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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia viral, Viral myocarditis
SMQs:, Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Bechterew''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21188165

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with severe (Acute respiratory distress syndrome) ARDS.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100079088

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

Write-up: Died doe to unknown causes.


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

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

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

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


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

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

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

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


VAERS ID: 1418568 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

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


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

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

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

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


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

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

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

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


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

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

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

Write-up: Death; Arrest respiratory; Hypertensive heart disease; Arrest cardiac; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), RESPIRATORY ARREST (Arrest respiratory), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) and CARDIAC ARREST (Arrest cardiac) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included PARACETAMOL (DEPON), GLICLAZIDE (DIAMICRON), NEBIVOLOL HYDROCHLORIDE (LOBIVON) and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (ORIZAL) for an unknown indication. On 06-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), RESPIRATORY ARREST (Arrest respiratory) (seriousness criteria death and medically significant), HYPERTENSIVE HEART DISEASE (Hypertensive heart disease) (seriousness criteria death and medically significant) and CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Arrest cardiac, Arrest respiratory and Hypertensive heart disease. An autopsy was not performed. No treatment information was provided. Action taken with Moderna Covid vaccine was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Concomitant medication has been added; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Arrest cardiac; Arrest respiratory; Hypertensive heart disease


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

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

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of UNRESPONSIVE TO STIMULI in a 94-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002186-05) for COVID-19 vaccination. The patient''s past medical history included Hematoma subdural since an unknown date. Concurrent medical conditions included Alzheimer''s disease. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced UNRESPONSIVE TO STIMULI (seriousness criterion death). The patient died on 20-May-2021. The reported cause of death was Unresponsive to stimuli. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was provided. Very limited information regarding the death event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received does not contain any new information; Sender''s Comments: Very limited information regarding the death event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unresponsive to stimuli


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

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

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

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


VAERS ID: 1419997 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

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


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

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BUVENTOL
Current Illness: Asthma; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Opioid abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of OBSTRUCTIVE AIRWAYS DISORDER in a 44-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Opioid abuse. Concurrent medical conditions included Asthma and Chronic obstructive pulmonary disease. Concomitant products included SALBUTAMOL SULFATE (BUVENTOL) for an unknown indication. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced OBSTRUCTIVE AIRWAYS DISORDER (seriousness criteria death, hospitalization and life threatening). The reported cause of death was Airways obstruction. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Translation received on 18-Jun-2021.Description to be coded was updated(Severe obstruction).; Sender''s Comments: This is a case of death in a 44-year-old male subject with a history of Asthma and Chronic obstructive pulmonary disease, who died after receiving second dose of vaccine Very limited information has been provided at this time.; Reported Cause(s) of Death: Airways obstruction


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

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Death, Loss of consciousness, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Asthma bronchial; Closed femur fracture
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100092398

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


VAERS ID: 1421009 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aneurysm of aorta; Aortic valve stenosis; Infarct myocardial
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

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


VAERS ID: 1421010 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Cardiac arrhythmia; Diabetes mellitus, antepartum
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

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


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

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

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

Write-up: Anorexia; This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE (Anorexia) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DECREASED APPETITE (Anorexia) (seriousness criterion death). The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death with unknown cause in a 47-year old female subject with reported unlisted event Anorexia, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1421877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Primary hypertension (Well controlled)
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumor NOS (Patient was in remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVMODERNATX, INC.MOD20212

