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.
five residents infected after prime vaccination were excluded in the study; five residents infected after prime vaccination were excluded in the study; This is a literature report for the following literature source(s): An elderly patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "five residents infected after prime vaccination were excluded in the study". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: Unknown results; Unknown results; Unknown results; Unknown results; SARS-CoV-2 IgG assay: Unknown results; Unknown results; SARS-CoV-2 antibody test: Unknown results. Authors have read with great interest the recent article showing that vaccine effectiveness against Covid-19 during an outbreak in a nursing home (NH) correlates with anti-Spike IgG. In this study, anti-Spike IgG below 50 BAU/mL 28 weeks after two vaccine doses resulted in a higher risk of SARS-CoV-2 infection and severe form of the disease. In this study performed between March and October 2021, compare the response to BNT162b2 vaccine in NH residents depending on their age, 95 years or older vs less than 95 years of age, and their history of prior SARS-CoV-2 infection. A total of 412 NH residents were tested at the 3 time points. Five residents infected after the prime vaccination were excluded.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded. ,Linked Report(s) : FR-PFIZER INC-202200853526 Same article/ drug/event and different patient.;
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | Unknown | Unknown |
| RECVDATE: | 06-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Test Name: anti-Spike IgG; Result Unstructured Data: Test Result:Unknown results; Test Name: nucleocapsid-IgG; Result Unstructured Data: Test Result:Unknown results; Test Name: Nucleoprotein-IgG; Result Unstructured Data: Test Result:Unknown results; Test Name: RBD-IgG; Result Unstructured Data: Test Result:Unknown results; Test Name: SARS-CoV-2 IgG assay; Result Unstructured Data: Test Result:Unknown results; Test Name: SARS-CoV-2 IgG II Quant assay; Result Unstructured Data: Test Result:Unknown results; Test Name: SARS-CoV-2 Receptor-Binding Domain (RBD); Result Unstructured Data: Test Result:Unknown results |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | FRPFIZER INC202200862483 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 06-23-2022 |
| 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.