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

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

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1208853 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-26
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Computerised tomogram head, Death, Traumatic intracranial haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: ACETYLSALICYLIC ACID; VALPROATE SODIUM; VALPROATE SODIUM; LITHIUM CARBONATE; LISINOPRIL; QUETIAPINE FUMARATE
Current Illness: Adiposis (WHO grade I (BMI 30.7 kg/m2)); Arterial hypertension; Bipolar affective disorder; Gonarthrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal insufficiency (most likely pharmacological secondary to lithium overdose)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Creatinine; Result Unstructured Data: high; Test Date: 20210226; Test Name: CT of neurocranium; Result Unstructured Data: cranial calvaria and posterior fossa, native and with i.v. contrast examination. RESULT: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression. Suspected left hemispheric brain edema. Non-dislocated, semi-circumferential fracture with involvement of the frontal, parietal, and occipital bones on the right and the occipital and parietal bones on the left: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression.
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; Cerebral hemorrhage traumatic; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) and TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) in a 76-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000427) for COVID-19 vaccination. The patient''s past medical history included Acute renal insufficiency (most likely pharmacological secondary to lithium overdose) in January 2021, Arterial hypertension since an unknown date, Adiposis (grade I (BMI 30.7 kg/m2)) since an unknown date, Bipolar affective disorder since an unknown date and Gonarthrosis since an unknown date. Concomitant products included ACETYLSALICYLIC ACID, VALPROATE SODIUM, VALPROATE SODIUM, LITHIUM CARBONATE, LISINOPRIL and QUETIAPINE FUMARATE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) (seriousness criterion death). The patient died on 01-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood creatinine: 92 (High) high. On 26-Feb-2021, Computerised tomogram head: abnormal (abnormal) cranial calvaria and posterior fossa, native and with i.v. contrast examination. RESULT: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression. Suspected left hemispheric brain edema. Non-dislocated, semi-circumferential fracture with involvement of the frontal, parietal, and occipital bones on the right and the occipital and parietal bones on the left: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Signs of CSF congestion and consecutive brain stem compression.. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death NOS) and TRAUMATIC INTRACRANIAL HAEMORRHAGE (Cerebral hemorrhage traumatic) to be unlikely related. CT of neurocranium incl. cranial calvaria and posterior fossa, native and with i.v. contrast examination was performed RESULTS: Large, space-occupying, acute subdural hematoma in the left hemisphere with consecutive midline shift. Subfalcine, uncal, and incipient transtentorial herniation. Extensive SAH [subarachnoid hemorrhage] emphasized in the left hemisphere and frontobasal contusion hemorrhages on the left. Based on reporter''s causality and the patient''s advanced age along with multiple comorbidities, the event is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality and the patient''s advanced age along with multiple comorbidities, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown case of death


VAERS ID: 1211461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKINE [VALPROATE SODIUM]; MYDOCALM [TOLPERISONE HYDROCHLORIDE]; NOVALGIN [METAMIZOLE SODIUM]; QUETIAPIN ACTAVIS; TEMESTA EXPIDET
Current Illness: Cramps of extremities; Epilepsy; Pain
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dementia (Neurodegenerative dementia); Glaucoma (bilateral glaucoma); Metastatic breast cancer (status post metastatic breast cancer)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Acute heart failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) in a 74-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included Dementia (Neurodegenerative dementia), Arterial hypertension, Metastatic breast cancer (status post metastatic breast cancer) and Glaucoma (bilateral glaucoma). Concurrent medical conditions included Epilepsy, Cramps of extremities and Pain. Concomitant products included TOLPERISONE HYDROCHLORIDE (MYDOCALM [TOLPERISONE HYDROCHLORIDE]) from 02-Mar-2021 to 21-Mar-2021 for Cramps of extremities, VALPROATE SODIUM (DEPAKINE [VALPROATE SODIUM]) from 18-Feb-2020 to 21-Mar-2021 for Epilepsy, METAMIZOLE SODIUM (NOVALGIN [METAMIZOLE SODIUM]) from 25-Feb-2020 to 21-Mar-2021 for Pain, QUETIAPINE FUMARATE (QUETIAPIN ACTAVIS) from 30-Oct-2020 to 21-Mar-2021 and LORAZEPAM (TEMESTA EXPIDET) from 02-Mar-2021 to 21-Mar-2021 for an unknown indication. On 19-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criterion death). The patient died on 21-Mar-2021. The reported cause of death was Acute heart failure. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute heart failure) to be unlikely related. Treatment information was not provided. This is a case of death in a 74-year-old female subject with a medical history of dementia, arterial hypertension, metastatic breast cancer and glaucoma, who died 2 days after receiving a dose of vaccine. Based on the reporters comment and the information received, the cardiac failure is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 74-year-old female subject with a medical history of dementia, arterial hypertension, metastatic breast cancer and glaucoma, who died 2 days after receiving a dose of vaccine. Based on the reporters comment and the information received, the cardiac failure is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1211889 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Embolism, Pyrexia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: SARS-CoV-2 infection (mild COVID-19 course)
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: Body temperature; Result Unstructured Data: FATAL; Test Date: 20210302; Test Name: Body temperature; Result Unstructured Data: FATAL
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Sudden cardiac arrest; Seizures; Embolism; Body temperature increased to 39.7; Subfebrile body temperature; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Sudden cardiac arrest), SEIZURE (Seizures), EMBOLISM (Embolism), PYREXIA (Body temperature increased to 39.7) and PYREXIA (Subfebrile body temperature) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 infection (mild COVID-19 course) from October 2020 to November 2020. Previously administered products included for an unreported indication: ELIQUIS. On 25-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 27-Feb-2021 at 1:00 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Subfebrile body temperature) (seriousness criterion death). On 02-Mar-2021, the patient experienced CARDIAC ARREST (Sudden cardiac arrest) (seriousness criterion death), SEIZURE (Seizures) (seriousness criterion death), EMBOLISM (Embolism) (seriousness criterion death) and PYREXIA (Body temperature increased to 39.7) (seriousness criterion death). The patient died on 02-Mar-2021. The reported cause of death was sudden cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 37.5 degree Celsius (abnormal) Fatal. On 02-Mar-2021, Body temperature: 39.7 degree Celsius (High) Fatal. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Treament was not reported/ unknown. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 77-year-old male subject with a medical history of recent SARS-CoV-2 infection but unknown other conditions, who died 5 days after receiving a dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Sudden cardiac arrest


VAERS ID: 1217122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 4
Permanent Disability? Yes
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: Carcinoma bladder (in treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Massive pulmonary embolism; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive pulmonary embolism) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in January 2021 and Carcinoma bladder (in treatment) since an unknown date. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criterion death). The patient died on 17-Mar-2021. The reported cause of death was Pulmonary embolism. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1217164 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 22-Mar-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was reported. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1217281 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; BELOC ZOK; COMILORID; FELODIPIN; CELECOXIB; DUODART; OMEZOL LYO
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct; Renal failure; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in an 86-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct, Stroke and Renal failure. Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL SUCCINATE (BELOC ZOK), AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (COMILORID), FELODIPIN, CELECOXIB, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART) and OMEPRAZOLE SODIUM (OMEZOL LYO) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-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. Treatment was not provided. On 22-Mar, he was visited by the attending physician for non-specific symptoms (fluctuating vertigo, mild chest tightness, arterial hypotension), partly known but aggravated symptoms. Clinical examination and ECG without pathological findings, D-Dimer negative, Troponin-T non-pathological in view of age and concomitant chronic renal failure.; Sender''s Comments: This is a case of death in a 86-year-old male subject with a medical history of Diabetes mellitus, Hypertension. Myocardial infarct, Stroke and Renal failure, who died 5 days after receiving the first dose of vaccine. Based on reporter''s causality that patient''s age and clinical condition with several known pathologies, the death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1217331 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616410261153

