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.
Hospitalized 10/8/2021; COVID-19 positive 10/8/2021; fully vaccinated Discharge Summary(Physician) ? ? General Medicine BRIEF OVERVIEW: Admission Date: 10/8/2021 Discharge Date: Oct 13, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] COVID-19 virus infection [U07.1] COVID-19 [U07.1] HOSPITAL COURSE: Patient is an 82-year-old male with a past medical history of cardiomyopathy, systolic CHF, aortic stenosis status post bioprosthetic aortic valve, dementia, CKD, hypertension and prostate cancer who presented secondary to a chief complaint of weakness. The patient developed a cough 3 days prior to admission which was nonproductive. He became weak during this time. Blood home the night prior to admission he slid out of his chair and required family to assist him to the floor. He did not lose consciousness. To decreased oral intake. He fell again and EMS was called. In the emergency department, he had a temperature of 39.0. CMP and complete blood count were unremarkable. Procalcitonin was 0.1. UA was positive for ketones and protein. No signs of infection. COVID PCR was positive. Chest x-ray was negative for acute process. Tylenol was given in the emergency department as well as a 500 mL bolus. The patient was admitted for COVID infection with generalized weakness. He was seen by PT/OT who recommended subacute rehab, but family opted for home with home care. The patient did not require oxygen. He was afebrile. He was discharged home on 10/13/2021 with home care.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EL9261 | IM | RA |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EL9265 | IM | LA |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | 301258A | IM | AR |
| RECVDATE: | 10-15-2021 | RPT_DATE: |
| CAGE_YR: | 82 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 5 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | alendronate (FOSAMAX) 70 MG tablet amiodarone (PACERONE) 200 MG tablet amLODIPine (NORVASC) 5 MG tablet apixaban (ELIQUIS) 5 MG tablet benzonatate (TESSALON) 100 MG capsule carvedilol (COREG) 25 MG tablet donepezil 23 MG tablet levothyroxin |
| CUR_ILL: | |
| HISTORY: | Allergic rhinitis HTN (hypertension), benign Nonischemic cardiomyopathy (HCC) Heart failure with recovered LV function post HVAD explant Atrial fibrillation, unspecified type NSVT (nonsustained ventricular tachycardia) (HCC) Gastroesophageal reflux disease without esophagitis COVID-19 Syncope Dementia (HCC) Chest pain Cervical myelopathy (HCC) CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min (HCC) Mixed hyperlipidemia Hypothyroidism H/O ventricular tachycardia History of aortic valve repair Generalized weakness |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-15-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Environmental, Isosorbide, Lisinopril |
| V_FUNDBY: |
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