How are adverse events reported to FDA?
Submitting Adverse Event Reports to FDA
- Report Online.
- Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission.
- Call FDA at 1-800-FDA-1088 to report by telephone.
- Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500.
How do I report the side effects of Moderna vaccine?
In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663- 3762).
How do I report a vaccine error?
If you want to report a non-preventable adverse reaction to a vaccine product, please visit the US Department of Health and Human Services Vaccine Adverse Event Reporting System (VAERS) (http://vaers.hhs.gov).
Who submits adverse events to FDA?
Healthcare professionals, consumers, and manufacturers submit reports to FAERS. FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
Who should not get the Moderna Covid vaccine?
People who should not have the Moderna vaccine anaphylaxis after exposure to any component of the vaccine, including polyethylene glycol (PEG) myocarditis and/or pericarditis attributed to a previous dose of an mRNA COVID-19 vaccine (Moderna or Pfizer)
Can you get the Covid vaccine if you had Covid?
Yes, you should be vaccinated regardless of whether you already had COVID-19 because: Research has not yet shown how long you are protected from getting COVID-19 again after you recover from COVID-19. Vaccination helps protect you even if you’ve already had COVID-19.
Do medication errors need to be reported?
Medication errors are detected by voluntary reporting, direct observation, and chart review. Organizations need to establish systems for prevention of medication errors through analyzing the cause of errors to identify opportunities for quality improvement and system changes (Morimoto, Seger, Hsieh, & Bates, 2004).