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history provided.). On 18-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on March 2021 The patient died in March 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. Reporter did not allow further contact; Sender''s Comments: Concomitant Product use was not provided. Treatment information was not provided. This case refers to a 75-year-old elderly female patient who died after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1218470 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via another Manufacturer (Reference number: QTS-210413-110) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 63-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 (No reported medical history). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 63-year-old male subject with unknown medical history of, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1218478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 70068 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: Crohn''s disease; Paranoid schizophrenia; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Exitus letalis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 70068) for COVID-19 vaccination. The patient''s past medical history included Nicotine abuse and Alcohol abuse. Concurrent medical conditions included Crohn''s disease, Paranoid schizophrenia and Renal insufficiency. On 26-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-Mar-2021 The patient died on 29-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Action taken with the mRNA-1273 was not applicable Very limited information regarding the event of death has been provided at this time. No further information has been requested. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of death has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1218479 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-10
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722; 3000 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Cerebrovascular accident, Echocardiogram, Electrocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, International normalised ratio, Loss of consciousness, Neutrophil count, Platelet count, Troponin T, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: ELTROXIN; KALEORID; LERCATIO; HEART MAGNIL; SPIRIVA; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Atherosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 248 Unit not specified; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: occlusion of the left ICA; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in the left a. Cerebri media; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: stenosis of the left a. Carotis interna; Test Date: 20210310; Test Name: Albumin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Alkaline phosphatase; Test Result: Inconclusive ; Result Unstructured Data: 145 Unit not specified; Test Date: 20210310; Test Name: Bilirubin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 187 Unit not specified; Test Date: 20210310; Test Name: Arterial blood gases; Test Result: Inconclusive ; Result Unstructured Data: Metabolic acidosis Unit not specified; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: LDH; Test Result: Inconclusive ; Result Unstructured Data: 1080 Unit not specified; Test Date: 20210310; Test Name: Lactate; Test Result: Inconclusive ; Result Unstructured Data: 11 to 14 Unit not specified; Test Date: 20210310; Test Name: Potassium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Sodium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Urea; Test Result: Inconclusive ; Result Unstructured Data: 10.5 Unit not specified; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in coronary artery; Test Date: 20210310; Test Name: EKG; Test Result: Inconclusive ; Result Unstructured Data: Inferior STEMI; Test Date: 20210310; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: $g35, too high to measure Unit not specified; Test Date: 20210310; Test Name: GGT; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 6.8 Unit not specified; Test Date: 20210310; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.11 Unit not specified; Test Date: 20210310; Test Name: Neutrophil count; Test Result: Inconclusive ; Result Unstructured Data: 19.3 Unit not specified; Test Date: 20210310; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: 303 Unit not specified; Test Date: 20210310; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 3130 Unit not specified; Test Date: 20210310; Test Name: Leukocyte count; Test Result: Inconclusive ; Result Unstructured Data: 22 Unit not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: Apoplexy; Brought to the hospital unconscious; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Apoplexy) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 300042722; 3000489 and 300042722; 3000489) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis since an unknown date. Previously administered products included for an unreported indication: VESICARE in 2016. Concurrent medical conditions included Apoplexy. Concomitant products included ACETYLSALICYLSYRE (HEART MANGIL) from 23-Jun-2014 to an unknown date for Anticoagulant therapy, TIOTROPIUM BROMIDE (SPIRIVA) from 23-Jun-2014 to an unknown date for Chronic obstructive pulmonary disease, LERCANIDIPINE HYDROCHLORIDE (LERCATIO) from 24-Mar-2014 to an unknown date and LOSARTAN POTASSIUM (LOSARSTAD) from 19-Feb-2014 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (ELTROXIN) from 24-Apr-2014 to an unknown date for Hypometabolism, POTASSIUM CHLORIDE (KALEORID) for Potassium supplementation. On 09-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Apoplexy) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) (seriousness criterion death). The patient died on 10-Mar-2021. The reported cause of death was Apoplexy and Unconscious. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Alanine aminotransferase: 248 248 Unit not specified. On 10-Mar-2021, Angiogram: occlusion of the left ICA, thrombus in the left a. Middle Cerebral and stenosis of the left artery Carotid On 10-Mar-2021, Blood albumin: (normal) Normal. On 10-Mar-2021, Blood alkaline phosphatase: 145 145 Unit not specified. On 10-Mar-2021, Blood bilirubin: (normal) Normal. On 10-Mar-2021, Blood creatinine: 187 187 Unit not specified. On 10-Mar-2021, Blood gases: Metabolic acidosis Unit not specified. On 10-Mar-2021, Blood glucose: mg/dl (normal) Normal. On 10-Mar-2021, Blood lactate dehydrogenase: 1080 1080 Unit not specified. On 10-Mar-2021, Blood lactic acid: 11-14 11 to 14 Unit not specified. On 10-Mar-2021, Blood potassium: (normal) Normal. On 10-Mar-2021, Blood sodium: (normal) Normal. On 10-Mar-2021, Blood urea: 10.5 10.5 Unit not specified. On 10-Mar-2021, C-reactive protein: (normal) Normal. On 10-Mar-2021, Echocardiogram: thrombus in coronary artery. See Sender comments. On 10-Mar-2021, Electrocardiogram: inferior stemi Inferior STEMI. On 10-Mar-2021, Fibrin D dimer: $g35 $g35, too high to measure Unit not specified. On 10-Mar-2021, Gamma-glutamyltransferase: (normal) Normal. On 10-Mar-2021, Haemoglobin: 6.8 6.8 Unit not specified. On 10-Mar-2021, International normalised ratio: 1.11 1.11 Unit not specified. On 10-Mar-2021, Neutrophil count: 19.3 19.3 Unit not specified. On 10-Mar-2021, Platelet count: 303 303 Unit not specified. On 10-Mar-2021, Troponin T: 3130 3130 Unit not specified. On 10-Mar-2021, White blood cell count: 22 22 Unit not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Echocardiography, 10 Mar2021: Thrombus in coronary artery. Confirmed by elevated troponin T and high D dimer. Severe aortic stenosis, initial localised inferior hypokinesia, later takotsubo like heart failure, likely due to the apoplexies. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Reporter did not allow further contact.; Sender''s Comments: Very limited information regarding the reported fatal events has been provided at this time. However, patient''s advanced age and underlying cardiovascular comorbidities may have been contributory. No further information has been requested.; Reported Cause(s) of Death: Apoplexy; Unconscious


VAERS ID: 1218495 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; COVID-19; Dementia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616333419620

Write-up: fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 30-Dec-2020, Chronic ischemic heart disease, unspecified, Dementia and Hypertension. In March 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1. In March 2021, the patient experienced PYREXIA (fever) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Fever


VAERS ID: 1228050 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Chest pain
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; METOPROLOL; PERINDOPRIL; SOLIFENACINE [SOLIFENACIN]; CLOPIDOGREL; BECLOMETASONE;FORMOTEROL; COLECALCIFEROL; GLICLAZIDE; PRAVASTATIN
Current Illness: Diabetes mellitus; Hypercholesteraemia
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Coronary bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Bradycardia; Acute chest pain; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia) and CHEST PAIN (Acute chest pain) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included Cerebrovascular accident and Coronary bypass. Concurrent medical conditions included Hypercholesteraemia and Diabetes mellitus. Concomitant products included PANTOPRAZOLE, METOPROLOL, PERINDOPRIL, SOLIFENACINE [SOLIFENACIN], CLOPIDOGREL, BECLOMETASONE;FORMOTEROL, COLECALCIFEROL, GLICLAZIDE and PRAVASTATIN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion death) and CHEST PAIN (Acute chest pain) (seriousness criterion death). The patient died on 25-Mar-2021. The reported cause of death was Cardiac death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1228055 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer; Chronic obstructive pulmonary disease; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616764386368

Write-up: D�DSFALL; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (D�DSFALL) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3000493 and 3000493) for COVID-19 vaccination. The patient''s past medical history included Asthma, Breast cancer in 2009, Chronic obstructive pulmonary disease and Obesity. Concurrent medical conditions included Diabetes and Hypertension. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. In March 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred in March 2021 The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231470 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: MORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No information on risk factors or previous illnesses.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death; Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.), SOMNOLENCE (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.) and DIZZINESS (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No information on risk factors or previous illnesses.). Concomitant products included MORPHINE for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death), SOMNOLENCE (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death) and DIZZINESS (Abwesenheit, benommen, m�de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death). The patient died on 24-Jan-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Within two hours of the vaccination, the patient was no longer normal and was delirious. He kept losing consciousness and gradually became colder and colder until he no longer woke up. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 81-year-old male subject with unknown medical history, who died on the same day after receiving the Moderna COVID-19 vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: SARS-CoV-2 PCR test positive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Malignant ischaemic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Malignant ischaemic stroke) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 PCR test positive on 11-Aug-2020. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 26-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (Malignant ischaemic stroke) (seriousness criterion death). The patient died on 27-Mar-2021. The reported cause of death was ictus isqu�mico. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was reported. This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: ischemic stroke.


VAERS ID: 1231868 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Axillary abscess; Chronic kidney disease stage 3; Diabetes mellitus; Dysphagia; Hypertensive cardiomyopathy; Metabolic syndrome; Peripheral arterial disease; Polyneuropathy; Spinal cord injury; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Septic shock; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SEPTIC SHOCK (Septic shock) in a 69-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. Concurrent medical conditions included Spinal cord injury, Polyneuropathy, Diabetes mellitus, Dysphagia, Stroke, Hypertensive cardiomyopathy, Atrial fibrillation, Peripheral arterial disease, Metabolic syndrome, Chronic kidney disease stage 3 and Axillary abscess since February 2021. On 09-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) at an unspecified dose. On 14-Mar-2021, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criterion death). The patient died on 14-Mar-2021. The reported cause of death was Septic shock. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPTIC SHOCK (Septic shock) to be unlikely related. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1234350 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-03-16
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EJ6795-EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiodepressive syndrome; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease; Senile macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: COVID-19 pneumonitis; Vaccination failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonitis) in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. EJ6795-EJ6789 and EJ6795-EJ6789) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Senile macular degeneration and Peripheral arterial occlusive disease. Concurrent medical conditions included Type 2 diabetes mellitus, Anxiodepressive syndrome and Hypertension arterial. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form every three weeks. On 12-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Vaccination failure). On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonitis) (seriousness criterion death). The patient died on 26-Mar-2021. The reported cause of death was COVID-19 pneumonitis. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event was not applicable. Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1235253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-13
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chromaturia, Confusional state, Fatigue, Heart rate, Hypophagia, Malaise, Oxygen saturation, Renal failure, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: LEVODOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: blood pressure; Test Result: Inconclusive; Result Unstructured Data: 155/135 mmhg; Test Date: 20210321; Test Name: body temperature; Test Result: Inconclusive; Result Unstructured Data: 36.3/min; Test Date: 20210321; Test Name: heartbeat; Test Result: Inconclusive; Result Unstructured Data: 68-90/min; Test Date: 20210322; Test Name: pulse; Test Result: Inconclusive; Result Unstructured Data: 90/min; Test Date: 20210321; Test Name: Saturation; Test Result: Inconclusive; Result Unstructured Data: variable 60-90%,; Test Date: 20210321; Test Name: urine stick; Test Result: Inconclusive; Result Unstructured Data: no increased leukocytes
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RENAL FAILURE (not tested but looks like kidney failure), MALAISE (not feeling well), CHROMATURIA (dark urine), CONFUSIONAL STATE (some confusion), HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) and FATIGUE (fatigue) in a 98-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included LEVODOPA 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 10-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criterion death), CONFUSIONAL STATE (some confusion) (seriousness criterion death) and FATIGUE (fatigue) (seriousness criterion death). On 20-Mar-2021, the patient experienced RENAL FAILURE (not tested but looks like kidney failure) (seriousness criterion death) and CHROMATURIA (dark urine) (seriousness criterion death). On 21-Mar-2021, the patient experienced HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) (seriousness criterion death). The patient died on 22-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: 155/135 mmhg (Inconclusive) 155/135 mmhg. On 21-Mar-2021, Body temperature: 36.3/min (Inconclusive) 36.3/min. On 21-Mar-2021, Heart rate: 68-90/min (Inconclusive) 68-90/min. On 21-Mar-2021, Oxygen saturation: 60-90% (Inconclusive) wisselend 60-90%. On 21-Mar-2021, Urine analysis: no increases leukocytes (Inconclusive) no increased leucocytes. On 22-Mar-2021, Heart rate: 90 (Inconclusive) 90/min. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications also included non specified anticoagulants. Treatment of these events were not reported. Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1235330 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN HEXAL; ARANESP; PYRIDOXIN HCL; SUSCARD BUCCAL TABLETS; MIRTAZAPIN ACTAVIS; ACETYLCYSTEIN ALTERNOVA; ETALPHA; FORMOTEROL FUMARATE DIHYDRATE; DIAFER [IRON ISOMALTOSIDE 1000]; GLYCERYL TRINITRATE; GABAPENTIN ACTAVIS; CHOLECALCIFEROL;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Angina pectoris; Cardiac failure; Chronic kidney disease stage 5; Chronic obstructive pulmonary disease; Crohn''s disease; Haemodialysis; Intestinal stoma; Nerve pain; Shingles
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1617195306721

