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.
Cellulitis; Blisters on left arm and shoulder; hot to the touch; left arm got swelled up; It had red ring all over it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 007B21A) for COVID-19 vaccination. Concurrent medical conditions included Idiopathic thrombocytopenic purpura. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and BUSPIRONE HCL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis) (seriousness criterion medically significant) with BLISTER (Blisters on left arm and shoulder), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE SWELLING (left arm got swelled up) and VACCINATION SITE ERYTHEMA (It had red ring all over it). At the time of the report, INJECTION SITE CELLULITIS (Cellulitis) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment of these events included Doxycycline for 10days, symptoms stopped about 14 days after taking the Doxycycline. Company Comment: 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)) | 2 | COVID19 | MODERNA | 026a21a | OT | LA |
| RECVDATE: | 05-07-2021 | RPT_DATE: |
| CAGE_YR: | 56 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | LEXAPRO; LISINOPRIL; BUSPIRONE HCL |
| CUR_ILL: | Idiopathic thrombocytopenic purpura |
| 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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