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If you or someone you care for develops a health problem after a hepatitis B (HepB) vaccination, you can report it directly to the Vaccine Adverse Event Reporting System (VAERS). Use the secure online VAERS form, which CDC identifies as the preferred route, or complete the writable PDF and upload it. Patients, parents and guardians, caregivers, family members, clinicians, manufacturers and other people may submit reports. Report a concerning event even when you are not sure the vaccine caused it. Seek emergency care first for severe symptoms; a VAERS report is not a substitute for diagnosis or treatment.
You do not need to wait for a final diagnosis, proof of causation or a healthcare professional’s permission before reporting. The purpose is to give CDC and FDA information for safety monitoring. Your report can describe a mild, persistent, unusual or serious problem, as long as you accurately explain what happened and what is known.
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1. Get medical help before filing when symptoms are dangerous
Call 911 or obtain emergency care immediately for possible severe allergic reaction. CDC lists hives, swelling of the face or throat, difficulty breathing, a fast heartbeat, dizziness and weakness as warning signs. These reactions can become life-threatening, so reporting should wait until urgent treatment is underway.
Do not drive yourself if you are having serious breathing trouble, feel faint or are rapidly worsening. Tell emergency personnel that a HepB vaccine was recently given and provide the vaccination date if you know it. Keep the vaccine record available for clinicians, but do not delay care while looking for a product label or lot number.
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For non-emergency symptoms, contact a clinician for an evaluation. A clinician can identify or rule out other causes, document a diagnosis, record treatment and advise whether additional care is needed. You may still file your own report even if a clinician does not believe the vaccine caused the problem. Reporting and medical evaluation serve different purposes: the clinician treats the individual, while VAERS collects information for population-level monitoring.
2. Record the event while the details are available
VAERS works best when the report has a clear timeline and identifiable vaccine information. Before opening the form, gather:
- The date and approximate time of the HepB vaccination.
- When each symptom began, how it changed, how long it lasted and whether it is improving.
- A plain-language description of what happened, including severity and any effect on normal activities.
- Diagnoses, tests, treatments, emergency visits, hospital stays and current status.
- The vaccine product name and lot number from the vaccination card, vial label or clinic record, if available.
- Other vaccines given at the same visit. If the HepB dose was part of a combination product, identify that combination.
- Current illnesses, medicines, relevant medical history and any previous vaccine reactions.
- The recipient’s demographic information and reliable contact details for follow-up.
Write the timeline in order rather than relying on a general statement such as “felt sick afterward.” For example, distinguish the vaccination date from the first symptom, the date a clinician was contacted, and the date symptoms improved or required hospital care. Include the approximate time when an exact time is unavailable. If symptoms occurred in stages, describe each stage separately.
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Do not delay emergency treatment while looking for a lot number. If a detail is unknown, state that it is unavailable rather than guessing. You can add information later if you obtain the vaccination record or medical chart.
3. Choose how to submit the VAERS report
There are two official submission routes. The online report is preferred for speed and convenience; the writable PDF is an alternative when you need to prepare the report offline or with help from another person.
| Route | Best when | What you do | Important consideration |
|---|---|---|---|
| Secure online report | You have the information available and can complete the form electronically. | Open the VAERS online reporting page, enter the event and vaccine details, review the record and submit it through the secure site. | CDC identifies this as the preferred method. |
| Writable PDF upload | You need an offline, printable or shareable form. | Download the writable VAERS PDF, complete it on a computer that can securely handle sensitive information, save it and upload it through the VAERS site. | Use a secure device and connection because the form contains health information. |
Choose the route that lets you provide the most accurate information without compromising privacy. A caregiver may help a child, older adult or person who is ill complete the form. The reporter should identify who is submitting the report and describe the relationship to the vaccinated person when the form requests it.
