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.
He presented with excessive fatigue, fevers, emesis, and chest pain. He received his second COVID-19 vaccination on 9/29, 3 days prior to ED presentation on 10/1. Per patient, he went to work the same day after receiving his second COVID vaccination. While at work, he became lightheaded and had to leave early. He went home and went to bed. He woke up in the middle of the night and vomited then went back to sleep for the rest of the night. The following day (9/30) he reports excessive fatigue and says he slept all day (~12-13 hours). Per mom, he was also very hot to the touch throughout the day. He then woke up on 10/1 with "really bad" left anterior, non-radiating chest pain in addition to his persistent dizziness, 3-4 episodes of emesis, and not being able to keep anything down - which prompted mom to bring him to the ED. He was transferred and admitted to a local hospital for myocarditis with a troponin of 27.33 and diffuse ST elevation with PR depression on EKG. A complete infectious disease workup was negative for other viral or bacterial causes of myocarditis. He received IVIG on 10/3. He also got tylenol and motrin and one dose of aspirin. His troponin down trended after receiving IVIG and his symptoms resolved. He was discharged on 10/6 with cardiology follow up outpatient.
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(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 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | 30145BA | IM | LA |
| RECVDATE: | 10-06-2021 | RPT_DATE: |
| CAGE_YR: | 16 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 6 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | (10/3) COVID-19 IgG by ELISA (Spike Ab) - Positive (10/3) Covid-19 IgG, Qualitative by CIA (Nucleocaspid Ab) - Negative (10/1) Blood culture - No growth (10/3) Enterovirus PCR - Negative (10/3) Enterovirus Stool culture- Pending (10/3) Enterovirus Throat culture - Pending (10/1) Adenovirus, Qualitative PCR - Negative (10/1) HHV 6 PCR - Pending (10/1) Parvovirus B19 Ab (IgG and IgM) - Negative (10/1) EBV Ab Panel - IgG Positive, IgM negative (10/1) CMV IgG screen - Positive, (10/1) CMV IgM screen - Negative (10/3) Varicella Zoster IgM - Negative (10/3) Varicella Zoster IgG - Negative (10/3) Varicella Zoster serology - Negative (10/3) HIV Ag/Ab combo 1/2 screen - Negative (10/1) VRP - Negative (10/1) Troponin 27.33 (10/6) Troponin 1.19 (10/1) CBC with WBC 17.6, Hg 15.4, Platelets 361 (10/1) CMP with AST/ALT 134/39 |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | ADHD, exercise induced asthma, delayed puberty |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-06-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | Onions (tongue swelling) |
| 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.