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.
I was weak all over/I didn't want to get out of bed; Malaise; Headache; This case was received via United Kingdom MHRA (Reference number: MOD21-131145) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Arm discomfort (a metal rod in the left humorous), Knee replacement (Both knees replaced) and Hip replacement (Left hip replacement). Concurrent medical conditions included Arthritis (Severe arthritis), Scoliosis and Stenosis. On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache) had resolved. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. The events lasted for 4 to 5 hours, came and went away for the patient. Reporter did not allow further contact
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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 | 013L20A | OT | RA |
| RECVDATE: | 09-02-2021 | RPT_DATE: |
| CAGE_YR: | 79 |
| 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: | |
| CUR_ILL: | Arthritis (Severe arthritis); Scoliosis; Stenosis |
| HISTORY: | Medical History/Concurrent Conditions: Arm discomfort (a metal rod in the left humorous); Hip replacement (Left hip replacement); Knee replacement (Both knees replaced) |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20212 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-01-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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