Write-up: SEPSIS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEPSIS (SEPSIS) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300493) for COVID-19 vaccination. The patient''s past medical history included Chronic kidney disease stage 5, Haemodialysis in 2016, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALIN HEXAL) from 23-Jul-2018 to an unknown date, DARBEPOETIN ALFA (ARANESP) from 22-Dec-2020 to an unknown date, PYRIDOXINE HYDROCHLORIDE (PYRIDOXIN HCL) from 18-Nov-2013 to an unknown date, GLYCERYL TRINITRATE (SUSCARD BUCCAL TABLETS) from 06-Apr-2017 to an unknown date, MIRTAZAPINE (MIRTAZAPIN ACTAVIS) from 29-Apr-2014 to an unknown date, ACETYLCYSTEINE (ACETYLCYSTEIN ALTERNOVA) from 25-Jul-2017 to an unknown date, ALFACALCIDOL (ETALPHA) from 09-May-2017 to an unknown date, FORMOTEROL FUMARATE DIHYDRATE from 18-Feb-2021 to an unknown date, IRON ISOMALTOSIDE 1000 (DIAFER [IRON ISOMALTOSIDE 1000]) from 30-Jun-2020 to an unknown date, GLYCERYL TRINITRATE from 29-Dec-2020 to an unknown date, GABAPENTIN (GABAPENTIN ACTAVIS) from 24-Sep-2020 to an unknown date, CHOLECALCIFEROL from 22-Oct-2019 to an unknown date, ZOPICLONE (ZOPIKLON PILUM) from 28-Nov-2013 to an unknown date, PARACETAMOL (ALVEDON DOS) from 06-Dec-2018 to an unknown date, METOCLOPRAMIDE HYDROCHLORIDE (PRIMPERAN) from 12-Mar-2019 to an unknown date, OXAZEPAM (OXASCAND) from 04-Dec-2015 to an unknown date, SALBUTAMOL SULFATE (BUVENTOL) from 02-Jan-2020 to an unknown date, LOPERAMIDE HYDROCHLORIDE (DIMOR) from 15-Nov-2013 to an unknown date and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) from 14-Mar-2019 to an unknown date for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced SEPSIS (SEPSIS) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Sepsis. 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 reported. Company comment: This is a case of death in a 85-year-old female subject with a medical history of CKD on hemodialysis, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris, who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 85-year-old female subject with a medical history of CKD on hemodialysis, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris, who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: SEPSIS


VAERS ID: 1235876 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: LAMIVUDINE; ABACAVIR SULPHATE; DOLUTEGRAVIR SODIUM; LERCANIDIPINE HYDROCHLORIDE; CARVEDILOL; CHLORPROTHIXENE HYDROCHLORIDE; OXAZEPAM; MIRTAZAPINE; SODIUM BICARBONATE; COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; CDC Group III HIV infection; Chronic hepatitis C; Haematuria; Mitral insufficiency; Personality disorder; Stage 3 acute kidney injury; Substance use; Thrombocytopenia; Ulcus cruris
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 56-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for an unknown indication. The patient''s past medical history included HIV infection, Chronic hepatitis C, Stage 3 acute kidney injury, Haematuria, Mitral insufficiency on 12-Aug-2016, Arteriopathy in February 2017, Ulcus cruris, Substance use, Personality disorder and Thrombocytopenia. Concomitant products included LAMIVUDINE from an unknown date to 13-Feb-2021, ABACAVIR SULFATE (ABACAVIR SULPHATE) from an unknown date to 13-Feb-2021, DOLUTEGRAVIR SODIUM from an unknown date to 13-Feb-2021, LERCANIDIPINE HYDROCHLORIDE from an unknown date to 13-Feb-2021, CARVEDILOL from an unknown date to 13-Feb-2021, CHLORPROTHIXENE HYDROCHLORIDE from an unknown date to 13-Feb-2021, OXAZEPAM from an unknown date to 13-Feb-2021, MIRTAZAPINE from an unknown date to 13-Feb-2021, SODIUM BICARBONATE from an unknown date to 13-Feb-2021 and COLECALCIFEROL from an unknown date to 13-Feb-2021 for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 13-Feb-2021 The patient died on 13-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information was not provided. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1235909 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-21
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: 2021-02-01
   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: Knee operation; Reanimation
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Cardiac arrest) in a 91-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Reanimation in 2011 and Knee operation in 2019. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on February 2021 The patient died in February 2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a case of death in a 91-year-old male subject with a medical history of Reanimation in 2011 and Knee operation in 2019., who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 91-year-old male subject with a medical history of Reanimation in 2011 and Knee operation in 2019., who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1235924 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-30
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sopor
SMQs:, Dementia (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: Atrial fibrillation; Chronic renal insufficiency; Dilated cardiomyopathy; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: 02/04/2021; This case was received via agency (Reference number: 710323) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence (02/04/2021) in an 88-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 Dilated cardiomyopathy, Atrial fibrillation, Vascular dementia and Chronic renal insufficiency. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter in total. On 30-Mar-2021, the patient experienced SOPOR (02/04/2021) (seriousness criterion death). The patient died on 02-Apr-2021. The reported cause of death was Sopor. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company Comment: Very limited information regarding the event of sopor has been provided at this time. No further information has been requested. Elderly age along with multiple comorbidities may have been contributory. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of sopor has been provided at this time. No further information has been requested. Elderly age along with multiple comorbidities may have been contributory.; Reported Cause(s) of Death: Sopor


VAERS ID: 1235938 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Cerebrovascular disorder; Chronic lymphocytic leukaemia; Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20210

Write-up: Sudden death; This case was received via a regulatory authority (Reference number: 021745) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cerebrovascular disorder, Chronic obstructive pulmonary disease, Chronic lymphocytic leukaemia, Hypertension and Asthma. Concomitant products included CLOPIDOGREL for an unknown indication. In March 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. The patient died in March 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. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on unknown date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown. Very limited information regarding the event of sudden death has been provided at this time. However, patient''s elderly age along with underlying comorbidities may have been contributory. No further information has been requested. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of sudden death has been provided at this time. However, patient''s elderly age along with underlying comorbidities may have been contributory. No further information has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1236007 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Hypotonic-hyporesponsive episode with loss of consciousness; Circulatory arrest; Hypotonic-hyporesponsive episode with loss of consciousness; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness), CARDIAC ARREST (Circulatory arrest) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) in a 76-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness) (seriousness criterion death), CARDIAC ARREST (Circulatory arrest) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) (seriousness criterion death). The reported cause of death was hypotonic-hyporesponsive episode with loss of consciousness, circulatory arrest and Loss of consciousness. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC ARREST (Circulatory arrest) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) to be possibly related. No further causality assessment was provided for HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness). No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Translation received; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities; Reported Cause(s) of Death: Hypotonic-hyporesponsive episode with loss of consciousness; Circulatory arrest; Loss of consciousness


VAERS ID: 1236426 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-21
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: 2021-03-29
   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: Prostatic neoplasm NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Aortic surgery; Comments: Npl. prostatae, St.p. Bauchaortenaneurysma -Op 2018
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: (Moderna) am 20.03.2021; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM ((Moderna) am 20.03.2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Npl. prostatae, St.p. Bauchaortenaneurysma -Op 2018. The patient''s past medical history included Aneurysm aortic in 2018 and Aortic surgery in 2018. Concurrent medical conditions included Prostatic neoplasm NOS. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM ((Moderna) am 20.03.2021) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was Pulmonary embolism. 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 reported. The treatment information included reanimation on 29 Mar 2021. Action taken with mRNA-1273 in response to the events was not applicable.; Sender''s Comments: This is a case of death in a 57-year-old male subject with a medical history of AAA, Ca Pancreas, who died 9 days after receiving the first dose of vaccine. Based on information received, death was due to pulmonary embolism, which is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1239867 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: ASPIRIN CARDIO; ATACAND; BELOC ZOK; FLUDEX [INDAPAMIDE]
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No significant Medical History
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Lost consciousness; Did not feel well; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Lost consciousness) and VACCINATION COMPLICATION (Did not feel well) in a 92-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No significant Medical History). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), CANDESARTAN CILEXETIL (ATACAND), METOPROLOL SUCCINATE (BELOC ZOK) and INDAPAMIDE (FLUDEX [INDAPAMIDE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion death) and VACCINATION COMPLICATION (Did not feel well) (seriousness criterion death). The patient died on 10-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Resuscitation attempted after the patient lost consciousness was ineffective and the patient died approximately 3 hours after not feeling well. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a 92 year-old, male patient who received mRNA-1273 Vaccine and experienced malaise and loss of consciousness with a fatal outcome, a day after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient''s pre-existing comorbidities Very limited information has been reported at this time. No further information is expected. Reporter did not allow further contact; Sender''s Comments: This is a 92 year-old, male patient who received mRNA-1273 Vaccine and experienced malaise and loss of consciousness with a fatal outcome, a day after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient''s pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1240322 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hemodialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Result: Lab test; Inconclusive; Test Date: 20201019; Test Name: corona (SARS-CoV-2 test positive) (23.1); Test Result: Positive; Result Unstructured Data: positive for COVID
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Overlijden) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 19-Oct-2020 and Hemodialysis. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 30-Mar-2021 The patient died on 30-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2020, SARS-CoV-2 test positive: positive Positive. On 29-Mar-2021, Laboratory test: inconclusive (Inconclusive). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1241486 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 31-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was parada cardiorrespiratoria (10007617). It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment: Based on the current available information and temporal association between the use of the product and the date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Parada cardiorrespiratoria (10007617)


