If you’ve experienced a serious health problem after receiving a vaccine, you may be wondering whether you can take legal action against the vaccine manufacturer. The answer is more complex than a simple yes or no. In the United States, federal law has created a unique system that limits direct lawsuits against vaccine companies while providing alternative paths to compensation. Understanding how this system works, and acting quickly, is critical to protecting your legal rights.
Key Takeaways
- In the U.S., you generally cannot immediately sue vaccine manufacturers in state or federal court. For most routine vaccines, you must first file a claim through the National Vaccine Injury Compensation Program (VICP), a no-fault federal program that compensates individuals harmed by covered vaccines.
- For COVID-19 vaccines and other emergency countermeasures, claims are handled through the Countermeasures Injury Compensation Program (CICP) under the PREP Act, which has different, and often more restrictive, rules and benefits.
- Vaccine manufacturers receive broad legal protection under the 1986 National Childhood Vaccine Injury Act and the PREP Act. However, civil lawsuits may still be possible in limited circumstances, such as after exhausting VICP remedies or proving certain manufacturing defects or willful misconduct.
- Strict filing deadlines apply: generally 3 years from the first symptom of injury (or 2 years from death) for VICP claims, and only 1 year from vaccination for most CICP claims. Missing these deadlines can permanently bar your recovery.
- Siri & Glimstad is a national law firm focused on vaccine injury claims and related matters. If you suspect a vaccine caused a serious injury, you should speak with an experienced vaccine attorney as soon as possible to preserve your options.
What Does It Mean to “Sue” a Vaccine Manufacturer in the United States?
When most people think of suing a company, they imagine filing a lawsuit in civil court, presenting evidence to a jury, and receiving a verdict that holds the company accountable. However, for vaccine injuries in the United States, this traditional path is largely unavailable—at least as a first step.
For vaccines routinely administered in the U.S., including DTaP, MMR, polio, seasonal flu, human papillomavirus (HPV), pneumococcal conjugate vaccines, meningococcal vaccines, and others, federal law requires injured individuals to first pursue compensation through the VICP. This program, administered through the U.S. Court of Federal Claims in Washington, D.C., handles vaccine injury claims as a prerequisite to any civil lawsuit.
Importantly, when you file a vaccine injury petition through VICP, you are not suing the vaccine manufacturer. Instead, you file a petition against the Secretary of Health and Human Services. The federal government defends against these claims, not pharmaceutical companies like Pfizer, Merck, Moderna, or Sanofi Pasteur.
This system exists because Congress passed the National Childhood Vaccine Injury Act in 1986, which shifted most vaccine injury liability away from manufacturers and into a federal no fault compensation program. Traditional product liability suits in state courts—the kind you might bring for a defective car or dangerous medication—are largely preempted for vaccines covered by this Act.
Only after the VICP process concludes can a person potentially pursue a conventional lawsuit in state or federal court, and even then, the circumstances are narrow. Understanding these limitations is essential, and working with legal professionals who specialize in vaccine injury law is critical to evaluating your options.
How Did the 1986 National Childhood Vaccine Injury Act Change My Right to Sue?
To understand why suing vaccine manufacturers is so restricted today, you need to understand the scenario that led Congress to act in the 1980s.
Vaccine Shortage
In the 1970s and 1980s, a wave of lawsuits over vaccines, particularly the DPT (diphtheria-pertussis-tetanus) vaccine, threatened the entire vaccine supply in the United States. Families whose children were injured filed tort law claims against drug manufacturers, and large jury verdicts followed. Some cases established precedents for manufacturer liability without proof of negligence in design. Facing mounting litigation costs and unpredictable jury verdicts, several vaccine manufacturers exited the market entirely.
Congress’s Response
In response, Congress passed the National Childhood Vaccine Injury Act of 1986 (NCVIA). This legislation created two fundamental changes:
- The National Vaccine Injury Compensation Program (VICP): A no-fault compensation system funded by an excise tax on each dose of covered vaccine, allowing injured individuals to receive compensation without proving negligence.
