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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: 2032247 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Unknown  
Vaccinated:2022-01-12
Onset:2022-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001J21-2A / 3 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, 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: 2022-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the Moderna vaccine at 4pm on Wednesday 01/12/22 at 4 pm. No complications were reported after the vaccine was administered. Patient did not report any symptoms prior to going to bed. Patient awoke feeling unwell around 6-7am on 01/13/22 and was given two tylenols from Wife to help with symptoms. They then request to move to the bathroom where thereafter they were found on the ground and unresponsive. Emergency response was called shortly afterwards.


VAERS ID: 2032374 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-11
Onset:2021-03-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 1 AR / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010A21A / 2 AR / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Decreased appetite, Injection site pain, Nausea, Proctitis, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain at injection site, complete loss of appetite, nausea/vomiting, weakness, and proctitis. Rushed to emergency on 3/19/2021. Discharged from hospital on 3/21/2021. Passed away on 4/22/2021


VAERS ID: 2032469 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-18
Onset:2022-01-04
   Days after vaccination:292
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Death, Disease progression, Dyspnoea, Metastatic neoplasm, Pulmonary mass, Respiratory distress, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2022-01-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Escitalopram, norphine CR, xarelto
Current Illness:
Preexisting Conditions: ? Asthma ? Carcinoma (HCC) metastatic adenocarcinoma colon, liver,lung ? COPD (chronic obstructive pulmonary disease) (HCC) ? Hyperlipidemia ? Hypertension ? Lung cancer (HCC) ? Scoliosis
Allergies: Penicillins and sulfa
Diagnostic Lab Data: 1/4/22 COVID19: positive 1/4/22 chest xray: Numerous bilateral pulmonary nodules consistent with metastatic disease. These nodules have increased in size when compared to the prior study, consistent with progression of disease
CDC Split Type:

Write-up: Patient received moderna COVID19 vaccine on 03/18/21 and 04/15/21. Presented to ER on 1/4/22 and admitted. Positive for COVID 1/4/22. history of colon cancer with Mets to the lung and liver, not on chemotherapy, PE on Xarelto presented with shortness of breath. she was vaccinated in April and had not received a booster. Patient found to be in respiratory distress due to COVID and COPD exacerbation. She was unable to tolerate BiPAP. She was treated with remdesivir and Decadron. Oncology was consulted and recommended hospice. Patient decided on comfort measures. She was pronounced dead at 1/10 at 5:55 a.m.


VAERS ID: 2032609 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-02-25
Onset:2021-12-18
   Days after vaccination:296
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031M20A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Death, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2022-01-13
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 26 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol PRN, buprenorphine, vitamin b-12, dexamethasone, ezetimibe, furosemide, gabapentin, levemir, metoprolol succinate, omeprazole, tamuslosin
Current Illness:
Preexisting Conditions: diabetes mellitus, chronic renal insufficiency, Revlimid-induced neuropathy. He has also had anemia secondary to chronic kidney disease. He has had aortic regurgitation, coronary artery disease. He has had a known right clavicle fracture, hypertensive heart disease. IgG kappa multiple myeloma
Allergies: levofloxacin, pravastatin, simvastatin, cephalexin
Diagnostic Lab Data: 12/13/21 COVID19: positive 12/13/21 chest xray: negative 12/18/21 chest xray: Evidence of COVID-19 pneumonia.
CDC Split Type:

Write-up: Presented to ER on 12/18/21. received moderna vaccine on 02/25/21, 03/24/21, and 12/6/21. COVID positive on 12/13/21. He was short of breath and was admitted on 12/13/2021. Since his admission, he has significantly improved in terms of his clinical situation. He stated that his breathing is so much improved. He has been diagnosed also with a small focus of acute pulmonary embolism involving the right middle lobe. No evidence of obvious right heart strain. The patient has received remdesivir (5 day duration) since admission. Also, currently, on antibiotics with Rocephin and doxycycline. He is also on Decadron 6 mg IV daily as part of the Covid treatment protocol. Passed away on 1/13/22


VAERS ID: 2034904 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-12-24
Onset:2021-12-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3279034 / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2022-01-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Resident had a stroke one month after his second dose in March
Other Medications: Morphine Sulfate Solution 20 MG/5ML Colace Capsule 100 MG (Docusate Sodium) Morphine Sulfate (Concentrate) Solution 20 MG/ML Acetaminophen Tablet Acetaminophen Suppository 650 MG Bisacodyl Suppository 10 MG Colace Capsule 100 MG (Docusate S
Current Illness: None
Preexisting Conditions: DYSPHAGIA FOLLOWING CEREBRAL INFARCTION HEMIPLEGIA AND HEMIPARESIS FOLLOWING CEREBRAL INFARCTION AFFECTING LEFT DOMINANT SIDE DYSPHAGIA, OROPHARYNGEAL PHASE PRESSURE ULCER OF LEFT HIP, UNSTAGEABLE PRESSURE ULCER OF RIGHT HEEL, UNSTAGEABLE HEMATURIA, UNSPECIFIED ANEMIA, UNSPECIFIED HYPERLIPIDEMIA, UNSPECIFIED PRESSURE ULCER OF LEFT HIP, STAGE 3 UNSPECIFIED ATRIAL FIBRILLATION ACUTE KIDNEY FAILURE, UNSPECIFIED UNSPECIFIED OSTEOARTHRITIS, UNSPECIFIED SITE PURE HYPERCHOLESTEROLEMIA, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION PRESENCE OF UROGENITAL IMPLANTS OTHER CHRONIC POSTPROCEDURAL PAIN
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Back in March at the completion of the resident''s second shot the resident had a stroke a few weeks later. In December when the resident received his booster shot the resident appeared to have a sharp decline about a week later. No stroke like symptoms were exhibited. The resident continued his decline and eventually went hospice and passed.


VAERS ID: 2034909 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-10-20
Onset:2021-10-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-27
   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: Unknown
Current Illness: None Reported
Preexisting Conditions: Patient had a stroke in 2018. Had craniotomy. Was bed-bound; tracheostomy, HTN
Allergies: NKA
Diagnostic Lab Data: None Reported
CDC Split Type:

Write-up: Wife states that patient was "fine after the vaccine. Had PT that week and did well". "He was tired and went to sleep".


VAERS ID: 2034979 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-07
Onset:2021-11-25
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Atrial fibrillation, COVID-19, COVID-19 pneumonia, Cough, Death, Diarrhoea, Dizziness, Dyspnoea, Fatigue, General physical health deterioration, Hypoxia, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive, Troponin increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-12-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient is fully vacciated. COVID+ on 11/25/2021. Hospitalized from 11/25/2021-12/5/2021. Dx on admission: hypoxia, new onset afib with rapid ventricular response, elevated troponin, COVID virus infection.Positive for fatigue. He presents to the ED due to a 2 day history of fatigue, cough, shortness of breath, fever, body aches, nausea, vomiting and diarrhea. Positive for dizziness. Denies chest pain. Upon arrival, patient was found to be in A. fib with RVR, which he does not have a history of. Patient started on a heparin drip and Cardizem drip due to A. fib with heart rate ranging from 100 up to 130-140s. He is followed by cardiology infectious disease and palliative care. He is followed by social work. He is treated for covid 19 pneumonia. DVT prophylaxis with heparin. Remdesivir and decatron given. Despite medical treatment he continued to decline and he subsequent passed away.


VAERS ID: 1018310 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042698 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SCIPPA; SEVENAL; QUAMATEL; MEFORAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block first degree; Bladder cancer; Chronic gastritis; Coronary sclerosis; Depression; Emphysema pulmonary; Strangulation ileus; Type 2 diabetes mellitus; Urinary bladder excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report was received from a physician, concerning a 78 year-old male patient, who received Moderna''s COVID-19 Vaccine and patient died. The patient''s medical history included strangulation ileus, depression, atrioventricular block first degree, coronary sclerosis, emphysema pulmonary, type 2 diabetes mellitus, urinary bladder excision, chronic gastritis, and bladder cancer. Products known to have been used by the patient, within two weeks prior to the event, included escitalopram oxalate, phenobarbital, famotidine, and metformin hydrochloride. On 16 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number 30042698) for COVID-19 infection prophylaxis. The patient died on the day of vaccination. The reporter stated that the patient had several chronic concurrent diseases at the time of the vaccination, however, the patient was in a fair general condition for the vaccination. It was reported that the patient was well-oriented and after the vaccination, no abnormalities were detected during the observation period. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 16 Jan 2021. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis. The reporter assessed the causality as unlikely related between the event and mRNA-1273. Follow-up received on 01 Feb 2021 included NNI.; Reporter''s Comments: An 78 year old vaccinated patient died on the day of vaccination. He had several chronic concurrent diseases at the time of the vaccination. However, The patient was in a fair general condition for the vaccination, he was well-oriented. After the vaccination, no abnormalities were detected during the observation period. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis. Based on above there is an unlikely the causal relationship between the suspect vaccine and the death of the patient. The case is serious due to the patient''s death as reported. Further information is expected. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis.; Reported Cause(s) of Death: bronchitis; cardiac failure; arteriosclerosis


VAERS ID: 1029973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Respiratory crisis; A regulatory report was received from a physician concerning a 92-years-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced respiratory crisis. The patient''s medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Jan 2021, approximately five days prior to death, the patient received their first of two planned doses of mRNA-1273 [Lot number 300042698] intramuscularly for prophylaxis of COVID-19 infection. The reporter reports that the patient was already on home O2 therapy for global respiratory failure in COPD, the diagnosis is suspected acute pulmonary edema. On 27 Jan 2021, the patient experienced a respiratory arrest which lead to death. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 27 Jan 2021. The cause of death was respiratory crisis. Plans for an autopsy were unknown.; Reporter''s Comments: Very limited information regarding the event has been provided at this time. The cause of death was respiratory crisis. Plans for an autopsy were unknown. However, the patient''s history of being on home O2 therapy for global respiratory failure in COPD is risk factors and confounds causality assessment.; Reported Cause(s) of Death: Arrest Respiratory


VAERS ID: 1033175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 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: PROLIA; CANDESARTAN ORION; SIMVASTATIN; BISOPROLOL SANDOZ; TROMBYL; Kalcipos-D forte
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Osteoporosis; Shellfish allergy; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1611646034519

Write-up: Death; A regulatory authority report was received from a healthcare professional concerning a 77-year-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and the patient died. The patient''s medical history included a shellfish allergy, hyperlipidemia, osteoporosis, hypertension, and type I diabetes. Concomitant medications included Prolia, candesartan orion, Simvastatin, bisoprolol Sandoz, trombyl, and kalcipos-D forte all for an unknown indications. In Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (lot number 300042698) intramuscularly for the COVID-19 vaccination. On an unknown date, the patient died. No treatment medication was reported. The patient died due to the unknown cause. Autopsy details were not provided.; Reporter''s Comments: This case concerns a 77 year-old, female patient with history of shellfish allergy, hyperlipidemia, osteoporosis, hypertension, and type I diabetes, who experienced event of death. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Cause of death was not reported. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the event is assessed as possibly related. However, the patient''s comorbidities are risk factors and confounds causality assessment.; Reported Cause(s) of Death: Death


VAERS ID: 1035753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-22
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood lactic acid, Computerised tomogram thorax, Sepsis, White blood cell count
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Lactate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210124; Test Name: CT thorax; Result Unstructured Data: Revealed abundant thickening in both lungs, no pulmonary embolism, small amount of pericardial fluid.; Test Date: 20210124; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Death due to sepsis; A regulatory authority report was received from a physician, concerning an 80-year-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273), experienced death due to sepsis (death, sepsis). The patient''s historical condition was not reported. No concomitant medications were reported. On an unknown date in Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient developed sepsis. On 24 Jan 2021, the patient had laboratory tests reported for computerised tomography (CT) thorax which revealed abundant thickening in both lungs, no pulmonary embolism, small amount of pericardial fluid, leucocyte count was 46 (unknown units), and lactate was 3-7. On the same day, the patient died due to sepsis. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 24 Jan 2021. The cause of death was reported as sepsis. Plans for an autopsy were not provided.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1037891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anuria, Asthenia, Fatigue, Muscular weakness, Oxygen saturation, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (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), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: LEVODOPA/CARBIDOPA; CLOZAPINE; DOMPERIDONE; FOLIUMZUUR; MIRABEGRON
Current Illness: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: saturation; Result Unstructured Data: normal level; Test Date: 20210129; Test Name: saturation; Test Result: 90 %; Test Date: 20210131; Test Name: saturation; Test Result: 80 %; Test Date: 20210129; Test Name: corona culture; Test Result: Negative
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Fatigue; Asthenia; Muscle weakness lower limb; Respiratory tract infection; Anuria; A regulatory authority report was received from a healthcare professional concerning an 89-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced respiratory tract infection, anuria, muscle weakness lower limb, asthenia, and fatigue. The patient''s medical history included Parkinson''s disease. Concomitant medications included carbidopa 50/12.5 mg, clozapine, carbidopa 100/25 mg, domperidone, folic acid, and mirabegron. On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273, for the prophylaxis of COVID-19 infection. On 28 Jan 2021, reported as four days after the vaccine, the patient experienced muscle weakness lower limb, asthenia, respiratory tract infection, and anuria. Diagnostic lab test revealed the patient''s O2 saturation rate was normal level. On 29 Jan 2021, the patient experienced fatigue. Additional diagnostic lab tests revealed the patient''s O2 saturation was 90 percent. The patient tested negative for SARS-COV-2 test. On 31 January 2021, diagnostic lab test revealed the patient''s O2 saturation was 80 percent. The patient died on 31 Jan 2021. The cause of death was reported as fatigue, respiratory tract infection and anuria. Plans for an autopsy were unknown. Action taken with second dose of mRNA-1273 in response to the events was not applicable.; Reporter''s Comments: This case concerns a 89-year-old male with medical history of Parkinson''s, who experienced serious unexpected fatal events of respiratory tract infection, fatigue, and anuria, and nonserious unexpected events of asthenia and muscular weakness. Events began 4 days after first dose mRNA-1273. SARS-COV-2 test negative. Treatment unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1040506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood culture, Blood culture positive, Cholecystitis, Pyrexia, Sepsis, Ultrasound abdomen
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: Atrial fibrillation; Living in nursing home; Polyneuropathy; Prostatic cancer; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood culture; Result Unstructured Data: Positive for e.coli; Test Date: 20210120; Test Name: Ultrasound abdomen; Result Unstructured Data: Findings compatible with cholecystitis.
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: SEPSIS; cholecystitis; FEVER; Blood cultures positive for E. Coli; A regulatory authority report was received from a physician concerning a 95-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sepsis and fever. The patient''s medical history, as provided by the reporter, included polyneuropathy, prostatic cancer, atrial fibrillation, urinary tract infection, and living in a nursing home. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for the prophylaxis of COVID-19 infection. On 20 Jan 2021, a blood culture showed positive for E. coli and an abdominal ultrasound showed findings compatible with cholecystitis. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 22 Jan 2021. The cause of death was reported as sepsis, fever, and cholecystitis. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 95-year-old male, who experienced a serious unexpected fatal events of sepsis and pyrexia, with blood culture positive for E. coli and ultrasound with cholecystitis. Events began the same day as the first dose of mRNA-1273. Autopsy not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sepsis; fever; cholecystitis


VAERS ID: 1057541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: AVLIDEN; A spontaneous report was received from a consumer (SWEDEN) concerning a 70 year old, female patient who was pronounced dead on ??-JAN-2021. The patient''s medical history included Chronic obstructive pulmonary disease. Concomitant product use was not provided/unknown by the reporter. The patient received the mRNA-1273 vaccine (Batch number not provided) on ??-JAN-2021. The dosage is unknown. The patient was pronounced dead on ??-JAN-2021. Treatment information was nor provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The patient died on ??-JAN-2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter''s Comments: Very limited information regarding this events has been provided at this time. The cause of death was not provided. Plan for an autopsy was not provided. Company assessed the events to be unlikely related to company product.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1062304 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

