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Report a concerning health problem after a hepatitis B (HepB) vaccination through the CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS), even when you are unsure the vaccine caused it. Use the secure online VAERS report (the preferred method) or complete the writable PDF and upload it. Patients, parents or guardians, caregivers, clinicians, manufacturers and other witnesses may submit reports.
Get emergency care before reporting if symptoms suggest a severe allergic reaction. A VAERS report helps public-health agencies look for safety signals; it does not diagnose you, prove causation or create a compensation claim.
Get medical help before you file when symptoms are dangerous
Reporting is not a substitute for treatment. Call 911 or use your local emergency service immediately for possible anaphylaxis after vaccination. The CDC lists hives, swelling of the face or throat, difficulty breathing, a fast heartbeat, dizziness and weakness as warning signs of a severe allergic reaction. These reactions can become life-threatening quickly.
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1Scan for outdated or missing drivers - takes under a minute2Clear out junk files and repair common Windows errors3Fix the driver behind crashes, sound loss and screen glitchesFor symptoms that are not an emergency, contact a healthcare professional for an evaluation. Ask the clinician to document the diagnosis, examination findings, treatment and recovery status. That record can make a VAERS report more complete, but you do not have to wait for a clinician before submitting your own report.
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Who can report a suspected HepB vaccine reaction?
Any person who experienced, witnessed or learned about a health problem after vaccination may submit a report. Eligible reporters include:
- The vaccinated patient.
- A parent or legal guardian reporting for a child.
- A family member or caregiver.
- A healthcare professional or health facility.
- A vaccine manufacturer.
- Another person who has relevant information about the event.
CDC and FDA encourage reporting even when the reporter is not sure the vaccine caused the problem. The CDC’s Hepatitis B clinical guidance says that any adverse event suspected to be associated with HepB vaccination should be reported through VAERS.
Choose a submission method
VAERS offers two practical ways to send a report. Both routes go to the same surveillance system; the main difference is how you enter the information.
| Method | How it works | Best choice when | Important considerations |
|---|---|---|---|
| Secure online report | Enter the event and vaccination details directly in the VAERS online reporting system and submit electronically. | You have internet access and want the fastest, most convenient process. | Have your timeline, vaccine record and medical information available before starting so you can complete the form accurately. |
| Writable PDF upload | Download the VAERS writable PDF, complete it on a computer that can safely handle sensitive information, then upload it through the VAERS site. | You prefer a document-based workflow or need to gather information in stages. | Use the current writable form, save it securely, and verify that the uploaded file is complete and readable. |
The online report is CDC’s preferred option. A patient or caregiver may report directly, and a healthcare professional may submit a separate report. VAERS can receive more than one report about the same event; staff link duplicates and follow-up submissions to the original record rather than automatically treating them as additional events.
Collect the information VAERS asks for
Gather what you know before opening the online form or filling the PDF. Do not delay an urgent medical evaluation while trying to locate every field. Unknown information can be explained in the report, and additional details can be supplied later if VAERS contacts you.
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Build a clear timeline
Write down the date and approximate time of the HepB vaccination, when each symptom began, how symptoms changed, how long they lasted and whether they are improving, resolved or continuing. Include emergency visits, clinic appointments, tests, diagnoses, medicines, procedures and other treatment. If symptoms occurred in more than one phase, list each onset and change separately rather than compressing the event into one vague description.
Identify the vaccine product
Use the vaccination record, a lot label, pharmacy record or clinic chart to capture the product name and lot number. Record the manufacturer if it appears on the record. Note whether the dose was a HepB-only product or part of a combination vaccine, and list other vaccines given at the same visit. Do not guess a lot number; state that it is unknown if the record does not provide it.
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Describe the person’s health context
VAERS collects current illnesses and medicines, relevant medical history, previous vaccine reactions and demographic information. Include pregnancy status when applicable, allergies, chronic conditions, recent infections, and any new medicine or procedure that could help a clinician interpret the event. Report the person’s usual health before vaccination and what changed afterward without claiming a cause you cannot establish.