- Broad legal protection for manufacturers: Under the Public Health Service Act provisions incorporated into the NCVIA, manufacturers of properly prepared vaccines with proper directions and adequate warnings became shielded from many state law design-defect lawsuits.
The Bruesewitz Decision
The scope of this protection was confirmed by the U.S. Supreme Court in the 2011 case Bruesewitz v. Wyeth. The Court held that when a vaccine manufactured according to federal standards is properly prepared and includes proper labeling, the manufacturer is protected from design-defect claims under the Vaccine Injury Act. The Court interpreted such provisions as reflecting Congress’s intent to channel claims into VICP rather than civil court.
This doesn’t mean vaccine companies have total immunity. Manufacturers may still face claims for:
- Manufacturing defects (when a particular vaccine batch is contaminated or improperly made)
- Certain failure-to-warn claims outside the scope of federally approved labeling
- Conduct that falls outside the Act’s protections
However, for the vast majority of vaccine related injuries involving properly made, properly labeled vaccines, the VICP is the exclusive initial remedy. Only after exhausting this process—or in rare cases—can you pursue a traditional lawsuit against the vaccine company.
What Is the National Vaccine Injury Compensation Program (VICP)?
The National Vaccine Injury Compensation Program is a federal, no-fault program created in 1988 to compensate individuals who suffer vaccine related injuries without requiring them to prove traditional negligence. Instead of suing the manufacturer in district court, you file a petition with the U.S. Court of Federal Claims.
Which Vaccines Are Covered?
As of 2026, vaccines covered by VICP include:
| Vaccine Type | Examples |
|---|---|
| Childhood vaccines | DTaP, MMR, Varicella (Chickenpox), Hib, Hepatitis A & B, Polio (IPV), Rotavirus |
| Adolescent/adult vaccines | Tdap, HPV, Seasonal Influenza, Pneumococcal conjugate , Meningococcal |
| Other covered vaccines | Certain combination vaccines |
The full list of covered vaccines is maintained by the Health Resources and Services Administration (HRSA), and new vaccines may be added over time.
Basic Eligibility Requirements
To file a VICP claim, you must meet several criteria:
- The vaccine must be a covered vaccine listed under the program
- The injury must have lasted more than 6 months after the vaccination, resulted in inpatient hospitalization and surgical intervention, or resulted in death
- The vaccine injury petition must be filed within the applicable deadlines with the U.S. Court of Federal Claims
- The vaccine must have been administered in the United States or its trust territories (with limited exceptions)
The Vaccine Injury Table
One of VICP’s most important features is the Vaccine Injury Table, which lists specific injuries and the time frames in which they must occur after vaccination to qualify for a presumption of causation.
The current table can be found at this location on HRSA’s website.
If your injury appears on the table and occurs within the specified time frame, causation is presumed—meaning you don’t have to prove the vaccine caused your injury through complex medical evidence. This significantly lowers the evidentiary burden compared to traditional tort claims.
Off-Table Injuries
Claims for injuries not on the table, commonly referred to as “off-table” injuries, can still succeed, but they require medical evidence and expert testimony showing the vaccine “more likely than not” caused the condition.
Compensation Statistics
Since the program began in 1988, VICP has:
- Awarded over $5 billion in total compensation
- Resolved more than 9,500 claims with awards
- Paid attorneys’ fees separately from Petitioner’s award
Most VICP cases are resolved through negotiated settlements rather than reasoned decisions, often without the federal government admitting that the vaccine caused the injury.
Siri & Glimstad regularly represents petitioners in VICP cases nationwide, coordinating medical records, securing qualified experts, and navigating the complex federal claims process.
Can I Ever Sue a Vaccine Manufacturer in Civil Court Instead of Using VICP?
While federal law channels most claims into VICP, there are limited situations where a traditional lawsuit against a vaccine manufacturer may still be possible. These situations are highly fact-dependent and require careful legal analysis.
After Exhausting VICP
If you complete the VICP process and reject the final judgment, or if you timely withdraw your petition, you may be able to pursue a civil lawsuit in state or federal court. However, this path comes with significant restrictions.