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

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

Write-up: Pyrexia; A regulatory authority report was received from a health care professional concerning a 90 years old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced pyrexia. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 02 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot number: 300042698) for prophylaxis of COVID-19 infection. On 05 Feb 2021, pyrexia has started, which was confirmed by conducting pyrexia lab test with test result as: 38 tot 40.5 degrees Celsius. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, pyrexia, was fatal.; Reporter''s Comments: Very limited information regarding the fatal event of pyrexia in this elderly patient has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1067559 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia bacterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Pneumonia bacterial; A regulatory authority report was received from a health care professionl concerning a 87-years old, male patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and experienced Pneumonia bacterial. The patient''s medical history, was not provided by the reporter. Concomitant medications were not provided. On 29 JAN 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection. On 31 JAN 2021, the patient experienced pneumonia bacterial. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 11 FEB 2021. The cause of death was reported as pneumonia bacteria. Plans for an autopsy were unknown.; Reporter''s Comments: This case concerns an 87-year-old male who experienced a serious unexpected event of bacterial pneumonia with fatal outcome. The event occurred 1 day after the first dose of mRNA-1273. Treatment not reported. Event outcome fatal. Cause of death reported as bacterial pneumonia. Autopsy not provided. 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: Pneumonia bacterial


VAERS ID: 1067873 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Injection site erythema, Injection site inflammation, Injection site swelling, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal haemorrhage (narrow), Extravasation events (injections, infusions and implants) (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLZUUR CARDIO; ASCORBINEZUUR CF; OMEPRAZOL [OMEPRAZOLE]; FUROSEMIDE [FUROSEMIDE SODIUM]; METFORMINE [METFORMIN]; SIMVASTATINE; INSULINE INSULATARD HM NPH; VALSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Myocardial infarction; Gastrointestinal haemorrhage; Injection site erythema; Injection site swelling; Injection site inflammation; A Regulatory Authority report was received from a physician concerning a 90-year-old, female patient who experienced Injection site erythema, Injection site swelling, Injection site inflammation, Myocardial infarction, and Gastrointestinal hemorrhage. The patient''s medical history was not provided. Products known to have been used by the patient included [ACETYLSALICYLZUUR TABLET 80MG, ASCORBINEZUUR TABLET 500MG, OMEPRAZOL CAPSULE MSR 40MG, FUROSEMIDE TABLET 40MG, METFORMINE TABLET 500MG, SIMVASTATINE TABLET FO 40MG, INSULINE ISOFAAN INJSUSP 100IE/ML, VALSARTAN TABLET OMHULD] On 28 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: [300042698]) intramuscularly for prophylaxis of COVID-19 infection. The patient developed Injection site erythema on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient developed Injection site swelling on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient developed Injection site inflammation on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient experienced Myocardial infarction and Gastrointestinal hemorrhage on 10 FEB 2021. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was unknown. The event(s), Injection site erythema, Injection site swelling, Injection site inflammation, were considered recovered/resolved on 08 FEB 2021. The patient died on UNK-Feb-2021. The cause of death was reported as Myocardial infarction, and Gastrointestinal hemorrhage. Plans for an autopsy were unknown.; Reporter''s Comments: This case concerns a 90 Y/O F with serious unexpected Myocardial infarction and Gastrointestinal hemorrhage and NS expected injection site erythema, injection site swelling, injection site inflammation. Serious events occurred 14 days after first dose of mRNA-1273. Treatment not reported. Event outcome fatal. Autopsy plan unknown. 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.; Reported Cause(s) of Death: myocard infarct;


VAERS ID: 1069027 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma; Gout; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death NOS; Feeling sick; A regulatory authority report (France) was received from a health care professional concerning a female patient of 92-year-old, who received Moderna''s COVID-19 vaccine(mRNA-1273) and felt sick and died. The patients medical history,as provided by the reporter, included hypertension arterial, glaucoma and gout. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: 300042722) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced feeling sick and passed away. No treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The patient died on 15 Feb 2021. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 92-year-old, female, patient, who received first of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042722) and felt sick and died. Very limited information regarding the reported events has been provided at this time. However, patient''s advanced age along with medical history of hypertension may have ben contributory.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1071062 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   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: No adverse event (no medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Unknown cause of death; A regulatory report received from a Physician concerning, a 58-year-old, female patient who received Moderna COVID-19 vaccine and died. The patient''s medical history was not included. Patient''s concomitant was not included. On 15 FEB 2 021, the patient received their second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042698) intramuscularly for prophylaxis of COVID-19 infection. First dose was given on 18 JAN 2021. Patient received the second dose of the Moderna COVID-19 vaccine on 15 FEB 2021 and patient passed away on 17 FEB 2021. No other information was report. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal.; Reporter''s Comments: This case concerns a 58-year-old, female, patient, who received second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042698) and died due to unknown cause. The medical history and concomitant medication is not provided. Very limited information regarding the event of death has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1071882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Circulatory collapse, Hyperpyrexia, SARS-CoV-2 test, Vaccination complication
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; COUMADIN; DAPAROX [PAROXETINE HYDROCHLORIDE]
Current Illness: Atherosclerosis; Atrial fibrillation; Atrial flutter; Chronic renal insufficiency; Cognitive disorder; COPD; Depression; Hypertensive heart disease; Monoclonal gammopathy; Unspecified hypertensive heart disease without congestive heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Decompensation cardiac; Cardiovascular collapse; Hyperpyrexia; Vaccination adverse reaction; A regulatory authority report (Italy) was received from a health professional concerning a 98-year-old, female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced vaccination adverse reaction /MedDRA PT: vaccination complication, hyperpyrexia, cardiovascular collapse/ MedDRA PT: circulatory collapse, and decompensation cardiac/ MedDRA PT: cardiac failure. The patient''s medical history included cognitive disorder, atherosclerosis, chronic obstructive pulmonary disease (COPD), atrial flutter, monoclonal gammopathy, unspecified hypertensive heart disease without congestive heart failure, hypertensive heart disease, atrial fibrillation, depression, and chronic renal insufficiency. Products known to have been used by the patient, within two weeks prior to the event, included furosemide, warfarin sodium, and paroxetine hydrochloride. On 10 Feb 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient experienced vaccination adverse reaction, hyperpyrexia, cardiovascular collapse, and decompensation cardiac. Treatment information was not provided. The patient died on 14 Feb 2021. The cause of death was reported as decompensation cardiac. There was no autopsy performed.. Action taken with the second dose of mRNA-1273 in response to the event was reported as not applicable. The outcome for the events of vaccination adverse reaction, hyperpyrexia, cardiovascular collapse, and decompensation cardiac was fatal.; Reporter''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: Decompensation cardiac


VAERS ID: 1074131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Death, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atheromatosis; Coronary heart disease; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Colonic polyp; Right inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20210

Write-up: Death; Probl�me cardiovasculaire; Uniquement une douleur au point d''injection le 05/02/21, aucune autre plainte/sympt�me; A regulatory authority report was received from a physician concerning a 55 years old, male patient who received Moderna''s Covid-19 Vaccine (mRNA-1273) and experienced cardiovascular disorder, injection site pain and death. The patient''s medical history, as provided by the reporter, included aortic aneurysm, hypertension, colonic polyp, atheromatosis, coronary heart disease, and right inguinal hernia. On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly (Lot number: 300042721) for prophylaxis of Covid-19 infection. On 05 Feb 2021, the patient experienced cardiovascular disorder and injection site pain. On 09 Feb 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, cardiovascular disorder, was fatal. The outcome of the event, injection site pain, was unknown. The cause of death was reported as cardiac disorder. It was unknown whether an autopsy was performed. Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of injection site pain, a causal relationship cannot be excluded. Based on reporter''s causality of unlikely the event of cardio vascular disorder is assessed as unlikely related to mRNA-1273. Of note, patient''s underlying HTA, coronary artery disease and aortic aneurysm may have been contributory to the occurrence of fatal cardio vascular disorder.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1074132 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Chills, Death, Dysstasia, Insomnia, Muscular weakness, Respiration abnormal, Restlessness, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass graft; Hypophysectomy; Neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20210

Write-up: Death; Cardiac arrest; Couldn''t wake him up; Breathing different; Shivering; No muscle strength; Unable to raise himself; Restless; Couldn''t sleep; A spontaneous report (United States) was received from a consumer concerning a 79-year-old, male patient was participated in the mRNA-1273 emergency use program and experienced cardiac arrest, could not sleep/insomnia, no muscle strength/muscular weakness, unable to raise/dysstasia, restlessness, could not wake up/somnolence, breathing different/respirations abnormal, shivering/chills, and died. The patient''s medical history included diabetes, triple bypass years ago, pituitary gland removal and neuropathy. Concomitant medications were not provided. On unknown date in Jan 2021, prior to the onset of the events,the patient received their first of two planned doses of mRNA-1273 (Batch number is not provided as well as the details of first dose of vaccination) for COVID-19 infection. On 11 FEB 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273(Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 FEB 2021,same day of second dose of vaccination the patient could not sleep, had no muscle strength and was unable to raise. On 12 FEB 2021,the patient become restless. On 13 FEB 2021,the patient could not wake up, was breathing different ,shivering, eyes were rolled up to the head. On 13 FEB 2021,the patient was taken to the hospital where he had cardiac arrest. The patient was resuscitated and was intubated, and was removed from the ventilator on 19 FEB 2021. On 21 FEB 2021,the patient died. An autopsy was done or not is unknown. The outcome of the event cardiac arrest is fatal. The outcome of the events insomnia, muscular weakness, unable to raise/dysstasia, restlessness, could not wake up/somnolence, breathing different/respirations abnormal, shivering/chills are not applicable.; Reporter''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: 1074140 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Hypophagia, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: No intake, From February 8th no appetite and don''t want to drink; Not feeling well; Fatigue; Pain in the joints; Headache; Myalgia; A regulatory report was received from a consumer concerning a 88-years-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myalgia, no intake, from February 8th no appetite and don''t want to drink, headache, pain in joints, fatigue and not feeling well. The patient''s medical history as provided by the consumer included dementia. No relevant concomitant medications were reported. On 03 Feb 2021, one day prior to the onset of events myalgia and headache, the patient received their dose of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient experienced medically significant events of myalgia and headache. On 04 Feb 2021, the patient had medically significant event of pain in joints. On 08 Feb 2021, the patient had medically significant events of no intake, from February 8th no appetite and don''t want to drink, fatigue and not feeling well. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date, the patient died. The cause of death was myalgia, no intake, from February 8th no appetite and don''t want to drink, headache, pain in joints, fatigue and not feeling well. Plans for an autopsy were unknown.; Reporter''s Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of vaccine cannot be excluded however, the fatal outcome is assessed as unlikely as the patient refused intake. Causality is confounded by the patient''s advanced age and dementia.; Reported Cause(s) of Death: Myalgia; No intake, From February 8th no appetite and don''t want to drink; Headache; Pain in the joints; Fatigue; Not feeling well


VAERS ID: 1074911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-05
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: 2021-02-17
   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: No adverse event (No medical history reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death of unknown causes; A regulatory authority report was received from a health care professional concerning a 58 years old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number: 300042698) for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced sudden death with an unknown cause. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. It was unknown whether an autopsy was performed.; Reporter''s Comments: This is a case of sudden death in a 58-year-old female patient with unknown medical history died 2 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: 1082667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Arresto cardio-circolatorio; A regulatory authority report (Italy) was received from a physician concerning a female patient of 87-year-old, who was received Moderna''s COVID-19 vaccine(mRNA-1273) and experienced arrest cardiac. The patients'' medical history was not provided. No relevant Concomitant medications were reported. On 08 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273(Lot number: 300042721) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced cardiac arrest and passed away. The event was also considered medically significant. Treatment information was not provided. Action taken with the mRNA-1273 was not applicable. The outcome of event was fatal as patient died on 11 Feb 2021 due to arresto cardio-circolatorio. The autopsy details were not provided.; Reporter''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The autopsy details were not provided. However, the patient''s age may be a confounding factor for causality assessment.; Reported Cause(s) of Death: Arresto cardio-circolatorio


VAERS ID: 1083756 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
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: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (Co-Amoxicillin and Codein)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COPD; Depression; Hypothyreosis; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report was received from a regulatory authority concerning a 96-years-old female patient, who was administered with Moderna''s Covid-19 vaccine and was died. Patient''s medical history included Renal failure, COPD, Hypertension arterial, Depression, and Hypothyroidism. Patient had allergy towards Co-amoxicillin and Codein. No relevant concomitant medications were mentioned. On 26-JAN-2021, prior to the onset of events patient received mRNA-1273 vaccine (Lot/Batch: unknown) for prophylaxis of Covid-19 infection. After vaccination, she had no local reaction, no fever, no discomfort. On 30-JAN-2021, she died acutely (patient found dead in bed, an hour before her condition was inconspicuous). Outcome for the event was considered fatal. Patient was dead on 30-JAN-2021 and the probable cause of death was heart attack or heart rhythm disorder.; Reporter''s Comments: Based on reporter''s causality of unlikely and patient''s advanced age along with multiple underlying conditions, the event of death is also assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1084929 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 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: Medical History/Concurrent Conditions: No adverse event (No medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report (Poland) was received from a physician concerning a 73-years old, patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and the patient died. The patient''s medical history was not provided by the reporter. On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number G26761A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient died. Death occurred several days after vaccination . The Reporter described as uncertain of the effect of the vaccination on death. There is a time relationship between vaccination and the occurrence of side effects. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The cause of death was not reported. Autopsy performed was unknown.; Reporter''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender''s Comments: Zgon wystapil kilka dni po szczepieniu u starszej osoby. Nieznana jest historia medyczna pacjenta. Lekarz opisal jako niepewny wplyw szczepionki na zgon. Istnieje zwiazek czasowy miedzy szczepieniem a wystapieniem dzialan niepozadanych. Osoba zglaszajaca NOP zakwalifikowala go jako ciezki. URPL ocenil NOP jako ciezki.; Reported Cause(s) of Death: death


