). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), PERINDOPRIL and AMIODARONE for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 28-May-2021 The patient died on 28-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Patient.) to be unlikely related. The reporter stated that it was unknown whether the patient had any sort of allergy. On 28 May 2021 the patient collapsed in his backyard and was found dead by his wife. The face turned blue and was given futile cardiopulmonary resuscitation. The reporter assumed that the death may be due to sudden cardiac death or pulmonary embolism. No further treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document was received on 07 Jul 2021. Patients medical history information and narrative was updated.; Sender''s Comments: Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467489 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   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:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; Pyrexia; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 75-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 25-May-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and PYREXIA (Pyrexia). On 20-Jun-2021, PYREXIA (Pyrexia) had not resolved. The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. Full strength broad spectrum antibiotic was given as treatment. No relevant concomitant medications were reported. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467705 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), 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), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CIRCULATORY COLLAPSE and CEREBRAL VENOUS SINUS THROMBOSIS in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant) and CEREBRAL VENOUS SINUS THROMBOSIS (seriousness criteria death and medically significant). The patient died on 25-Jun-2021. The reported cause of death was Thrombosis of venous sinuses. An autopsy was not performed. The concomitant medications were not reported. The treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 68-year-old male subject, who died 15 days after receiving second dose of vaccine. Very limited information has been provided at this time. Very limited information has been provided at this time. Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1468781 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: XARELTO; DEMENTIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Encephalopathy (degenerative encephalopathy); Hip fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius; Test Date: 20210625; Test Name: Oxygen saturation; Result Unstructured Data: 83
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Stupor; Fever; Consciousness decreased; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased), STUPOR (Stupor) and PYREXIA (Fever) in a 74-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Encephalopathy (degenerative encephalopathy) in November 2020, Hip fracture in December 2020 and Cardiac pacemaker insertion. Concomitant products included RIVAROXABAN (XARELTO) from 12-Aug-2020 to an unknown date and DONEPEZIL HYDROCHLORIDE (DEMENTIS) for an unknown indication. On 22-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased) (seriousness criteria death and medically significant) and PYREXIA (Fever) (seriousness criteria death and medically significant). On 25-Jun-2021, the patient experienced STUPOR (Stupor) (seriousness criteria death and medically significant). On 26-Jun-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 26-Jun-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 24-Jun-2021, Body temperature: 38 degree Celsius (High) 38. On 25-Jun-2021, Oxygen saturation: 83 (abnormal) 83. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reporter''s Comments: Initial Report with additional information; Sender''s Comments: This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1468920 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Pyrexia, Terminal state
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 61
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: 20210618; Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: second dose Moderna (Covid19)17/06/2021. 18/06/2021 ; dyspnea; This regulatory authority case was reported by a physician and describes the occurrence of TERMINAL STATE 16 del 17/06/2021. 18/06/2021 and DYSPNOEA (dyspnea) in a 96-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021 at 4:00 PM, 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 DYSPNOEA (dyspnea) (seriousness criterion death). On 18-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced TERMINAL STATE . (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 18-Jun-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 18-Jun-2021, Body temperature: 39.5?c (High) increased. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported. The patient had the second dose of Moderna (Covid-19 vaccine) at 16:00 on June 17, 2021. At 05:00 on June 18, 2021 the patient had a body temperature of 39.5?C and dyspnea. At 06:50 the 118 physician declared the patient deceased. This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected. . Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Lab details updated.; Sender''s Comments: This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1469367 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-14
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: 2021-06-30
   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: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; ATACAND
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Hypertension; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM in a 76-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Embolism pulmonary in 2014 and Prostate cancer in 2014. Concurrent medical conditions included Hypertension. Concomitant products included CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]) and CANDESARTAN CILEXETIL (ATACAND) for an unknown indication. On 07-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant). The patient died on 30-Jun-2021. The reported cause of death was Embolism pulmonary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PULMONARY EMBOLISM (to be possibly 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 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: EMBOLISM PULMONARY


VAERS ID: 1469552 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EFTERS?KS / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Hypertension; Obesity; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: PATIENTEN AVLED; This regulatory authority case was reported by a physician and describes the occurrence of EMBOLIC STROKE (PATIENTEN AVLED) in a 64-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EFTERS?KS) for COVID-19 vaccination. Concurrent medical conditions included Obesity, Psoriasis and Hypertension. In June 2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. In June 2021, the patient experienced EMBOLIC STROKE (PATIENTEN AVLED) (seriousness criteria death and medically significant). The patient died in June 2021. The reported cause of death was Thromboembolic 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 Concomitant medication information was provided. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Thromboembolic stroke