Design-Defect Claims Are Generally Barred
Even after leaving VICP, design-defect claims—arguing that the vaccine’s basic formula is inherently dangerous—are generally preempted for vaccines covered by the Act. The Supreme Court’s Bruesewitz v. Wyeth decision interpreted the NCVIA as shielding manufacturers from such claims when vaccines are properly prepared and include proper directions and warnings.
When Civil Suits May Be Viable
Traditional lawsuits may still be possible in limited circumstances:
- Manufacturing defects: If a particular vaccine batch was contaminated or improperly produced
- Failure to warn: In rare cases where the manufacturer failed to include warnings beyond what federal labeling required
- Vaccines not covered by VICP: Some travel vaccines (like yellow fever) or newly authorized products not yet added to the table may allow traditional product liability claims under state law
Non-Covered Vaccines
If a particular vaccine is not covered by VICP, traditional product liability principles may apply. In such cases, you might pursue claims in civil court as you would for any other defective product.
Because of preemption, immunity provisions, and complex case law, anyone considering a direct lawsuit against a vaccine manufacturer should consult a law firm deeply experienced in vaccine litigation. Siri & Glimstad can assess whether such claims are legally available based on your specific circumstances.
How Are COVID-19 and Other Emergency Vaccines Treated Differently (CICP and the PREP Act)?
COVID-19 vaccines and certain other emergency countermeasures follow a completely different legal path than childhood or adult vaccines. Understanding these differences is critical if you believe you were injured by a COVID-19 vaccine.
The PREP Act and Manufacturer Immunity
The Public Readiness and Emergency Preparedness Act (PREP Act), enacted in 2005, grants sweeping immunity to vaccine manufacturers, distributors, health care providers, and government officials during declared public health emergencies. When the federal government declared a public health emergency for COVID-19, the PREP Act activated, providing legal protection to those involved in producing and administering COVID-19 vaccines.
Under the emergency preparedness act framework, the only way to overcome this immunity is to prove willful misconduct—an extremely high bar that essentially requires showing the manufacturer or provider acted with intentional wrongdoing.
The Countermeasures Injury Compensation Program (CICP)
Instead of VICP, COVID-19 vaccine injuries are handled through the Countermeasures Injury Compensation Program (CICP), administered entirely within the Department of Health and Human Services. CICP differs significantly from VICP:
| Feature | VICP | CICP |
|---|---|---|
| Oversight | U.S. Court of Federal Claims (judicial) | HHS only (administrative) |
| Pain and suffering | Up to $250,000 | Not available |
| Attorneys’ fees | Paid by program | Not covered |
| Filing deadline | 3 years from onset of injury | 1 year from vaccination |
| Approval rate | ~70-80% of claims resolved favorably | Under 10% compensated |
As of 2026, over 14,000 COVID-19 vaccine injury claims have been filed with CICP, but only a few hundred have resulted in awards.
The Critical 1-Year Deadline
For CICP claims, the filing deadline is generally only 1 year from the date of vaccination. This is far shorter than VICP’s 3-year deadline and leaves little time for injured individuals to gather medical evidence and file claims. Missing this deadline can permanently bar recovery.
Ongoing Policy Discussions
There is ongoing debate about whether some COVID-19 vaccines should be transitioned to VICP, which would provide more favorable compensation terms and judicial oversight. However, as of early 2026, most COVID-19 vaccines remain under CICP and the PREP Act framework.
Siri & Glimstad assists clients in determining whether a COVID-19 vaccine injury may be compensable under CICP and helps assemble the extensive medical documentation required by HHS.
What Kinds of Injuries Might Qualify for Compensation?
Certain adverse events are recognized patterns that may be compensable if the timing and medical evidence align with established medical criteria.
Common VICP-Compensable Injuries
Anaphylaxis: A sudden, severe allergic reaction that can occur within minutes of exposure to an allergen. It causes a massive release of chemicals that constricts the airways and dilates blood vessels, leading to symptoms such as hives or skin rash, swelling of the face or throat, difficulty breathing (wheezing), nausea or vomiting, and a rapid weak pulse from a dangerous drop in blood pressure. This condition is life-threatening and requires immediate treatment with an epinephrine injection and emergency medical care.
