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.
Impotent; Muscle pain; Chills; This spontaneous report was received from a consumer concerning a 56-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, muscle pain/ myalgia and was impotent/ erectile dysfunction. The patient's medical history was not provided. Concomitant medications included metformin, glimepiride, atorvastatin, losartan, pantoprazole and doxazosin. On 26 Feb 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced the got chills, muscle pain and the patient was impotent a medically significant event. Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, chills, muscle pain and was impotent was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
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 | 037K20A | OT | RA |
| RECVDATE: | 03-30-2021 | RPT_DATE: |
| CAGE_YR: | 57 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | METFORMIN; GLIMEPIRIDE; ATORVASTATIN; LOSARTAN; PANTOPRAZOLE; DOXAZOSIN |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: No adverse event (No recorded medical history) |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20210 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 03-30-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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