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.
Suspected heart attack; Severe Chest and arm pain; Severe Chest and Arm pain; The injection site became hot to the touch; Itching injection site; Painful Injection Site; Hard to the touch; Raised red spot on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Raised red spot on the injection site). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE PAIN (Painful Injection Site). On 21-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Suspected heart attack) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Severe Chest and arm pain) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Severe Chest and Arm pain) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 22-Apr-2021 due to PAIN IN EXTREMITY, and then on 21-Apr-2021 due to MYOCARDIAL INFARCTION. On 27-Apr-2021, VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Raised red spot on the injection site) and VACCINATION SITE PAIN (Painful Injection Site) had resolved. On 29-Apr-2021, MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Echocardiogram: normal (normal) normal. On 21-Jan-2021, Electrocardiogram: normal (normal) results. On 21-Jan-2021, Myocardial necrosis marker: raised Raised. On 21-Jan-2021, Oxygen saturation: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 21-Apr-2021, the patient had severe chest and arm pain. She went to the emergency room. The ER doctor suspected a heart attack. She was hospitalized overnight under observation and was released the next day. No relevant concomitant medications were provided. No treatment information was provided. Company Comment: Very limited information regarding the events (Myocardial infarction) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.; Sender's Comments: Very limited information regarding the events (Myocardial infarction) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 025B21A | OT | LA |
RECVDATE: | 05-07-2021 | 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: | Test Date: 20210121; Test Name: Echo Cardiogram; Result Unstructured Data: normal; Test Date: 20210121; Test Name: EKG; Result Unstructured Data: results; Test Date: 20210121; Test Name: Heart Enzymes; Result Unstructured Data: Raised; Test Date: 20210121; Test Name: Blood O2 level; Result Unstructured Data: normal |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
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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