VAERS ID: 1085212 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Blood glucose fluctuation, Dyspnoea, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: ACETYLSALICYLIC ACID CARDIO; LOSARTAN POTASSIUM; TORSEMIDE; FLUVASTATIN SODIUM; TAMSULOSIN HYDROCHLORIDE; PREDNISOLONE; PREGABALIN; NALOXONE HYDROCHLORIDE; METAMIZOLE SODIUM; PARACETAMOL; OMEPRAZOLE; SODIUM BICARBONATE; MAGNESIUM ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (known for allergy to Klacid.); Omarthrosis (the patient was known for severe pain from bilateral massive omarthrosis.)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: creatinine; Result Unstructured Data: 94 mcmol/l; Test Date: 20210122; Test Name: blood sugar; Result Unstructured Data: 6.3 mmol/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: severe pain; hardly eaten, asthenic, very tired; Dyspnoea; high temperature 2 days; A regulatory authority report was received from a physician concerning a 88 years old male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The reported patient''s medical history includes that he was a polymorbid (list of diagnoses not known) patient known for severe pain from bilateral massive omarthrosis. He was in palliative care according to the reporter. Allergic to Klacid. Concomitant medications included ASS Cardio Spirig 100mg 1x1, Losartan Spirig 25mgx1, Torasemid Sandoz 10mg 2x2, Fluvastatin Sandoz 20mg 1x1, Tamsulosin 0.4mg 1x1, Targin 5 / 2.5mg 2X1, Lyrica 75mg 2x1, Novalgin 500mg 3x1 (+ in reserve max 3x1), Paracetamol SA 160mg 2x1 (+ in reserve max 4x1), Omeprazil Sandoz 20mg 1x1, Macrogol Sandoz 1x1, Magnesiocard 10mmol 1x1, and Spiricot 5mg 1x1. The patient was generally weak, deconditioned and no longer mobile, so they had proceeded with a conservative approach and purely palliative. On 20-Jan-2021, eight days prior to the death, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at an unspecified site for prophylaxis of COVID-19 infection. On 21-Jan-2021, the patient appeared weak and bedridden. On 22-Jan-2021, the patient had hardly eaten, was very tired, asthenic with blood pressure 98/60, temperature 37.8 � C, dyspneic, received 2L of oxygen. In the evening he experienced pain in the shoulders and in the whole body, was very thirsty with blood sugar of 6.3 mmol / L and from this moment on the usual pharmacotherapy was no longer given. On an unknown date in Jan 2021 the creatinine level was 94 mcmol/L . On 23-Jan-2021, the patient had severe pain and could only eat 1 yogurt. He was afebrile. On 24-Jan-2021, from this moment the patient had difficulty to awaken but remained afebrile. On 25-Jan-2021, the patient could no longer be awakened and a fixed morphine dose was set. On 28-Jan-2021 in the morning, the patient died. Further course was not known. Death occurred 8 days after the administration of the Covid-19-Moderna vaccine. Reporter stated that immediately after vaccination, the patient did not experience any adverse reactions, in particular none were observed symptom attributable to a possible anaphylactic allergic reaction. In consideration of the palliative context, in the absence of laboratory and imaging data (not performed), only in the presence of a data of high temperature 2 days after the vaccine, which however normalized the following day, no other elements were emerged suggestive for a possible causal correlation between the vaccine and death. The reporter stated they believed there was unlikely the causal correlation between the Covid-19-Moderna vaccine and the death of this patient. Treatment of the event was not available. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event, death was fatal. The patient died on 28-Jan-2021. The cause of death was unknown. The autopsy report was not provided.; Reporter''s Comments: Based on reporter''s causality and rationale, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Asthenia; Dyspnoea; High temperature; pain


VAERS ID: 1085213 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: AMANTADINE; SCOPODERM [HYOSCINE HYDROBROMIDE]; AMLODIPINE; METOPROLOL
Current Illness: COPD; Multiple sclerosis; Syndrome respiratory distress adult (restrictive respiratory syndrome (CV 14% of the predetermined value) with the installation of a non-ventilated invasive (VNI)); Tetraplegia; Urinary infection (recurrent); Von Willebrand''s disease (Type 2 A)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; A regulatory report was received from a physician concerning a 53-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac arrest and died. The patient''s medical history included restrictive respiratory syndrome, multiple sclerosis, tetraplegia, COPD, urinary infection, and von Willebrand''s disease. The concomitant medications included amantadine, amlodipine, metoprolol, scopolamine/hyoscine. On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 26-Jan-2021, 4 days after receiving the vaccine, the patient experienced cardiac arrest and was transported to the hospital in an ambulance. The patient died before arriving. Treatment information was not reported. Action taken with mRNA-1273 was not applicable. On 26-Jan-2021, the patient died due to cardiac arrest. Autopsy details were unknown.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. Patient''s underlying conditions may have been contributory for the occurrence of this fatal event. No further follow-up information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1093284 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anal sphincter atony, Death, Seizure, Sopor
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Convulsive seizure; Anal sphincter atony; Sopor; Death; A spontaneous report was received from a Healthcare professional concerning a 94-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273), experienced convulsive seizure, anal sphincter atony and sopor (profound or lethargic sleep), and while hospitalized, the patient died. The patient''s medical history was not reported. No concomitant medications were provided. On 18-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of COVID-19 infection. On 18-Feb-2021, the patient was presented with conclusive seizure, anal sphincter atony and sopor that resulted in hospitalization. Treatment provided to the patient was unknown. Action taken with mRNA-1273 in response to the events was not reported. Follow-up for the case was received and the patient was reported to be dead on 20-FEB-2021. Autopsy details were unknown.; Reporter''s Comments: Very limited information regarding the death of the patient has been provided at this time. Patient''s advanced age may have been contributory for the occurrence of the death. No further follow-up information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1103586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EM04777 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, General physical health deterioration, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Epileptic seizure; Convulsions; General physical health deterioration; A regulatory authority report was received from a pharmacist concerning, a 79 years old female patient who received Moderna (mRNA-1273) vaccine and experienced Epileptic seizure, Convulsions and General physical health deterioration. The patient had no history of epilepsy. Concomitant product use was not provided by the reporter. On 22 Jan 2021, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: EM04777) for prophylaxis of COVID-19 infection. Two hours post vaccine the patient experienced Epileptic seizure and was admitted to Emergency room. The patient''s condition stabilized with initiation of depakene and brought to the state of consciousness, but with visible general degradation of patient''s health. The patient was back to nursing home. The patient tested positive for COVID-19 on 26 Jan 2021 and was transferred in Hospital Covid unit. The patient had very degraded output on 3 Feb 2021. Call received from the Nursing home on 4 Feb 2021 for DEG. The patient was readmitted to the hospital. The patient developed the condition of epileptic pain. The patient was given second and then third line of treatment with no success Passage Palliative care. The patient died on 10 Feb 2021. No laboratory information was provided by the reporter. Treatment information for the event Epileptic seizure, provided included: Depakene. Action taken with mRNA-1273 in response to the event(s) was Not applicable. The event(s), Epileptic seizure, Convulsions and General physical health deterioration were considered as Fatal. The cause of death was reported as Epileptic seizure, Convulsions and General physical health deterioration. Plans for an autopsy were unknown.; Reporter''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.; Sender''s Comments: Case narrative was translated from the source document by the case processor. Errors in translation could be expected. Please refer the source document.; Reported Cause(s) of Death: Epileptic seizure; General physical health deterioration


VAERS ID: 1113820 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLECALCIFEROL; TRITTICO; PANTOPRAZOLE; RAMIPRIL
Current Illness: Alzheimer''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Febbre massimo 38�C; A regulatory authority report (ITALY) was received from a physician, concerning a 79-years-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced febbre massimo 38�C/pyrexia. The patient''s medical history included alzheimer''s disease since 01 Jan 2016. Concomitant medications included colecalciferol, trazodone hydrochloride, pantoprazole and ramipril. On 20 Feb 2021, approximately three days prior to the onset of the events, the patient received their unknown dose of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient experienced febbre massimo 38�C. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event was fatal, as patient died on 28 Feb 2021 due to febbre massimo 38�C. It was unknown if an autopsy was performed.; Reporter''s Comments: This is a report of fever resulting in death of 79-years-old female patient 3 days after administration of mRNA-1273 (Lot number: 300042721. Although fever is consistent with the known safety profile of the vaccine, it is unlikely that a temperate of 38�C cold have resulted in a fatal outcome. No additional information was provided such as other clinical presentation and diagnostic findings. Hence, the event is assessed as unlikely related to mRNA-1273 administration. No further information is expected.; Reported Cause(s) of Death: Febbre massimo 38�C


VAERS ID: 1114029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain
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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung lobectomy; Metastatic renal cell carcinoma; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; Chest pain; A regulatory authority report was received from a physician concerning a 76-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardio-respiratory arrest and chest pain. The patient''s medical history, as provided by the reporter, included metastatic renal cell carcinoma, and procedures of lung lobectomy and nephrectomy. Concomitant medications was not reported. On 11 Feb 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: 721 ) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced cardio-respiratory arrest and chest pain. No laboratory details was provided. Treatment information was not provided. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 16 Feb 2021. The cause of death was reported as cardio-respiratory arrest. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 76 year old male with medical history of metastatic renal cell carcinoma, who experienced the unexpected events of cardio-respiratory arrest with fatal outcome and chest pain. The events occurred 6 days after the first dose of mRNA-1273. Very limited information regarding the events has been provided at this time. Additional information is not expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1114857 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: CARDIRENE; ELIQUIS; LASIX [FUROSEMIDE]; ATORVASTATIN; LANSOPRAZOLE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arthrosis; Chronic renal failure; IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: muscle spasms; Vomiting; A regulatory authority report was received from a healthcare professional concerning a 97-year-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced muscle spasms, vomiting and died. The patient''s medical history was atrial fibrillation, Myocardial ischaemia, Osteoarthritis, Chronic renal failure. Concomitant medications were reported as Cardirine, Eliquis, Lasix, atorvastatin, lorazepalm, lansoprazole. On 23 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042723) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021 patient has experienced muscle spasms and vomiting. The patient died on 23 Feb 2021. The cause of death is unknown. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On 23 Feb 2021, outcome of the events muscle spasms and vomiting were FATAL.; Reporter''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: cause of death unknown


VAERS ID: 1121813 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fracture bone; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Inappetence; harder to drink, drank; A regulatory report was received from a 100-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced inappetence and difficulty to drink that led to death. The patients medical history included current illness of bone fracture and pain which started from 04-JAN-2021. The relevant concomitant medications were not provided. On 16-JAN-2021, prior to the onset of the events, the patient received their unknown dose of two planned doses of mRNA (Lot number: 300042698) through intramuscular route of administration for prophylaxis of COVID-19 infection. On unknown date on JAN-2021, patient experienced inappetence and difficulty to drink. No laboratory data was provided. Action taken with mRNA-1273 in response to the events was not applicable. The reporter indicated that the causal relationship between the suspected drug and the event is considered unlikely. The outcome of the event inappetite was Fatal on 28-JAN-2021. The details of autopsy done was unknown. No treatment information was provided.; Reporter''s Comments: Based on reporter''s causality, the advanced patient''s age and the prior medical history, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: death due to Inappetence


VAERS ID: 1122460 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-24
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Hypotension, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-25
   Days after onset: 365
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20200124; Test Name: COVID-19 rapid POC test; Result Unstructured Data: positive
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: low blood pressure; weakness; throat pain; A regulatory authority report was received from a physician concerning a 84 year-old male patient who after the administration of Moderna''s COVID-19 vaccine (mRNA-1273) developed low blood pressure (Hypotension), weakness (Asthenia), throat pain (Oropharyngeal pain) and subsequently died. The patient''s medical history and concomitant medications were not reported. On 16-JAN-2021, 9 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch# 300042698) intramuscularly for prophylaxis of COVID-19 infection. On 24-JAN-2021, the patient developed low blood pressure, weakness and throat pain and eventually died the following day. Action taken with mRNA-1273 in response to the events was not applicable. Outcome of event, outcomes of events, weakness and throat pain, were not resolved. On 25-JAN-2021, the patient was death and cause of death was hypotension. It was not known whether an autopsy was performed. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to fatal outcome.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (weakness and throat pain), a causal relationship cannot be excluded. Very limited information regarding hypotension has been provided at this time.; Reported Cause(s) of Death: Hypotension


VAERS ID: 1122779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram, Generalised tonic-clonic seizure, Glomerular filtration rate, Haemoglobin, International normalised ratio
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: SINTROM; RIVAROXABAN; HIDROFEROL; CALCIUM ACETATE; OMEPRAZOLE; FERRO SANOL; NEPHROTRANS; ROCALTROL; RESONIUM-A; IRBESARTAN; ARTEDIL; QUETIAPINE
Current Illness: Chronic renal failure; Dementia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Reduced general condition; Vulval ulceration
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: computerised tomography; Result Unstructured Data: shows massive intraparenchymatous hemorrhage and signs of intracranial hypertension (HTIC); Test Date: 20210117; Test Name: GFR; Result Unstructured Data: 11 ml/min; Test Date: 20210131; Test Name: GFR; Result Unstructured Data: 15 ml/min; Test Date: 20210117; Test Name: Hb; Result Unstructured Data: decreased 102 gpl; Test Date: 20210131; Test Name: Hb; Result Unstructured Data: decreased 88 gpl; Test Date: 20210117; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.7; Test Date: 20210131; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 9.68
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: cerebral hemorrhage; clonic-tonic convulsions; A regulatory authority report was received from a health care professional concerning an 89-year old, female patient who wreceived Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cerebral hemorrhage, clonic-tonic convulsions and passed away. The patients medical history, as provided by the reporter, included dementia, hypertension, arterial chronic renal failure, reduced general condition and vulval ulceration. Products known to have been used by the patient, within two weeks prior to the event, included rivaroxaban, hidroferol, calcium acetate, omeprazole, ferro sanol, nephrotrans, rocaltrol, resonium-A, irbesartan, artedil and quetiapine. Additional suspected products included acenocoumarol. On 29 Jan 2021, prior to the onset of events, the patient received their unknown dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient experienced cerebral hemorrhage and generalized tonic-clonic attack followed by a disorder of the state of consciousness,and patient was hospitalized. Computerized tomography showed massive intraparenchymatous hemorrhage and signs of intracranial hypertension (HTIC). The International normalized ratio was 9.68, Hemoglobin 88 g/L and Glomerular filtration rate 15 ml/min. Treatment information for the event was not provided. Action taken with the mRNA-1273 in response to the event was not applicable as the patient deceased. The patient died on 31 Jan 2021. The cause of death was reported as cerebral hemorrhage and clonic-tonic convulsions. Plans for an autopsy were not provided.; Reporter''s Comments: Very limited information regarding the reported events has been provided at this time. No further information has been requested. Patient''s advanced age, concomitant use of acenocoumarol known to cause bleeding, along with multiple comorbidities may have been contributory.; Reported Cause(s) of Death: Cerebral hemorrhage; Clonic-tonic convulsions


VAERS ID: 1123483 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

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

Write-up: Hypoxia; A Regulatory Authority report was received from a healthcare professional concerning a 95-year-old, female patient, who received Moderna''s covid-19 vaccine(mRNA-1273) and experienced important desaturation. The patient''s medical history was not provided. Concomitant product use was not provided by the reporter. On 18-FEB-2021, the patient received mRNA-1273 (Batch number:300042723) intramuscularly for prophylaxis of COVID-19 infection. On 21-FEB-2021, the patient experienced important desaturation. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on an unknown date. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. Patient''s advanced age may have been contributory for the occurrence of death. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown


VAERS ID: 1127882 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-24
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: 2021-01-23
   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: METFORMIN HYDROCHLORIDE; ACETYLSALICYLIC ACID; TORASEMIDE; METOPROLOL SUCCINATE; LERCANIDIPINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Stenosis aortic valve
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; A regulatory report (CH-SM-2021-10913) (Switzerland) was received from a consumer concerning a 85 year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and expired. The patient''s medical history was provided by the reporter which included stenosis aortic valve and chronic renal insufficiency. Concomitant medications reported included metformin hydrochloride, acetylsalicylic acid, torasemide, metoprolol succinate, Lercanidipine hydrochloride and Hydrochlorothiazide On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:unknown) through unknown route for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient expired and reason for death was unknown. It was not known whether an autopsy was performed on this individual. No treatment information was provided Lab details were not provided. Action taken with mRNA-1273 in response to the events was not applicable The outcome of the event was fatal.; Reporter''s Comments: This is a case of death in a 85-year-old female subject with a hx of aortic stenosis and chronic renal insufficiency, who died 8 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: 1127955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Unattended Death; A regulatory authority report was received from a other health care professional concerning a 84-Year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) experienced unattended death. The patient''s medical history included Diabetes and hypertension. No relevant concomitant medications were reported. On 23-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042723) intramuscularly for prophylaxis of COVID-19 infection. On 24-FEB-2021, the patient experienced unattended death. As per reporter death could be because of natural cause. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event death is not applicable. The patient died on 24-Feb-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter''s Comments: This is a case of death in an 84-year-old female subject with a hx of HTN and DM, who died one 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: 1128823 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Condition aggravated, Vomiting
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Diabetes; Overweight; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1614187417332