VAERS ID: 1469749 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatinine, Diarrhoea, Dyspnoea, Glomerular filtration rate, Glycosylated haemoglobin, Headache, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 88
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; Chronic renal insufficiency; Diabetes mellitus; Hypothyreosis; Polymyalgia rheumatica
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 112 mcmol/L; Test Date: 20210310; Test Name: Estimated glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: 40ml/min/1.73m2; Test Date: 20210310; Test Name: HbA1c; Test Result: Inconclusive ; Result Unstructured Data: 6.5%
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: The Patient passed away on 20.05.2021; Dyspnoea; Headache; Vomiting; Diarrhoea; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Die Patient passed away on 20.05.2021), HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypothyreosis, Polymyalgia rheumatica, Arterial hypertension and Chronic renal insufficiency. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). On 02-Mar-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). On 20-May-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (The patient passed away on 20.05.2021) (seriousness criteria death, hospitalization and medically significant). In March 2021, HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) had resolved. The patient died on 20-May-2021. The reported cause of death was Acute myocardial infarction. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood creatinine: 112 mcmol/l (Inconclusive) 112 mcmol/L. On 10-Mar-2021, Glomerular filtration rate: 40ml/min/1.73m2 (Inconclusive) 40ml/min/1.73m2. On 10-Mar-2021, Glycosylated haemoglobin: 6.5% (Inconclusive) 6.5%. 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. 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. Patient died on 20-May-2021 and was Judged the causal link between the Moderna COVID-19 vaccine and acute myocardial infarction to be unlikely. However, this view regarding causality does not entirely rule out the role of the vaccine. On 11 Mar 2021, lab reports showed TTE dilated LV, large scar anteroapically, anteroseptally, and septally. LVEF 25%. Aortic valve sclerosis, mild pericardial effusion inferobasal 4mm. PH approximately 50mmHg, IVC severely congested. Therapy: 10 Mar 2021 right pleural puncture (transudate) 10 Mar 2021 -15 Mar 2021, Lasix i.v. Company comment Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation for Case Narrative, Reporter''s comments and Sender''s comments.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1469763 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure acute, Influenza like illness, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Beidseitige bakterielle Lungenentz?ndung; flu-like syndrome; Herzversagen; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Beidseitige bakterielle Lungenentz?ndung) and CARDIAC FAILURE ACUTE (Herzversagen) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lymphoma in 2016. Concurrent medical conditions included Hypertension and Atrial fibrillation. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PNEUMONIA (Beidseitige bakterielle Lungenentz?ndung) (seriousness criteria death, hospitalization and medically significant) and CARDIAC FAILURE ACUTE (Herzversagen) (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like syndrome). The patient died on 26-Apr-2021. The reported cause of death was Acute heart failure and Pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS (flu-like syndrome) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Reporter stated the day after the second vaccine the patient started experiencing flu-like symptoms. The patient was admitted to the hospital in intensive care with pneumonia. Reporter stated patient experienced cardiac failure as well. Company Comment: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translation received included sender''s comments updated and historical condition updated. Event added.; Sender''s Comments: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected.; Reported Cause(s) of Death: Acute heart failure; Pneumonia


VAERS ID: 1469954 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Heart rate, Lung disorder, Oxygen saturation, Pneumonia aspiration, Pyrexia, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: increased; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: decreased; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: increased
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Dyspnoea; General physical health deterioration; Lung disorder; Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DYSPNOEA (Dyspnoea), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration), LUNG DISORDER (Lung disorder) and PYREXIA (Pyrexia) in a 78-year-old male patient 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 first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DYSPNOEA (Dyspnoea) (seriousness criterion death), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) (seriousness criterion death), LUNG DISORDER (Lung disorder) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: increased (High) increased. In 2021, Oxygen saturation: decreased (Low) decreased. In 2021, Respiratory rate: increased (High) increased. No concomitant medication details were reported. Oxygen therapy was used for treatment, however, no additional treatment information was reported. This is a case of death in a 78-year-old male subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 78-year-old male subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cause of death unknown