VAERS ID: 1245538 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Mesenteric artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hypothyroidism; Osteoarthritis; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Mesenteric artery thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hypothyroidism, Osteoarthritis and Osteoporosis. On 17-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 MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) (seriousness criterion death). The patient died on 01-Apr-2021. The reported cause of death was mesenteric ischemia. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. sender''s case number 2021035738 Company comment: This case refers to an 80 year-old elderly female patient, with a history of hypertension and hypothyroidism, who died due to mesenteric artery thrombosis 15 days after receiving the first dose of mRNA-1273 vaccine. Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This case refers to an 80 year-old elderly female patient, with a history of hypertension and hypothyroidism, who died due to mesenteric artery thrombosis 15 days after receiving the first dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: mesenteric ischemia


VAERS ID: 1245549 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   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: Hypertension; Vascular stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: hoemelked�s; gyenge; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (hoemelked�s) and ASTHENIA (gyenge) in a 98-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Vascular stenosis. On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 15-Feb-2021, the patient experienced PYREXIA (hoemelked�s) (seriousness criterion death) and ASTHENIA (gyenge) (seriousness criterion death). The patient died on 21-Feb-2021. The reported cause of death was Subfebrile and Weakness. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (hoemelked�s) and ASTHENIA (gyenge) to be unlikely related. The patient had suspected COVID-19 infection with symptoms starting 10 days after the presumably first dose of vaccination with COVID-19 VACCINE MODERNA. Immunity might have not developed within this time period. Concomitant medications were not reported. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Subfebrile; Weakness


VAERS ID: 1245551 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history was reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: IL PAZIENTE IN DATA 05/04/2021 E'' STATO TROVATO DA UN SUO FAMILIARE PRIVO DI VITA A LETTO PRESSO IL PROPRIO DOMICILIO .; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (IL PAZIENTE IN DATA 05/04/2021 E'' STATO TROVATO DA UN SUO FAMILIARE PRIVO DI VITA A LETTO PRESSO IL PROPRIO DOMICILIO .) in a 76-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history was reported). On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. The patient died on 05-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1245553 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Alzheimer''s disease; Breast carcinoma NOS; Postinfarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: decesso; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (decesso) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Breast carcinoma NOS, Alzheimer''s disease and Postinfarction. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 01-Apr-2021 The patient died on 01-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment not provided.; Sender''s Comments: Limited information regarding the patient''s death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1245564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-31
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: pyrexia; Test Result: Inconclusive ; Result Unstructured Data: fever: 38 to 40.5 Celcius
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden death; Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an elderly male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 ml. On 30-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criterion death) and PYREXIA (Pyrexia). The patient died on an unknown date. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Pyrexia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Pyrexia: Koorts: 38 tot 40.5 graden Celcius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not provided. Treatment not provided. Very limited information regarding the event of sudden death has been provided at this time. No further information has been requested. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of purexia, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding the event of sudden death has been provided at this time. No further information has been requested. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of purexia, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1245861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 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: 2021-03-23
   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: Aortic stricture; Arterial hypertension; Breast cancer; Chronic renal failure anemia; Hypercholesterolaemia; Monoclonal gammopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death unexplained; Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death unexplained) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Monoclonal gammopathy, Aortic stricture, Breast cancer, Chronic renal failure anemia, Hypercholesterolaemia and Arterial hypertension. On 19-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Pyrexia). The patient died on 23-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Pyrexia) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Treatment of the events was not reported.; Sender''s Comments: Very limited information regarding this events has been provided at this time. However, this patient''s concurrent medical conditions (chronic renal failure anemia, breast cancer, aortic stricture, arterial hypertension, and monoclonal gammopathy) and advanced age may remain as confounders in the reported death of unspecified cause that occurred five days after the administration of COVID-19 Moderna vaccine. No further information can be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1246057 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: No adverse event (No Medical History reported.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No Medical History reported.). On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 03-Apr-2021 The patient died on 03-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. 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 provided. Company comment: This case of death concerns a 71-year-old male patient who received mRNA-1273 vaccine and died 6 days post vaccination. Although a temporal association exist, very limited information regarding this event has been provided at this time. Critical details such as the patient''s medical history, hospitalization report if any, and final cause of death is lacking. No further information is expected; Sender''s Comments: This case of death concerns a 71-year-old male patient who received mRNA-1273 vaccine and died 6 days post vaccination. Although a temporal association exist, very limited information regarding this event has been provided at this time. Critical details such as the patient''s medical history, hospitalization report if any, and final cause of death is lacking. No further information is expected; Reported Cause(s) of Death


VAERS ID: 1248615 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: OMEPRAZOLE [OMEPRAZOLE MAGNESIUM]; LEVODOPA/CARBIDOPA; MACROGOL; SOTALOL; MIRTAZAPINE; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200423; Test Name: corona, confirmed with test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: acute cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (acute hartstilstand) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COVID-19 on 23-Apr-2020. Concomitant products included OMEPRAZOLE MAGNESIUM (OMEPRAZOLE [OMEPRAZOLE MAGNESIUM]), CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA), MACROGOL, SOTALOL, MIRTAZAPINE and RIVAROXABAN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CARDIAC ARREST (acute cardiac arrest) (seriousness criterion death). The patient died on 30-Mar-2021. The reported cause of death was acute cardiac arrest. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2020, SARS-CoV-2 test positive: positive (Positive) Positive. Action taken was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a 92 year-old, male patient who received mRNA-1273 Vaccine and experienced Cardiac Arrest and died, a day after receiving first dose of vaccine. Concurrent medical conditions included COVID-19 and conmeds of omeprazole, levodopa/carbidopa, macrogol, sotalol, mirtazapine and rivaroxaban were provided. The reported cause of death was cardiac arrest. Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: acute cardiac arrest.


VAERS ID: 1248634 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cardiac failure; Obstructive sleep apnea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Cardiac failure. Concurrent medical conditions included Obstructive sleep apnea syndrome and AFib. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 30-Mar-2021. The reported cause of death was Cardio-respiratory arrest. 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 reported. No treatment information was provided. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was not applicable. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1250633 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; PROCORALAN; PERINDOPRIL; ZOFENOPRIL; ZYLORIC; METFORAL; DILATREND AP
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included IHD on 01-Jan-2010 and Type 2 diabetes mellitus since 01-Jan-2010. Concomitant products included ACETYLSALICYLIC ACID (CARDIOASPIRIN), IVABRADINE HYDROCHLORIDE (PROCORALAN), PERINDOPRIL, ZOFENOPRIL, ALLOPURINOL (ZYLORIC), METFORMIN HYDROCHLORIDE (METFORAL) and CARVEDILOL (DILATREND AP) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. Action taken was not applicable. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. There was no treatment information provided; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1257553 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood test, Chest pain, Colonoscopy, Death, Endoscopy upper gastrointestinal tract, Haemoglobin, Haemorrhage, Infarction, Pulmonary oedema, Thrombosis
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 3
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: Aortic stenosis (Moderate); Chronic disease (Severe); Hypercholesteraemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: Blood pressure; Result Unstructured Data: Hypovolemic shock; Test Name: Blood test; Test Result: Inconclusive ; Result Unstructured Data: Broad arrange of blood tests; Test Date: 20210318; Test Name: Colonoscopy; Result Unstructured Data: left colon filled with clots.; Test Date: 20210318; Test Name: Gastroscopy; Result Unstructured Data: left colon filled with clots.; Test Date: 20210318; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 2.8 Not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: Altered state of consciousness; During wake up at the hospital the PT develops high pressure lung oedema; Type II infarction; Acute gastro- and colonoscopy finds the left colon filled with clots.; Chest pain; death; Bleeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death), HAEMORRHAGE (Bleeding), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema), INFARCTION (Type II infarction), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) and CHEST PAIN (Chest pain) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Aortic stenosis (Moderate), Hypercholesteraemia and Chronic disease (Severe). On 09-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion death), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion hospitalization), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema) (seriousness criterion hospitalization), INFARCTION (Type II infarction) (seriousness criterion hospitalization), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) (seriousness criterion hospitalization) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient died on 21-Mar-2021. The reported cause of death was Circulatory failure, Bleeding and Chronic disease. An autopsy was not performed. At the time of death, ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema), INFARCTION (Type II infarction), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure measurement: 80/40 mmhg (Low) Hypovolemic shock. On 18-Mar-2021, Colonoscopy: abnormal (abnormal) left colon filled with clots.. On 18-Mar-2021, Endoscopy upper gastrointestinal tract: abnormal (abnormal) left colon filled with clots.. On 18-Mar-2021, Haemoglobin: incocnclusive (Inconclusive) 2.8 Not specified. On an unknown date, Blood test: incocnclusive (Inconclusive) Broad arrange of blood tests. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: This is a case of death in a 85-year-old male subject with a medical history of Hypertension, Aortic stenosis (Moderate), Hypercholesterolemia and unspecified chronic disease, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Hypertension, Aortic stenosis (Moderate), Hypercholesterolemia and unspecified chronic disease, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Circulatory failure; Bleeding; Chronic disease