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


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

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

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis eci), NEUROLOGICAL SYMPTOM , CONFUSIONAL STATE , MALAISE and HEADACHE in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication. The patient''s past medical history included Appendicitis perforated in 2010, Percutaneous coronary intervention (Drug eluting stent placement) in 2008, Abscess drainage transrectaal), Dialysis (dialysis patient) since an unknown date and Drug-eluting stent placement (CX and LAD) in 2008. Concurrent medical conditions included Hypercholesterolaemia since 2004, Cirrhosis liver, Hypertension since 2004, Type II diabetes mellitus since 2004, Chronic renal insufficiency , Atherosclerosis of renal artery, Vascular disorder , Iliac artery disease since 2008, COPD (Gold II) since 2008, Hepatic steatosis and Superficial femoral arterial stenosis since 2008. Concomitant products included SODIUM BICARBONATE (NATRIUM HYDROGENCARBONATE), INSULIN ISOPHANE BOVINE (INSULIN ISOPHANE), CEFTRIAXONE SODIUM (CEFTRIAXON), SEVELAMER CARBONATE , LEVOTHYROXINE, SALBUTAMOL (AIROMIR [SALBUTAMOL]), ALFACALCIDOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ESOMEPRAZOL [ESOMEPRAZOLE], ACETYLSALICYLZUUR, CODEINE, CINACALCET, ROSUVASTATINE [ROSUVASTATIN] and METOPROLOL for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced NEUROLOGICAL SYMPTOM (seriousness criteria death and hospitalization), CONFUSIONAL STATE (seriousness criteria death and hospitalization), MALAISE (seriousness criterion death), HEADACHE (Hoofdpijn) (seriousness criterion death) and INJECTION SITE PAIN. In April 2021, the patient experienced SEPSIS (Sepsis eci) (seriousness criteria death and medically significant). The patient died on 07-May-2021. The reported cause of death was sepsis. It is unknown if an autopsy was performed. At the time of death, INJECTION SITE PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2008, Angiocardiogram: unknown (Inconclusive) CAG SPECT-scan. In 2008, Magnetic resonance imaging: unknown (Inconclusive) In 2008, Single photon emission computerised tomogram: unknown (Inconclusive) In 2014, Computerised tomogram thorax: unknown (Inconclusive) unknown. In April 2021, Blood test: unknown (Inconclusive) In April 2021, Chest X-ray: unknown (Inconclusive) In April 2021, Computerised tomogram head: unknown (Inconclusive) In April 2021, Magnetic resonance imaging head: unknown (Inconclusive) CT-scan DD 23/4/2021. In April 2021, Polyomavirus test: unknown (Inconclusive) BK virus negative. In April 2021, SARS-CoV-2 test: negative (Negative) negative. In April 2021, Ultrasound abdomen: unknown (Inconclusive) On 06-May-2021, C-reactive protein: unknown (Inconclusive) 100 For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Reported Cause(s) of Death: MRI-scan


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

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

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

Write-up: Asphyxia; Erythema; This regulatory authority case was reported by a physician and describes the occurrence of ASPHYXIA (Asphyxia) in a 66-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001937) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis and Trigeminal neuralgia. Concomitant products included CLADRIBINE (MAVENCLAD) from 11-Feb-2021 to an unknown date for Multiple sclerosis, GABAPENTIN (NEURONTIN) from 14-Apr-2021 to an unknown date for Trigeminal neuralgia. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema). On 28-Apr-2021, the patient experienced ASPHYXIA (Asphyxia) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Asphyxia. An autopsy was performed. At the time of death, VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Autopsy: asphyxia (abnormal) Found residue of food in airways. Suspected cause of death is obstruction of airways with following asphyxia and death. On 22-Apr-2021, C-reactive protein: 9 (Inconclusive) 9 mg/L. On 22-Apr-2021, White blood cell count: 0.3 (Low) 0.3. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) to be probably related. No further causality assessment was provided for ASPHYXIA (Asphyxia). No treatment information was provided. For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: ASPHYXIA


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DELTACORTENE; XARELTO; DUROGESIC; LANSOPRAZOLE; ESIDREX; ALLOPURINOL; LASIX [FUROSEMIDE]; FERRO GRAD C
Current Illness: Aortic valve stenosis; Atrial fibrillation; Chronic anemia; Chronic ischemic heart disease, unspecified; Decompensation cardiac; Dyspnoea; Kyphosis; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


VAERS ID: 1425711 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002336 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Joint pain
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Blood pressure; Result Unstructured Data: Increased; Test Date: 20210508; Test Name: Pulse rate; Result Unstructured Data: Rapid pulse
CDC Split Type: HUMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GALANTAMINE; LOSATRIX; PLAVIX; NITROSID; PIOGLITAZONE; PARACETAMOL; SIMVASTATIN; ATENBLOCK; TRAJENTA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

