When a serious injury follows vaccination, families often ask one urgent question: Can we pursue a claim if the injury is not listed on the Vaccine Injury Table?

The answer may be yes.

The National Vaccine Injury Compensation Program (VICP) provides two pathways for compensation. One pathway covers injuries listed on the Vaccine Injury Table. The other covers injuries that are not listed, or symptoms that began outside the Table's specified timeframe.

These claims are called off-Table vaccine injury claims. They require proof that the vaccine actually caused the injury. The leading legal framework is the Althen standard, established in Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005).

The standard is demanding. But it is not impossible. With strong medical evidence, careful preparation, and experienced advocacy, families can pursue justice even when an injury is not automatically presumed vaccine-related. 

Our goal is simple...Righting Wrongs and Protecting Futures.

Table Claims and Off-Table Claims Follow Different Paths

The Vaccine Injury Table lists certain vaccines, injuries, and required onset periods.

A Table claim generally requires proof that:

• The person received a covered vaccine.
• The person developed an injury listed on the Table.
• The injury began within the Table's required timeframe.
• Other statutory eligibility requirements are satisfied.

When those requirements are met, the law generally provides a presumption of causation. The petitioner does not have to prove the vaccine caused the injury through separate scientific evidence, although the government may rebut the presumption.

An off-Table claim is different. The injury may not appear on the Table. Or the injury may have begun outside the Table's timeframe. In either situation, the petitioner must prove actual causation under 42 U.S.C. § 300aa-11(c)(1)(C)(ii).

That is where Althen matters.

The Althen Standard Requires Three Connected Proof Points

Under Althen, an off-Table petitioner must prove three elements by a preponderance of the evidence:

1. A medical theory connecting the vaccine to the injury.
2. A logical sequence of cause and effect showing the vaccine caused this person's injury.
3. A proximate temporal relationship between vaccination and injury.

These prongs work together. A strong claim presents one unified story supported by medical records, vaccination records, expert opinions, diagnostic testing, and reliable medical literature.

Prong One: Show a Medically Plausible Theory

The first prong asks whether the vaccine can cause the type of injury claimed.

A petitioner must present a reputable medical or scientific theory explaining the connection. The theory must be medically plausible and supported by reliable evidence. It does not need to be universally accepted. It does not require scientific certainty.

Importantly, Althen does not require a petitioner to identify one precise molecular or cellular mechanism. Medical science does not always know every step between vaccination and injury. A legally persuasive theory can be sufficient even when science has not identified the exact biological pathway.

Evidence supporting a medical theory may include the following:

• Peer-reviewed medical literature.
• Medical textbooks and accepted pathophysiology.
• Case reports.
• Package inserts and safety information.
• Evidence involving related vaccines or immune responses.
• Qualified expert medical opinions.

The question is not whether every doctor agrees with the theory. The question is whether the theory is sufficiently sound and reliable to show that the vaccine could cause the type of injury alleged.

Prong Two: Connect the Theory to This Person's Injury

The second prong requires individualized proof. It asks whether the vaccine actually caused this petitioner's injury.

This is where medical history and chronology become critical.

A persuasive claim may compare the following:

• The person's health before vaccination.
• The vaccination date and product received.
• The first symptom or manifestation.
• Medical visits and diagnostic findings.
• Changes in symptoms over time.
• Treatment and response to treatment.
• Other possible explanations for the injury.

Pre-vaccination records can establish a baseline. Post-vaccination records can show what changed. Specialist evaluations can help identify the injury and rule out competing diagnoses.

The evidence should explain why the vaccine (not an infection, trauma, genetic condition, autoimmune disease, medication, or natural progression) was the likely cause.

That does not mean a petitioner must eliminate every imaginable alternative. But unexplained alternative diagnoses and pre-existing conditions can weaken a claim if they are not addressed.

The Federal Circuit's decision in Capizzano v. Secretary of HHS, 440 F.3d 1317 (Fed. Cir. 2006) emphasizes the importance of the totality of the record. Treating physicians' opinions and contemporaneous medical records may provide powerful case-specific evidence.

A treating physician does not have to use the exact words, “The vaccine caused this injury.” The record may support causation through the physician's diagnosis, treatment decisions, observations, and overall opinion.

Prong Three: Establish a Medically Acceptable Timing

The third prong requires a proximate temporal relationship between the vaccination and the onset or significant aggravation of the injury.

Timing matters. A clear chronology can help show that symptoms began within a period consistent with the proposed medical theory.

But timing alone is not enough.

The statement “I received the vaccine, and then I became sick” does not automatically establish causation. The timing must fit the medical explanation. An expert should explain why the interval (whether hours, days, weeks, or longer) is medically reasonable for the injury and proposed mechanism.

In Pafford v. Secretary of HHS, 451 F.3d 1352 (Fed. Cir. 2006), the Federal Circuit reinforced that a petitioner must satisfy all three Althen prongs. Temporal proximity cannot replace a reliable medical theory or individualized proof.

The Burden Is “More Likely Than Not”

An off-Table petitioner must prove causation by a preponderance of the evidence. In plain language, the vaccine must be more likely than not to have caused or significantly aggravated the injury.

This is not proof beyond a reasonable doubt. It is also not scientific certainty.