VAERS ID: 1257580 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: End stage renal disease (ESRD)
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of lung; Colon cancer; Myelodysplasia; Open angle glaucoma; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Multi-organ failure; Thrombocytopenia; This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Cancer of lung, Open angle glaucoma, Type 2 diabetes mellitus in 2002, End stage renal disease (ESRD) since an unknown date, Myelodysplasia and Colon cancer. On 17-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Multiorgan failure. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications were provided. Treatment medications was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1257604 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension arterial; Hypertrophic cardiomyopathy; Kidney failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Mar-2021 The patient died on 10-Mar-2021. The cause of death was not reported. An autopsy was not performed. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021033608 Company Comment: This case of a 69 year old female patient on the same day after the administration of mRNA-1273 vaccine. Although patient had strong confounders in the underlying condition diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy, there is strong temporal association between the onset and the fatal outcome., hence a causal association cannot be excluded.; Sender''s Comments: This case of a 69 year old female patient on the same day after the administration of mRNA-1273 vaccine. Although patient had strong confounders in the underlying condition diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy, there is strong temporal association between the onset and the fatal outcome., hence a causal association cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1260474 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Death
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: FUROSEMIDE TEVA; NORVASC; NEURABEN; PANTORC; CARDURA; KAYEXALATE; ZEMPLAR; QUETIAPINA TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Shock cardiogenic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and CARDIOGENIC SHOCK (Shock cardiogenic) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included FUROSEMIDE (FUROSEMIDE TEVA) from 23-Mar-2021 to 05-Apr-2021, AMLODIPINE BESILATE (NORVASC) from 23-Mar-2021 to 05-Apr-2021, BENMETIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE (NEURABEN) from 23-Mar-2021 to 05-Apr-2021, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTORC), DOXAZOSIN MESILATE (CARDURA) from 23-Mar-2021 to 05-Apr-2021, SODIUM POLYSTYRENE SULFONATE (KAYEXALATE) from 23-Mar-2021 to 05-Apr-2021, PARICALCITOL (ZEMPLAR) from 23-Mar-2021 to 05-Apr-2021 and QUETIAPINE FUMARATE (QUETIAPINA TEVA) from 23-Mar-2021 to 05-Apr-2021. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 dosage form in total. On 05-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Death) (seriousness criterion death) and CARDIOGENIC SHOCK (Shock cardiogenic) (seriousness criterion medically significant). The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, CARDIOGENIC SHOCK (Shock cardiogenic) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment not provided. This is a case of death in a 77-year-old male subject with unknown medical history, who died on an unknown date after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 77-year-old male subject with unknown medical history, who died on an unknown date after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1260491 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cyanosis, Death, Deep vein thrombosis, Oedema, Pain in extremity, Pyrexia, Ultrasound Doppler, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; RAMIPRIL; GLYCERYL TRINITRATE; POTASSIUM CANRENOATE; IVABRADINE; LOPRESOR [METOPROLOL FUMARATE]
Current Illness: Angina pectoris; Cardiac failure; Hyperaldosteronism; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: body temperature; Result Unstructured Data: 37.2 degree celsius; Test Name: Ultrasound Doppler; Test Result: Inconclusive ; Result Unstructured Data: not provided
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY, OEDEMA , PYREXIA , CYANOSIS and VOMITING in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. Concurrent medical conditions included Cardiac failure, Hypertension arterial, Angina pectoris and Hyperaldosteronism. Concomitant products included GLYCERYL TRINITRATE and IVABRADINE for Angina pectoris, FUROSEMIDE for Cardiac failure, POTASSIUM CANRENOATE for Hyperaldosteronism, RAMIPRIL and METOPROLOL FUMARATE (LOPRESOR [METOPROLOL FUMARATE]) for Hypertension arterial. On 01-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 05-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (seriousness criterion medically significant), PAIN IN EXTREMITY (seriousness criterion medically significant), OEDEMA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant), CYANOSIS (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). The patient died on 06-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY, OEDEMA, PYREXIA , CYANOSIS and VOMITING outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 37.2 degree celcius (abnormal) 37.2 degree celsius. On an unknown date, Ultrasound Doppler: not provided (Inconclusive) not provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event of death added as none of the reported events are likely to directly result in death but could have contributed to the fatal outcome. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event of death added as none of the reported events are likely to directly result in death but could have contributed to the fatal outcome.; Reported Cause(s) of Death: Death


VAERS ID: 1260497 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: ALPRASOX; NEBIVOLOL; SIMVASTATIN; CARDIRENE; PALEXIA; COTAREG
Current Illness: Glaucoma; Hypertension arterial; IHD; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: 05/03/2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of VOMITING (05/03/2021) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, IHD, Hypertension arterial and Glaucoma. Concomitant products included ALPRASOX, NEBIVOLOL, SIMVASTATIN, ACETYLSALICYLATE LYSINE (CARDIRENE), TAPENTADOL HYDROCHLORIDE (PALEXIA) and HYDROCHLOROTHIAZIDE, VALSARTAN (COTAREG) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 04-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VOMITING (05/03/2021) (seriousness criterion death). The patient died on 05-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company comment: This case of a 92-year-old female patient who experienced vomiting on the same day after the administration of mRNA-1273 and died the following day. Based on the information which shows a strong temporal association between the onset of vomiting and the fatal outcome, a causal association cannot be excluded.; Sender''s Comments: This case of a 92-year-old female patient who experienced vomiting on the same day after the administration of mRNA-1273 and died the following day. Based on the information which shows a strong temporal association between the onset of vomiting and the fatal outcome, a causal association cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1260500 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cyanosis, Hyperpyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CYANOSIS and CHILLS in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form(s) in total. On 08-Apr-2021, the patient experienced CYANOSIS (seriousness criterion death), HYPERPYREXIA (seriousness criterion death) and CHILLS (seriousness criterion death). The patient died on 09-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Treatment was not reported. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1260506 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease (Chronic renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: End ileostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Thoracic pain; This case was received via an unknown source (no reference has been entered for a health authority or Regulatory Authority) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and CHEST PAIN (Thoracic pain) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included End ileostomy. Concurrent medical conditions included Chronic kidney disease (Chronic renal insufficiency). On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 25-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and CHEST PAIN (Thoracic pain) (seriousness criterion medically significant). On 06-Apr-2021, CHEST PAIN (Thoracic pain) outcome was unknown. The patient died on 06-Apr-2021. The reported cause of death was Thoracic pain. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment drug was reported. The patient underwent ileostomy (25 Mar 2021 to 06 Apr 2021). Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 87-year-old female subject with a medical history of chronic renal insufficiency, who died one day after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 87-year-old female subject with a medical history of chronic renal insufficiency, who died one day after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Thoracic pain


VAERS ID: 1260508 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: Hypertensive heart disease ; Ischemic leukoencephalopathy ; Transient ischaemic attacks
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA and ASTHENIA in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Hypertensive heart disease , Ischemic leukoencephalopathy and Transient ischaemic attacks . On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (seriousness criterion death) and ASTHENIA (seriousness criterion death). The patient died on 02-Apr-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Sender''s Case Number 713706 Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded.; Sender''s Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded.; Reported Cause(s) of Death: see case description.


VAERS ID: 1260509 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Malaise, Oxygen saturation decreased
SMQs:, Dementia (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: Diabetes mellitus; Ischaemic heart disease ("cardiopatia ischemica (pregressa PTCA)")
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon ("pregresso K del colon"); Angina pectoris ("episodi anginosi in soggetto diabetico"); Percutaneous transluminal coronary angioplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Oxygen saturation low; General malaise; Fuzzy head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), MALAISE (General malaise) and FEELING ABNORMAL (Fuzzy head) in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The patient''s past medical history included Adenocarcinoma of colon ("pregresso K del colon"), Percutaneous transluminal coronary angioplasty and Angina pectoris ("episodi anginosi in soggetto diabetico"). Concurrent medical conditions included Ischaemic heart disease ("cardiopatia ischemica (pregressa PTCA)") and Diabetes mellitus. On 19-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion death), MALAISE (General malaise) (seriousness criterion death) and FEELING ABNORMAL (Fuzzy head) (seriousness criterion death). The patient died on 21-Mar-2021. The reported cause of death was Oxygen saturation low, General malaise and Fuzzy head. 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 was not reported. Company Comment This is a case of death of an 81-year-old female patient 2 days post mRNA-1273 vaccination. Patient experienced oxygen saturation low, general malaise and fuzzy head prior to death. Based on temporal association between the use of the product and onset of oxygen saturation lo, general malaise and fuzzy head, a causal relationship cannot be excluded. The primary cause of death was not provided and hence cannot be assessed. No further information is expected.; Sender''s Comments: This is a case of death of an 81-year-old female patient 2 days post mRNA-1273 vaccination. Patient experienced oxygen saturation low, general malaise and fuzzy head prior to death. Based on temporal association between the use of the product and onset of oxygen saturation lo, general malaise and fuzzy head, a causal relationship cannot be excluded. The primary cause of death was not provided and hence cannot be assessed. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation low; general malaise; fuzzy head


VAERS ID: 1260511 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pseudomonas infection, Urine output decreased
SMQs:, Acute renal failure (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Infection Pseudomonas aeruginosa; Urinary output diminished; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PSEUDOMONAS INFECTION (Infection Pseudomonas aeruginosa) and URINE OUTPUT DECREASED (Urinary output diminished) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 31-Mar-2021, the patient experienced PSEUDOMONAS INFECTION (Infection Pseudomonas aeruginosa) (seriousness criterion death) and URINE OUTPUT DECREASED (Urinary output diminished) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Infection Pseudomonas aeruginosa and Urinary output diminished. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable No relevant concomitant medications were reported No treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD. Both events reported as resulting in death in SD and conservatively retained as serious / fatal; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD. Both events reported as resulting in death in SD and conservatively retained as serious / fatal; Reported Cause(s) of Death: Infection Pseudomonas aeruginosa; Urinary output diminished


VAERS ID: 1260706 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Loss of consciousness, Malaise, Nausea, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischaemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEIZURE and LOSS OF CONSCIOUSNESS in an 84-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. Co-suspect product included non-company product ACENOCOUMAROL tablet for TIA. The patient''s past medical history included Transient ischaemic attack. In 2011, the patient started ACENOCOUMAROL (unknown route) 1 mg. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death), SEIZURE (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), MALAISE and NAUSEA. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE, LOSS OF CONSCIOUSNESS, MALAISE and NAUSEA outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added; Reported Cause(s) of Death: Death