Guillain-Barré Syndrome (GBS): GBS is an autoimmune condition where the immune system attacks the peripheral nerves, stripping away their myelin sheath. It usually begins with tingling and weakness in the feet and legs, which often rapidly spreads upward to the arms and torso. Because it can escalate quickly, severe cases may lead to paralysis of the breathing muscles, requiring emergency care (such as assisted ventilation) until recovery begins. Large-scale studies have been conducted to investigate the association between vaccines and GBS, providing important evidence for vaccine safety.
SIRVA (Shoulder Injury Related to Vaccine Administration): An inflammatory shoulder injury that occurs when a vaccine intended for the deltoid muscle is injected too high or deep, entering the joint or bursa. The vaccine contents then trigger an immune-mediated inflammatory response, often causing bursitis, tendonitis, or other painful conditions of the shoulder. Symptoms can begin immediately or hours to days later, typically with severe shoulder pain and limited motion.
Transverse Myelitis: Inflammation across a segment of the spinal cord, interrupting nerve signals to and from the brain. Patients usually experience sudden onset of neurological symptoms at or below the affected spinal level – such as a band-like numbness or tingling around the trunk, weakness in the legs (and sometimes arms), and bowel or bladder dysfunction. This is a serious condition that often requires prompt medical treatment to minimize lasting neurological damage.
Brachial Neuritis: A rare neurological condition that causes sudden, intense pain in the shoulder and upper arm, typically followed by significant muscle weakness. The acute pain phase usually lasts from days to a few weeks, after which strength gradually returns; it is common for recovery of nerve function to take several months or longer even after the pain subsides. This condition is thought to involve an immune-mediated injury to the nerves of the brachial plexus, often triggered by infection or vaccination.
Seizure Disorders: Certain seizure conditions in infants occurring within defined time frames after DTP or similar vaccines.
On-Table vs. Off-Table Injuries
- On-table injuries are listed on the Vaccine Injury Table with specific onset windows. If your injury matches, causation is presumed, simplifying your case.
- Off-table injuries require medical evidence demonstrating a causal relationship between the vaccine and your condition. This typically involves:
- Differential diagnosis ruling out other causes
- Medical imaging (MRIs, CT scans)
- Laboratory testing
- Expert testimony from neurologists, immunologists, or other specialists
Each Case Is Unique
Determining whether your injury qualifies requires careful review of medical provider notes, specialist consultations, imaging, lab results, and vaccination records. An experienced vaccine attorney can identify whether your symptoms match a recognized pattern and whether the timing supports a viable claim.
Why Do I Need a Vaccine Injury Lawyer Instead of Handling This Myself?
Although VICP is technically a “no-fault” system, it is far from simple. The process is adversarial, involves the Department of Justice, requires expert medical testimony, and follows federal procedural rules. Professional legal representation is critical to achieving a successful outcome.
What a Vaccine Injury Lawyer Does
Case Evaluation: Determines whether your injury fits the vaccine injury table or requires an off-table theory, and whether your claim is timely.
Medical Expert Coordination: Identifies and retains qualified specialists—neurologists, immunologists, orthopedists—who can provide testimony supporting the causal relationship between your vaccination and injury.
Petition Drafting: Prepares comprehensive, persuasive petitions that present medical evidence clearly and meet all procedural requirements.
Record Gathering: Obtains and organizes complete medical records, including records the vaccine recipient or injured person may not know exist.
Settlement Negotiation: Negotiates with DOJ attorneys for fair settlements, which account for approximately 80% of VICP resolutions.
Appellate Advocacy: If necessary, handles appeals to the U.S. Court of Federal Claims or beyond.
Attorneys’ Fees Are Often Covered
In successful VICP cases, and even in some unsuccessful cases where there was a reasonable basis for the claim, attorneys’ fees and costs are paid separately by the program. This means you can access skilled legal counsel without paying legal fees out of pocket or having fees deducted from your compensation award.