VAERS ID: 1470165 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Decreased appetite, Dizziness, Fatigue, Haemoglobin, Ischaemic cerebral infarction, Magnetic resonance imaging head, SARS-CoV-1 test
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; DILATREND; ALDACTONE [SPIRONOLACTONE]
Current Illness: Anemia; Arterial hypertension; COPD (Vd. a. COPD); Malnutrition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Computerised tomogram head; Test Result: Positive ; Result Unstructured Data: Brain computerised tomography; Test Date: 202105; Test Name: Haemoglobin; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210508; Test Name: Magnetic resonance imaging head; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202105; Test Name: SARS-CoV-1 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of ISCHAEMIC CEREBRAL INFARCTION in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia, Arterial hypertension, COPD (Vd. a. COPD) and Malnutrition. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), CARVEDILOL (DILATREND) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication. On 31-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DECREASED APPETITE, DIZZINESS and FATIGUE. On 07-May-2021, the patient experienced ISCHAEMIC CEREBRAL INFARCTION (seriousness criteria death and medically significant). The patient died on 16-May-2021. It is unknown if an autopsy was performed. At the time of death, DECREASED APPETITE, DIZZINESS and FATIGUE outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Computerised tomogram head: positive (Positive) Brain computerised tomography. On 08-May-2021, Magnetic resonance imaging head: positive (Positive) Positive. In May 2021, Haemoglobin: positive (Positive) Positive. In May 2021, SARS-CoV-1 test: negative (Negative) Negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered FATIGUE to be possibly related and ISCHAEMIC CEREBRAL INFARCTION, DECREASED APPETITE and DIZZINESS to be unlikely related. Treatment information was not provided This a report of dead 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. 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: This a report of dead 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. 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. Translation of the source document has been requested.


VAERS ID: 1470956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: End stage renal disease
SMQs:, Rhabdomyolysis/myopathy (broad), Chronic kidney disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: Pramipexol; NEO-MERCAZOLE; Vascord; TORASEMIDE SODIUM; SERESTA; PALEXIA; PANTOPRAZOLE SODIUM
Current Illness: Anxiety disorder; Chronic kidney disease stage 5 (CNI Grad V--); Coronary heart disease; Hyperthyroidism; Macular degeneration; Oedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Chronic kidney disease stage 5; This regulatory authority case was reported by a physician and describes the occurrence of END STAGE RENAL DISEASE (Chronic kidney disease stage 5) in an elderly female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 5 (CNI Grad V--), Macular degeneration, Hyperthyroidism, Coronary heart disease, Oedema and Anxiety disorder. Concomitant products included Pramipexole (Pramipexol), CARBIMAZOLE (NEO-MERCAZOLE), Amlodipine besilate, Olmesartan medoxomil (Vascord), TORASEMIDE SODIUM, OXAZEPAM (SERESTA), TAPENTADOL HYDROCHLORIDE (PALEXIA) and PANTOPRAZOLE SODIUM for an unknown indication. On 18-Feb-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced END STAGE RENAL DISEASE (Chronic kidney disease stage 5) (seriousness criteria death and medically significant). The patient died on 24-Feb-2021. The reported cause of death was end stage renal disease. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Reported Cause(s) of Death: End stage renal disease


VAERS ID: 1473784 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: ZYLLT; FURON [FUROSEMIDE]; VITAMIN D3 FRESENIUS; KALDYUM; EMOZUL
Current Illness: Hypertension; Osteoporosis; Polyarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchitis; Atherosclerosis; Toxic shock syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 96-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001946 and 3002916) for COVID-19 vaccination. The patient''s past medical history included Toxic shock syndrome, Acute bronchitis and Atherosclerosis. Concurrent medical conditions included Polyarthritis, Hypertension and Osteoporosis. Concomitant products included CLOPIDOGREL BISULFATE (ZYLLT), FUROSEMIDE (FURON [FUROSEMIDE]), COLECALCIFEROL (VITAMIN D3 FRESENIUS), POTASSIUM CHLORIDE (KALDYUM) and ESOMEPRAZOLE MAGNESIUM (EMOZUL) for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred on 09-Jun-2021 The patient died on 09-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. No treatment information was 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. Company Comment This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1476427 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-07-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feverish; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Feverish) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fever. On 11-Jun-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 03-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Feverish) (seriousness criterion death). The patient died on 07-Jul-2021. The reported cause of death was Feverish. 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 test: Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient died of high fever/brain dead from high fever the vaccine caused. Patient was not enrolled in clinical trial. Treatment medication was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) for events was not applicable. Company Comment This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected.; Sender''s Comments: This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected; Reported Cause(s) of Death: Feverish


VAERS ID: 1476728 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Musculoskeletal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 41
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: Essential thrombocytosis; Neutrophilia; Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; This regulatory authority case was reported by a physician and describes the occurrence of DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The patient''s past medical history included Neutrophilia on 01-Dec-2020, Essential thrombocytosis on 01-Jan-2000 and Splenectomy on 01-Jan-2013. On 29-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criteria death and medically significant), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death). The patient died on 09-Jun-2021. The reported cause of death was Disseminated intravascular coagulation, Arthromyalgia and Intermittent pyrexia. 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 was given Laboratory data was mentioned as the person undergoes C-reactive protein test on 14 May 2021 and results was not given No treatment information was given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Decesso dopo 42 giorni di malattia, iniziata il giorno della vaccinazione.; 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: Intermittent pyrexia; Disseminated intravascular coagulation; Arthromyalgia


