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.
discharge of blood from penis; heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating; felt fatigued and felt like he was ready to go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PENILE HAEMORRHAGE (discharge of blood from penis) and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arrhythmia and Cardiac ablation. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PENILE HAEMORRHAGE (discharge of blood from penis) (seriousness criterion medically significant), ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) (seriousness criterion medically significant) and FATIGUE (felt fatigued and felt like he was ready to go to sleep). On 12-Mar-2021, FATIGUE (felt fatigued and felt like he was ready to go to sleep) had resolved. At the time of the report, PENILE HAEMORRHAGE (discharge of blood from penis) outcome was unknown and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) had resolved. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
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|COVID19 (COVID19 (MODERNA))||1||COVID19||MODERNA||024M20A||OT||LA|
|HISTORY:||Medical History/Concurrent Conditions: Arrhythmia; Cardiac ablation|