Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
temperatures of 38.4C; 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 38.4C 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
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 300042460 | OT |
| RECVDATE: | 03-26-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 01-25-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 4 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| 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 |
| V_ADMINBY: | |
| OTHER_MEDS: | COLCHICINE; ALLOPURINOL; ASPIRIN CARDIO; HYDROCHLOROTHIAZIDE;VALSARTAN; CALCIMAGON D3 UNO; GABAPENTIN MEPHA; SPIRICORT; TOREM COR; TRAMAL RETARD; VITAMIN D3 STREULI; ZOLPIDEM STREULI |
| CUR_ILL: | Arterial hypertension; Chronic renal failure; Colon diverticulitis; Polymyalgia rheumatica; Urolithiasis (relapsing) |
| HISTORY: | Medical History/Concurrent Conditions: Spondylolisthesis |
| PRIOR_VAX: | |
| SPLTTYPE: | CHMODERNATX, INC.MOD20210 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-25-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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