VAERS ID: 1477488 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002181 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: JPTAKEDA2021TJP050779

Write-up: Acute aortic dissection; This regulatory authority case was reported by a physician and describes the occurrence of AORTIC DISSECTION (Acute aortic dissection) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002181) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced AORTIC DISSECTION (Acute aortic dissection) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was acute aortic dissection. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered AORTIC DISSECTION (Acute aortic dissection) to be unlikely related. No Treatment information was provided by the reporter. No concomitant medication was reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Although the event developed immediately after the vaccination, the event is unlikely related to the vaccine. However, a statistical investigation is considered necessary. This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1477526 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Computerised tomogram, Myocardial ischaemia, Nausea, Tryptase, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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:
Current Illness: Dementia; Hypertension; Large intestine polyp
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Whole-body CT scan of the cadaver; Result Unstructured Data: severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion.; Test Name: Tryptase; Result Unstructured Data: the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.
CDC Split Type: JPTAKEDA2021TJP057641

Write-up: Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Pain in the vaccinated arm; This case was received via a regulatory authority (Reference number: v21118572) on 09-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Large intestine polyp and Dementia. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION SITE PAIN (Pain in the vaccinated arm) (seriousness criterion death). On 10-Jun-2021, the patient experienced NAUSEA (Queasy) (seriousness criterion death), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) (seriousness criterion death) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) (seriousness criteria death and medically significant). The patient died on 10-Jun-2021. The reported cause of death was pain in the vaccinated arm, Queasy, coronary arteriosclerosis and Ischaemic heart disease. An autopsy was performed. The autopsy-determined cause of death was coronary arteriosclerosis and Ischaemic heart disease. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion. On an unknown date, Tryptase (2.1-9.0): 1.6 mcg/l (Low) the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) to be not related. Company comment: The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority(the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority. The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority (the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pain in the vaccinated arm; Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Autopsy-determined Cause(s) of Death: Coronary arteriosclerosis; Ischaemic heart disease


VAERS ID: 1477527 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Pneumonia aspiration, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.7; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 37.8; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 38; Test Date: 20210708; Test Name: percutaneous oxygen saturation (SpO2); Result Unstructured Data: 87 percent
CDC Split Type: JPTAKEDA2021TJP057666

Write-up: Sepsis; Aspiration pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. Family history included Dementia Alzheimer''s type. Concurrent medical conditions included Dementia Alzheimer''s type. On 07-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant) and PNEUMONIA ASPIRATION (Aspiration pneumonia) (seriousness criteria death and medically significant). The patient was treated with ACETAMINOPHEN on 08-Jul-2021 for Pyrexia, at a dose of 100 mg. The patient died on 08-Jul-2021. The reported cause of death was Sepsis and aspiration pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 37.8 (High) 37.8 and 38 (High) 38. On 08-Jul-2021, Oxygen saturation: 87 (abnormal) 87 percent. On an unknown date, Body temperature: 36.7 (Inconclusive) 36.7. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) to be possibly related. The patient''s body temperature before vaccination was 36.7 degree Celsius. On 08-Jul-2021, at 06:00 AM the patient had sputum sticking sensation. On 08-Jul-2021, at 07:00, the signs of circulatory failure were noted. At 08:25, the patient experienced pyrexia of 38.0 degrees Celsius and took antipyretic (acetaminophen 100 mg) through a gastric fistula. At 09:45, the sign of respiratory failure was noted with percutaneous oxygen saturation (SpO2) of 87 percent. At 11:25, the patient had cardiopulmonary arrest. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear. This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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: Sepsis; Aspiration pneumonia


VAERS ID: 1478711 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-06-01
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Infection, Mesenteric haemorrhage, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100129257