VAERS ID: 1260715 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-13
Onset:2021-03-30
   Days after vaccination:1995
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hyperammonaemia
SMQs:, Liver related investigations, signs and symptoms (narrow), 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: INSULATARD HUMAN; CARVEDILOL; PANTOPRAZOL [PANTOPRAZOLE]; NOVORAPID; METFORMINE [METFORMIN]; IRBESARTAN; PREDNISON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; idiopathische hyperammoniaemie; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and HYPERAMMONAEMIA (idiopathische hyperammoniaemie) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Co-suspect product included non-company product TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) capsule for an unknown indication. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (INSULATARD HUMAN), CARVEDILOL, PANTOPRAZOL [PANTOPRAZOLE], INSULIN ASPART (NOVORAPID), METFORMINE [METFORMIN], IRBESARTAN and PREDNISONE (PREDNISON) for an unknown indication. On 13-Oct-2015, the patient started TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) (unknown route) 2d1. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERAMMONAEMIA (idiopathische hyperammoniaemie) (seriousness criteria death and medically significant). 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. On 14-Oct-2014 the patient started additional Co-suspect non company product PREDNISON TABLET (brand name not specified) for an unknown indication, action taken dose increased. Additional concomitant medications included Gliclazide and Irbesartan for an unknown indication. Company comment: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender''s Comments: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1260721 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Body temperature, Coma scale, Computerised tomogram head, Depressed level of consciousness, Electroencephalogram, Glomerular filtration rate, Haemoglobin, Heart rate, Intraventricular haemorrhage, Lumbar puncture, Mini mental status examination, Neutrophil count, Oxygen saturation, Platelet count, Red blood cell sedimentation rate increased, Respiratory rate, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTAN KRKA [LOSARTAN]; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]; ELIQUIS; METOPROLOL; SOMAC
Current Illness: Atrial fibrillation; Bronchiectasis; COPD; Esophagitis (Esophagitis/gastritis. Negative H.pylori test.); Hypertension; Liver cirrhosis; Palliative care; Pancreatic calcification; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: Creatinine; Result Unstructured Data: 105 umol/L; Test Date: 20210226; Test Name: Potassium; Result Unstructured Data: 3.9 mmol/L; Test Date: 20210226; Test Name: Diastolic blood pressure; Test Result: 78 {DF}; Result Unstructured Data: 78 mmHg; Test Date: 20210226; Test Name: systolic blood pressure; Test Result: 166 {DF}; Result Unstructured Data: 166 mmHg; Test Date: 20210226; Test Name: Sodium; Result Unstructured Data: 141 mmol/L; Test Date: 20210226; Test Name: Body temperature; Result Unstructured Data: 37 degrees Celsius; Test Date: 20210226; Test Name: Glasgow coma scale; Test Result: Inconclusive ; Result Unstructured Data: 12-10; Test Date: 20210226; Test Name: Head CT; Test Result: Inconclusive ; Result Unstructured Data: Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.; Test Date: 20210226; Test Name: EEG; Result Unstructured Data: Slow activity, not epileptiform activity.; Test Date: 20210226; Test Name: GFR; Test Result: Inconclusive ; Result Unstructured Data: 41 mL/min/1.73m^2; Test Date: 20210226; Test Name: Hemoglobin; Result Unstructured Data: 12.2 g/dL; Test Date: 20210226; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 83 /min; Test Date: 20210226; Test Name: Spinal tap; Test Result: Inconclusive ; Result Unstructured Data: Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.; Test Date: 20210226; Test Name: MMSE; Test Result: Inconclusive ; Result Unstructured Data: 25 out of a total of 30; Test Date: 20210226; Test Name: Neutrophils; Test Result: Inconclusive ; Result Unstructured Data: 8 x 10^9/L; Test Date: 20210226; Test Name: Oxygen saturation; Result Unstructured Data: 98%; Test Date: 20210226; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 263 x 10^9/L; Test Date: 20210226; Test Name: Raised ESR; Test Result: Inconclusive ; Result Unstructured Data: 30 mm/hr; Test Date: 20210226; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: 20 /min; Test Date: 20210226; Test Name: sars-cov-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210226; Test Name: Cardiac troponin; Test Result: Inconclusive ; Result Unstructured Data: 26 ng/L; Test Date: 20210226; Test Name: White blood cells; Test Result: Inconclusive ; Result Unstructured Data: 12.5 x 10^9
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Intraventricular hemorrhage; Depressed level of consciousness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) and DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis, Palliative care, Esophagitis (Esophagitis/gastritis. Negative H.pylori test.) since 2008, Liver cirrhosis since January 2020, Pancreatic calcification since January 2020, Atrial fibrillation, COPD, Hypertension and Bronchiectasis. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, LOSARTAN (LOSARTAN KRKA [LOSARTAN]), FLUTICASONE PROPIONATE, SALMETEROL (SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]) and METOPROLOL for an unknown indication, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC). On 24-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) (seriousness criteria death, hospitalization and medically significant). On 26-Feb-2021, the patient experienced INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) (seriousness criteria death, hospitalization and medically significant). DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood creatinine: 105 (abnormal) 105 umol/L. On 26-Feb-2021, Blood potassium: 3.9 (abnormal) 3.9 mmol/L. On 26-Feb-2021, Blood pressure diastolic: 78 mmHg (abnormal) 78 mmHg. On 26-Feb-2021, Blood pressure systolic: 166 mmHg (abnormal) 166 mmHg. On 26-Feb-2021, Blood sodium: 141 (abnormal) 141 mmol/L. On 26-Feb-2021, Body temperature: 37 (abnormal) 37 degrees Celsius. On 26-Feb-2021, Coma scale: 12-10 (Inconclusive) 12-10. On 26-Feb-2021, Computerised tomogram head: intraventricular hemorrhage (Inconclusive) Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.. On 26-Feb-2021, Electroencephalogram: slow activity, not epileptiform activity (abnormal) Slow activity, not epileptiform activity.. On 26-Feb-2021, Glomerular filtration rate: 41 (Inconclusive) 41 mL/min/1.73m^2. On 26-Feb-2021, Haemoglobin: 12.2 g/dL (normal) 12.2 g/dL. On 26-Feb-2021, Heart rate: 83 /min (Inconclusive) 83 /min. On 26-Feb-2021, Lumbar puncture: leukocytes: 79 (Inconclusive) Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.. On 26-Feb-2021, Mini mental status examination: 25 (Inconclusive) 25 out of a total of 30. On 26-Feb-2021, Neutrophil count: 8 10^9/L (Inconclusive) 8 x 10^9/L. On 26-Feb-2021, Oxygen saturation: 98 % (normal) 98%. On 26-Feb-2021, Platelet count: 263 10^9/L (Inconclusive) 263 x 10^9/L. On 26-Feb-2021, Red blood cell sedimentation rate increased: 30 mm/hr (Inconclusive) 30 mm/hr. On 26-Feb-2021, Respiratory rate: 20 /min (Inconclusive) 20 /min. On 26-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 26-Feb-2021, Troponin: 26 ng/L (Inconclusive) 26 ng/L. On 26-Feb-2021, White blood cell count: 12.5 10^9/L (Inconclusive) 12.5 x 10^9. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected. Reporter did not allow further contact; Reporter''s Comments: NIPH will request additional information from hospital. 25 / Mar / 2021 NIPH: Additional information received from hospital, the report is updated (posted under "Person" and "Disease", "Product" and "Lab"). Background: A woman in her late 80s was vaccinated with COVID-19 vaccine Moderna in January and February 2021. According to the report, she has subsequently had several admissions due to impaired consciousness, GCS 9-10. Thoroughly investigated. Spinal fluid with leukocytes of 79, primarily mononuclear cells, but some blood in the gastric system for unexplained reason. Proven less deep cerebral infarction right side. No explanation the patient''s condition based on the report. Sign up for inflammation of the spinal fluid, without the agent becoming proven after thorough investigation. Possible immunological reaction to the vaccine? Transition to palliative care treatment. Comment: The current event is per now no known side effect of this vaccine, but your message is important to increase knowledge about side effects which may not have been discovered in the studies. Unexpected and serious incidents after vaccination are monitored and assessed, both continuously and collectively, as a acquires further experience from completed vaccination. In this case, it is difficult to know whether the symptoms can be attributed to the vaccine or another, random simultaneous cause that has nothing to do with it current vaccine to do. If the reporter has more information that may be relevant for the assessment of causal connection, then these can be communicated to us. Information that is of interest is details about the course of events, onset of symptoms in relation to vaccination time, any relevant comorbidity and drugs in use. It can be said to be a temporal connection between the current medical history and time for vaccination, and on that basis we have therefore considered it to be a possible causal relationship. According to international criteria, a possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to underlying disease, other drugs or chemicals (1). References: Adverse reactions: definitions, diagnosis and management. Lancet 2000; 356: 1255-59.; Sender''s Comments: Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected.


VAERS ID: 1260723 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30001176 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Dementia; Frailty; Life expectancy shortened; Ovarian cancer metastatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION and DEATH in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30001176) for COVID-19 vaccination. Concurrent medical conditions included Ovarian cancer metastatic, Life expectancy shortened, Frailty and Dementia. On 30-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION(seriousness criterion death). The patient died in April 2021. The reported cause of death was Reduced general condition. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered GENERAL PHYSICAL HEALTH DETERIORATION and DEATH to be possibly related. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Company comment:This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown cause of death; Reduced general condition


VAERS ID: 1260820 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-30
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Bladder neoplasm. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 30-Mar-2021 The patient died on 30-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.; ; Reported Cause(s) of Death: death


VAERS ID: 1260851 (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: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Implantable defibrillator user; Ischemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1617257859120

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and DEATH (Death NOS) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Implantable defibrillator user and Ischemic cardiomyopathy. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (seriousness criterion death) and DEATH (Death NOS) (seriousness criterion death). 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 concomitant medication reported. No treatment information was provided. On unspecified date in 2021, patient received the vaccination. On unspecified date in 2021, patient had cardiac arrest. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment:This case of a cardiac arrest and death of a 78-year-old male patient after the administration of mRNA-1273. Very limited information regarding this event/s has been provided at this time. Dates of mRNA-1273 administration and onset of the reported events are lacking. No further information is expected.; Sender''s Comments: This case of a cardiac arrest and death of a 78-year-old male patient after the administration of mRNA-1273. Very limited information regarding this event/s has been provided at this time. Dates of mRNA-1273 administration and onset of the reported events are lacking. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Death NOS


VAERS ID: 1261888 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: IEMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 2 dosage form. Death occurred on 27-Mar-2021 The patient died on 27-Mar-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. No concomitant medications were reported. The action taken with mRNA-1273 in response to the events was not applicable. Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1261890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2020-04-04
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-04-04
   Days after onset: 365
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.MOD20210