Write-up: Late effects of cerebral stroke; Vomiting; Condition aggravated; .A regulatory authority report was received a physician which concerns a 78-year old, male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced vomiting, late effects of cerebral stroke and condition aggravated. The patient''s medical history included diabetes, overweight., and stroke. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient experienced vomiting, late effects of cerebral stroke and condition aggravated. Treatment information was unknown. Action taken with mRNA-1273 was unknown. The outcome of the events, vomiting, late effects of cerebral stroke and condition aggravated, was considered not recovered. No further information was provided.; Reporter''s Comments: This is a case of death in a 78-year-old male subject with a medical history of diabetes, overweight and stroke, who died on an unknown day after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1129623 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 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: 2021-02-27
   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: Interstitial heart fibrosis; Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20210

Write-up: Sudden death following vaccination; A regulatory authority report was received from a physician concerning a 91-years-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sudden death following vaccination (sudden death). The patient''s medical history included angina pectoris, interstitial heart fibrosis, and ischemic heart disease. No concomitant medications were reported. On 26 Feb 2021, 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 300042721) intramuscularly for the prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced sudden death following vaccination. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 27 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter''s Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1131124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-06
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: Adipositas; Alcohol abuse; Arterial hypertension; Heart failure (Not otherwise specified); Hypercholesterolemia; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A Regulatory Authority report was received from other healthcare professional for a 82 year old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history included heart failure (not otherwise specified), hypercholesterolemia, arterial hypertension, nicotine abuse, adipositas, and alcohol abuse. No concomitant product use was reported. On 19-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 06-Feb-2021, the patient died. Autopsy was not performed. The cause of death is pending. Action taken with mRNA-1273 was not applicable. The outcome was fatal.; Reporter''s Comments: This is a case of death in a 82-year-old male subject with a medical history of heart failure, hypercholesterolemia, arterial hypertension, nicotine abuse, adipositas/obesity, and alcohol abuse, who died 18 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1131173 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-02-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral vascular lesion; Hiatus hernia; Iron deficiency anemia; Late effects of cerebrovascular disease; Lichen simplex; Obesity; Sleep disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1614173305574

Write-up: A regulatory authority report was received from a healthcare professional concerning, an 84-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac failure. The patient''s medical history included lichen simplex, late effects of cerebrovascular disease, iron deficiency anemia, cerebral vascular lesion, hiatus hernia, obesity, and sleep disturbance. No concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection on 11 Jan 2021. On an unknown date in Feb-2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date in Feb-2021, the patient experienced cardiac failure and died. The patient died on unknown date of Feb 2021. Plans for an autopsy were not provided. Action taken with mRNA-1273 was not applicable. The outcome of the event, cardiac failure, was fatal.; Reporter''s Comments: This is a case of death in a 84-year-old female subject with a medical history of cerebrovascular disease, iron deficiency anemia, cerebral vascular lesion, hiatus hernia, obesity, and sleep disturbance, who died on an unknown date after receiving second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death:


VAERS ID: 1135603 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-15
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood culture, Blood gases, COVID-19, Chest X-ray, Chills, Dyspnoea, Exposure to SARS-CoV-2, Fatigue, Fibrin D dimer, Legionella test, Oxygen saturation decreased, Polymerase chain reaction, Productive cough, Pyrexia, Rales, Respiratory failure, SARS-CoV-2 test, Sepsis, Streptococcal urinary tract infection
SMQs:, Anaphylactic reaction (broad), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COLCHICINE; ALLOPURINOL; ASPIRIN CARDIO; HYDROCHLOROTHIAZIDE;VALSARTAN; CALCIMAGON D3 UNO; GABAPENTIN MEPHA; SPIRICORT; TOREM COR; TRAMAL RETARD; VITAMIN D3 STREULI; ZOLPIDEM STREULI
Current Illness: Arterial hypertension; Chronic renal failure; Colon diverticulitis; Polymyalgia rheumatica; Urolithiasis (relapsing)
Preexisting Conditions: Medical History/Concurrent Conditions: Spondylolisthesis
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Creatinine; Result Unstructured Data: 185 mcmol/L; Test Date: 20210122; Test Name: blood culture; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210122; Test Name: arterial blood gas; Result Unstructured Data: acute partial respiratory insufficiency; Test Date: 20210122; Test Name: chest x-ray; Result Unstructured Data: bilateral peripheral- and basal-predominant interstitial infiltrates; Test Date: 20210122; Test Name: fibrin degradation products; Result Unstructured Data: 879 mcg/L; Test Date: 20210125; Test Name: fibrin degradation products; Result Unstructured Data: 901 mg/L; Test Date: 20210122; Test Name: legionella; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210122; Test Name: PCR; Result Unstructured Data: 172 mg/L; Test Date: 20210125; Test Name: PCR; Result Unstructured Data: 313 mg/L; Test Date: 20210122; Test Name: SARS-CoV-2; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210122; Test Name: streptococcal urine antigen; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: temperatures of 38.4�C; dependent on oxygen,adequate level could not be reached with 10 L oxygen suppply; Respiratory insufficiency; Covid-19; severe dyspnoea; productive cough; basilar rales; shivering; fatigue; sepsis; SARS-CoV-2 exposure; A regulatory report (CH-SM-2021-10854) was received from a physician concerning a 85-years-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced events COVID-19 severe dyspnoea (dyspnoea), productive cough, rales, decreased oxygen saturation, respiratory insufficiency (respiratory failure), sepsis, fatigue, shivering (chills), temperature of 38.4 degrees Celsius (pyrexia) and exposure to SARS-CoV-2 . The patient''s medical history was Arterial hypertension, Spondylolisthesis, chronic renal insufficiency, urolithiasis, colon diverticulitis, polymyalgia rheumatica. Concomitant medications reported was colchicine, allopurinol, acetylsalicylic acid, hydrochlorothiazide valsartan, calcium carbonate colecalciferol, gabapentin, prednisolone, torasemide, tramadol hydrochloride, colecalciferol, and zolpidem tartrate. On 21 Jan 2021, prior to the onset of the events, the patient received their mRNA-1273 (lot batch: 300042460) intramuscularly for prophylaxis of COVID-19 infection. The patient had a previous exposure to SARS-CoV-2 on 15Jan2021 which was not made known at the time of vaccination. On 21 Jan 2021, the patient experienced temperatures of 38.4�C which resolved by 22Jan2021. The practitioner initially suspected a reaction to the vaccination, however since the fever returned, recommended testing for SARS-CoV-2. On 22Jan2021, the patient was evaluated at the emergency department with severe dyspnoea and tested positive for SARS-CoV-2. The patient was experienced shivering, productive cough, and fatigue with a slightly deteriorated general condition but was stable and afebrile. The patient had bilateral basilar rales which were stronger on the right than left. Laboratory tests included elevated infection parameters, increased creatinine, and elevated D-Dimer levels. Blood gases showed acute partial respiratory insufficiency. Legionella and streptococcal urine antigen test as well as the blood cultures were negative. A chest x-ray was done and showed bilateral peripheral- and basal-predominant interstitial infiltrates. After being admitted to the hospital, treatment included antibiotics, pulse steroid therapy, oxygen therapy and remdesivir. The patient became oxygen dependent. On 25Jan2021, the patient continued to deteriorate and died in the evening. The cause of death being covid-19 infection. Autopsy information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events was fatal.; Reporter''s Comments: This fatal case concerns an 85 Y/O M with exposure to SARS-CoV-2 was hospitalized with serious unexpected COVID-19, sepsis, respiratory failure, oxygen saturation decreased, dyspnea, productive cough, rales, and expected pyrexia, chills, fatigue. Event onset Day 1 after first dose mRNA-1273. Cause of death COVID-19. Autopsy unknown. 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.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1135604 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Haemothorax, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, PCO2, PO2, pH body fluid
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Hypertension arterial; Obstructive airways disease (chronic); Renal failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia, unspecified; Aortic valve disease; Atrial fibrillation; Cardiomyopathy; Metabolic syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: O2 Saturation; Test Result: Inconclusive ; Result Unstructured Data: Percent; Test Date: 20210122; Test Name: pCO2; Test Result: Inconclusive ; Result Unstructured Data: kPa; Test Date: 20210122; Test Name: pH; Test Result: Inconclusive ; Result Unstructured Data: unk; Test Date: 20210122; Test Name: pO2; Test Result: Inconclusive ; Result Unstructured Data: kPa; Test Date: 20210122; Test Name: creatinine; Test Result: Inconclusive ; Result Unstructured Data: micromole per litre; Test Date: 20210122; Test Name: NT-proBNP; Test Result: Inconclusive ; Result Unstructured Data: pg/ml
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Haemothorax; A regulatory authority report was received from a physician concerning a 77-years old male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced Hemothorax. The patient''s medical history as provided by the reporter included Obstructive airways disease (chronic), Renal failure chronic, Hypertension arterial, Cardiomyopathy, Aortic valve disease, Atrial fibrillation, Metabolic syndrome and Anemia, unspecified. Concomitant medications were not listed. On 22 Jan 2021, at 11 am prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown) intramuscularly for prophylaxis of covid 19 infection. On 22 Jan 2021, at 3pm the patient Collapsed in a wheelchair and transferred to the emergency room on the same day, with a finding of hemothorax (the patient was anticoagulated, not known with what and not known unfortunately the INR value at the time of admission) and subsequent death. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event hemothorax were fatal on 23 Jan 2021 at 1:23 PM The autopsy results were not provided. The cause of death was reported as hemothorax. From the point of view of the treating physicians, there is no causal relationship to the Sars-Cov2 vaccination. An autopsy in pathology KSBL was planned.; Reporter''s Comments: This is a case of death in a 77-year-old male subject with a hx of HTN, CRF, A fib, cardiomyopathy, Aortic valvular disease, metabolic syndrome, and anemia, who died on the same day after receiving first dose of vaccine. Very limited information has been provided at this time. The reporting physician considers that is not related to Moderna''s COVID-19 vaccine.; Reported Cause(s) of Death: Haemothorax


VAERS ID: 1135606 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Death, Decreased appetite, Dry mouth, Dyspnoea, Fatigue, Hyperhidrosis, Pain, Pyrexia, SARS-CoV-2 test negative, Unresponsive to stimuli, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM ACTAVIS; SIFROL; SERESTA; ESCITALOPRAM HELVEPHARM; TORASEMID ACTAVIS; METFIN; GALVUS; NALOXONE HCL;OXYCODONE HCL; MACROGOLUM; HALDOL DECAN
Current Illness: Alzheimer''s disease; Arterial hypertension; Cerebrovascular insufficiency; Dementia; Diabetes mellitus; Epilepsy NOS (Elderly); Osteoporosis; Polymyalgia rheumatica; Sleepiness; Stroke; Tiredness
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Diarrhea
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Body temperature; Result Unstructured Data: 38.1 degree celsuis; Test Date: 20210126; Test Name: Body temperature; Result Unstructured Data: Upto 38 degree celsuis; Test Date: 20210125; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; Not responding to pain stimuli; Dyspnoea; Wheezing; Dry mouth; Pain; Profuse sweating; Febrile; Very tired; Loss of appetite; A regulatory authority report, was received from a physician, concerning an 80 year-old female patient, who was administered Moderna''s COVID-19 vaccine (mRNA-1273), and experienced death NOS (death), not responding to pain stimuli (unresponsive to stimuli), dyspnoea, loss of appetite (decreased appetite), wheezing, dry mouth, profuse sweating (hyperhidrosis), pain, very tired (fatigue), and febrile (pyrexia). The patient''s current condition included history of diabetes mellitus, arterial hypertension, dementia, stroke, epilepsy NOS, ethanol abuse, osteoporosis, polymyalgia rheumatic, cerebrovascular insufficiency syndrome, alzheimer''s, tired, and kept falling asleep. Concomitant medications used included levetiracetam, pramipexole dihydrochloride, oxazepam, escitalopram oxalate, torasemide, metformin hydrochloride, vildagliptin, naloxone hydrochloride; oxycodone hydrochloride, macrogol and haloperidol decanoate. No lab tests were carried out since 2017. On 18 Jan 2021, the patient had diarrhea and was not examined with stool bacteriology or imaging. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the day of vaccination, afterwards patient was very tired, otherwise no complaints, but loss of appetite. On 23 Jan 2021, the patient was still very tired. They were unable to take medication in the morning. Non-specific deterioration in general condition, refusal to take medication and food. On 24 Jan 2021, the patient experienced profuse sweating, tiredness, refused food. In the evening, there was fever up to 38.1 degree Celsius (�C), isolation and COVID 19 test. In addition, no pain, only tiredness, objectively no apparent suffering according to nursing care. On 25 Jan 2021, the patient was still febrile and very tired. Refused meals, drank little. The patient received morphine for the first time because of pain and vital signs were doing good. On 26 Jan 2021, the patient received morphine for pain (appeared to be in pain), breathes were regular. They no longer responded to questions. The doctor''s visit indicated that the patient was no longer responsive, apathetic, febrile up to 38 �C. The patient''s mouth was clinically dry, not responding to pain stimuli and wheezing. Lungs free to auscultate from the ventral side. Abdomen was normal, no pain on pressure, soft abdomen and bowel noises normal. Blood pressure was normotonic, and normocardial. On the same day, COVID-19 test was negative, therefore no isolation was required and no admission to hospital. The death of this elderly, polymorbid and Alzheimer''s-impaired patient was not completely unexpected, differential diagnosis (DD) bacterial or viral infection. The patient was decided to opt for a palliative procedure, no further diagnostics or therapy. The patient died on 26 Jan 2021. Autopsy was not performed. Cause of death was not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, death, not responding to pain stimuli, dyspnoea were considered as fatal, and that of rest events loss of appetite, wheezing, dry mouth, profuse sweating, pain, very tired, and febrile, were not reported.; Reporter''s Comments: This case refers to an elderly patient with history of diabetes mellitus, arterial hypertension, dementia (Alzheimer''s), stroke, epilepsy, ethanol abuse, and cerebrovascular insufficiency syndrome. Based on the current available information and temporal association between the use of the product and the start date of the events (not responding to pain stimuli, dyspnea, loss of appetite, wheezing, dry mouth, profuse sweating, pain, very tired, and febrile), a causal relationship cannot be excluded. Although there is temporal association, there is no clear cause and effect relationship between the use of the product and this patient''s death.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1135620 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Escherichia pyelonephritis, Nausea, Pain, Supraventricular tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   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: ELIQUIS; PREDNISOLON; OXYCONTIN DEPOT; BISOPROLOL; KETIPINOR; LANTUS; FURESIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Chronic pain; Hypertension; Polymyalgia rheumatica; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Supraventricular tachycardia; Escherichia pyelonephritis; Chest pain; Nausea; Vomiting; Pain; A regulatory authority report was received from a health care professional concerning a 95-year old, female patient who experienced supraventricular tachycardia, escherichia pyelonephritis, chest pain, nausea, vomiting, pain and died. Patient''s medical history was not provided. Concomitant medications known to have been used by the patient, within two weeks prior to the event, included apixaban, prednisone, oxycodone hydrochloride, bisoprolol, quetiapine fumarate, insulin glargine, and furosemide. On 12-FEB-2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 300042698) intramuscularly for prophylaxis of COVID-19 infection. On 13 FEB 2021, the patient experienced supraventricular tachycardia, escherichia pyelonephritis, chest pain, nausea, vomiting, pain and died on 21 FEB 2021. Autopsy information was unknown. The cause of death is unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not possible. The outcome of the events, supraventricular tachycardia, escherichia pyelonephritis, chest pain, nausea, vomiting, pain were FATAL.; Reporter''s Comments: This is a case of sudden death in a 95-year-old female patient with unknown history died 9 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: 1136561 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukaemia; Cardiomyopathy (Hypertensive, valvular and rhythmogenic cardiomyopathy.); Chronic myelomonocytic leukaemia; Craniotomy; Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Fever; Death; A regulatory authority report(CH-SM-2021-10503) was received on 25 Feb 2021, from a physician concerning a 78 years old female patient who received Moderna''s COVID-19(mRNA-1273) vaccine and experienced fever, death. The Patient medical history includes Chronic myelomonocytic leukaemia, Acute myeloid leukaemia, Cardiomyopathy, Subarachnoid haemorrhage, Craniotomy. No concomitant medications was reported. On 18 Jan 2021, prior to the onset of events, patient received her first dose of mRNA-1273(Batch:unknown) intramuscularly for the prophylaxis of covid-19 infection. On 18 Jan 2021, patient experienced the events, fever. On 19 Jan 2021, patient experienced the event death. No laboratory information was provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event was fatal. The patient died on 19 JAN 2021. The information about the autopsy was unknown. The cause of the death was unknown. The reporter assessed event fever as possibly related to vaccine and death as unlikely related to vaccine.; Reporter''s Comments: This is a case of sudden death in a 78-year-old female patient with a history of Chronic myelomonocytic leukaemia, Acute myeloid leukaemia, Cardiomyopathy, Subarachnoid haemorrhage and Craniotomy, who died 1 dayafter re ceiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown


