How to Report COVID Vaccine-Related Adverse Events

The national effort to vaccinate Americans against COVID-19 shifted into high gear in mid-December following the US Food and Drug Administration's (FDA's) authorization of both the Pfizer-BioNTech and Moderna COVID-19 vaccines. Because the safety of vaccines is critical to the success of any vaccination effort, safety data from large clinical trials conducted over the past several months helped inform the FDA's decision to grant an Emergency Use Authorization (EUA). These data also guided CDC's development of recommendations for COVID-19 vaccination schedules.

However, additional data on potential adverse events are needed in real time as more Americans receive their first COVID-19 vaccinations. Especially critical is collection of data for populations underrepresented in clinical trials, including people who are pregnant, and the sharing of these data with CDC and FDA.

Healthcare providers will play a critical role in reporting vaccine-related adverse events through the Vaccine Adverse Event Reporting System (VAERS). Providers can also encourage individual patients to self-report potential adverse events as they occur through v-safe, CDC's new patient reporting platform.

VAERS

VAERS is a national vaccine safety monitoring system that helps CDC and FDA monitor adverse events reported by healthcare providers or the public after vaccination. VAERS does not determine causation but helps detect potential safety signals or serious adverse events that warrant further investigation. As a condition of the EUA, FDA requires healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. These are specified in the EUA Fact Sheet for Healthcare Providers and FDA's EUA Letter of Authorization.

It is important for healthcare providers to submit a VAERS report in accordance with the EUA instructions and CDC guidance, which encourages reporting of an adverse event that occurs after vaccination, whether or not it is clear that the vaccine caused the adverse event. If patients wish to report adverse events themselves, providers are encouraged to help them navigate the VAERS reporting process. Reporting adverse events after vaccination, regardless of whether the provider or patient believes that the reaction is associated with the vaccine or purely coincidental, helps CDC and FDA monitor the safety of COVID-19 vaccines.

Reports can be submitted to VAERS in two ways:

Submit a VAERS report online (preferred). This online report must be completed and submitted in the same session; it cannot be saved and edited later.
Download a form. The writable PDF form can be completed electronically on the reporter's own time. When ready, the reporter should return to the VAERS writable PDF web page (use link above) and follow the instructions to upload the form.

When submitting a VAERS report, all requested information, if known, should be provided in its entirety. CDC and/or FDA experts will follow up on selected cases of serious adverse events immediately upon receipt of the report. Providers should be prepared to promptly give any missing information, as well as patient records, so that the events can be better understood. Any delay in the provision of needed patient information could result in missed opportunities for identifying and investigating causally associated vaccine-related adverse events. Any information given to VAERS is protected to maintain patient confidentiality and privacy.

V-safe

V-safe is CDC's new smartphone-based program for monitoring COVID-19 vaccine safety. This tool provides personalized check-ins to patients after they receive the vaccine so patients can let CDC know directly how they feel. Patients should also be advised to report serious adverse events to their healthcare providers, who should then promptly submit a report to VAERS. Any information given to v-safe is protected to maintain patient confidentiality and privacy.

Once a patient enrolls and completes a brief survey, the reporting process is quick and easy: v-safe sends daily reminders for the first week post-vaccination and weekly reminders for the next 6 weeks. Enrollees are then asked to check in with any potential adverse events at 3, 6, and 12 months post-vaccination. The v-safe system even alerts patients when their second COVID-19 vaccination is due, if needed.

CDC is relying on healthcare providers to encourage all vaccinated patients to enroll in v-safe, as this tool enables safety monitoring of COVID-19 vaccines in real time. It is especially important that all pregnant people receiving the vaccine participate in this program, because clinical safety data for this population are currently limited.

Healthcare providers can help their patients enroll in the program, but only the patients themselves should complete check-ins. Providers who receive the COVID-19 vaccine themselves should also enroll in the v-safe program and carefully monitor and report potential adverse events from their own vaccination experiences as soon as they occur. This is particularly important because providers will be some of the first Americans to be vaccinated against COVID-19.

For more information about v-safe, visit www.cdc.gov/vsafe.