Write-up: sudden death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (sudden death) in a 95-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. The patient died on 04-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment information was not provided. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD for confirmation of events and dates. SD currently has reaction start date captured as 4-apr-2020 which is likely an error as the event is sudden death and this date is a year prior to the stop date (the death of the patient) Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: no new information; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD for confirmation of events and dates. SD currently has reaction start date captured as 4-apr-2020 which is likely an error as the event is sudden death and this date is a year prior to the stop date (the death of the patient); Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1261891 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 01-Apr-2021. The reported cause of death was Death sudden. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. It is unclear if the sudden death occurred after the first or second dose of vaccine as the SD senders comments suggest first dose administered on 02-mar-2021 while the fields completed in the SD suggest first dose occurred on 30-mar-2021 02/03/2021 - 300042723)"; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. It is unclear if the sudden death occurred after the first or second dose of vaccine as the SD senders comments suggest first dose administered on 02-mar-2021 while the fields completed in the SD suggest first dose occurred on 30-mar-2021; Reported Cause(s) of Death: Death sudden


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidaemia; Hypertension arterial; Type 2 diabetes mellitus (Diabetes mellitus Typ 2)
Preexisting Conditions: Comments: Diabetes mellitus Typ 2, art. Hypertonie
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

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


VAERS ID: 1262015 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Fibrosis lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; CARVEDILOL
Current Illness: Duchenne muscular dystrophy; Endotracheal intubation; Percutaneous endoscopic gastrostomy; Respiration failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

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


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

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

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

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Myalgia, Nausea, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history information reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Unknown cause of death; Nausea; Generalized joint pain; Neuralgia; Fatigue; Myalgia; Headache; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death), NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history information reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Apr-2021, the patient experienced NEURALGIA (Neuralgia) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MYALGIA (Myalgia) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced ARTHRALGIA (Generalized joint pain) (seriousness criterion medically significant). On 04-Apr-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1266191 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Sudden death; This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Sudden death) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 03-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Limited information regarding the death of this elderly man has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1266206 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTIROX; ATENOLOLO EG; LASIX [FUROSEMIDE]; COAPROVEL; HUMALOG
Current Illness: Artificial cardiac pacemaker wearer; Diabetes mellitus; Hypertension; Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

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


VAERS ID: 1269866 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORMETAZEPAM; FUROSEMIDE; METFORMIN; CONGESCOR; SOLDESAM; PANTOPRAZOLE; CARDIOASPIRIN
Current Illness: Antiinflammatory therapy; Anxiety; Cardiac failure; Cardiomyopathy; Chronic gastritis; Diabetes; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included Antiinflammatory therapy since an unknown date. Concurrent medical conditions included Cardiomyopathy, Chronic gastritis, Cardiac failure, Diabetes, Hypertension arterial and Anxiety. Concomitant products included DEXAMETHASONE SODIUM PHOSPHATE (SOLDESAM) from 07-Apr-2021 to an unknown date for Antiinflammatory therapy, LORMETAZEPAM from 07-Apr-2021 to an unknown date for Anxiety, BISOPROLOL FUMARATE (CONGESCOR) from 07-Apr-2021 to an unknown date for Cardiac failure, ACETYLSALICYLIC ACID (CARDIOASPIRIN) from 07-Apr-2021 to an unknown date for Cardiomyopathy, PANTOPRAZOLE from 07-Apr-2021 to an unknown date for Chronic gastritis, METFORMIN from 07-Apr-2021 to an unknown date for Diabetes, FUROSEMIDE from 07-Apr-2021 to an unknown date for Hypertension arterial. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 08-Apr-2021 The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1269867 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TARGINIQ; DICLOREUM [DICLOFENAC]; OXATOMIDE
Current Illness:
Preexisting Conditions: Comments: Relevant medical history still needs to be translated
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: 110/80; Test Date: 20210409; Test Name: heart rate; Test Date: 20210409; Test Name: SO2; Result Unstructured Data: 100 %
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; BP 110/80 P 100 SO2 100% This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), GAZE PALSY and SEIZURE. BP 110/80 P 100 SO2 100% in a 68-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001655) for COVID-19 vaccination. Relevant medical history still needs to be translated. Concomitant products included NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE (TARGINIQ), DICLOFENAC (DICLOREUM [DICLOFENAC]) and OXATOMIDE for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced GAZE PALSY (seriousness criterion medically significant) and SEIZURE (seriousness criterion medically significant). On 11-Apr-2021, GAZE PALSY and SEIZURE outcome was unknown. The patient died on 11-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood pressure measurement: 110/80 110/80. On 09-Apr-2021, Heart rate: 100. On 09-Apr-2021, Oxygen saturation: 100 % 100 %. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Death event added, the outcome were changed for other than death event.; Reporter''s ; Sender''s Comments: Limited translated information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1276136 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-04-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEROQUEL; PROMETHAZINE - CODEINE [CITRIC ACID;CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE;SODIUM CITRATE ACID; HALOPERIDOL 1A PHARMA; METFORMINE [METFORMIN]; ACETYLSALICYLZUUR; COLECALCIFEROL; SIMVASTATINE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemia myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MELATONINE; QUETIAPINE; OXAZEPAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history provided
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: body temperature; Result Unstructured Data: 38 tot 40.5 Celcius; Test Date: 20210413; Test Name: SaO2 69%; Test Result: 69 %; Result Unstructured Data: 69%; Test Date: 20210413; Test Name: sputum; Result Unstructured Data: bloody
CDC Split Type: NLMODERNATX, INC.MOD20210

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; Tonic clonic jerking; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Epilepsy. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criterion death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) (seriousness criterion medically significant) and PYREXIA (Pyrexia) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. At the time of death, TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided. Pyrexia retained as serious / MS per assessment included in Authority report. It is not clear if the vaccine dose administered prior to the events was the first or second dose.; Reported Cause(s) of Death: sudden death


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

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Respiratory insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

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


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

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

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

Write-up: Death sudden; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Death sudden) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Dysphagia in 2017. Concurrent medical conditions included Cerebral hemorrhage since 2017, Aneurysm ruptured since 2017 and Aphasia since 2017. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form in total. The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information included. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Translated Document added. NNI; Sender''s Comments: This case of death concerns an 87-year-old, female patient who experienced sudden death after the administration of mRNA-1273 (Lot number: unknown). Although a temporal association exist, very limited information regarding this event have been provided at this time. Patient''s medical history and autopsy report is lacking. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1288585 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: mogelijk overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (mogelijk overlijden) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 01-Mar-2021. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. Death occurred on 18-Mar-2021 The patient died on 18-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Conflictingly date of death also reported as 30 Mar 2021.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information can''t be requested.; Reported Cause(s) of Death: niet meer aanspreekbaar, somnolent en hierop overleden


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOSORBIDE MONONITRAAT RETARD RPH; RENVELA; FUROSEMIDE; NOVOMIX; ARANESP; BISOPROLOL [BISOPROLOL FUMARATE]; LOSARTAN; ADIRO AP; CARDURA; AKOSTOL; ALOPURINOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Sudden death; Fever; General malaise; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. xhbvc439ab) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRAAT RETARD RPH) from 16-Mar-2019 to an unknown date for Cardiac ischaemia, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) from 05-Mar-2013 to an unknown date for Diabetes with renal manifestations, BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]) from 12-May-2017 to an unknown date for Dyspnea, LOSARTAN from 08-Aug-2018 to an unknown date for Hypertension arterial, SEVELAMER CARBONATE (RENVELA) from 21-Nov-2013 to an unknown date and FUROSEMIDE from 11-May-2013 to an unknown date for Nephropathy, ACETYLSALICYLIC ACID (ADIRO AP) from 09-Jun-2017 to an unknown date and ACOTIAMIDE HYDROCHLORIDE (AKOSTOL) from 15-May-2019 to an unknown date for Peripheral vascular disease, unspecified, DARBEPOETIN ALFA (ARANESP) from 10-Sep-2020 to an unknown date for Peritoneal dialysis, DOXAZOSIN MESILATE (CARDURA) from 15-Jan-2021 to an unknown date and ALOPURINOL from 15-Jun-2012 to an unknown date for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever) and MALAISE (General malaise). On 10-Apr-2021, PYREXIA (Fever) and MALAISE (General malaise) had not resolved. The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


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

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

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

Write-up: syndrome grippal; fibrillation; Hypotension; death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (fibrillation), HYPOTENSION (Hypotension) and INFLUENZA LIKE ILLNESS (syndrome grippal) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD). On 15-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (fibrillation) (seriousness criteria death, hospitalization and medically significant) and HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization). On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (syndrome grippal) (seriousness criteria death and hospitalization). The patient died on 02-Apr-2021. The reported cause of death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. The action taken for mRNA-1273 was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: The date of death of and event hypotension was added.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed. Cause and dates of hospitalization not specified.