VAERS ID: 1137187 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

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

Write-up: Gastrointestinal bleeding; Coffee ground emesis; A regulatory authority report was received from a physician concerning a 82-year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced coffee ground emesis/haematemesis and gastrointestinal bleeding/gastrointestinal haemorrhage and died. The patient''s medical history was not provided. Concomitant product use was not provided. On 16 Feb 2021, prior to the onset of events , the patient received a dose of mRNA-1273(Lot/batch:300042698) for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced coffee ground emesis and gastrointestinal bleeding. Treatment information were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on an unspecified date. The events of gastrointestinal bleeding and coffee ground emesis were considered fatal. Plans for an autopsy was not provided.; Reporter''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: gastrointestinal bleeding; coffee ground emesis


VAERS ID: 1137667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-16
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA INCONNU / UNK - / 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: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INLYTA; KEYTRUDA
Current Illness: Kidney cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; A Regulatory authority report was received from a physician concerning a 76-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history, as provided by the reporter, included kidney cancer. Other suspected medications included axitinib and pembrolizumab for kidney cancer. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: INCONNU ) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021 the patient died. Cause of death is unknown. Autopsy report was unknown. Treatment for the event was unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event death was considered fatal on 16 Feb 2021.; Reporter''s Comments: Very limited information regarding the event of sudden death has been provided at this time. However, patient''s underlying malignancy may have been contributory. Concurrent medications axitinib and pembrolizumab were considered suspect. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypophagia, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: FOSINOPRIL; METFORMINE [METFORMIN]; NITROFURANTOINE; COMBIGAN; OXAZEPAM; CLOPIDOGREL; NORTRIPTYLINE; CALCIUM CARBONATE; AMLODIPINE; PARACETAMOL; HYDROXOCOBALAMINE; CLOBETASOL
Current Illness: Alzheimer''s disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Multiple myeloma; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: corona sneltest; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A Regulatory Authority report was received from a pharmacist for a 78 year old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and who experienced fatigue, nausea, vomiting, and decreased oral intake (hypophagia). The patient''s medical history included cerebrovascular accident, type 2 diabetes mellitus, urinary tract infection, alzheimer''s dementia, and plasma cell myeloma. The concomitant medications included clopidogrel, nortriptyline, calcium carbonate, amlodipine, paracetamol, hydroxocobalamine, clobetasol, fosinopril, metformine [metformin], nitrofurantoine, brimonidine tartrate timolol maleate and oxazepam. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 30042721) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-2021, one day after receiving the vaccine, the patient experienced fatigue, nausea and vomiting. A SARS-CoV-2 test was performed which was negative. On a date not reported, the patient experienced decreased oral intake. The patient died on 18 Feb 2021. The cause of death was reported as nausea and decreased oral intake. No autopsy was performed. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the events nausea, vomiting, and decreased oral intake was fatal and the outcome for the event of fatigue was unknown. On 11Mar2021, follow up information was received which provided cause of death as decreased oral intake with no autopsy performed. A SARS-CoV-2 test was performed on 12Feb2021 which was negative.; Reporter''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, the patient''s comorbidities may confound causality assessment. This case concerns a 78-year-old female who experienced serious unexpected events of fatigue, nausea, vomiting. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. As above, a causal relationship cannot be excluded.


VAERS ID: 1152975 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Malaise, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: CLOPIDOGREL; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Oxygen saturation; Result Unstructured Data: Decreased; Test Date: 20210305; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Covid PCR test; Test Date: 20210304; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Result Unstructured Data: Covid test
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; oxygen saturation decreased; A regulatory authority report was received from a physician, concerning an 81 year-old male patient, who was administered Moderna''s COVID-19 vaccine (mRNA-1273), and experienced oxygen saturation decreased, malaise (malaise), asthenia, and pyrexia and subsequently died (Death). The patient''s medical history was not reported. Concomitant medications reported included clopidogrel, and furosemide. On 25 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 300042722), intramuscularly for the prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient experienced oxygen saturation decreased, malaise, asthenia and pyrexia. On the same day, the patient underwent COVID-19 rapid point-of care (POC) test which was negative. On 05 Mar 2021, the patient underwent COVID-19 polymerase chain reaction (PCR) test which was negative. On 07 Mar 2021, the patient died. Cause of death was not reported. Plans for an autopsy were unknown. No treatment information was reported. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcomes of the events, oxygen saturation decreased, malaise, asthenia and pyrexia, were unknown.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (oxygen saturation decreased, malaise, asthenia and pyrexia), a causal relationship cannot be excluded. Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152976 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Headache, Hyperpyrexia, Malaise, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: INSULINE ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No adverse event history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report was received from a consumer concerning a 87-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced generalized joint pain, malaise, hyperpyrexia, pain, chills, headache and died. The patient''s medical history was not provided. Concomitant products known to have been used by patient, within two weeks prior to the event, included Insulin Aspartate. On 12-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-FEB-2021, after receiving mRNA-1273, the patient began experiencing generalized joint pain, malaise, hyperpyrexia, pain, chills and headache and finally resulted in death of patient. The patient died on 12FEB2021. The cause of death is unknown. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, generalized joint pain, malaise, hyperpyrexia, pain, chills and headache were not provided.; Reporter''s Comments: This is a case of death in a 87-year-old male subject with unknown medical history, who died same day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1153587 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-06
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Haemorrhagic 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune hepatitis; Cachexia; Calcinosis; Cirrhosis of liver; CREST syndrome; Enteroparesis; Gastroparesis; Hydrops fetalis; Large intestine angiodysplasia; Malnutrition; Peripheral artery occlusion; Portal hypertension; Sigmoid diverticulosis; Sjoegren''s syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Finger amputation; Gastrooesophageal varices ; Oesophageal variceal ligation; Pleural cavity drainage; Procedural pneumothorax; Upper gastrointestinal bleeding; Upper gastrointestinal bleeding; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning, a 60-year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myocardial infarction and cerebral hemorrhage. The patient''s medical history included finger amputation, large intestine angiodysplasia, cachexia, autoimmune hepatitis, portal hypertension, peripheral artery occlusion, upper gastrointestinal bleeding, esophageal variceal ligation, cirrhosis of liver, enteroparesis, pleural cavity drainage, sigmoid diverticulosis, procedural pneumothorax, gastroesophageal varices, malnutrition, CREST syndrome, gastroparesis, sjogren''s syndrome, hydrops fetalis, calcinosis and drug intolerance to ilomedin and rivotril . No concomitant medications were reported. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 626761A) for prophylaxis of COVID-19 infection. On 6 Mar 2021, the patient experienced myocardial infarction and cerebral hemorrhage and subsequently died. No treatment information were provided. Cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the events was not applicable.; Reporter''s Comments: Very limited information regarding circumstances leading to fatal myocardial infarction and fatal cerebral hemorrhage has been provided at this time.


VAERS ID: 1153614 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Rarely was conscious; Could not eat and drink; Bronchiolitis; A regulatory authority report was received concerning a 100-year-old, female patient who experienced bronchiolitis, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness. The patient''s medical history included COVID-19 in Oct 2021. Concomitant product use was not provided by the reporter. On 15 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced reduced level of consciousness with difficulty in eating and drinking by mouth. On an unknown date,the patient was hospitalized. On 27 Feb 2021, the patient died with a diagnosis of bronchiolitis, with no accompanying fever. Treatment for the event included oxygen, buscopan as needed and morphine for pain and discomfort as well as temesta for sedation. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness was unknown. The Patient died on 27 Feb 2021. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reporter''s Comments: This case concerns a 100-year-old, female patient who experienced fatal event of bronchiolitis, decreased appetite and depressed level of consciousness. Very limited information regarding this event has been provided at this time. The patient''s advanced age and previous COVID-19 infection remains a risk factor. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reported Cause(s) of Death: Bronchiolitis


VAERS ID: 1153800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000042722 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test positive, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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:
Current Illness: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden death; A Agency Regulatory Authority report was received by a healthcare professional, concerning a female patient of 81 years of age, who received Moderna''s COVID-19 vaccine on 02 Mar 2021 and later suddenly died on 04 Mar 2021. The patient''s medical history included Covid-19. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of events, the patient received a dose of mRNA-1273 (lot number - 3000042722) via an unknown route for COVID-19 infection prophylaxis. On 04 Mar 2021, after dose of vaccine, the patient suddenly died. Treatment medication was not reported by the reporter . Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, Sudden death was considered to be fatal at the time of this report.; Reporter''s Comments: This is a case of sudden death in a 81-year-old female subject with unknown medical history except recent history of Covid infection, who died 2 days after receiving Moderna''s COVID-19 vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: morbus subitum


VAERS ID: 1153802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Herpes zoster, Malaise, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Drowsiness/waardoor suf worden en uiteindelijk overlijden; Decreased appetite/verminderde intake; Malaise/algehele malaise zonder koorts; Herpes zoster; A regulatory report was received from a physician concerning a 101-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced drowsiness/waardoor suf worden en uiteindelijk overlijden, decreased appetite/verminderde intake, malaise/algehele malaise zonder koorts and herpes zoster. The patient''s medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. On 1 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042722) intramuscularly for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced drowsiness, decreased appetite, malaise and herpes zoster. As per the report, drowsiness, decreased appetite, malaise and herpes zoster resulted in patient death. The patient died on 10 Mar 2021. Autopsy information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events, drowsiness, decreased appetite, malaise and herpes zoster, were considered fatal.; Reporter''s Comments: This fatal case concerns a 101 Y/O F with serious unexpected events of somnolence, malaise, decreased appetite, and herpes zoster. Event onset 4 days after first dose mRNA-1273. Event outcome death. Autopsy information not provided. 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: algehele malaise zonder koorts; waardoor suf worden; verminderde intake; herpes zoster


VAERS ID: 1157293 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-02-22
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Condrosulf; COVERAM; INVOKANA [CANAGLIFLOZIN]; JANUMET; PLAVIX
Current Illness: Arterial hypertension; Lumbo-sacral pain; Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stent insertion (mesenteric artery and celiac trunk); Mesenteric ischemia; Percutaneous coronary intervention (mesenteric artery and celiac trunk)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report, was received from a physician concerning a 76-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced death. The patient''s medical history included type 2 diabetes mellitus, arterial hypertension, obesity, mesenteric ischemia, lumbovertebral syndrome, and PTCA and stenting of the mesenteric artery and celiac trunk. Concomitant medications included chondroitin sulfate sodium, amlodipine besilate/perindopril arginine, canagliflozin, metformin hydrochloride/sitagliptin phosphate, and clopidogrel bisulfate. On 23 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch: 300042460) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 FEB 2021, the patient received their second of two planned doses of mRNA-1273 (Batch: 300042723) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 22 FEB 2021, the patient died. Cause of death was unknown. Plans for an autopsy was not provided. The action taken with mRNA-1273 in response to the event was not applicable. The reporter considered the death unlikely related to mRNA-1273.; Reporter''s Comments: This case concerns a 76-year-old, male, with multiple comorbidities, who experienced a serious (fatal) unexpected event of death (unknown cause). Death occurred 2 days after receiving 2nd dose of mRNA-1273 (Lot# 300042723). Based on the current available information, the event was considered unrelated to the study medication in agreement with the reporter''s assessment. The advance age and multiple co-morbidities may remain as risk factors. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1157379 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Malaise, Nausea, Pneumonia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Atrial fibrillation; Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning a 90- year old-female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced pneumonia, malaise, dyspnea,f atigue, vomiting, nausea, fever and died. The patient''s medical history included Covid-19, dementia and atrial fibrillation. No relevant concomitant medications were reported. On 23-Feb-2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient experienced fatigue. On 26 Feb 2021,t he patient experienced pneumonia, malaise, dyspnea, vomiting, nausea and fever. Treatment information was not provided. The date and the cause of the death was not provided. Autopsy details were not provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date,t he outcome of the events, pneumonia, malaise, dyspnea, fatigue, vomiting, nausea and fever were considered fatal.; Reporter''s Comments: A case of death of a 90- year old-female (date and cause unknown). Patient experienced fatigued 1-day post mRNA-1273, pneumonia, malaise, dyspnea, vomiting, nausea and fever 2-day post mRNA-1273. With pneumonia being of an infective origin and the patient''s advanced age. The other events are assessed as symptoms of pneumonia, Hence, the reported events with fatal outcome is assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown


VAERS ID: 1157383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-04
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Plasma cell myeloma
SMQs:, Haematological malignant tumours (narrow)

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:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Multiple myeloma progression; death; A regulatory authority report was received from a physician concerning a female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history included multiple myeloma. Concomitant product use was not provided by the reporter. On 26-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 23-FEB-2021 the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 04 March 2021, the patient died. No other details were reported. Treatment information was unknown. Action taken with the drug in response to the event was unknown. The patient died on 04 March 2021. The cause of death was multiple myeloma progression. Plans for an autopsy were unknown.; Reporter''s Comments: This is a case of death in a female subject of unknown age with a medical history of multiple myeloma, who died 9 days after receiving second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death:


