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.
She has been informed of similar adverse effects with other implant recipients (implants became infected); This spontaneous case was reported by a consumer and describes the occurrence of DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included Breast prosthesis implantation. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) (seriousness criterion medically significant). At the time of the report, DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | OT | Unknown |
| RECVDATE: | 01-18-2022 | 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: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Breast prosthesis implantation |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20224 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 01-17-2022 |
| 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.