Gather supporting records
Keep copies of the vaccination record, discharge summary, laboratory or imaging results, prescriptions, photographs of a rash or swelling, and clinician notes. Submit only through the VAERS process or another secure channel it specifies. Do not email medical records to an unverified address or include unnecessary identifiers in a public post.
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Submit the VAERS report step by step
- Stabilize the patient first. Call emergency services for hives with breathing difficulty, facial or throat swelling, faintness, a fast heartbeat or marked weakness. For other concerning symptoms, arrange a clinical evaluation.
- Open the VAERS online report. This is the preferred route. If you use the writable PDF instead, download the form from the official VAERS site and complete it electronically before uploading it there.
- Enter reporter information. Provide your name and contact details so VAERS can send a confirmation and ask follow-up questions. Explain your relationship to the patient when filing for someone else.
- Enter patient information. Provide the requested demographic and health details. Use the minimum information necessary for the report and check spelling and dates before submission.
- Describe the vaccination. Enter the HepB product, manufacturer, lot number, date, dose information and administration site when known. List combination products and other vaccines administered during the same visit.
- Describe the event in chronological order. State the first symptom, onset date and time, progression, duration, treatment, medical visits, diagnoses and current outcome. Distinguish what you observed from what a clinician diagnosed.
- Identify other possible contributors. List current medicines, illnesses, prior reactions and relevant medical history. If information is unknown, say so instead of leaving a misleading impression.
- Attach or retain supporting information as directed. Keep the original records and photographs. Upload documents only when the VAERS instructions request them and the connection is secure.
- Review and submit. Check that the vaccination date, onset date, product and contact information are internally consistent. Save the submission confirmation and VAERS identification number.
A clinician can file independently even if the patient already submitted a report. Tell the clinician about the existing report so the office can identify it as a follow-up or duplicate when appropriate.
What HepB reactions are commonly reported?
CDC lists injection-site pain, soreness, redness or swelling, headache, fever and fatigue among common HepB vaccine side effects. For healthy infants and children receiving certain combination products, CDC also lists irritability, diarrhea, loss of appetite, vomiting, crying and drowsiness. These common effects are usually mild and last one to two days.
A symptom’s being common or mild does not prevent you from reporting it if it concerns you. Conversely, a symptom appearing after vaccination is not automatically caused by the vaccine; the report records timing and clinical information for safety monitoring.
| Information to report | Examples | Why it matters |
|---|---|---|
| Local reaction | Pain, soreness, redness or swelling at the injection site; size and duration if known. | Shows the type and course of the reaction. |
| General symptoms | Fever, headache, fatigue, irritability, vomiting, diarrhea or drowsiness. | Allows analysts to group similar reports and examine timing. |
| Serious or unusual event | Emergency treatment, hospitalization, life-threatening illness, permanent disability or death. | Prompts additional review and may lead staff to seek medical records. |
| Administration details | HepB-only versus combination product, lot number, date and other vaccines given. | Helps identify product, lot, administration or co-vaccination patterns. |
Understand what a VAERS report can—and cannot—show
What VAERS is designed to do
VAERS is a passive surveillance system co-managed by CDC and FDA. Its purpose is to detect possible safety signals, unusual or rare events, clusters of reports, administration errors and other patterns that warrant follow-up. Analysts may compare reports with clinical knowledge and other data sources, then conduct additional scientific investigation.
What a report does not establish
CDC states: “A report to VAERS does not mean the vaccine caused an adverse event.” A report demonstrates that a health event occurred after vaccination and was reported; it does not establish that vaccination caused it. Timing alone cannot separate a vaccine effect from an illness that would have happened anyway, an underlying condition, another medicine or another exposure.
