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.
Myopericarditis; Pyrexia; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP109779) on 19-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This case, initially reported to the Regulatory Agency (RA) by a physician, was received via the RA (Ref, v21129527). On an unknown date, the patient received the 1st dose of the vaccine. On 09-Oct-2021, the patient received the 2nd dose of the vaccine. From 10-Oct-2021 to 11-Oct-2021, the patient had pyrexia of 38s degrees Celsius. On 12-Oct-2021, at 03:00, the patient was aware of pain in the left chest for approximately 10 minutes. As chest discomfort sensation persisted thereafter, the patient visited a hospital. An electrocardiogram showed ST elevations in II, III, and aVF, and the result of blood sampling revealed an inflammatory response and elevated cardiac enzymes. Echocardiography showed enhanced pericardium brightness and accumulation of pericardial fluid. The patient was admitted to the hospital for suspected myopericarditis. On an unspecified date, as of the date, any virus that can cause myocarditis had not been detected. Cardiac contrast-enhanced MRI showed findings suggestive of myocarditis. The result of myocardial biopsy showed normal findings of myocardium. After being hospitalized, the patient had no chest pain, cardiac failure, or arrythmia, and the course of the disease was favorable without transformation to fulminant myocarditis. The symptoms had not resolved. The outcome of pyrexia and myopericarditis was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender's Comments: This case concerns a 17 year old male patient, with no relevant medical history reported, who experienced serious unexpected AESI of myocarditis after second dose of mRNA-1273. The event occurred 4 days after second dose of mRNA-1273. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 3005791 | OT |
| RECVDATE: | 10-27-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: Myocardial biopsy; Result Unstructured Data: Normal; Test Date: 20211012; Test Name: Blood sampling; Result Unstructured Data: Revealed an inflammatory response and elevated cardiac enzymes; Test Date: 20211010; Test Name: Body temperature; Result Unstructured Data: 38s Cel; Test Date: 20211011; Test Name: Body temperature; Result Unstructured Data: 38s Cel; Test Date: 20211012; Test Name: Echocardiography; Result Unstructured Data: Showed enhanced pericardium brightness and accumulation of pericardial fluid.; Test Date: 20211012; Test Name: Electrocardiogram; Result Unstructured Data: Showed ST elevations in II, III, and aVF; Test Name: Cardiac contrast-enhanced MRI; Result Unstructured Data: Showed findings suggestive of myocarditis |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPMODERNATX, INC.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-26-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.