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.
In and out of consciousness; feeling faint, fainted briefly/Passed out multiple times; Couldn't stand up; Flu-like symptoms; Fever with a temperature of 103 degress; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (In and out of consciousness) and SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010N120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. Concomitant products included AMITRIPTYLINE for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (In and out of consciousness) (seriousness criteria hospitalization and medically significant), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) (seriousness criteria hospitalization and medically significant), DYSSTASIA (Couldn't stand up) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). 24-Mar-2021, the patient experienced PYREXIA (Fever with a temperature of 103 degress). At the time of the report, LOSS OF CONSCIOUSNESS (In and out of consciousness), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times), DYSSTASIA (Couldn't stand up), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever with a temperature of 103 degress) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received treatment medication included Tylenol, to alleviate the symptoms. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 010N120A | OT | LA |
RECVDATE: | 05-07-2021 | RPT_DATE: |
CAGE_YR: | 59 |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Test Date: 20210324; Test Name: Body temperature |
V_ADMINBY: | |
OTHER_MEDS: | AMITRIPTYLINE |
CUR_ILL: | |
HISTORY: | Comments: No reported medical history |
PRIOR_VAX: | |
SPLTTYPE: | USMODERNATX, INC.MOD20211 |
FORM_VERS: | |
TODAYS_DATE: | 05-07-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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