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.
Myocarditis; Pyrexia; This case was received via regulatory authority(Reference number: 2021TJP106263) on 12-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21129161). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 04-Oct-2021, at 17:00, the patient received the 2nd dose of this vaccine. Pyrexia developed. On 07-Oct-2021, at 06:00, chest discomfort developed. The patient visited the reporting hospital. Echocardiography was performed. Increased myocardial enzyme was noted. The patient was hospitalized with a diagnosis of myocarditis. Fluid replacement and anti-inflammatory analgesics were administered with rest. On 11-Oct-2021, the symptoms were resolving, and the patient was discharged from the hospital. The outcome of pyrexia and myocarditis was reported as resolving. 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: This case was considered as adverse reactions to this vaccine.; Sender's Comments: This is a regulatory case concerning a 16-year-old, male patient with no relevant history reported , who experienced the unexpected serious AESI event of myocarditis and pyrexia . The event myocarditis occurred approximately 4 days after the 2nd dose of mRNA-1273 Moderna vaccine, pyrexia occurred on the same day of 2nd dose. The rechallenge was not applicable (no more doses are expected) . Lab data: Increased myocardial enzyme was noted. The benefit-risk relationship of Spikevax is not affected by this report.
Open in Wayback Machine
(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 | 3005701 | OT |
| RECVDATE: | 10-21-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: Body temperature; Result Unstructured Data: 36.4 degree Celsius; Test Date: 20211007; Test Name: Echocardiogram; Result Unstructured Data: Increased myocardial enzyme was noted |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPMODERNATX, INC.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-20-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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