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VAERS data generally cannot calculate how often an event occurs in the population because reliable denominator data—the total number of people vaccinated and their comparable follow-up—are usually unavailable. The 20,231 reports in the CDC’s 2005–2015 HepB review are counts of reports, not a rate, risk estimate or number of confirmed vaccine injuries. That review found no new or unexpected safety concerns.
Why reporting still matters when causation is uncertain
Under-reporting can hide rare patterns, while a single report can prompt questions about a product, lot, administration error or clinical syndrome. Reporting an event you are unsure about gives CDC and FDA information to investigate without requiring you to make a scientific judgment first.
What happens after submission?
- VAERS assigns an identification number. A confirmation letter is sent electronically or by mail. Keep the number with the patient’s medical records.
- Staff review the report for completeness and coding. They may contact the reporter to clarify symptoms, obtain missing dates or ask about recovery.
- Serious reports may receive additional follow-up. For reports involving death, life-threatening illness, hospitalization or prolonged hospitalization, permanent disability, or a congenital deformity or birth defect, staff may seek records from healthcare institutions or public-health authorities.
- Further contact is not guaranteed. A confirmation may be the only communication. If the patient’s condition changes, use the VAERS process to provide an update and reference the original identification number.
VAERS staff do not replace the treating clinician. Continue medical follow-up through the patient’s healthcare team, including evaluation of symptoms that persist or worsen.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.VAERS reporting is separate from vaccine compensation
Submitting a VAERS report does not start a claim under the National Vaccine Injury Compensation Program (VICP) or the Countermeasures Injury Compensation Program (CICP). A person seeking compensation must file directly with the relevant Health Resources and Services Administration program and meet that program’s eligibility, filing and evidence requirements. The VAERS identification number is not an award, eligibility decision or substitute for a compensation filing.
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CDC and FDA expanded public access to VAERS data on May 8, 2025, through the WONDER database and downloadable files. The public data now include subsequent reports linked to the same patient, vaccine and dose combination. A linked follow-up does not necessarily represent another adverse event; it may add information to the original report.
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Public files omit patient-identifying information. Even so, do not publish names, addresses, medical-record numbers or unredacted documents yourself. Use the official submission channel for sensitive information, and store confirmation letters and records securely.
Common reporting mistakes and how to prevent them
Waiting for certainty
You do not need proof that HepB caused the event. Report the observed facts, timing and medical evaluation, and let the surveillance process assess whether the pattern warrants investigation.
Putting emergency care second
Do not spend time completing a form while someone has breathing difficulty, throat swelling, faintness or other signs of a severe allergic reaction. Call 911 first; report after the patient is safe.
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Leaving out combination vaccination
Check the record for every vaccine given at the visit. A combination product or multiple same-day vaccines changes how analysts interpret the report.
Guessing dates or lot numbers
Use exact records when available. If a detail cannot be verified, label it unknown or approximate and explain the basis for the estimate.
Confusing a report with a diagnosis
Describe symptoms and clinician findings separately. VAERS collects reports; it does not determine the patient’s diagnosis or causation.
Submitting repeated reports without the original number
If new information becomes available, reference the existing VAERS identification number so staff can link the update instead of creating confusion about whether another event occurred.
A practical checklist before you click Submit
- Emergency symptoms were treated before reporting.
- Vaccination date and symptom-onset date are recorded.
- Product name, lot number and manufacturer are copied from a reliable record when available.
- Combination products and other vaccines at the same visit are listed.
- Symptoms, duration, treatment, diagnoses and current outcome are described chronologically.
- Current medicines, illnesses, allergies, medical history and prior vaccine reactions are included when relevant.
- Reporter contact details are correct.
- Supporting records are stored securely and uploaded only through the official process when requested.
- The confirmation and VAERS identification number are saved.
The most useful report is prompt, factual and specific: seek urgent care when needed, document the timeline, identify the product as accurately as possible, submit through the online system or writable PDF, and continue medical care independently of VAERS.
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