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 out; Right arm became norm down to her fingers; No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm; Terrible pain in the entire right arm; Heart rate dropped; Vomited; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: unknown (Inconclusive) result unknown. On an unknown date, Heart rate: low (Low) Drop in heart rate was reported. On an unknown date, Spinal X-ray: normal (normal) Reported to be normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment details included the use of ibuprofen and oral steroid prednisone. A week later the patient's arm was still very painful and some functioning had returned but not up to 50%. Company comment: 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. This case was linked to MOD21-083933 (E2B Linked Report).; Sender'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. MOD21-083933:2nd dose
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | 039k20a | OT | RA |
| RECVDATE: | 05-07-2021 | RPT_DATE: |
| CAGE_YR: | 39 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Test Name: EMG; Test Result: Inconclusive ; Result Unstructured Data: result unknown; Test Name: Heart rate; Result Unstructured Data: Drop in heart rate was reported; Test Name: Neck X-ray; Result Unstructured Data: Reported to be normal |
| V_ADMINBY: | |
| OTHER_MEDS: | XYZAL |
| CUR_ILL: | |
| HISTORY: | Comments: No medical history was reported. |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20210 |
| FORM_VERS: | |
| TODAYS_DATE: | 05-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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