Write-up: Renal failure; Infection; Mesenteric bleeding; This regulatory authority case was reported by a physician and describes the occurrence of RENAL FAILURE (Renal failure), INFECTION (Infection) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) in a 72-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: MODERNA COVID-19 VACCINE on 21-Apr-2021. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria death, hospitalization and medically significant), INFECTION (Infection) (seriousness criteria death and hospitalization) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) (seriousness criteria death, hospitalization and medically significant). The patient died on 02-Jul-2021. The reported cause of death was Renal failure. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication and treatment medication were not provided. Very limited information regarding the event Mesenteric hemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Sender''s Comments: Very limited information regarding the event Mesenteric haemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1480157 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain natriuretic peptide, Cardiac failure, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Brain natriuretic peptide; Result Unstructured Data: BNP-2000 (Increased)
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Dyspnoea; Heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Heart failure) and DYSPNOEA (Dyspnoea) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 24-May-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria death, medically significant and life threatening). On an unknown date, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criteria death and life threatening). The patient died on 14-Jun-2021. The reported cause of death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Brain natriuretic peptide: 2000 (High) BNP-2000 (Increased). For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Sender''s Comments: This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Reported Cause(s) of Death


VAERS ID: 1480178 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a non-health professional and describes the occurrence of CARDIAC ARREST , NAUSEA, MALAISE and FATIGUE in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced FATIGUE (seriousness criterion death). On 11-Apr-2021, the patient experienced CARDIAC ARREST (Haar lichaam/hart stopte er gewoon mee) (seriousness criteria death and medically significant), NAUSEA (seriousness criterion death) and MALAISE (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death. An autopsy was not performed. 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


VAERS ID: 1480185 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood gases, Blood lactic acid, Blood test, Chest X-ray, Computerised tomogram head, Death, Glomerular filtration rate, Haemoglobin, International normalised ratio, Neck pain, PCO2, PO2, Platelet count, Prothrombin time, Troponin I, White blood cell count, pH body fluid
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: aPTT; Result Unstructured Data: 60 sec; Test Date: 20210619; Test Name: CAG; Test Result: Inconclusive ; Result Unstructured Data: date was estimated most likely date, between start of events 19/6 and death 22/6; Test Date: 20210619; Test Name: bicarbonaat; Test Result: Inconclusive ; Result Unstructured Data: 19 mmol/L; Test Date: 20210619; Test Name: CK; Result Unstructured Data: 902 = high (<200= normal); Test Date: 20210619; Test Name: kreatinine; Result Unstructured Data: 97= normal for male; Test Date: 20210619; Test Name: fibrinogeen; Result Unstructured Data: 2.6 g/L = normal; Test Date: 20210619; Test Name: bloedgassen; Test Result: Inconclusive ; Result Unstructured Data: pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.; Test Date: 20210619; Test Name: lactaat; Result Unstructured Data: 3.1 mmol/l; Test Date: 20210619; Test Name: Electrolyten; Result Unstructured Data: electrolytes normal; Test Date: 20210619; Test Name: Thorax X; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: CT Cerebrum; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: eGFR; Result Unstructured Data: $g90= normal; Test Date: 20210619; Test Name: hemoglobine; Result Unstructured Data: 11.3 mmlo/l = increased; Test Date: 20210619; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.2= normal; Test Date: 20210619; Test Name: pco2; Test Result: Inconclusive ; Result Unstructured Data: 5.5 kPa; Test Date: 20210619; Test Name: PH; Test Result: Inconclusive ; Result Unstructured Data: 7.28; Test Date: 20210619; Test Name: trombocyten; Result Unstructured Data: 454 = increased; Test Date: 20210619; Test Name: pao2; Test Result: Inconclusive ; Result Unstructured Data: 19 kPa; Test Date: 20210619; Test Name: PT; Result Unstructured Data: 16 sec = high; Test Date: 20210619; Test Name: Troponine I; Result Unstructured Data: 4319; Test Date: 20210619; Test Name: leukocyten; Result Unstructured Data: 19.6 = increased
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 29-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced NECK PAIN (nekpijn). On 22-Jun-2021, NECK PAIN outcome was unknown. The patient died on 22-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Activated partial thromboplastin time (30-40): 60 (High) 60 sec. On 19-Jun-2021, Angiocardiogram: inconclusive (Inconclusive) date was estimated most likely date, between start of events 19/6 and death 22/6. On 19-Jun-2021, Blood bicarbonate: 19 mmol/l (Inconclusive) 19 mmol/L. On 19-Jun-2021, Blood creatine phosphokinase: 902 (High) 902 = high (<200= normal). On 19-Jun-2021, Blood creatinine: normal (normal) 97= normal for male. On 19-Jun-2021, Blood fibrinogen: 2.6 (normal) 2.6 g/L = normal. On 19-Jun-2021, Blood gases: ph 7.28, pco2 5.5 kpa, bicarbonaat 19 mmol/l. (Inconclusive) pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.. On 19-Jun-2021, Blood lactic acid: 3.1 (High) 3.1 mmol/l. On 19-Jun-2021, Blood test: normal (normal) electrolytes normal. On 19-Jun-2021, Chest X-ray: unknown (Inconclusive) unknown. On 19-Jun-2021, Computerised tomogram head: unknown (Inconclusive) unknown. On 19-Jun-2021, Glomerular filtration rate: normal (normal) $g90= normal. On 19-Jun-2021, Haemoglobin: 11.3 (High) 11.3 mmlo/l = increased. On 19-Jun-2021, International normalised ratio: 1.2 (Inconclusive) 1.2= normal. On 19-Jun-2021, PCO2: 5.5 kpa (Inconclusive) 5.5 kPa. On 19-Jun-2021, PO2: 19 kpa (Inconclusive) 19 kPa. On 19-Jun-2021, Platelet count: 454 (High) 454 = increased. On 19-Jun-2021, Prothrombin time (11-14): 16 sec (High) 16 sec = high. On 19-Jun-2021, Troponin I: 4319 (High) 4319. On 19-Jun-2021, White blood cell count: 19.6 (High) 19.6 = increased. On 19-Jun-2021, pH body fluid: 7.28 (Inconclusive) 7.28. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment drug information was not given. Company Comment : This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Sender''s Comments: This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death