The Risks of Self-Representation
Petitioners who represent themselves (pro se) face significant disadvantages:
- Higher rates of claim denial
- Incomplete medical documentation
- Missed deadlines that bar recovery
- Failure to preserve civil lawsuit options
- Awards that are 2-3 times lower than represented petitioners
The federal government contests 70-80% of off-table claims, deploying experienced DOJ attorneys and medical experts. Without an attorney, you’re at a significant disadvantage.
When Should I Contact a Lawyer About a Possible Vaccine Injury?
Timing is everything in vaccine injury cases. The earlier you contact an experienced attorney, the better your chances of preserving evidence, meeting deadlines, and maximizing recovery.
Red-Flag Scenarios Requiring Urgent Consultation
Contact a vaccine injury lawyer immediately if you experience:
- Hospitalization within days or weeks of vaccination
- Rapidly progressing neurological symptoms: weakness, numbness, paralysis, difficulty walking, or seizures
- Severe shoulder pain and loss of range of motion: specifically, if symptoms began within 48 hours of an injection
- Allergic reactions requiring emergency treatment: anaphylaxis, difficulty breathing, or cardiovascular symptoms
- Death of a family member: temporally associated with vaccination
Remember the Deadlines
| Program | Injury Deadline | Death Deadline |
|---|---|---|
| VICP | 3 years from first symptom | 2 years from death (max 4 years from first symptom) |
| CICP | 1 year from vaccination | 1 year from vaccination |
Medical investigations, record collection, and expert review take considerable time. Starting the process early gives you the best chance of meeting deadlines and building a strong case.
Siri & Glimstad’s National Practice
Siri & Glimstad represents vaccine injured clients across the United States. Our practice extends to related matters including vaccine exemptions for clinical students, immigration vaccine waivers, and civil rights claims involving vaccine mandates. We understand both the medical complexity of vaccine injuries and the legal intricacies of federal vaccine law.
If you suspect a vaccine caused a serious injury to you or a loved one, contact Siri & Glimstad for a confidential evaluation of your potential claim.
Frequently Asked Questions
What if the vaccine I received is not listed on the Vaccine Injury Table?
Vaccines not currently on the table may still be covered by VICP if they fall within the program’s statutory definitions or are later added. However, proving causation for off-table claims is more demanding, requiring stronger medical evidence and expert testimony showing a reasonable basis for concluding the vaccine caused your condition. Some vaccines, particularly certain travel vaccines or newly authorized products, may not be covered by VICP at all. In such cases, traditional product liability claims through state or federal court might be available, depending on the facts. Consulting a qualified attorney is essential to determine which legal avenue applies to your particular vaccine.
Can non-U.S. citizens file vaccine injury claims in VICP or CICP?
Eligibility for VICP and CICP is based primarily on where the vaccine was administered and other statutory criteria, not solely on citizenship. Many non-citizens vaccinated in the United States may be eligible to file claims, including tourists, visa holders, and immigrants. Siri & Glimstad also handles immigration cases involving vaccine exemptions and waivers, which can overlap with vaccine injury concerns for people navigating the U.S. immigration system. If you’re a non-citizen who believes you were injured by a vaccine administered in the U.S., contact us to discuss your eligibility.
How much money can I receive for a successful vaccine injury claim?
Compensation varies widely based on the severity and permanence of your injury, your age and earning capacity, and the strength of your medical evidence. Generally: VICP compensation may include: – Past and future medical expenses (no cap) – Lost earnings, including projected lifetime earnings for disabled adults or others with permanent injuries – Pain and suffering (capped at $250,000) – Death benefit (up to $250,000) – Attorneys’ fees and costs (paid separately) CICP compensation is more limited: – Medical expenses and lost income only – No pain and suffering awards – No attorneys’ fees coverage In rare cases with severe, permanent injuries, VICP awards have exceeded $1 million when accounting for future medical care, lost wages, and pain and suffering. However, every case is unique. An individualized legal evaluation is necessary to estimate potential recovery based on your specific circumstances.