VAERS ID: 1158404 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 20210127; Test Name: pulse; Result Unstructured Data: normal
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; A regulatory authority report was received from a health care professional concerning a 75-year-old male patient who after the administration of Moderna''s COVID-19 vaccine (mRNA-1273) died (Death). The patient''s medical history was not provided. Concomitant product use was not provided. On 27 Jan 2021, the patient received first dose of two planned doses of mRNA-1273 (Batch number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, approximately 15 minutes after receiving the vaccination, the patient''s pulse (73/ min) and pressure (117/80 mmHg) were taken. Results were normal. On 29 Jan 2021, the patient was found dead by his relatives in his apartment. The patient died on 29 Jan 2021. The cause of death was not reported. Plans for autopsy was not provided. Action taken with the mRNA-1273 was not applicable.; Reporter''s Comments: Very limited information regarding this elderly patient''s death has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1158406 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: BRIVIACT; LAMICTAL; TEVETEN COMP; ZOLPIDEM; PANTOZOL CONTROL
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Compression fracture; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; Myalgia; Fatigue; A regulatory authority report was received from a pharmacist concerning 80year old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myalgia, fatigue and Death. The patient''s medical history included epilepsy, arterial hypertension and compression fracture with vitamin D deficiency. Products known to have been used by the patient, included brivaracetam, lamotrigine, eprosartan mesylate, zolpidem tartrate and pantoprazole sodium sesquihydrate. On 17 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021 the patient had myalgia and fatigue. On 19 Feb 2021, the patient died. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 19 Feb 2021. The cause of death was not provided. An autopsy was not done.; 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 (myalgia and fatigue), a causal relationship cannot be excluded. Very limited information regarding this elderly patient''s death has been provided at this time.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1161377 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Confusional state, Death, Hypotension, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia; Depression
Preexisting Conditions: Medical History/Concurrent Conditions: Difficulty in walking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death unexplained; Confusional state; Hypotension; Asthenia; Pyrexia; This regulatory authority case was reported by a consumer and describes the occurrence of confusional state, hypotension, asthenia and pyrexia 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 Difficulty in walking. Concurrent medical conditions included Arrhythmia and Depression. On 24-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In February 2021, the patient experienced confusional state, hypotension, asthenia and pyrexia. On 09-Mar-2021, the patient died. The cause of death was not reported. It is unknown if an autopsy was performed.; Reporter''s Comments: A case of death of an 89-year-old female patient 13 days post mRNA-1273 administration. Very limited information has been provided about the cause of death hence difficult to assess. However, the patient is of an advanced age. The other events are temporarily associated with the administration of mRNA-1273. Hence causality with mRNA-1273 cannot be excluded; Reported Cause(s) of Death: Death of unknown cause


VAERS ID: 1161759 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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: 2021-03-07
   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: TERAPROST; BISOPROLOL FUMARATE; RAMIPRIL; LASIX [FUROSEMIDE]; XARELTO; ROLUFTA
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No provide medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Il A regulatory authority report was received from a physician concerning a 79-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced hyperpyrexia and death. The patient''s medical history was not provided. Concomitant medications included terazosin hydrochloride, bisoprolol fumarate, ramipril, furosemide, rivaroxaban, and umeclidium bromide. On 04 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 300042723) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, the patient experienced hyperpyrexia. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. On 07 Mar 2021, the patient died. The event of hyperpyrexia was considered fatal. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 79-year-old male patient who experienced hyperpyrexia and death. Very limited information regarding this event has been provided at this time. The event of hyperpyrexia was considered fatal. Plans for an autopsy were not provided.; Sender''s Comments: 12-Mar-2021, the sender is asked to activate the clinical report follow-up procedure.; Reported Cause(s) of Death: hyperpyrexia


VAERS ID: 1168808 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Aortic stenosis (no report available yet from a physician); Prediabetes; Smoker (20 cigarettes a day)
Preexisting Conditions: Medical History/Concurrent Conditions: Altered state of consciousness (patient examined for neurology - cause not identified, epilepsy not ruled out); Comments: Medical history: - no allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; A Regulatory Authority report was received from a physician concerning 57-years-male patient, received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac arrest The patient''s medical history provided by the reporter included prediabetes, smoker, altered state of consciousness and aortic stenosis. No relevant Concomitant medications were reported. On 8 mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 3000493 ) via unknown route for prophylaxis of COVID-19 infection. On 9 mar 2021, the patient experience fatal event of cardiac arrest. Treatment information was not provided Action taken with mRNA-1273 in response to the event was not applicable The patient died on 9 Mar 2021. The cause of the death was reported as cardiac arrest. It was unknown If autopsy was performed. Outcome of the event, cardiac arrest was fatal. The reporter assessed the causality of the event cardiac arrest as not related to mRNA-1273.; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1168836 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: VITAMINE B COMPLEXE; ALLOPURINOL; CLOPIDOGREL +PHARM; PERINDOPRIL ARGININE; ROSUVASTATINE [ROSUVASTATIN]; METOPROLOL [METOPROLOL TARTRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden cardiac death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This regulatory authority case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included NICOTINAMIDE, PANTOTHENATE SODIUM, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (VITAMINE B COMPLEXE), ALLOPURINOL, CLOPIDOGREL BESYLATE (CLOPIDOGREL +PHARM), PERINDOPRIL ARGININE, ROSUVASTATINE [ROSUVASTATIN] and METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]). On 29-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. The patient died on 06-Mar-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. Treatment information was unknown. Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death:


VAERS ID: 1168843 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20210

Write-up: Fixed mydriasis; Convulsive crisis; Unconsciousness; Bilious vomiting; Cardiac arrest; This case was received via an unknown source (no reference has been entered for a health authority) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 08-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient was hospitalized on sometime in March 2021 due to LOSS OF CONSCIOUSNESS, MYDRIASIS, SEIZURE and VOMITING. The patient died on 11-Mar-2021. The reported cause of death was acute cardio-respiratory failure. An autopsy was performed, but no results were provided. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 55-year-old female patient with unknown medical history, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Acute cardio-respiratory failure


VAERS ID: 1170615 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-02-19
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: BRIVARACETAM; LAMOTRIGINE
Current Illness: Epilepsy grand mal
Preexisting Conditions: Medical History/Concurrent Conditions: Craniocerebral injury (Traumatic brain injury 4 years ago with subdural hematoma); Operation NOS; Subdural haematoma (traumatic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Subdural haematoma (traumatic), Craniocerebral injury (Traumatic brain injury 4 years ago with subdural hematoma) in 2017 and Operation NOS. Concurrent medical conditions included Epilepsy grand mal. Concomitant products included BRIVARACETAM and LAMOTRIGINE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 19-Feb-2021 The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. Reporter did not allow further contact.; Sender''s Comments: Based on reporter''s causality of unlikely and considering patient''s underlying epilepsy with possible epileptic seizure the night before with possible tongue bite, the event of death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1170617 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000455 / 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: Bundle branch block left; Cardiac insufficiency; Coronary artery disease; Hypertension arterial; Renal insufficiency; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Effusion pleural
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3000455) for COVID-19 vaccination. The patient''s past medical history included Effusion pleural. Concurrent medical conditions included Bundle branch block left, Coronary artery disease, Hypertension arterial, Cardiac insufficiency, Renal insufficiency and Type II diabetes mellitus. On 08-Mar-2021, 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. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding this event has been provided at this time Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1170711 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-28
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 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: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCATON; ASPIRIN
Current Illness: Hypercholesteraemia; Hypertension; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Gonarthrosis; Myocardial ischaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Death; A Agency Regulatory Authority report was received from a Physician, concerning, a 88-year old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died/ Sudden death. The patient''s medical history included myocardial ischaemia, gonarthrosis, osteoporosis, hypercholesteraemia and hypertension. Concomitant medication included lercanidipine hydrochloride and acetylsalicylic acid On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number G26761A) intramuscularly for COVID-19 infection prophylaxis. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 28-Feb-2021.The cause of the death was unknown. Plans for an autopsy was unknown. The reporter had assessed the causality between the event and mRNA-1273 as unlikely.; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1170712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVEREX-AS KOMB; CARDURA XL
Current Illness: Aortic stenosis; Generalised arteriosclerosis; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: chest pain; This case was received via an unknown source (no reference has been entered for a health authority) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (chest pain) in an 89-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Generalised arteriosclerosis and Aortic stenosis. Concomitant products included indapamide, perindopril arginine (COVEREX-AS KOMB) and DOXAZOSIN MESILATE (CARDURA XL) for Hypertension. On 04-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Feb-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CHEST PAIN (chest pain) (seriousness criterion death). The patient died on 16-Feb-2021. The reported cause of death was Chest pain. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CHEST PAIN (chest pain) to be not related. No treatment information provided; Sender''s Comments: This is a case of death in a 89-year-old male subject with a medical history of hypertension, generalized arteriosclerosis and aortic stenosis, who died 12 days after receiving a dose (unknown whether it is first vs second dose) of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Chest pain


VAERS ID: 1171955 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-25
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Cardiac failure, Nausea, Poor quality sleep
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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: RAMIPRIL; DENOSUMAB
Current Illness: Arterial hypertension; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Cardiac failure; Abdominal pain; Poor sleep; Nausea; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arterial hypertension and Osteoporosis. Concomitant products included RAMIPRIL for Arterial hypertension, DENOSUMAB for Osteoporosis. On 27-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea). On 26-Feb-2021, the patient experienced CARDIAC FAILURE (Cardiac failure) (seriousness criterion death). The patient died on 26-Feb-2021. The reported cause of death was Cardiac failure. An autopsy was not performed. At the time of death, ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE (Cardiac failure), ABDOMINAL PAIN (Abdominal pain), POOR QUALITY SLEEP (Poor sleep) and NAUSEA (Nausea) to be unlikely related. Very limited information regarding these events has been provided at this time and additional information is not expected. A causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1171957 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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; Aspiration pneumonia; Cardiac insufficiency; Cardiomyopathy (hypertensive, valvular and arrhythmogenic cardiopathy); Chronic renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Haemorrhage subarachnoid (status post traumatic subarachnoid haemorrhage); Syncope (recurrent syncope)
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Body temperature; Result Unstructured Data: 38�C
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; Acute dyspnea; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), DYSPNOEA (Acute dyspnea) and PYREXIA (Fever) in a 90-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Syncope (recurrent syncope), Haemorrhage subarachnoid (status post traumatic subarachnoid haemorrhage) in 2019 and Aortic valve replacement. Concurrent medical conditions included Cardiac insufficiency, Cardiomyopathy (hypertensive, valvular and arrhythmogenic cardiopathy), Arterial hypertension, Aspiration pneumonia and Chronic renal insufficiency. On 12-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (Acute dyspnea) (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 06-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 38 �C (High) 38�C. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (Fever) to be possibly related and DEATH (Death) and DYSPNOEA (Acute dyspnea) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality and patient''s advanced age along with multisystem underlying conditions, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1172004 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Medical History/Concurrent Conditions: Atrial fibrillation; AV block third degree; Carotid artery repair; Hyperlipidemia; Hypertension arterial; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; An Agency Regulatory authority report was received from a physician concerning an 82-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history was hypertension arterial, hyperlipidemia, carotid artery repair, nephrectomy, atrial fibrillation, AV block third degree. Concomitant product use was not provided by the reporter. On 08 Mar 2021, prior to onset of the event, the patient received the dose of mRNA-1273 (lot/batch number: 3000495) via unknown route for prophylaxis of COVID-19 infection. On 09 Mar 2021, the patient died. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 09 Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Sender''s Comments: This is a case of death in an 82-year-old male subject with a medical history of hypertension arterial, hyperlipidemia, carotid artery repair, nephrectomy, atrial fibrillation, AV block third degree, who died one day after receiving one dose (unknown whether it is first vs second) of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1173209 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G 26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericardial haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: CHINOTAL; TALLITON; INDAPAMIDE; CAVINTON FORTE; ELIQUIS; TENAXUM; FURON [FUROSEMIDE SODIUM]; POTASSIUM CHLORIDE; BETASERC
Current Illness: Atrial fibrillation; Dizziness; Generalized arteriosclerosis; Hypertension; Myocardial ischaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Haemopericardium; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERICARDIAL HAEMORRHAGE (Haemopericardium) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G 26761A) for COVID-19 vaccination. Concurrent medical conditions included Generalized arteriosclerosis, Myocardial ischaemia, Atrial fibrillation, Hypertension and Dizziness. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, VINPOCETINE (CAVINTON FORTE) and BETAHISTINE HYDROCHLORIDE (BETASERC) for Dizziness, PENTOXIFYLLINE (CHINOTAL) for Generalised arteriosclerosis, INDAPAMIDE and RILMENIDINE PHOSPHATE (TENAXUM) for Hypertension, CARVEDILOL (TALLITON) and POTASSIUM CHLORIDE for Myocardial ischaemia, FUROSEMIDE SODIUM (FURON [FUROSEMIDE SODIUM]) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PERICARDIAL HAEMORRHAGE (Haemopericardium) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Haemopericardium. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PERICARDIAL HAEMORRHAGE (Haemopericardium) to be unlikely related. 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. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Haemopericardium


VAERS ID: 1174442 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-06
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 01-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on 06-Mar-2021 The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered DEATH (Death) to be unlikely related. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unkown cause of death


VAERS ID: 1174833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Death, Glomerular filtration rate, Heart rate, White blood cell count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; METFORMIN; ENALAPRIL; EPOETINE BETA; PARACETAMOL; BUMETANIDE; FUSIDINEZUUR CREME; ATORVASTATINE; FLUTICASON-PROPIONAAT NEUSSPRAY; OXYCODON; TACROLIMUS; FERROFUMARAAT; CALCIUMCARB/COLECALC KAUWTB; MAGNESIUMGLUCONAAT; LANETTECREME
Current Illness: Decompensation cardiac; Polycystic kidney
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 146/68; Test Date: 20210301; Test Name: T; Result Unstructured Data: 36.6 degree Celsius; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 190 milligram per litre; Test Date: 20210302; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 291; Test Date: 20210302; Test Name: eGFR; Test Result: Inconclusive ; Result Unstructured Data: 26; Test Date: 20210301; Test Name: P; Test Result: Inconclusive ; Result Unstructured Data: 68 per minute; Test Name: leucocyten; Test Result: Inconclusive ; Result Unstructured Data: 16.6x10^9/L; Test Date: 20210302; Test Name: leucocyten; Test Result: Inconclusive ; Result Unstructured Data: 24x10^9/L
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 immunization. The patient''s past medical history included Kidney transplant in 2012. Concurrent medical conditions included Polycystic kidney and Decompensation cardiac since 2019. Concomitant products included AMLODIPINE, METFORMIN, ENALAPRIL, EPOETINE BETA, PARACETAMOL, BUMETANIDE from 02-Mar-2021 to 05-Mar-2021, FUSIDINEZUUR CREME, ATORVASTATINE, FLUTICASON-PROPIONAAT NEUSSPRAY, OXYCODON from 02-Mar-2021 to 05-Mar-2021, TACROLIMUS, TACROLIMUS, FERROFUMARAAT, CALCIUMCARB/COLECALC KAUWTB, MAGNESIUMGLUCONAAT, LANETTECREME MET VASELINE, ESOMEPRAZOL, METOPROLOL, PREDNISONE (PREDNISON), MYCOFENOLAAT MOFETIL, METOCLOPRAMIDE ZETPIL from 02-Mar-2021 to 05-Mar-2021, MACROGOL POEDER V DRANK 1G/G and POVIDON OOGDRUPPELS. On 01-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 04-Mar-2021 The patient died on 04-Mar-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Blood pressure measurement: 146/68 millimetre of mercury 146/68. On 01-Mar-2021, Body temperature: 36.6 degree Celsius 36.6. On 01-Mar-2021, Heart rate: 68 per minute 68. On 02-Mar-2021, C-reactive protein: 291 milligram per litre 291. On 02-Mar-2021, Glomerular filtration rate: 26ml/min millilitre per minute 26ml/min. On 02-Mar-2021, White blood cell count: 24x10^9/l 10^9/L 24x10^9/L. On an unknown date, C-reactive protein: 190 190. On an unknown date, White blood cell count: 16.6x10^9/l 10^9/L 16.6x10^9/L. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and additional information is not expected. A causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1176377 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-16
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VASCORD HCT
Current Illness: Apnea (Moderate combined sleep apnea); Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: GI bleed (History of intestinal bleeding with Diclofenac use); Glaucoma; Rotator cuff tear (Transmural lesion of the infraspinatus tendon right); Rotator cuff tear (Right rotator cuff lesion); Tendon dislocation (Medially displaced right long biceps tendon); Tendon rupture (Rupture of right supraspinatus tendon); Tendon rupture (At least partial rupture of the right subscapularis tendon)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. UNK and UNK) for COVID-19 vaccination. The patient''s past medical history included GI bleed (History of intestinal bleeding with Diclofenac use), Rotator cuff tear (Right rotator cuff lesion), Tendon rupture (Rupture of right supraspinatus tendon), Rotator cuff tear (Transmural lesion of the infraspinatus tendon right), Tendon rupture (At least partial rupture of the right subscapularis tendon) and Tendon dislocation (Medially displaced right long biceps tendon). Concurrent medical conditions included Arterial hypertension, Apnea (Moderate combined sleep apnea) and Glaucoma. Concomitant products included AMLODIPINE BESILATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (VASCORD HCT) from an unknown date to 16-Mar-2021 for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 16-Mar-2021 The patient died on 16-Mar-2021. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. No treatment information was provided. Reporters comment: First vaccination date is unclear (28 days before apparently), second was on Mar 11, 2021 The only medication he was taking was Vascord HCT Case narrative: Patient with no known allergies. On Dicloflenac history of intestinal bleeding Smoker: no Alcohol: no Kidney disease: no Liver disease: no Known for arterial hypertension, moderate combined sleep apnoea, right rotator cuff lesion, rupture of right supraspinatus tendon transmural lesion of right infraspinatus tendon at least partial rupture of right subscapularis tendon medially displaced right long biceps tendon. Glaucoma The only medication he was taking was Vascord HCT. The patient was vaccinated with Moderna for the second time on Mar 11, 2021 (first dose 28 days before), and on Mar 16, 2021 he was suddenly found dead in his flat. No relevant previous illnesses which could explain the death. Cause of death unclear, a forensic autopsy is not scheduled. Reporter did not allow further contact; Reporter''s Comments: Death in temporal correlation with the Moderna vaccine (after 5 days) in an elderly patient with high blood pressure and sleep apnoea. Age as well as high blood pressure and sleep apnoea, in the first instance, suggest an acute cerebrovascular event. At the moment, there are no known data in the literature correlating sudden deaths with the Moderna Vaccine and, for this reason, even given an initial hypothesis of an acute cerebrovascular event, we consider the causal link to be unlikely, which does not completely rule out a possible involvement in the absence of data that can shed more light (e.g., autopsy).; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information is required.; Reported Cause(s) of Death: Cause of death