VAERS ID: 1480372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002333 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Erythema, Haemoptysis, Localised oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

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

Write-up: cough (blood in the discharge); redness and swelling in the abdominal area; dyspnoea; redness and swelling in the abdominal area; cough (blood in the discharge); This regulatory authority case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (cough (blood in the secretion)), LOCALIZED OEDEMA (redness and swelling in the abdominal area), DYSPNOEA (shortness of breath), ERYTHEMA (redness and swelling in the abdominal area ) and COUGH (cough (blood in the secretion))in an elderly male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002333) for COVID-19 vaccination. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced HAEMOPTYSIS (cough (blood in the secretion)) (seriousness criterion death), LOCALISED OEDEMA (redness and swelling in the abdominal cavity) (seriousness criterion death), DYSPNOEA (dyspnoea) (seriousness criterion death), ERYTHEMA (redness and swelling in the cavity area abdominal) (seriousness criterion death) and COUGH (cough (blood in the discharge))(seriousness criterion death). The patient died on 14-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No concomitant medications were reported. No treatment information was provided. Company Comment 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: 1480374 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITTICO
Current Illness: Insomnia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Suspicion of pulmonary embolism; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Suspicion of pulmonary embolism) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Insomnia. Concomitant products included TRAZODONE HYDROCHLORIDE (TRITTICO) for Insomnia. On 26-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Jun-2021 at 1:00 AM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEADACHE (Headache) (seriousness criterion death). On 04-Jun-2021 at 11:33 AM, the patient experienced PULMONARY EMBOLISM (Suspicion of pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 04-Jun-2021. The reported cause of death was suspicion of pulmonary embolism. An autopsy was not performed. No Treatment information was provided. This is a case of sudden death in a 28-year-old male subject, who died 9 days after receiving first dose of vaccine, cause of death was not specified, an autopsy was not performed, Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 28-year-old male subject,who died 9 days after receiving first dose of vaccine, cause of death was not specified an autopsy was not performed, Very limited information has been provided at this time.; Reported Cause(s) of Death: Suspicion of pulmonary embolism


