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.
Woke up at night with severe left shoulder pain, 12 days after 1st vaccination, which receded and he went to bed. No symptoms the next day. Woke up early the following morning (now 14 days after vaccination) with L shoulder pain, chest pain, nausea, pale in color, at which point he was taken to the local ED. He was treated with ibuprofen and colchicine and had symptomatic resolution in less than twelve hours. Troponin began to decrease 12 hours after admission, decreased from high of 18 ng/ml to 0.34 ng/ml at time of discharge 3 days after presentation.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FC3184 | IM | UN |
| RECVDATE: | 10-04-2021 | RPT_DATE: |
| CAGE_YR: | 13 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | 9/29 troponin: 0.64->16->18 ; 9/30 troponin: 13->12 ; EKG: Diffuse ST segment elevations ; Echo: normal; Cardiac MRI showed edema consistent with myocarditis (10/1). Enterovirus PCR and Adenovirus PCR drawn 9/29 were negative. No other likely cause of myocarditis was identified prior to discharge |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | Claritin |
| CUR_ILL: | |
| HISTORY: | Seasonal allergies |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 09-30-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.