Still, the claim cannot rest only on the petitioner's allegations. Under 42 U.S.C. § 300aa-13(a)(1), the court cannot make required findings solely on a petitioner's testimony or statements. The record must include medical records or medical opinion supporting the claim.

The record as a whole matters. Every piece of evidence should reinforce the same causal story.

Experts Turn Medical History into Persuasive Proof

Qualified experts often play a central role in an off-Table vaccine injury claim.

A persuasive expert report should do the following:

• Clearly identify the injury.
• Explain how the vaccine could cause that injury.
• Apply the medical theory to the petitioner's individual facts.
• Explain why the timing is medically appropriate.
• Address pre-existing conditions.
• Analyze alternative causes.
• Discuss relevant literature and medical evidence.
• Acknowledge limitations without undermining the opinion.

The expert should not simply state that the vaccine “probably caused” the injury. The report should show the reasoning behind that conclusion.

The HRSA VICP program materials explain the program's federal structure and claim process. Petitions are filed in the U.S. Court of Federal Claims, where a Special Master evaluates the evidence.

What Can Defeat an Off-Table Claim?

Several common problems can undermine an otherwise serious vaccine injury claim:

• Relying only on timing.
• Offering no reliable medical theory.
• Failing to identify the injury accurately.
• Ignoring pre-existing medical conditions.
• Leaving alternative diagnoses unexplained.
• Presenting an expert opinion that is conclusory or unsupported.
• Failing to explain gaps in treatment or medical records.
• Proving that symptoms followed vaccination but not that the vaccine caused them.

The government may rebut a claim by showing that the injury was caused by a factor unrelated to the vaccine. Section 300aa-13(a)(1)(B) addresses this defense. A purely hypothetical or unknown cause is not necessarily enough. The government must present a more persuasive explanation supported by the record.

Several related cases help define these boundaries:

• Capizzano highlights the totality of the record and confirms that treating physicians do not need to use a specific causation phrase.
• Pafford confirms that all three Althen prongs must be satisfied.
• Moberly v. Secretary of HHS, 592 F.3d 1315 (Fed. Cir. 2010) emphasizes that the petitioner carries the burden and that speculation is not enough.
• Broekelschen v. Secretary of HHS, 618 F.3d 1339 (Fed. Cir. 2010) explains that the injury must be properly identified before causation can be evaluated.
• Locane v. Secretary of HHS, 685 F.3d 1375 (Fed. Cir. 2012) addresses significant aggravation by comparing the actual post-vaccination course with the condition's natural course.
• Contreras v. Secretary of HHS, 844 F.3d 1363 (Fed. Cir. 2017) reinforces the importance of evaluating the injuries and medical evidence supported by the full record.

Families Can Strengthen Their Evidence Early

If you are considering a vaccine injury claim, begin gathering evidence as soon as possible:

1. Obtain vaccination records, including the vaccine name, date, and administration location.
2. Request complete medical records from before and after vaccination.
3. Write down the first symptom, when it appeared, and how it progressed.
4. Keep a detailed chronology of appointments, diagnoses, testing, and treatment.
5. Identify treating physicians and specialists who understand the injury.
6. Preserve relevant diagnostic imaging, laboratory results, and hospital records.
7. Discuss possible alternative causes with qualified medical professionals.
8. Consult experienced VICP counsel before important deadlines expire.

The general deadline for an injury claim is usually 36 months from the first symptom or manifestation of onset or significant aggravation. For a fatality, the petition generally must be filed within 24 months of death and no more than 48 months from the first symptom or manifestation of the injury that led to death. These rules come from 42 U.S.C. § 300aa-16, and exceptions or special circumstances may apply.

Do not assume that an injury is too late (or too unusual) to qualify without having the facts reviewed.

How Braden Blumenstiel Legal Advocates Group Helps

Braden Blumenstiel Legal Advocates Group helps individuals and families pursue VICP claims involving serious vaccine injuries.

Our team works to do the following:

• Build a medically sound causation theory.
• Gather and organize complete records.
• Develop a clear symptom chronology.
• Consult qualified medical experts.
• Address alternative causes and pre-existing conditions.
• Prepare the petition and supporting evidence.
• Advocate before the Special Master.

VICP attorney's fees and reasonable costs may be paid separately by the program. Our clients do not pay fees out of pocket, and we do not take a percentage of a recovery.

Righting Wrongs. Protecting Futures. That is our mission. We keep building the case, challenging the doubt, and protecting the future.

The Takeaway: Off-Table Does Not Mean Off-Limits

An injury does not have to appear on the Vaccine Injury Table for a family to pursue compensation. But an off-Table vaccine injury claim must satisfy the Althen standard.

You must show:

• A medically plausible theory.
• A logical connection between the vaccine and your injury.
• A medically acceptable timeframe.
• Supporting medical records or expert opinion.
• Evidence that addresses alternative causes.

The standard is based on what is more likely than not (not on absolute scientific certainty). Strong preparation can turn a complicated medical history into a clear, credible claim.

If you or a family member suffered a serious injury after vaccination, drop us a line. Call Braden Blumenstiel Legal Advocates Group at 614-508-1677 or 888-343-9796, or visit bblag.com to learn how we can help.

Righting Wrongs. Protecting Futures.