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After submission, keep a copy of the completed form and any supporting notes. A patient or caregiver may report directly, and a healthcare professional may submit a separate report. Multiple reports about the same event are allowed; VAERS links duplicates and follow-up information to the original record instead of automatically counting them as separate events. If both you and a clinician submit reports, retain both confirmation details and tell VAERS when you know that the reports concern the same event.
4. Complete the form accurately
Describe the health event
Use chronological, specific language: state what the person felt or what was observed, when it started, how severe it became, what treatment was given and the current outcome. Include objective information such as a measured temperature, test result or documented diagnosis when available. Explain whether symptoms resolved, continue, recur or are worsening.
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Separate the original symptom from later consequences. For example, identify the initial reaction, then explain whether it led to an emergency visit, admission, additional testing or missed normal activities. If a clinician changed a medicine or provided treatment, include that action and the date if known. Avoid copying speculation from social media or labeling an event with a diagnosis that has not been made.
Identify every vaccine given that day
Record the HepB product and lot number if possible, plus any other vaccines administered during the same visit. This matters because a CDC review of VAERS reports from 2005 through 2015 found that 78% of reports after hepatitis B or hepatitis B-containing vaccines followed combination vaccines or visits involving other vaccines.
Check whether the HepB component was administered alone or in a combination product. If the record lists several products, enter each one rather than assuming the HepB component was the only possible exposure. When the product or lot number cannot be found, report the information you do have and identify the missing field as unknown.
Add medical context
List medicines, current conditions, allergies, prior vaccine reactions and relevant events before vaccination. Include the names of facilities that evaluated the patient and dates of hospitalization or emergency treatment. A clinician can help supply missing records, but you do not need to wait for a clinician to file.
Include information that could help staff interpret the timeline, such as a pre-existing illness, another infection, a new medicine or another vaccination close in time. This context does not decide causation; it gives reviewers a fuller record for follow-up. Use the patient’s legal name and contact information as requested so VAERS can clarify missing details, while limiting copies of the form to people involved in care or reporting.
Tell VAERS about serious outcomes
Mark the report as serious when the event involved death, a life-threatening illness, hospitalization or prolonged hospitalization, permanent disability, or a congenital deformity or birth defect. These are federal serious-report categories. Explain the outcome and provide facility details so staff can request records if needed.
If the event was serious but the patient later recovered, report both the serious outcome and the recovery. If the outcome is still unknown, say so and update VAERS when the status changes. A report does not become less important because symptoms improved, and a mild event should not be described as serious unless it meets one of the federal categories.
5. What side effects are commonly reported after HepB vaccination?
CDC lists injection-site pain, soreness, redness or swelling, headache, fever and fatigue as common HepB vaccine effects. In 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. Report any event that concerns you, including an event that seems unusual, severe, persistent or medically important. The report should describe the actual experience rather than attempt to prove a cause. If a symptom lasts longer than expected, becomes more intense, or prompts medical evaluation, include those details.
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How to interpret the CDC report count
CDC reviewed 20,231 VAERS reports following hepatitis B or hepatitis B-containing vaccines during 2005–2015. The review found no new or unexpected safety concerns. The 20,231 figure is a count of reports submitted during that period, not the number of confirmed vaccine injuries and not an incidence rate. The 78% combination-vaccine figure describes the same review period and does not show that combination vaccination caused the reported events.
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6. Understand what VAERS can and cannot establish
What VAERS is for
VAERS is a passive surveillance system co-managed by CDC and FDA. It helps public-health officials detect possible safety signals, unusual or rare events, clusters of reports, administration errors and other patterns that may require follow-up. The system accepts reports from patients and the public as well as healthcare professionals and manufacturers, which broadens the information available for monitoring.
Because reporting is open to many groups, VAERS can receive information from someone who first noticed the event, a clinician who evaluated it, or a manufacturer that learned about it through its reporting responsibilities. These perspectives can supplement one another. A report is entered for review; it is not automatically accepted as a confirmed diagnosis.