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abdominal aortic aneurysm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

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


VAERS ID: 1301855 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-05
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20210

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Hypertension; Hypothyroidism; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) and DEPRESSED LEVEL OF CONSCIOUSNESS in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Heart failure, Hypertension and Type II diabetes mellitus. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Unknown cause of death) (seriousness criterion death) and DEPRESSED LEVEL OF CONSCIOUSNESS (seriousness criterion death). The patient died on 14-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021039777 Company comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Reported Cause(s) of Death


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

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

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

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


VAERS ID: 1304048 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN "KRKA"; ALLOPURINOL; TOSTRAN; ANCOZAN
Current Illness: Atrial fibrillation; Dyspnoea; Shooting pain
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); COVID-19; Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia and units not specified); Test Date: 20210409; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 117 heart beats per minute; Test Date: 20210409; Test Name: Blood neutrophils; Result Unstructured Data: 7.5 (slightly increased) Units not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: death 1.5 days after vaccination.; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death 1.5 days after vaccination.) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The dyspnoea was recovering around christmas, but then worsening. The patient''s past medical history included COVID-19 in November 2020 and Alcohol abuse (No alcohol in a year.) in 2020. Concurrent medical conditions included Dyspnoea since November 2020, Shooting pain since December 2020 and Atrial fibrillation. Concomitant products included Simvastatin from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM from 07-Jan-2015 to an unknown date for Blood pressure high, ALLOPURINOL from 01-Feb-2013 to an unknown date for Gout, TESTOSTERONE (TOSTRAN) from 06-Mar-2019 to an unknown date for Testosterone low. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Apr-2021 The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) normal. On 09-Apr-2021, C-reactive protein: 18 (High) 18. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia and units not specified). On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304250 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

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

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

Write-up: Anaphylactic shock; Hypoxia; Dyspnea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), HYPOXIA (Hypoxia) and DYSPNOEA (Dyspnea) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Cardiovascular disease, unspecified Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Chronic kidney disease , Atrial fibrillation and Hypertrophic cardiomyopathy. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, METFORMIN HYDROCHLORIDE, VILDAGLIPTIN (EUCREAS) for Diabetes mellitus, VALSARTAN (DIOVAN) for Hypertension, DILTIAZEM HYDROCHLORIDE (MASDIL), TORASEMIDE (TORASEMID), FUROSEMIDE (SEGURIL) and PRAVASTATINA [PRAVASTATIN] for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death and hospitalization), HYPOXIA (Hypoxia) (seriousness criteria death and hospitalization) and DYSPNOEA (Dyspnea) (seriousness criteria death and hospitalization). The patient died on 11-Apr-2021. The reported cause of death was Anaphylactic shock, Dyspnea and Hypoxia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Tryptase: 30.8 microgram per litre abnormal. On 10-Apr-2021, Tryptase: 33.5 microgram per litre abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.; Reported Cause(s) of Death: Anaphylactic shock; Dyspnea; Hypoxia


VAERS ID: 1304251 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Arterial bypass operation; Bladder cancer; Chronic lymphoid leukaemia; Ischaemic cardiomyopathy; Peripheral arterial occlusive disease; Prostatitis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer, Aortic valve calcification, Arterial bypass operation, Prostatitis, Chronic lymphoid leukaemia, Peripheral arterial occlusive disease, Type 2 diabetes mellitus and Ischaemic cardiomyopathy. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 was not applicable. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306269 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Bipolar disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension and Bipolar disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was Haemorrhagic stroke. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications and treatment information were provided.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Haemorrhagic stroke


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Blood pressure high; Treatment noncompliance
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma; Hernia repair (scrotal hernia surgery); Scrotal hernia; Traumatic brain injury; Comments: art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Pulse rate; Test Result: Negative ; Result Unstructured Data: Pulse absent
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS and PULSE ABSENT in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance. The patient''s past medical history included Scrotal hernia, Cranioencephalic trauma, Traumatic brain injury and Hernia repair (scrotal hernia surgery). Concurrent medical conditions included Arterial hypertension, Blood pressure high and Treatment noncompliance. On 12-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion death) and PULSE ABSENT (seriousness criterion death). The patient died on 19-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Heart rate: pulse absent (Negative) Pulse absent. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Company Comment: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received. On 05-May-2021: Dose 1 added.; Sender''s Comments: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306453 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL [PANTOPRAZOLE]; SOLIAN; D-CURE; GLUCOPHAGE; APOCARD RETARD; BISOPROLOL [BISOPROLOL FUMARATE]; ZYPREXA VELOTAB; FOLAVIT; L-THYROXINE [LEVOTHYROXINE]; PROTHIADEN
Current Illness: Cardiac failure; Diabetes; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac failure and Psychiatric disorder NOS. Concomitant products included PANTOPRAZOL [PANTOPRAZOLE], AMISULPRIDE (SOLIAN), COLECALCIFEROL (D-CURE), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), FLECAINIDE ACETATE (APOCARD RETARD), BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]), OLANZAPINE (ZYPREXA VELOTAB), FOLIC ACID (FOLAVIT), L-THYROXINE [LEVOTHYROXINE] and DOSULEPIN HYDROCHLORIDE (PROTHIADEN) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications included MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Description: The patient had not reported any complaints during the day or signs after vaccination. The patient fell down in her room and must have died right away. She was hanging stockings on a heater, the position of the body clearly showed that she had fallen down and had not moved. The patient did not receive any treatment. Action taken with the drug in response to events was not applicable. Company comment:This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received included medical history information.; Sender''s Comments: This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306512 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Coronary heart disease; Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. Concurrent medical conditions included Dialysis, Cardiac failure and Coronary heart disease. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYOCARDIAL INFARCTION seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION to be unlikely related. The concomitant medications were not reported. The patient was resuscitated and later died at the hospital. The relationship to the vaccine was considered unlikely because the patient had severe heart disease. The action taken with mRNA 1273 with the event was not applicable. Company comment: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received. Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1308645 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIRENE; ENALAPRIL IDROCLOROTIAZIDE EG; COLECALCIFEROL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoptysis, Loss of consciousness, Oesophageal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENTELAN; PALEXIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP); Surgery (hernia operation); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: ch
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOINE; RISPERIDON; AZITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test positive
CDC Split Type: NLMODERNATX, INC.MOD20211

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; FAMOTIDINE ACID REDUCER; TRAMADOL; CLONAZEPAM; ALFACALCIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident ("5 months ago"); COVID-19; Dialysis; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: Corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Renal insufficiency, Dialysis, Cerebrovascular accident ("5 months ago") in December 2020, Renal insufficiency, Dialysis and COVID-19 on 02-Apr-2020. Concomitant products included ALLOPURINOL, FAMOTIDINE (FAMOTIDINE ACID REDUCER), TRAMADOL, CLONAZEPAM and ALFACALCIDOL for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2020, SARS-CoV-2 test positive: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: The follow-up received has NNI.; Sender''s Comments: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely.; Reported Cause(s) of Death: Cardiac arrest


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: pulmonary embolism; The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) and PULMONARY EMBOLISM (pulmonary embolism) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) (seriousness criterion death). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 07-Apr-2021. The reported cause of death was pulmonary embolism presumably from thrombotic. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received; The event verbatim changed for both the events and the stop date for the event thrombosis leg updated; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required.; Reported Cause(s) of Death: Pulmonary embolism presumably from thrombotic


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Diathesis skin-mucosal; Respiratory tract bleeding; Failure heart; Acute thrombocytopenia; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding), THROMBOCYTOPENIA (Acute thrombocytopenia) and CARDIAC FAILURE (Failure heart) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Mar-2021, the patient experienced THROMBOCYTOPENIA (Acute thrombocytopenia) (seriousness criterion death). On 18-Mar-2021, the patient experienced HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal) (seriousness criterion death), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding) (seriousness criterion death) and CARDIAC FAILURE (Failure heart) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Respiratory tract bleeding, Heart failure, acute thrombocytopenia and diathesis skin-mucosal. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Cardiac failure, thrombocytopaenia (both immune and toxic thrombocytopaenia) and the associated dermatomucosal diathesis and respiratory tract bleeding are unexpected adverse reactions which are not listed in section 4.8 of the COVID-19 Vaccine Moderna Summary ofProduct Characteristics. A causal relationship between the administration of the Moderna vaccine and the occurrence of immune thrombocytopaenia cannot be ruled out or confirmed at the current stage of development. Based on the information in the report, although acute immune thrombocytopaenia was reported as an adverse reaction, the type of thrombocytopaenia has not been confirmed (immune thrombocytopaenia or toxic thrombocytopaenia was merely suspected). There is a temporal relationship between vaccine administration and the onset of thrombocytopaenia, but due to the reasons listed above, a causal relationship has not been established. No information is available on whether cardiac failure existed before the vaccination (an attempt to obtain information was unsuccessful); therefore, no temporal or causal relationships can be established. The reporting physician assessed the adverse reactions as severe (death). The regulatory authority classified the report as severe. This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Translation received. Sender''s comments added.; Sender''s Comments: This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Respiratory tract bleeding; Heart failure; Acute thrombocytopenia; Diathesis skin-mucosal


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAMICRON; SIMVASTATIN; JANUMET; FORXIGA
Current Illness: Hyperlipidaemia (Hyperlipid�mie); NIDDM (NIDDM)
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOVASCULAR INSUFFICIENCY and CORONARY ARTERY OCCLUSION in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. Concurrent medical conditions included NIDDM (NIDDM) and Hyperlipidaemia (Hyperlipid�mie). Concomitant products included GLICLAZIDE (DIAMICRON), SIMVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA) for an unknown indication. On 16-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CARDIOVASCULAR INSUFFICIENCY (seriousness criterion death) and CORONARY ARTERY OCCLUSION (seriousness criterion death). The patient died on 18-Apr-2021. The reported cause of death was Occlusion coronary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company comment:This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient autopsy info, Medical History, and Concomitant medication info added; Sender''s Comments: This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: Occlusion coronary


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; ATORVASTATIN; SPIRONOLACTONE; BISOPROLOL FUMARATE; EZETIMIBE; Aldactone; CONCOR; Fludex; Triatec; ZANIDIP; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute blood loss anemia; Acute on chronic renal failure; Acute renal failure; Chronic renal failure; Coronary artery disease; Coronary artery disorder; Thrombopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bardet-Biedl syndrome; End stage renal disease (ESRD); Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Shock circulatory; Arterial hypotension; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Arterial hypotension) and SHOCK (Shock circulatory) in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD) and Bardet-Biedl syndrome. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPOTENSION (Arterial hypotension) (seriousness criteria death and hospitalization). On 21-Mar-2021, the patient experienced SHOCK (Shock circulatory) (seriousness criteria death and hospitalization). The patient died on 21-Mar-2021. The reported cause of death was �tat de choc avec hypoperfusion globale. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021040371. This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No new information On 04-May-2021: Follow up received on 04MAY2021 included an updated date of death (21MAR2021), no autopsy completed, and an updated start date of the event, shock, to 21MAR2021.; Sender''s Comments: This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: �tat de choc avec hypoperfusion globale


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse event NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTMODERNATX, INC.MOD20211

Write-up: Death; Pale; Weakness; Feeling unwell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Adverse event NOS in 2005. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEATH (Death) (seriousness criterion death), PALLOR (Pale) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and MALAISE (Feeling unwell) (seriousness criterion medically significant). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death; Reported Cause(s) of Death: Unknown cause of death


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