Patient Safety Initiative ReportHarm.online
Report to VAERS opens the official government form at vaers.hhs.gov in a new tab

Patient Safety Initiative

Something happened after a vaccine?

You don't have to know what caused it to report what happened.

I’m ready to report opens VAERS, the official government form at vaers.hhs.gov in a new tab

Takes you to VAERS, the official U.S. vaccine adverse-event reporting system, at vaers.hhs.gov. We never see your report.

Observe it.Document it.Report it.

“Your report can save lives.”

U.S. Food and Drug Administration (opens in a new tab), from the page “Report a problem to the FDA”

Start anywhere.

Open only what you need. The report button is always one tap away.

Who can report?

Anyone. If you lived it, saw it, or treated it.
  • Patient
  • Parent
  • Family member
  • Caregiver
  • Paramedic / EMS
  • Nurse
  • Physician
  • Pharmacist
  • Other healthcare professional
Voluntary: anyone can report

Patients, parents, family members, caregivers, and healthcare professionals can all report. CDC and FDA ask people to report a health problem after vaccination even if they aren't sure the vaccine caused it.

Required by law: some healthcare providers

Healthcare providers must report to VAERS:

Providers are strongly encouraged to report any other adverse event after a licensed vaccine, whether or not it's clear the vaccine caused it. Vaccine manufacturers must report every adverse event that comes to their attention.

Not sure whether the requirement applies to your role? Check the Table and the VAERS instructions (opens in a new tab), which cite 42 USC 300aa-25, and ask your employer. It doesn't stop you from reporting. Some vaccines given under emergency use authorization have their own rules, and VAERS keeps the current list (opens in a new tab).

Observe it.

What happened?

What harms have people reported after vaccination?

You don't have to know what caused it.

You can report a health problem that happened after vaccination even if you don't know whether the vaccine caused it.

The examples below can help you recognize the kinds of experiences people report. They are examples, not a complete list.

Heart or chest

Chest pain, racing or irregular heartbeat, shortness of breath, or a diagnosed heart condition.

Neurologic

Numbness, tingling, burning sensations, weakness, severe or persistent headache, seizures, facial paralysis, or other new neurologic symptoms.

Hearing or balance

New ringing in the ears, hearing changes, dizziness, or vertigo.

Blood or circulation

Unusual clotting, unusual bleeding or bruising, or stroke-like symptoms.

Menstrual or reproductive

Unexpected changes in menstrual timing, duration, or amount of bleeding, or another reproductive health concern.

Skin or immune

Hives, severe or persistent rash, shingles, unexpected hair loss, or an allergic reaction.

Children

Seizures, unusual weakness, changes in walking, or significant changes in behavior or functioning.

Injection or shoulder problems

Severe or persistent pain, weakness, reduced range of motion, or another significant problem beginning after the injection.

Something else happened?

You don't need to find your experience on this list before reporting it. If a health problem happened after vaccination, you can report what you observed even if you don't know what caused it.

What does the evidence say?

Some health problems have been shown to be caused by particular vaccines. Others have been studied without evidence showing that the vaccine caused them. For still others, there isn't enough evidence yet to know.

Document it.

What do I need to report it?

Optional. Open any of these, in any order, or none.

Before you start

A few details, and one thing about the timer.

Gather what you can first. Having your details in front of you is the easiest way to report. You don't need everything.

Online form

The form times out after 20 minutes of inactivity on each page. VAERS warns you when 5 minutes remain. If it times out, everything you entered is lost.

Fillable PDF: take your time

VAERS offers a fillable PDF you can complete offline, then upload.

  1. Download the fillable PDF
  2. Fill it in on a desktop or laptop you trust. It will hold personal and health information, so save it only on a computer you can keep secure.
  3. Upload the finished PDF to VAERS (opens in a new tab)

VAERS strongly encourages online reporting when you can.

From ReportHarm.online (Patient Safety Initiative), built from the official VAERS instructions and checklist. Official source: vaers.hhs.gov. Last verified: October 1, 2026

Your VAERS checklist

VAERS's own checklist (PDF) opens vaers.hhs.gov in a new tab
  • VAERS will still accept a report if you can't provide all of this. That is VAERS's own wording on its checklist.
  • If you don't know an exact number, date or time, give your best guess. VAERS says you may leave it blank if you're not comfortable guessing.
  • Use one report for each person who was vaccinated.
  • The clinic or pharmacy that gave the vaccine can tell you the vaccine name and lot number.
The form flags these as essential (8 items)

VAERS asks that you complete these. Where you're missing part of an answer, the hint under the item says what VAERS accepts.

Helpful if you have it (15 items)

These help VAERS understand the report. Skip anything you don't have.

Only if it applies (2 items)

I’m ready to report opens VAERS at vaers.hhs.gov in a new tab

Read the walkthrough

Five pages. What each one asks.

The form has five pages: Patient, Reporter, Facility, Vaccine, and Additional Information. A status list at the top tracks them. Not sure of an answer? Dates can be month and year, and you can give your best guess.

