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.
Passed away yesterday, found deceased in her apartment; This spontaneous report was received from a consumer which refers to a 91-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and next day the patient passed away. The patient's medical history was not provided. Concomitant medications were not reported. On 19 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided) for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient passed away and she was found deceased in her apartment. No treatment medication was provided. Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away. On 20 Jan 2021, the patient died, cause of death was unknown. Autopsy result was unknown. The reporter assessed the causality as related between the event and Moderna COVID-19 vaccine.; Reporter's Comments: This case concerns a 91-year old female patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.; Reported Cause(s) of Death: Unknown Cause of Death
Open in Wayback Machine
(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 (MODERNA)) | 1 | COVID19 | MODERNA | OT | Unknown |
RECVDATE: | 02-04-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | 01-20-2021 |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | Medical History/Concurrent Conditions: No adverse event (No reported medical history) |
PRIOR_VAX: | |
SPLTTYPE: | USMODERNATX, INC.MOD20210 |
FORM_VERS: | |
TODAYS_DATE: | 02-03-2021 |
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.