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.
surgery for twisted intestine; issue with their throat, was not being able to swallow; A spontaneous report was received from a Consumer concerning an 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Volvulus and Dysphagia. The patient's medical history was not provided. No relevant concomitant medications were e reported. On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the Anatomical location unspecified for prophylaxis of COVID-19 infection. On 27-Feb-2021, the patient experienced the events Volvulus and Swallowing impaired and the patient was hospitalized for 12 days. The patient underwent surgery for twisted intestine. The patient had an issue with their throat that has not been settled and was not being able to swallow. It was not related to the vaccine at all. The patient was discharged on 11-Mar-2021. The second dose was scheduled on 13-Mar-2021. As they could not drive and take their second dose. it will be re-scheduled. Laboratory details were not provided. Treatment details were included sodium chloride 1 gm 3 tablets by mouth three times a day with meals and potassium chloride 2 tablets by mouth everyday for 5 doses. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Volvulus and Swallowing impaired was unknown. The reporter did not provide the causality between the events Volvulus and Swallowing impaired and the study drug.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
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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 (MODERNA)) | 1 | COVID19 | MODERNA | 015M20A | OT |
| RECVDATE: | 03-26-2021 | RPT_DATE: |
| CAGE_YR: | 80 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 13 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Surgery |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20210 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-23-2021 |
| 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.