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.
Previously healthy 13 yo old boy presenting with chest pain and vomiting. Symptoms started Sunday night with myalgias and generalized body aches. Received 2nd COVID19 vaccine on Sun. Post vaccine complained of generalized body aches, malaise, until Tuesday morning, when the patient returned to feeling at baseline. Tuesday night complaints of new onset substernal chest pain. Pain was worse when laying down and when raising hands. Sitting up helped with pain but walking around made pain increasingly achy. EMS was called who performed EKG, which was reportedly read as normal and at that time did not pursue further treatment. The patient only slept about 3 hours and the next morning, experienced multiple episodes of vomiting that worsened pain. The patient was subsequently brought to the ED.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FF2587 | IM |
| RECVDATE: | 10-15-2021 | RPT_DATE: |
| CAGE_YR: | 13 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | In ED (10/13) Troponin 7.78 and BNP 99 EKG: diffuse ST segment concerning for pericarditis ECHO normal ventricular function Chest X-ray: unremarkable. On 10/13 the patient was admitted to the local medical center for NSAID therapy and serial troponin evaluation. On 10/14 the patient was transferred to the ICU after a follow-up troponin, approximately 8 hrs after initial, resulted at 22. Cardiology was contacted and the on-call cardiologist recommended transfer to the ICU for IVIG therapy and repeat EKG. 10/14: Repeat EKG showed normal sinus rhythm with ST elevation in inferior leads. Troponin level has begun to downtrend (see below) s/p IVIG. BNP was elevated slightly at 118. Troponin: 10/13[08:57]=7.78, [17:30]=21.72,10/14 [04:30]=14.3, 10/14 [13:24]=9.22, 10/14 [22:49]=7.74, 10/15 [6:25]=4.44 Originally for Pericarditis, but then was diagnosed with myopericarditis due to persistently elevated troponin level |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | none |
| CUR_ILL: | none |
| HISTORY: | none |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-15-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | Cats, dogs, penicillin, soy |
| V_FUNDBY: |
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