What a report does not prove
CDC states: “A report to VAERS does not mean the vaccine caused an adverse event.” A health problem can occur after vaccination by coincidence, because of another illness, or for several contributing reasons. Establishing causation requires a thorough scientific investigation that can include medical records, background rates, clinical details and other data.
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Why report when you are uncertain?
CDC and FDA encourage anyone who has, or is made aware of, an adverse event after vaccination to report it even when they are unsure the vaccine caused the problem. CDC’s HepB clinical guidance likewise says: “Any adverse event suspected to be associated with HepB vaccination should be reported through the Vaccine Adverse Event Reporting System (VAERS).” Reporting preserves a signal for review; it does not assign blame or make a diagnosis.
Uncertainty is normal when symptoms have several possible explanations. State what is known, what is suspected and what remains unknown. That approach is more useful than withholding a report until every question has been answered.
7. What happens after you submit?
Confirmation and identification number
VAERS assigns a unique identification number and sends a confirmation letter electronically or by mail. Keep that number with your medical records. Use it when providing additional information or asking about the status of the report.
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The confirmation acknowledges receipt; it is not a finding that the vaccine caused the event, a medical diagnosis or an approval for compensation. Save the confirmation with the vaccination record, discharge papers and any notes about symptom progression.
Possible follow-up
For reports classified as serious, VAERS staff may seek medical records from healthcare institutions or public-health authorities. Staff may contact the reporter to clarify missing information or ask about recovery. Some reporters receive only the confirmation, so do not assume that a lack of further contact means the event was dismissed.
If staff contact you, answer as accurately as possible and distinguish your own observations from information supplied by a clinician. You may be asked for dates, test results, treatment details or the current outcome. Keep copies of records so you can refer to the same timeline.
Adding new information
If symptoms change, a diagnosis is confirmed, a hospitalization occurs or the patient recovers, provide the update using the original report’s identification number. Follow-up entries are linked to the initial record.
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Do not create a new report merely because the same event continues. Use the original identification number for a recovery update or additional medical documentation. A genuinely separate event can be reported separately, with its own timeline and vaccine information.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.8. VAERS is not a diagnosis or compensation application
| Need | Where to address it | What VAERS does |
|---|---|---|
| Immediate safety or treatment | 911, an emergency department or your clinician | Nothing; reporting does not provide medical care. |
| Medical diagnosis and recovery plan | A qualified healthcare professional | Collects the reported history but does not diagnose the patient. |
| Public-health safety monitoring | VAERS | Collects reports for signal detection and follow-up investigation. |
| Financial compensation | A direct claim with the relevant federal program | Does not create a claim or award compensation. |
Submitting a VAERS report does not file a claim under the National Vaccine Injury Compensation Program (VICP) or the Countermeasures Injury Compensation Program (CICP). Someone seeking compensation must file directly with the relevant Health Resources and Services Administration (HRSA) program and follow that program’s requirements. A VAERS confirmation number is not a compensation claim number.
If compensation is a concern, handle the medical-care and reporting steps separately from the legal or administrative claim. VAERS staff cannot turn a report into a VICP or CICP application, and filing a VAERS report does not guarantee eligibility, payment or a finding that vaccination caused the injury.
9. Privacy and public VAERS data
VAERS reports contain sensitive health information. Complete the form on a secure device, limit copies to people involved in care or reporting and avoid posting the completed form publicly.
Check the recipient’s name, contact details and medical dates before submitting. If another person helps prepare the report, share only what is needed and make sure the final narrative is accurate. Keep any downloaded PDF in a protected location and delete unnecessary duplicate copies.
CDC and FDA expanded public access to VAERS data on May 8, 2025. The WONDER database and downloadable files 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 simply add information to the original report. Public files omit patient-identifying information, but other details can still be descriptive, so interpret records carefully.
Public data are useful for observing reported patterns, not for identifying a particular patient or calculating a personal risk. A record in the public database should be read in light of its report status, possible follow-ups and the limitations of passive surveillance.
