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.
Patient had common side effects on post-vaccination day 1 (body aches, fatigue, HA) which resolved within 24hr however patient then developed stabbing mid-sternal chest pain on the morning of 10/11 (3 days post-vaccination). Initial troponin level was 2.18 as well as CKMB at 19.6. Troponin peaked at 7.84 (roughly 24hr after symptom onset - 10/12@0400) then began declining that evening (10/12@1600). Chest pain was mild, intermittent and completely resolved within 12 hours of arrival after NSAID initiated.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FF8841 | IM |
| RECVDATE: | 10-16-2021 | RPT_DATE: |
| CAGE_YR: | 12 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Troponin: 2.18 -- >7.01 -- > 7.84 -- > 3.52 -- > 3.42 CKMB: 19.6, total CK 189 (normal) EKG: no abnormal rhythms noted ECHO: normal structure and function |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | levocarnitine |
| CUR_ILL: | asymptomatic COVID19 infection - tested positive 9/1/2021 |
| HISTORY: | MCAD deficiency |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-16-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | none |
| V_FUNDBY: |
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