Educate COVID-19 Vaccine Recipients on How to Report Adverse Events

Pharmacists should be aware not only of the requirement to report adverse events resulting from the COVID-19 vaccine but also of new methods the public can use to do that. Also find out how to distinguish reactions to the vaccines from infection with SARS-CoV-2. One advantage is that the vaccine doesn’t affect COVID-19 test results.

ATLANTA – Pharmacists and other providers of COVID-19 vaccines are being urged to encourage recipients to report any adverse events that follow immunizations.

According to the national Centers for Disease Control and Prevention, adverse events that occur in a recipient after getting any COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS). In addition, the Food and Drug Administration requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under the emergency use orders granted for two COVID-19 vaccines.

“Reporting by anyone who gives or receives a COVID-19 vaccine is encouraged for any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event,” public health officials add.

Information on how to submit a report to VAERS is available at icon or 1-800-822-7967.

This year, CDC also has developed a new, voluntary smartphone-based tool, v-safe, that uses text messaging and web surveys to provide near real-time health check-ins after patients receive COVID-19 vaccination. The CDC/v-safe call center follows up on reports that indicate a medically significant health impact to collect additional information for completion of a VAERS report. Information on v-safe is available at Information on how to use both reporting systems is included in the EUA Fact Sheet that pharmacists and other vaccine providers are asked to distribute before vaccination.

The CDC also urges that vaccine recipients be counseled about expected local and systemic reactogenicity.

In a Dec. 14 call, the CDC offered advice on distinguishing between vaccine reactions and COVID-19 itself.

David T. Kuhar, MD, of the COVID-19 response team at the CDC, emphasizes that a positive nucleic acid and antigen testing for SARS-CoV-2 should not be attributed to the COVID-19 vaccine, because the vaccine doesn’t influence those test results. Kuhar added that “this is important, because we can still test vaccinated persons for acute disease when indicated.”

According to Kuhar, in addition to pain and swelling at the vaccine site, expected post-vaccine symptoms might include:

  • fever,
  • fatigue,
  • headache,
  • chills,
  • myalgia, and

“And now, most are mild-to-moderate in severity, occur within the first three days of vaccination, and resolve within one to two days of onset,” Kuhar explained. “Now systemic adverse reactions have been more commonly reported after the second dose, rather than after the first, and generally, more frequent and severe in persons aged 18 to 55 than those older than 55 years.”

On the other hand, he advises that cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell – typical symptoms of infection with SARS-CoV-2 are not consistent with postvaccination symptoms and would be attributable to something else.

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