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.
Seizures; Pain at the vaccination site; Malaise; This case was received via regulatory authority (Reference number: 2021TJP098245) on 25-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21128843). On an unknown date, the patient received the 1st dose of this vaccine. On 22-Sep-2021, the patient received the 2nd dose of this vaccine. The patient slept until early afternoon because of pain at the vaccination site and malaise. Around 15:25, the patient woke up and went to the toilet. The patient experienced seizure (clonic convulsion, upward eye deviation, and cyanosis of lip) for several minutes in the toilet, and an ambulance was called, and the patient was transported to the reporting hospital. It was 38.0 degrees Celsius when the ambulance crew contacted the patient. On arrival in the hospital, the patient's level of consciousness was clear, but quadriplegia persisted. There were no obvious abnormalities in blood tests or head CT. The patient was hospitalized for follow-up. On an unknown date, the general condition rapidly improved after hospitalization. On 24-Sep-2021, recovery of the symptoms was confirmed. The patient was discharged from the hospital. The outcome of pain at the vaccination site, malaise, and seizures was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender's Comments: This case concerns a 13 year-old female patient with no medical history reported, who experienced the unexpected serious events of a seizure, vaccination site pain and malaise leading to hospitalization. The events occurred on the same day after receiving the second dose of mRNA-1273 vaccne. The rechallenge was not applicable since no information for the first dose is available, and no additional dosing will be given. The reporter assessed the events as related to the product. The benefit-risk relationship of the product is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting,
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 3005289 | OT |
| RECVDATE: | 10-04-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPMODERNATX, INC.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-04-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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