10. A practical reporting checklist
- Call 911 for hives, facial or throat swelling, breathing difficulty, a fast heartbeat, dizziness, weakness or another emergency.
- Arrange clinical evaluation for non-emergency symptoms and follow the treatment plan.
- Write a timeline from vaccination through symptom onset, treatment and current status.
- Find the product name, lot number and whether the dose was part of a combination vaccine.
- List other vaccines, medicines, illnesses, allergies, prior reactions and relevant medical history.
- Submit the secure online VAERS report, or complete the writable PDF and upload it.
- Save the confirmation and unique identification number.
- Respond if VAERS requests records or recovery information, and use the same identification number for updates.
- If compensation is your goal, contact the applicable HRSA compensation program separately; VAERS does not start that process.
Before pressing submit, read the narrative once for dates, spelling and sequence. Confirm that the vaccine listed is the product actually administered, that combination vaccines and other same-day vaccines are included, and that unknown details are marked as unknown rather than estimated. A short, accurate report is better than a long report filled with assumptions.
11. Common reporting mistakes to avoid
- Waiting for certainty: You may report a suspected event without proving causation.
- Replacing care with paperwork: A report cannot treat an allergic reaction, diagnose an illness or determine whether vaccination caused it.
- Leaving out combination-vaccine information: Record every product administered at the visit when known.
- Guessing a lot number or date: Mark information as unknown and obtain records later if possible.
- Counting a report as a confirmed injury: VAERS counts submitted reports; it does not by itself establish incidence or causality.
- Filing a compensation claim through VAERS: VICP and CICP claims require separate direct filing with the relevant HRSA program.
- Submitting duplicate updates as new events: Use the original identification number when adding recovery information or records about the same event.
- Sharing the completed form publicly: Remove or protect sensitive health information and use secure channels for submission.
Frequently Asked Questions
Can I report a HepB vaccine side effect myself?
Yes. Patients, parents or guardians, caregivers, family members, clinicians, manufacturers and other people may submit a VAERS report. You do not need to prove that the vaccine caused the event, and a clinician’s separate report can be linked to yours.
What if I do not know the vaccine lot number?
Submit the report with the information you have and state that the lot number is unknown. Check the vaccination card, vial label or clinic record later and provide an update with the original identification number if you obtain it.
Should I report mild pain, fever or fatigue?
You may report any event that concerns you. CDC lists injection-site pain, soreness, redness or swelling, headache, fever and fatigue as common HepB effects, usually mild and lasting one to two days. Describe the actual duration and severity rather than trying to prove causation.
Does a VAERS report prove the HepB vaccine caused the problem?
No. CDC states, “A report to VAERS does not mean the vaccine caused an adverse event.” VAERS is a passive surveillance system for detecting possible signals; causal conclusions require thorough scientific investigation.
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Get urgent medical care first. Call 911 for hives, facial or throat swelling, difficulty breathing, a fast heartbeat, dizziness, weakness or another emergency. You can complete the VAERS report after treatment is underway.
Will VAERS pay compensation?
No. A VAERS report does not create a VICP or CICP claim and does not award compensation. A person seeking compensation must file directly with the relevant HRSA program and meet that program’s requirements.
What happens after VAERS receives my report?
VAERS assigns a unique identification number and sends confirmation electronically or by mail. For serious reports, staff may seek medical records or contact you for missing details or recovery status. Some reporters receive no further communication.
Can I add a later diagnosis or recovery update?
Yes. Use the original report’s identification number to provide a confirmed diagnosis, hospitalization, recovery or other new information. Follow-up entries are linked to the initial record and do not necessarily represent a separate adverse event.
The Bottom Line
Report a suspected HepB vaccine side effect through the secure online VAERS form, or upload the writable PDF. Document the timeline and vaccine details, obtain medical care when needed, and remember that VAERS supports safety monitoring—it does not prove causation, replace clinical care or file a compensation claim.
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