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


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

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Myocarditis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyreosis; Variant angina
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100100794

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


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

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SORTIS; ANOPYRIN; TROMBEX; MILURIT; TRITACE; CORYOL [CARVEDILOL]; EZEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct (stents used); Myocardial infarct (bypasses used)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Dizziness, Dyspnoea, Gait disturbance, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

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


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

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

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

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; SOMAC; BRILIQUE; BISOPROLOL; DIURAMIN; DISPERIN; SEPRAM; ATORVASTATIN
Current Illness:
Preexisting Conditions: Comments: No significant medical history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; BELOC ZOK; OLMESARTAN MEPHA; TOREM [TORASEMIDE]; METOLAZON; EUTHYROX; ATORVASTATIN MEPHA; ACIDUM FOLICUM STREULI; ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]; ROCALTROL; HUMALOG; MAGNESIOCARD CITRON
Current Illness: Triple vessel disease; Type 1 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure); Diabetic nephropathy (Not histologically confirmed); Dialysis (worsening of kidney failure.); Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.); Hashimoto''s thyroiditis; Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23); Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome)
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Coronary angiography; Result Unstructured Data: triple vessel disease; Test Date: 2021; Test Name: Cardiological assessment; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes; Test Date: 2021; Test Name: Transthoracic echocardiography; Test Result: Inconclusive ; Result Unstructured Data: LVEF of 65% without detectable changes
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH and DISEASE PROGRESSION in a 55-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunization. The patient''s past medical history included Left heart failure (Predominantly left-sided cardiac decompensation NYHA IV for coronary triple vessel disease (HFpEF), initial diagnosis Feb 23) on 23-Feb-2021, Polyglandular autoimmune syndrome type I (Polyglandular autoimmune syndrome), Chronic renal failure (Chronic kidney failure CKD stage G3b-4A3. Dialysis-dependent kidney failure), Diabetic nephropathy (Not histologically confirmed) in 1985, Hashimoto''s thyroiditis, Elective hospitalization (Hospitalized for double organ (combined pancreas and kidney) transplantation clarification. Patient was diagnosed with triple vessel disease with cardiac decompensation with significant dyspnea and need for oxygen.) from 22-Feb-2021 to 26-Feb-2021 and Dialysis (worsening of kidney failure.) on 12-Mar-2021. Concurrent medical conditions included Type 1 diabetes mellitus since 1973 and Triple vessel disease since 23-Feb-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), METOPROLOL SUCCINATE (BELOC ZOK), OLMESARTAN MEDOXOMIL (OLMESARTAN MEPHA), TORASEMIDE (TOREM [TORASEMIDE]), METOLAZONE (METOLAZON), LEVOTHYROXINE SODIUM (EUTHYROX), ATORVASTATIN CALCIUM (ATORVASTATIN MEPHA), FOLIC ACID (ACIDUM FOLICUM STREULI), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (ALUCOL [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]), CALCITRIOL (ROCALTROL), INSULIN LISPRO (HUMALOG) and MAGNESIUM ASPARTATE HYDROCHLORIDE (MAGNESIOCARD CITRON) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISEASE PROGRESSION (seriousness criterion death). The patient died on 13-Mar-2021. The reported cause of death was Disease progression, Type 1 diabetes mellitus, dialysis-dependent kidney failure and Triple vessel disease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Angiocardiogram: abnormal (abnormal) triple vessel disease. In 2021, Cardiovascular evaluation: unknown (Inconclusive) LVEF of 65% without detectable changes. In 2021, Echocardiogram: unknown (Inconclusive) LVEF of 65% without detectable changes. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH and DISEASE PROGRESSION to be possibly related. It was reported that the patient was scheduled for a cardiac MRI (magnetic resonance imaging) on 09-Mar-2021, after which an aortic coronary bypass surgery was planned. It was reported that the rapid progression of the underlying diseases, after 22-Feb-2021, was presumed as the primary factor for the patient''s death. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Translated document uploaded. Added additional causes of death (as per sender''s comments), medical history, lab data, frequency of con-meds, causality as reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded; Reported Cause(s) of Death: Disease progression; type 1 diabetes mellitus; dialysis-dependent kidney failure; Triple vessel disease