  1. Open the form. Select Report to VAERS. The form opens on the VAERS website. A status list at the top shows five pages: Patient, Reporter, Facility, Vaccine, and Additional Information.
  2. Read the timeout notice. A notice explains the 20-minute limit and points you to VAERS's checklist. Select I understand to continue.
  3. Patient information (page 1). You enter details about the person who was vaccinated: name and address, date of birth, sex, date of vaccination, when the problem started, age at vaccination, pregnancy, medicines, allergies, recent illnesses, and long-term conditions. Fields marked with an asterisk (*) are the essential ones. Most items have a small # link that opens a short explanation.
  4. When you don't know an answer.
    • Dates: give as much as you know. Month and year is enough when you don't know the day.
    • Numbers, dates or times you're unsure of: give your best guess. VAERS says you may leave it blank if you're not comfortable guessing.
    • Vaccine name: choose Unknown at the bottom of the vaccine list.
    • Pregnancy: the form offers Yes, No, and Unknown.
    • Not sure the vaccine caused it: report anyway. You don't need to know the cause.
  5. The other four pages. Reporter, Facility, Vaccine, and Additional Information ask about you (the person filling in the form), a healthcare professional VAERS can contact, where the vaccine was given, the vaccine details, what happened, test results, the outcome, and other health history. The checklist above uses the same groups as VAERS's own checklist.
  6. Describe what happened. VAERS asks for the health problem, the treatment, and the outcome: signs and symptoms, when they occurred, any diagnosis, and any treatment. Specifics help, such as a temperature reading if there was a fever. Write what you observed. You don't have to name a cause.
  7. Review and submit. If you get stuck, call the VAERS help line at 1-800-822-7967 or email vaersinfo@cdc.gov.

What to expect

What VAERS sends back, and who might contact you.
After you submit
  • VAERS gives your report an identification number and sends it to you in a confirmation letter, by email or mail depending on the communication preference on your report. Keep it.
  • Other than the confirmation letter, for online reports VAERS says it reaches out only if essential fields are missing, by mail or electronically and never by phone. For reports filed with the PDF form, VAERS says its staff may in rare cases contact the reporter by phone. Its privacy notice also says you or your healthcare provider may be contacted for further information.
  • For reports classified as serious, VAERS tries to obtain medical records. Those requests go to health institutions or public health authorities, not to you.
  • Information that identifies the person vaccinated and the person who filed the report isn't made public.
If you need to add something later

VAERS has a page for follow-up information (opens in a new tab). Have your VAERS ID ready and include it with the follow-up.

Report what you actually observed, even if you don't know the cause. Just don't make anything up. VAERS warns that knowingly filing a false report with the intent to mislead the Department of Health and Human Services is a federal offense (18 U.S. Code § 1001).

Report it.

Ready to report?

You'll leave this site and go to VAERS, the official U.S. vaccine adverse-event reporting system. Your report goes to VAERS. We never see it.

I’m ready to report opens VAERS at vaers.hhs.gov in a new tab

Opens the official government form at vaers.hhs.gov.

Prefer to work at your own pace? Download the fillable PDF instead.

Need help with the form? Call the VAERS help line at 1-800-822-7967 or email vaersinfo@cdc.gov.

Official source: VAERS, co-managed by CDC and FDA. Last verified: October 1, 2026

What happens after I report?

A report does not establish that a vaccine caused an event.

Reporting makes your observation available to the vaccine safety-surveillance system for analysis and investigation. VAERS accepts reports without judging whether the vaccine caused the problem, and VAERS staff don't decide that for you.

What the system does with reports:

  • CDC and FDA look across all reports for unexpected or unusual patterns.
  • Reports classified as serious get extra follow-up. VAERS tries to obtain medical records to understand the event better.
  • A concern that stands out can be studied in other safety systems, including controlled scientific studies, to see whether the event happens more often after vaccination.

A report alone can't show cause. That is what investigation is for.

Could compensation be available?

Some vaccine injuries and deaths may qualify for federal compensation.

Different federal programs cover different vaccines and circumstances, and filing deadlines apply. If you or a family member experienced a serious injury or death after vaccination, check whether a federal compensation program may apply.

Check vaccine injury compensation programs (opens the HRSA comparison page in a new tab)

Why report before I know the cause?

Because reports are how patterns get noticed.

Optional. You don't need this to report.

A report is the first step in noticing a pattern. It isn't a claim about cause.

  1. ObservationSomeone notices a health problem after a vaccination.
  2. ReportThey report what they saw, without needing to know why it happened.
  3. SignalSafety monitors look across many reports for unusual or unexpected patterns.
  4. InvestigationA pattern that stands out can be studied with more controlled methods.
  5. EvidenceStudies can show whether an event really is more common after vaccination, and whether the vaccine is the reason.

Safety monitors work from the reports people file. Deciding what caused an event comes later, through investigation.

The center is what happened. The rings are what we can observe, report, and investigate. The dotted line marks what isn't in the picture: what caused it. Only investigation can show that. A report can't.

“Your report can save lives.” U.S. Food and Drug Administration (opens in a new tab)

What other medical harms can be reported?

Drugs, biologics, medical devices, and other products.

Choose what you want to report about.

Drug or medicationPrescription and over-the-counter medicines opens contact.fda.gov in a new tab BiologicBlood products, gene therapies, and cell and tissue products opens contact.fda.gov in a new tab Medical deviceSuch as glucose test kits, hearing aids, and breast pumps opens contact.fda.gov in a new tab Other products or not sureNot sure where your report belongs? Start with FDA's reporting page. opens contact.fda.gov in a new tab

Outside the U.S.?

Find the official medical-harm reporting system where you live.
United KingdomYellow Card SchemeSuspected problems with medicines, vaccines, medical devices, and other healthcare products. opens yellowcard.mhra.gov.uk in a new tab AustraliaTherapeutic Goods AdministrationSuspected adverse events involving medicines, vaccines, and medical devices. opens www.tga.gov.au in a new tab CanadaHealth CanadaOptions for reporting suspected vaccine adverse events, including direct consumer reporting. opens www.canada.ca in a new tab
More countries comingWe’re continuing to add official reporting systems as we verify them.