VAERS ID: 1480488 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-06-16
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Heart rate, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: FILOTEMPO; TAMSULOSIN; RAMIPRIL; BUDESONIDE; UMECLIDINIUM BROMIDE;VILANTEROL; CARVEDILOL; FUROSEMIDE; ROSUVASTATIN; ALLOPURINOL; ACETYLSALICYLIC ACID; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell small lymphocytic lymphoma (with clinical stability.); Benign prostatic hyperplasia; Chronic respiratory failure; Dyslipidemia; Fibrillation atrial; Interstitial lung disease; Comments: It is unknown if there is a history of COVID-19 infection prior to vaccination
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38,8?C Iu international unit(s); Test Date: 20210612; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: 110bpm Iu international unit(s); Test Date: 20210612; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 93% Iu international unit(s); Test Date: 20210616; Test Name: SARS-CoV-2 test; Result Unstructured Data: unknown
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Severe SARS-CoV-2 pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001414) for COVID-19 vaccination. It is unknown whether there is a history of COVID-19 infection prior to vaccination. The patient''s past medical history included Interstitial lung disease, Fibrillation atrial, Dyslipidemia, B-cell small lymphocytic lymphoma (with clinical stability.), Benign prostatic hyperplasia and Chronic respiratory failure. Concomitant products included AMINOPHYLLINE (FILOTEMPO), TAMSULOSIN, RAMIPRIL, BUDESONIDE, UMECLIDINIUM BROMIDE;VILANTEROL, CARVEDILOL, FUROSEMIDE, ROSUVASTATIN, ALLOPURINOL, ACETYLSALICYLIC ACID and ESOMEPRAZOLE for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 milliliter. On 19-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) dosage was changed to 1 milligram. On 16-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) (seriousness criteria death, hospitalization prolonged and life threatening). The patient died on 21-Jun-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 12-Jun-2021, Body temperature: 38.8 (Inconclusive) 38,8?C Iu international unit(s). On 12-Jun-2021, Heart rate: 110 (Inconclusive) 110bpm Iu international unit(s). On 12-Jun-2021, Oxygen saturation: 93% (Inconclusive) 93% Iu international unit(s). On 16-Jun-2021, SARS-CoV-2 test: unknown unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral), the reporter did not provide any causality assessments. No treatment information is provided. Previous history of COVID-19 infection prior to vaccination was unknown. Action taken with mRNA-1273 in response to the events were not applicable This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document received on 06-JUL-2021, Other Relevant History updated, Concomitant medication (Filotempo-extended released tablet) added, Reporter''s comment updated.; Sender''s Comments: This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1480696 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: Septic shock; D?DSFALL; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (D?DSFALL) and SEPTIC SHOCK (Septic shock) in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Septic shock. It is unknown if an autopsy was performed. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Very limited information regarding the event has been provided.; Sender''s Comments: Very Limited information regarding the event has been provided.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1484301 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COMPLETED SUICIDE in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced COMPLETED SUICIDE (seriousness criteria death and medically significant). The patient died on 12-Jun-2021. The reported cause of death was Suicide. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Suicide


VAERS ID: 1484362 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-21
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coagulopathy
SMQs:, Haemorrhage laboratory terms (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: Coagulation factor V level abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of COAGULOPATHY in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Coagulation factor V level abnormal. On 07-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COAGULOPATHY (seriousness criterion death). The patient died on 21-Apr-2021. The reported cause of death was Coagulation disorder. An autopsy was not performed. No concomitant medications were reported. No treatment information was reported by reporter. This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Coagulation disorder


VAERS ID: 1485770 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL
Current Illness: Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree celsius
CDC Split Type: JPTAKEDA2021TJP058475

Write-up: Subarachnoid hemorrhage; This spontaneous case was reported by a physician and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003190) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)). Concomitant products included CANDESARTAN CILEXETIL for Hypertension. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 13-Jul-2021. The reported cause of death was Subarachnoid haemorrhage. An autopsy was performed. The autopsy-determined cause of death was Subarachnoid haemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (Low) 36.5 degree celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) to be possibly related. concomitant product included atorvastatin calcium hydrate. No treatment information was given. Very limited information regarding this event has been provided at this time. No further follow-up information is expected The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected; Reported Cause(s) of Death: Subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1488327 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Infarct myocardial; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. No medical history was reported. On 28-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was Cardio-respiratory arrest and Infarct myocardial. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not provided. Treatment information was not provided. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-NC20212796. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Infarct myocardial