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

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

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

Write-up: PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 31946) for COVID-19 immunisation. No medical history was reported by the reporter. The patient''s past medical history included Cardiopulmonary resuscitation on 09-Jun-2021. Concomitant products included DIENOGEST, ETHINYLESTRADIOL (EFFIPREV [DIENOGEST;ETHINYLESTRADIOL]) for an unknown indication. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 09-Jun-2021, the patient experienced PULMONARY EMBOLISM (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant), CARDIAC ARREST (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant) and PULMONARY INFARCTION (PULMONARY EMBOLISM, PULMONARY INFARCTION, CARDIAC ARREST) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Alanine aminotransferase: 106 (Inconclusive) 106 INTERNATIONAL UNIT(S)-(UNDER 1000) 50/5. On 09-Jun-2021, Blood creatinine: 1.74 (Inconclusive) 1.74 MILLIGRAM(S) 1.18/0.55. On 09-Jun-2021, Blood glucose (74-106 milligram): 321 milligram (abnormal) 321. On 09-Jun-2021, C-reactive protein: 18.1 (Inconclusive) 18.1 MILLIGRAM(S) 5/0. On 09-Jun-2021, Fibrin D dimer: 29.30 (Inconclusive) 29.30 MILLIGRAM(S) 0.5/0. On 09-Jun-2021, Lipase: 115 (Inconclusive) 115 INTERNATIONAL UNIT(S)-(UNDER 100) 67/5. On 09-Jun-2021, Troponin: 878 (Inconclusive) 878 NANOGRAM(S) 11.6/2.3. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. Patient was arrived emergency room at 11:24 AM patient was experienced lacking consciousness, pulse and absence of spontaneous breathing and pronounced extreme cyanosis and marble veined. No treatment information was provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. CT REPORTS AND COPIES OF BLOOD TESTS ARE AVAILABLE, CLINICAL DIARY FROM THE EMERGENCY ROOM AVAILABLE. REQUESTED TODAY DETAILED CLINICAL REPORT TO THE REPORTER This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Translation uploaded for initial SD containing narrative case summary and further information. On 18-Jun-2021: Follow-up received on 18-JUN-2021 Contains No new information. On 21-Jun-2021: Follow-up received on 21-JUN-2021 Contains No new information.; Sender''s Comments: This is a case of death in a 24-year-old female patient, that occurred 26 days after receiving first dose of vaccine (Lot number 31946)). Based on the provided information, the patient had cardiac arrest and expired. No further information is expected.; Reported Cause(s) of Death: CARDIAC ARREST


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery atheroma; Cerebral atrophy; Cognitive deterioration; Diabetes mellitus; Hypertensive cardiomyopathy; Hypoxic-ischaemic encephalopathy; Nephropathy; Peripheral obliterative arteriopathy; Retinopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Decompensation cardiac; Implantable defibrillator user; Prostatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


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

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

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

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


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

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

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

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. The patient''s past medical history included Dizziness. On 10-May-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 03-Jun-2021 The patient died on 03-Jun-2021. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug was reported. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1435748 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Benign prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Cardiac failure, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; COSYREL; NEXIUM; FLEIDERINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma gastrointestinal; Hypertension arterial; Partial nephrectomy; Previous renal neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonitis
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: Unknown
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PERIPHERAL ISCHAEMIA in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Pneumonitis. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL ISCHAEMIA (seriousness criterion death). The patient died on 05-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Platelet count: unknown (Inconclusive) Unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information received and does not contain any new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


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

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

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

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


VAERS ID: 1444272 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial carcinoma; Myelodysplastic syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

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


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

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

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

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


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