VAERS ID: 1176425 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history reported.). On 04-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form(s). On 05-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1181203 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

Administered by: Unknown       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: CARDICOR; URBASON [METHYLPREDNISOLONE ACETATE]; GLAZIDIM; LASIX [FUROSEMIDE]; SEVELAMER
Current Illness: Dialysis NOS; Lung neoplasm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death from natural causes; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death from natural causes) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. Concurrent medical conditions included Dialysis NOS and Lung neoplasm Concomitant products included BISOPROLOL FUMARATE (CARDICOR), METHYLPREDNISOLONE ACETATE (URBASON [METHYLPREDNISOLONE ACETATE]), CEFTAZIDIME (GLAZIDIM), FUROSEMIDE (LASIX [FUROSEMIDE]) and SEVELAMER for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage form in total. Death occurred on 04-Mar-2021 The patient died on 04-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. This is a case of sudden death in a 80-year-old male patient with a history of Dialysis NOS and Lung neoplasm, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 80-year-old male patient with a history of Dialysis NOS and Lung neoplasm, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: death from natural causes


VAERS ID: 1181240 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoglobin, Pancytopenia, Platelet count, Subdural haematoma, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   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: CALCIGRAN FORTE; NORMORIX; SIMVASTATIN; BEHEPAN [CYANOCOBALAMIN]; SELO-ZOK; SOMAC; AMLODIPINE; ZYLORIC; PROLIA; ALBYL-E
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Hemoglobin; Result Unstructured Data: 7.0; Test Date: 20210315; Test Name: Thrombocyte count; Result Unstructured Data: <5 Not measurable; Test Date: 20210315; Test Name: Leukocyte count; Result Unstructured Data: 1.1
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Pancytopenia; Subdural hematoma; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PANCYTOPENIA (Pancytopenia) and SUBDURAL HAEMATOMA (Subdural hematoma) in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation, Hypertension and Aortic stenosis. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIGRAN FORTE) from an unknown date to 16-Mar-2021, AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (NORMORIX) from an unknown date to 16-Mar-2021, SIMVASTATIN from an unknown date to 16-Mar-2021, CYANOCOBALAMIN (BEHEPAN [CYANOCOBALAMIN]) from an unknown date to 16-Mar-2021, METOPROLOL SUCCINATE (SELO-ZOK) from an unknown date to 16-Mar-2021, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC) from an unknown date to 16-Mar-2021, AMLODIPINE, ALLOPURINOL (ZYLORIC) from an unknown date to 16-Mar-2021, DENOSUMAB (PROLIA) from an unknown date to 16-Mar-2021 and ACETYLSALICYLIC ACID, MAGNESIUM OXIDE (ALBYL-E) from an unknown date to 16-Mar-2021 for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced SUBDURAL HAEMATOMA (Subdural hematoma) (seriousness criterion death). On an unknown date, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criterion death). The patient died on 16-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Haemoglobin: 7.0 7.0. On 15-Mar-2021, Platelet count: <5 not measurable <5 Not measurable. On 15-Mar-2021, White blood cell count: 1.1 1.1. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PANCYTOPENIA (Pancytopenia) and SUBDURAL HAEMATOMA (Subdural hematoma) to be possibly related. This is a case of sudden death in a 89-year-old female patient with a history of Atrial fibrillation, Hypertension and Aortic stenosis, who died after receiving first dose of vaccine (date unknown). Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 89-year-old female patient with a history of Atrial fibrillation, Hypertension and Aortic stenosis, who died after receiving first dose of vaccine (date unknown). Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1183627 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-19
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Arrhythmia (NOS); Arterial hypertension; Atrial fibrillation; Chronic renal failure; Cognitive disturbance; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Myocardial infarction; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in an 89-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Chronic renal failure, Arterial hypertension, Arrhythmia (NOS), Aortic stenosis, Diabetes mellitus, Cognitive disturbance and Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criterion death). The patient died on 19-Mar-2021. The reported cause of death was suspected myocardial infarction as a cause of death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Myocardial infarction) to be unlikely related. No treatment included Reporter did not allow further contact; Sender''s Comments: This is a case of sudden death in a 89-year-old male patient with a history of Chronic renal failure, Arterial hypertension, Arrhythmia (NOS), Aortic stenosis, Diabetes mellitus, Cognitive disturbance and Atrial fibrillation, who died of Myocardial infarction 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Suspected myocardial infarction as a cause of death


VAERS ID: 1183680 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: Body temperature; Result Unstructured Data: 39.4 degree Celsius
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA (Pyrexia) in a 98-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Pyrexia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 39.4 degree Celsius (High) 39.4. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided. Treatment medication was not provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the fatal event of pyrexia has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1185588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-03-08
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No relevant medical history provided)
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: glasgow score; Result Unstructured Data: Glasgow score 6
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Hemorrhagic stroke; A regulatory authority report was received from a health care professional concerning a 78-year-old, female patient who received Moderna''s Covid-19 vaccine (mRNA-1273) and experienced Hemorrhagic stroke. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot number: Unkown) intramuscularly in the arm for prophylaxis of COVID-19 infection.. On 25 Feb 2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: Unkown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 8 Mar 2021, the patient had a glasgow score of 6, which then rose to 3/15. She presented with several episodes of biliary vomiting and bronchial aspiration. After intubation on site, she was transferred to the emergency room and then to intensive care. In the emergency room, the brain CT scan showed a right hemispherical cerebral hemorrhage with signs of herniation that appeared hypertensive at initial hypothesis. On 09 Mar 2021, the patient died. The cause of death was hemorrhagic stroke. Plans for an autopsy were unknown. Treatment information was not provided.; Reporter''s Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1187734 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Cardiac failure congestive, Decreased appetite, Dehydration, Diarrhoea, Malaise, Pneumonia viral, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210212; Test Name: SARS-CoV-2 trapid test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: SIMODERNATX, INC.MOD20210

Write-up: Viral pneumonia; Acute renal failure; Congestive heart failure; Dehydration; Acute respiratory failure; Fever; DIARRHEA; Significant general malaise; Inappetence; A regulatory authority report was received from a physician concerning a 92-years-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced viral pneumonia, diarrhea, significant general malaise/malaise, acute renal failure/acute kidney injury, fever/pyrexia, congestive heart failure/cardiac failure congestive, dehydration, acute respiratory failure and inappetence/decreased appetite. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 11 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 300042698) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced inappetence, diarrhea and significant general malaise. On 12 Feb 2021, the patient experienced fever and tested positive for COVID-19 PCR test and COVID-19 virus test. On 14 Feb 2021, the patient experienced viral pneumonia, acute renal failure, congestive heart failure, acute respiratory failure and dehydration. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, viral pneumonia, diarrhea, significant general malaise, acute renal failure, fever, congestive heart failure, dehydration, acute respiratory failure and inappetence, were reported as fatal. The patient died on 24 Feb 2021. The cause of death was reported as viral pneumonia. Plans for an autopsy were not provided.; Sender''s Comments: This is a case of death in a 92-year-old male subject with unknown medical history, who died 13 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Viral pneumonia


VAERS ID: 1188895 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-25
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042723 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   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 MESILATE; VORTIOXETINE HYDROBROMIDE; MELATONIN; COLECALCIFEROL; GLYCOPYRRONIUM BROMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial carcinoma cell type unspecified stage III; COPD; Depression; Hypertension; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Patient collapsed and died while out walking; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Patient collapsed and died while out walking) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 30042723 and 30042723) for COVID-19 vaccination. The patient''s past medical history included Bronchial carcinoma cell type unspecified stage III in 2011, Hypertension, Depression, Sleep disorder and COPD. Concomitant products included AMLODIPINE MESILATE, VORTIOXETINE HYDROBROMIDE, MELATONIN, COLECALCIFEROL and GLYCOPYRRONIUM BROMIDE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on 25-Feb-2021 The patient died on 25-Feb-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown Route), the reporter considered DEATH (Patient collapsed and died while out walking) to be unlikely related. Concomitant medications were amlodipine mesilate, vortioxetine hydrobromide, melatonin, colecalciferol, gycopyronnium bromide. This is a case of death in a 80-year-old male subject with a medical history of bronchial carcinoma cell type unspecified stage III in 2011, hypertension, depression, sleep disorder and COPD, who died 6 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 80-year-old male subject with a medical history of bronchial carcinoma cell type unspecified stage III in 2011, hypertension, depression, sleep disorder and COPD, who died 6 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1189254 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Echocardiogram, Malaise, Nausea
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 (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
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: COPD; Interstitial lung disease (Was waiting for a lung transplantation); Pulmonary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Echocardiography; Result Unstructured Data: good left ventricle function, dilated right ventricle
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Dyspnoea; Feeling unwell; NAUSEA; Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DYSPNOEA (Dyspnoea), MALAISE (Feeling unwell) and NAUSEA (NAUSEA) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Interstitial lung disease (Was waiting for a lung transplantation), COPD and Pulmonary hypertension. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization), MALAISE (Feeling unwell) (seriousness criterion hospitalization) and NAUSEA (NAUSEA) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 16-Mar-2021. The reported cause of death was Cardiac arrest. An autopsy was performed, but no results were provided. At the time of death, DYSPNOEA (Dyspnoea), MALAISE (Feeling unwell) and NAUSEA (NAUSEA) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Echocardiogram: dilated right ventricle (abnormal) good left ventricle function, dilated right ventricle. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1193830 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cardiogenic shock, Confusional state, Dyspnoea, Electrocardiogram, Hypotension, Sinus tachycardia, Syncope, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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: ASPIRIN CARDIO; CONCOR; JANUVIA [SITAGLIPTIN PHOSPHATE]; EUTHYROX; NITRODERM; CITALOPRAM MEPHA; PANTOZOL CONTROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hashimoto''s thyroiditis; Ischaemic cardiomyopathy; Metabolic syndrome; Terminal renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: blood pressure; Result Unstructured Data: 80/60 mmHg, hypovolemic shock; Test Date: 20210313; Test Name: ECG; Result Unstructured Data: revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2; Test Date: 20210313; Test Name: troponin; Result Unstructured Data: ng/L; Test Date: 20210314; Test Name: troponin; Result Unstructured Data: ng/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: cardiogenic shock; dyspnoeic; confused; syncope; sinus tachycardia; low blood pressure (80/60); Asthenia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock), HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) in a 93-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Ischaemic cardiomyopathy in 2017, Terminal renal insufficiency and Metabolic syndrome. Concurrent medical conditions included Diabetes mellitus in 1981 and Hashimoto''s thyroiditis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE (CONCOR), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), LEVOTHYROXINE SODIUM (EUTHYROX), GLYCERYL TRINITRATE (NITRODERM), CITALOPRAM HYDROBROMIDE (CITALOPRAM MEPHA) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOZOL CONTROL) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPOTENSION (low blood pressure (80/60)) (seriousness criteria hospitalization and medically significant) and ASTHENIA (Asthenia) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced SYNCOPE (syncope) (seriousness criteria hospitalization and medically significant) and SINUS TACHYCARDIA (sinus tachycardia) (seriousness criterion hospitalization). On 14-Mar-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criteria death, hospitalization and medically significant), DYSPNOEA (dyspnoeic) (seriousness criterion hospitalization) and CONFUSIONAL STATE (confused) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to ASTHENIA, CARDIOGENIC SHOCK, CONFUSIONAL STATE, DYSPNOEA, HYPOTENSION, SINUS TACHYCARDIA and SYNCOPE. The patient died on 14-Mar-2021. The reported cause of death was Cardiogenic shock. An autopsy was not performed. At the time of death, HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood pressure measurement: 80/60 mmhg 80/60 mmHg, hypovolemic shock. On 12-Mar-2021, Electrocardiogram: Inconclusive. On 13-Mar-2021, Electrocardiogram: abnormal revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2. On 13-Mar-2021, Troponin increased: 1889 ng/L. On 14-Mar-2021, Troponin increased: 8175 ng/L. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIOGENIC SHOCK (cardiogenic shock) to be unlikely related. No further causality assessments were provided for HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused). On 13/03/2021, during her usual hemodialysis session, after approx. 1 h 30 min from the start of dialysis, presented with marked low blood pressure with an episode of syncope lasting approximately 10-15 minutes, fluctuate with unstable haemodynamic Treatment medication include "Noradrenaline and Dobutamine support" and also gradually reduce the catecholamine therapy in progress and to accompany this with palliative care. The patient died on 14/03/2021 at 12:48 with her family present. Reason for death: cardiogenic shock following acute STEMI-type coronary syndrome in a context of ischemic-hypertensive heart disease. Company comment:Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1193833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (death) 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 No adverse event (No reported medical history.). On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 05-Mar-2021 The patient died on 05-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (death) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: This case refers to an 88 year-old elderly female patient who died 48 hours after receiving the mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1193836 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 722 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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: Cardiac failure; Immobilization prolonged; Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA and PYREXIA (Fever) in a 101-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 722) for COVID-19 vaccination. The patient''s past medical history included Immobilization prolonged, Cardiac failure and Weakness. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 08-Mar-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1193971 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-03-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Dizziness, Feeling hot, Myalgia, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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:
Current Illness: Spinal disorder (Degeneration of the spine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Respiratory failure; Dizziness; Feeling hot; Weakness generalized; Muscle pain; COVID-19; This regulatory authority case was reported by a non-health professional and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) and COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal disorder (Degeneration of the spine). On 20-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain). On 05-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criterion death) and COVID-19 (COVID-19) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Respiratory failure and covid-19, virus identified. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. The reporter''s contact information was not provided. Reporter did not allow further contact; Reported Cause(s) of Death: Respiratory failure; COVID-19, virus identified