VAERS ID: 1488348 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Insufficiency renal
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001657) for COVID-19 vaccination. The patient''s past medical history included Cancer of prostate. Concurrent medical conditions included Hypertension arterial and Insufficiency renal. On 10-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. Death occurred on 07-Jun-2021 The patient died on 07-Jun-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 were not reported. This sender''s number was reported as PO20213284 Treatment medication were not reported. Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1488395 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-21
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Obesity; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; Chest pain; Abdominal pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of SUDDEN DEATH (Sudden death), ABDOMINAL PAIN (Abdominal pain) and CHEST PAIN (Chest pain) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Obesity, Smoker and Hypercholesterolaemia. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion death). On 22-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death). The patient died on 23-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-RS20212053 No concomitant medications were provided by the reporter. This is a case of sudden death in a 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether an autopsy was performed. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether an autopsy was performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1488561 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-05-01
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a consumer and describes the occurrence of FOETAL DEATH (Fetal death) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 01-Jan-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment details were not provided. This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1489446 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 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: 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: SODIUM HYDROGEN CARBONATE; MIMPARA; PREDNISOLON ALTERNOVA; MIRTAZAPIN KRKA; ADPORT; MYCOPHENOLATE MOFETIL SANDOZ; ZOPIKLON PILUM; BACTRIM; OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]; OXASCAND; BISOPROLOL SANDOZ; CANDESARTAN SANDOZ; VALGANCICLOVIR T
Current Illness: Anxiety; Cardiomyopathy; Depression; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blisters (Bl?sor p? kroppen som en tidigare l?kemedelsbiverkan av Furosemid); Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: LUNGEMBOLI; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (LUNGEMBOLI) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 immunisation. The patient''s past medical history included Blisters (Blisters on the body as a previous drug side effect of Furosemide) and Kidney transplant on 18-Feb-2021. Concurrent medical conditions included Hypertension since 2005, Anxiety, Cardiomyopathy since 2005 and Depression. Concomitant products included SODIUM HYDROGEN CARBONATE, CINACALCET HYDROCHLORIDE (MIMPARA), PREDNISOLONE (PREDNISOLON ALTERNOVA), MIRTAZAPINE (MIRTAZAPIN KRKA), TACROLIMUS (ADPORT), MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL SANDOZ), ZOPICLONE (ZOPIKLON PILUM), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OMEPRAZOLE SODIUM (OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]), OXAZEPAM (OXASCAND), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), CANDESARTAN CILEXETIL (CANDESARTAN SANDOZ), VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR TEVA) and SERTRALINE HYDROCHLORIDE (SERTRALIN TEVA) for Adverse event. In April 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (LUNGEMBOLI) (seriousness criteria death and medically significant). The reported cause of death was Pulmonary embolism. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. 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 event, a causal relationship cannot be excluded The past history of cardiomyopathy and hypertension are confounders; 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 The past history of cardiomyopathy and hypertension are confounders; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1489467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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: 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 was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: smrt; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medications were provided. Treatment for the events were not provided. This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Sender''s Comments: This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1489921 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: Fibrillation atrial; Hyperlipidemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Sudden death; Haemorrhage nasal; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) and EPISTAXIS (Haemorrhage nasal) in a 67-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fibrillation atrial, Hypertension arterial and Hyperlipidemia. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Jun-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criteria death and medically significant) and EPISTAXIS (Haemorrhage nasal) (seriousness criterion death). The patient died on 18-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was Sudden cardiac death. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information provided. Company Comment : Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Autopsy-determined Cause(s) of Death: Sudden cardiac death


VAERS ID: 1497104 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dehydration, General physical health deterioration, Pain, Sepsis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (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: FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pelvic fracture; Renal failure (3 years ago)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Pelvic fracture and Renal failure (3 years ago). Concomitant products included FUROSEMIDE for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (seriousness criteria death, hospitalization and medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (seriousness criterion hospitalization), DEHYDRATION (seriousness criterion hospitalization) and PAIN (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was Sepsis. An autopsy was performed, but no results were provided. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased. Treatment information was not provided. This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1499915 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / 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: 2021-07-10
   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: TORVAST; CARDIOASPIRIN; VASORETIC
Current Illness: Dyslipidaemia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 PCR test positive
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) in a 76-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003601) for COVID-19 vaccination. The patient''s past medical history included Abdominal aortic aneurysm on 01-Oct-2019 and Dyslipidaemia. Concurrent medical conditions included Hypertension arterial. Concomitant products included ATORVASTATIN CALCIUM (TORVAST), ACETYLSALICYLIC ACID (CARDIOASPIRIN) and ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASORETIC) for an unknown indication. On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) (seriousness criteria death and medically significant). The patient died on 10-Jul-2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR test positive. 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. On 07-Jul-2021, laboratory tests of angiogram cerebral, brain CT and hematology were performed and results were not reported. Treatment information was not provided.; Sender''s Comments: This is a case of a 76-year-old male patient who experienced Cerebral haemorrhage 7 days following a dose of mRNA-1273 and subsequently died 10 days following vaccination. Very limited information regarding the event has been provided at this time. Detailed information regarding clinical course of the event was not provided. It is also unknown whether an autopsy was performed. Major confounder in this particular case is patient''s reported medical history of Hypertension arterial, in addition to patient''s advanced age.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1500341 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, Malaise
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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: CARBAMAZEPINE
Current Illness: Epilepsy (Family History is negative for epilepsy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of EPILEPSY and MALAISE in a 29-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy (Family History is negative for epilepsy.). Concomitant products included CARBAMAZEPINE for an unknown indication. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced EPILEPSY (seriousness criteria death and medically significant) and MALAISE (seriousness criterion death). The patient died on 10-Jul-2021. The reported cause of death was unknown. 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. No treatment information was provided by the reporter. 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


VAERS ID: 1500367 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Bl?dning; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bl?dning) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included PARACETAMOL for an unknown indication. On 21-Jun-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bl?dning) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. Treatment medication use information was not provided by reporter. Action taken with mRNA-1273 in response to the events was not applicable. The reporter did not provide causality assessment between mRNA-1273 and the events. This is a case of death in a 72-year-old female subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 72-year-old female subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


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