VAERS ID: 1197417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-18
Submitted: 0000-00-00
Entered: 2021-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea
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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker user; Fibrosis lung; Oxygen therapy (O2 therapy at home)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: dyspnea for one week with worsening; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibrosis lung, Oxygen therapy (O2 therapy at home) and Artificial cardiac pacemaker user. On 19-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form in total. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (dyspnea for one week with worsening). On 19-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criterion death). The patient died on 19-Mar-2021. The reported cause of death was Standstill cardiac. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (dyspnea for one week with worsening) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact; Reporter''s Comments: Cardiac arrest in patient with multiple conditions (severe pulmonary fibrosis on O2 therapy at home + implanted PM) that occurred this morning after the second dose of the Moderna vaccine. Relatives reported dyspnea for one week with worsening since yesterday evening.; Reported Cause(s) of Death: Standstill cardiac


VAERS ID: 1202833 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0004246 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchoalveolar lavage, Computerised tomogram, Death, Decreased appetite, Dyspnoea, Fatigue, Headache, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Ex-tobacco user; Hepatic cirrhosis; Hypothyroidism; Idiopathic pulmonary fibrosis; Osteoporosis; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Bronchoalveolar lavage; Result Unstructured Data: Severely contaminated with bronchial secretion and blood; Test Date: 2021; Test Name: CT; Result Unstructured Data: CT shows ground glass changes; Test Date: 2021; Test Name: SpO2; Test Result: 85 %; Result Unstructured Data: low; Test Date: 2021; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: COVID swab 2 x negative
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: dyspnea exacerbated; headache; inappetence; fatigue; death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death), DYSPNOEA (dyspnea exacerbated), HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 0004246) for COVID-19 vaccination. The patient''s past medical history included Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis. On 21-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DEATH (death) (seriousness criterion death), DYSPNOEA (dyspnea exacerbated) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization), DECREASED APPETITE (inappetence) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). The patient died on an unknown date. At the time of death, DYSPNOEA (dyspnea exacerbated), HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Bronchoalveolar lavage: abnormal (abnormal) Severely contaminated with bronchial secretion and blood. In 2021, Computerised tomogram: abnormal (abnormal) CT shows ground glass changes. In 2021, Oxygen saturation: 85 percent (Low) low. In 2021, SARS-CoV-2 test: negative (Negative) COVID swab 2 x negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) to be possibly related and DYSPNOEA (dyspnea exacerbated) to be unlikely related. No further causality assessment was provided for DEATH (death). No concomitant medication were reported. No treatment medications were provided. This is a case of death in a 79-year-old female subject with a medical history of Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis, who died 18 days after receiving the first dose of vaccine. Based on reporter''s causality of attributing to pulmonary fibrosis exacerbation, the death is assessed as unlikely related to mRNA-1273. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 79-year-old female subject with a medical history of Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis, who died 18 days after receiving the first dose of vaccine. Based on reporter''s causality of attributing to pulmonary fibrosis exacerbation, the death is assessed as unlikely related to mRNA-1273. No follow up is possible.


VAERS ID: 1202846 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: IMOVANE 3.75 mg; LEVOTHYROXINE SODIUM; LASILIX 40 mg; BISOPROLOL FUMARATE; MONOPROST 50 mg/ml; SIMBRINZA 10 mg/ml + 2 mg/ml; PRAVASTATIN SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial; Ischaemic heart disease; Subdural haematoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Ischemic stroke; This case was received via Company (Reference number: QTS-210409-125) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Ischemic stroke) in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. The patient''s past medical history included Subdural haematoma, Ischaemic heart disease and Fibrillation atrial. Concomitant products included PRAVASTATIN SODIUM [PRAVASTATIN SODIUM] from an unknown date to 10-Mar-2021 for Dyslipidaemia, LEVOTHYROXINE SODIUM from an unknown date to 10-Mar-2021 for Hypothyroidism, LASILIX 40 mg from an unknown date to 10-Mar-2021 and BISOPROLOL FUMARATE from an unknown date to 10-Mar-2021 for Ischaemic heart disease, IMOVANE 3,75 mg from an unknown date to 10-Mar-2021, MONOPROST 50 mg/ml from an unknown date to 10-Mar-2021 and SIMBRINZA 10 mg/ml and 2 mg/ml from an unknown date to 10-Mar-2021 for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 12-Mar-2021. The reported cause of death was Ischemic stroke. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included PRAVASTATIN SODIUM from an unknown date to 10-Mar-2021 for Dyslipidaemia, LEVOTHYROXINE SODIUM from an unknown date to 10-Mar-2021 for Hypothyroidism, LASILIX 40 mg from an unknown date to 10-Mar-2021 and BISOPROLOL FUMARATE from an unknown date to 10-Mar-2021 for Ischaemic heart disease, IMOVANE 3,75 mg from an unknown date to 10-Mar-2021, MONOPROST 50 mg/ml from an unknown date to 10-Mar-2021 and SIMBRINZA 10 mg/ml + 2 mg/ml from an unknown date to 10-Mar-2021 for an unknown indication. This is a case of death in a 92-year-old male subject with unknown medical history of Subdural hematoma, Ischemic heart disease and Fibrillation atrial, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 92-year-old male subject with unknown medical history of Subdural hematoma, Ischemic heart disease and Fibrillation atrial, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1202862 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Mouth haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: LASITONE; DUOPLAVIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Mild febrile episode the day after vaccination, death overnight, blood stains found at labial commisure; blood stains found at labial commisure; Mild febrile episode the day after vaccination; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021 and was forwarded to Moderna on 01-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Mild febrile episode the day after vaccination, death overnight, blood stains found at labial commisure) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event. Previously administered products included for Product used for unknown indication: GASTROLOC - "20 MG COMPRESSE GASTRORESISTENTI" 14 COMPRESSE IN BLISTER AL/OPA/AL/PVC (GLAX and FOSTER (CHIESI FARMACEUTICI S.P.A.) (R03AK08). Past adverse reactions to the above products included No adverse reaction with FOSTER (CHIESI FARMACEUTICI S.P.A.) (R03AK08) and GASTROLOC - "20 MG COMPRESSE GASTRORESISTENTI" 14 COMPRESSE IN BLISTER AL/OPA/AL/PVC (GLAX. Concomitant products included ACETYLSALICYLIC ACID, CLOPIDOGREL BISULFATE (DUOPLAVIN) from 06-Jul-2016 to 19-Mar-2021 for Atherothrombosis prophylaxis, FUROSEMIDE, SPIRONOLACTONE (LASITONE) from 01-Aug-2012 to 19-Mar-2021 for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 18-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Mild febrile episode the day after vaccination). On 19-Mar-2021, the patient experienced MOUTH HAEMORRHAGE (blood stains found at labial commisure). The patient died on 19-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOUTH HAEMORRHAGE (blood stains found at labial commisure) and PYREXIA (Mild febrile episode the day after vaccination) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Per the patient''s family, the patient was in a state of well-being at the time of vaccination. Treatment information was not provided. Company comment: Very limited information regarding these events has been provided at this time. Patient''s age along with unknown underlying conditions may have been contributory for the occurrence of the death. No further follow-up information is expected. Reporter did not allow further contact; Reported Cause(s) of Death: Death


VAERS ID: 1202944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Cerebral thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by an other and describes the occurrence of BLOOD GLUCOSE INCREASED and CEREBRAL THROMBOSIS in a 76-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Diabetes, Ehlers-Danlos syndrome and Hypertension. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In February 2021, the patient experienced BLOOD GLUCOSE INCREASED (seriousness criterion death) and CEREBRAL THROMBOSIS (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Treatment information was not provided. Concomitant medications were not reported. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1206437 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000424 60 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate, International normalised ratio, Ultrasound scan
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: ATORVASTATIN CALCIUM ANHYDROUS; BILOL; DILTIAZEM HYDROCHLORIDE R; PHENPROCOUMON
Current Illness: Arterial hypertension; Atrial fibrillation paroxysmal (Paroxysmal atrial fibrillation/flutter - CHADs2 Score 1); Atrial flutter; Dyslipidemia; Hypertensive heart disease (mild concentric left ventricular hypertrophy); Prostatic hyperplasia
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (Asymptomatic infrarenal partially thrombosed abdominal aortic aneurysm Aneurysm of left common femoral artery); Aortic dissection (History of de/rebranching of internal iliac artery and bilateral endovascular aortic prosthesis May 2008); Aortic ectasia (Ectasia of internal and common iliac arteries, right common femoral and left popliteal artery); Arterial graft (Stent graft extension of the left iliac artery); Artery dissection (Asymptomatic dissection of distal superior mesenteric artery); Colonic polyp; Polyp removal (polyp removal in 2011 and 2014); Polypectomy (of 4 polyps); Renal cyst (Two large cortical renal cysts on left (9.9 and 5.1 cm),); Total hip replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: BP; Result Unstructured Data: Normal; Test Date: 20210127; Test Name: Pulse; Result Unstructured Data: Normal; Test Date: 20210112; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 2.8; Test Name: Abdominal sonogram; Test Result: Inconclusive ; Result Unstructured Data: Two large cortical renal cysts on left (9.9 and 5.1 cm)
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 75-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000424 60) for COVID-19 vaccination. The patient''s past medical history included Aneurysm (Asymptomatic infrarenal partially thrombosed abdominal aortic aneurysm Aneurysm of left common femoral artery) in May 2008, Renal cyst (Two large cortical renal cysts on left (9.9 and 5.1 cm),), Colonic polyp on 13-Mar-2018, Aortic ectasia (Ectasia of internal and common iliac arteries, right common femoral and left popliteal artery), Artery dissection (Asymptomatic dissection of distal superior mesenteric artery), Polyp removal (polyp removal in 2011 and 2014) in 2011, Polypectomy (of 4 polyps) in August 2018, Total hip replacement on 15-Oct-2020, Aortic dissection (History of de/rebranching of internal iliac artery and bilateral endovascular aortic prosthesis May 2008) in May 2008 and Arterial graft (Stent graft extension of the left iliac artery) on 13-Mar-2018. Concurrent medical conditions included Atrial fibrillation paroxysmal (Paroxysmal atrial fibrillation/flutter - CHADs2 Score 1), Arterial hypertension, Hypertensive heart disease (mild concentric left ventricular hypertrophy), Dyslipidemia, Prostatic hyperplasia since June 2020 and Atrial flutter. Concomitant products included ATORVASTATIN CALCIUM ANHYDROUS, BISOPROLOL FUMARATE (BILOL), DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE R) and PHENPROCOUMON for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-Jan-2021 The patient died on 29-Jan-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-Jan-2021, International normalised ratio: 2.8 (Inconclusive) 2.8. On 27-Jan-2021, Blood pressure measurement: 117/80 (normal) Normal. On 27-Jan-2021, Heart rate: 73 (normal) Normal. On an unknown date, Ultrasound scan: abnormal (Inconclusive) Two large cortical renal cysts on left (9.9 and 5.1 cm). For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. Causality is also confounded by the patient''s advanced age and medical history of Atrial fibrillation paroxysmal / atrial flutter- CHADs2 Score 1, Arterial hypertension, Hypertensive heart disease , Aneurysm and previous surgery for aortic dissection. The cause of death was not reported. Reporter did not allow further contact; Sender''s Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. Causality is also confounded by the patient''s advanced age and medical history of Atrial fibrillation paroxysmal / atrial flutter- CHADs2 Score 1, Arterial hypertension, Hypertensive heart disease , Aneurysm and previous surgery for aortic dissection. The cause of death was not reported.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1206443 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: ESOMEPRAZOLE; NICOBION; TRIMBOW; LEXOMIL 6 mg, double-scored tablet; OROCAL; VENLAFAXINE; VITAMINE B1 B6 BAYER; VENTOLINE
Current Illness: Cachexia
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (Gold IV); Depression; Dyspnoea on effort; Reflux esophagitis (Grade 3); Smoker; Ulcer peptic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Ulcer peptic, Depression, COPD (Gold IV), Smoker, Reflux esophagitis (Grade 3) and Dyspnoea on effort. Concurrent medical conditions included Cachexia. Concomitant products included ESOMEPRAZOLE, NICOTINAMIDE (NICOBION), BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (TRIMBOW), BROMAZEPAM (LEXOMIL 6 mg, double-scored tablet), CONCENTRAT DE CHOLECALCIFEROL, FORME PULVERULENTE, CALCIUM (CARBONATE DE), CARBONATE DE CALCIUM (OROCAL), VENLAFAXINE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMINE B1 B6 BAYER) and SALBUTAMOL (SULFATE DE), SULFATE DE SALBUTAMOL (VENTOLINE) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 11-Mar-2021. The reported cause of death was Sudden death unexplained. 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 . This case was received from a regulatory authority (FR-AFSSAPS-NY20210563). Reporter did not allow further contact; Sender''s Comments: Very limited information regarding this event has been provided at this time. Patient''s advanced age along with underlying conditions may have been contributory for the occurrence of the death. No further follow-up information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1208852 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Circulatory collapse, Hypotension, Hypoxia, Oxygen saturation, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

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: ATORVASTATIN; ASPIRIN CARDIO; PERINDOPRIL
Current Illness: Aortic valve sclerosis; Dementia; Hypertensive heart disease; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210313; Test Name: temperature; Result Unstructured Data: fever 38.4 celsius; Test Date: 20210313; Test Name: oxygen saturation; Result Unstructured Data: 80
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Hypotension; Cardiovascular collapse; Hypoxemia; Fever; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Hypotension) and CIRCULATORY COLLAPSE (Cardiovascular collapse) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertensive heart disease, Aortic valve sclerosis, Osteoporosis and Dementia. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN CARDIO) and PERINDOPRIL for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPOTENSION (Hypotension) (seriousness criterion death), CIRCULATORY COLLAPSE (Cardiovascular collapse) (seriousness criterion death), HYPOXIA (Hypoxemia) and PYREXIA (Fever). On 13-Mar-2021, HYPOXIA (Hypoxemia) and PYREXIA (Fever) had not resolved. The patient died on 13-Mar-2021. The reported cause of death was Hypotension, Cardiovascular collapse, Hypoxemia and Fever. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature increased: 38.4 celsius (High) fever 38.4 celsius. On 13-Mar-2021, Oxygen saturation: 80 (Low) 80. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered PYREXIA (Fever) to be possibly related and HYPOTENSION (Hypotension), CIRCULATORY COLLAPSE (Cardiovascular collapse) and HYPOXIA (Hypoxemia) to be unlikely related. Action taken with mRNA-1273 in response to the events was not Applicable. Patient experienced pyrexia (38.4� C), breathing difficulty (80% saturation; "Bioxx ca 80"), for which she was administered with oxygen and, afterwards, experienced low blood pressure with cardiovascular collapse and died (on 13/03/2021). This case concerns an 88 year old female patient, with a medical history of Hypertensive heart disease and Aortic valve sclerosis, who experienced a serious unexpected event of Death (fatal) 1 day after receiving her 1st dose of mRNA- 1273. Very limited information regarding these events has been provided at this time. However, the patient''s advance age and multiple co-morbidities may remain as risk factors. Further information is not expected. Reporter did not allow further contact; Sender''s Comments: This case concerns an 88 year old female patient, with a medical history of Hypertensive heart disease and Aortic valve sclerosis, who experienced a serious unexpected event of Death (fatal) 1 day after receiving her 1st dose of mRNA- 1273. Very limited information regarding these events has been provided at this time. However, the patient''s advance age and multiple co-morbidities may remain as risk factors. Further information is not expected.; Reported Cause(s) of Death: Hypotension; Cardiovascular collapse; Hypoxemia; Fever


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