D

Appendix D

Appendix D-1

Appendix D: Vaccine Safety

Vaccine Adverse Event Reporting System (VAERS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

Vaccine Administration: Preventing Vaccine Administration Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8

Vaccine Injury Compensation Program (VICP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10

Countermeasures Injury Compensation Program (CICP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-14

Additional Resources for Vaccine Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-15
D

Appendix D

Appendix D-2
D

Appendix D

Appendix D-3

Vaccine Adverse Event Reporting System (VAERS)

VAERS is a national post-licensure vaccine safety surveillance program co-managed by the Centers for Disease 

Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA.  VAERS serves as an ear

warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse event

(possible side effects or health problems) that occur after vaccination. A report to VAERS does not indicate that a

vaccine caused an adverse event, only that the adverse event occurred sometime after vaccination

Who can report?

Anyone can submit a report to VAERS — healthcare professionals, vaccine manufacturers, and the general public

VAERS welcomes all reports, regardless of seriousness, and regardless of how likely the vaccine may have been to 

have caused the adverse event

What should be reported?

Healthcare providers are required by law to report:

y Any adverse event listed by the vaccine manufacturer as a contraindication to subsequent doses 

of the vaccine

y Any adverse event listed in the Reportable Events Table that occurs within the specified time period 

after the vaccination

Healthcare providers are strongly encouraged to report:

y Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it 

is or is not clear that a vaccine caused the adverse event

y Vaccine administration errors

A copy of the Reportable Events Table can be found on the following page, or at 

https://vaers.hhs.gov/resources/infoproviders.h

Note: COVID-19 vaccines under an Emergency Use Authorization have additional VAERS reporting requirements

See https://vaers.hhs.gov/faq.h

How do I report?

There are two ways to report to VAERS:

Option 1: Online (preferred). Submit a VAERS report using the online reporting tool at 

https://vaers.hhs.gov/esub/index.

Before you begin, review the Checklist for Completing the VAERS form at https://vaers.hhs.gov/reportevent.ht

Information submitted using the online reporting tool is transmitted securely to VAERS

Option 2: Writeable PDF Form. Download the writable PDF form (located at https://vaers.hhs.gov/uploadFi

index.jsp) to your computer, complete it, and then return to the VAERS website to upload the completed for

It is important that you use a desktop or laptop computer on which you can securely save a document that 

contains protected health information, personal identifiers or other sensitive personal or patient information

When you upload the form, the information is transmitted securely to VAERS
D

Appendix D

Appendix D-4

What are the strengths and limitations of VAERS data?

When evaluating VAERS data, it is important to understand the strengths and limitations. VAERS data contain

both coincidental events and those truly caused by vaccines

Strengths:

y VAERS collects national data from all U.S. states and territori

y VAERS accepts reports from anyone

y The VAERS form collects information about the vaccine, the person vaccinated, and the adverse event

y Data are publicly available

y VAERS can be used as an early warning system to identify rare adverse events

y It is possible to follow-up with patients to obtain health records, when necessary

Limitations

y It is generally not possible to find out from VAERS data if a vaccine caused the adverse events

y Reports submitted to VAERS often lack details and sometimes contain errors

y Serious adverse events are more likely to be reported than mild side effects

y Rate of reports may increase in response to media attention and increase public awareness

y It is not possible to use VAERS data to calculate how often an adverse event occurs in a population

Where can I find more information?

If you need further assistance with reporting to VAERS, please email info@vaers.org or call 1-800-822-796

Operators are on duty from 9:00 a.m. to 5:00 p.m., Eastern Time, Monday through Fr

For more information, visit the VAERS website at https://vaers.hhs.go
D

Appendix D

Appendix D-5

VAERS Table of Reportable Events Following Vaccination*

Vaccine/Toxoid Event and Interval ** from Vaccination

Tetanus in any combination: 

DTaP, DTP, DTP-Hib, DT, Td, TT, 

Tdap, DTaP-IPV, DTaP-IPV/Hib, 

DTaP-HepB-IPV

A. Anaphylaxis or anaphylactic shock (7 days)

B. Brachial neuritis (28 days)

C. Shoulder Injury Related to Vaccine Administration (7 days)

D. Vasovagal syncope (7 days)

E. Any acute complications or sequelae (including death) of above events (interval - not applicable)

F. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Pertussis in any combination: 

DTaP, DTP, DTP-Hib, Tdap, 

DTaP-IPV, DTaP-IPV/Hib, 

DTaP-HepB-IPV

A. Anaphylaxis or anaphylactic shock (7 days)

B. Encephalopathy or encephalitis (7 days)

C. Shoulder Injury Related to Vaccine Administration (7 days)

D. Vasovagal syncope (7 days)

E. Any acute complications or sequelae (including death) of above events (interval - not applicable)

F. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Measles, mumps and rubella 

in any combination: MMR, 

MMRV, MM

A. Anaphylaxis or anaphylactic shock (7 days)

B. Encephalopathy or encephalitis (15 days)

C. Shoulder Injury Related to Vaccine Administration (7 days)

D. Vasovagal syncope (7 days)

E. Any acute complications or sequelae (including death) of above events (interval - not applicable

F. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Rubella in any combination: 

MMR, MMRV

A. Chronic arthritis (42 days)

B. Any acute complications or sequelae (including death) of above event (interval - not applicable)

C. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Measles in any combination: 

MMR, MMRV, MM

A. Thrombocytopenic purpura (7-30 days)

B. Vaccine-strain measles viral infection in an immunodeficient recipient 

y Vaccine-strain virus identified (interval – not applicable) 

y If strain determination is not done or if laboratory testing is inconclusive (12 months)

C. Any acute complications or sequelae (including death) of above events (interval - not applicable)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Oral Polio (OPV) A. Paralytic polio

y in a non-immunodeficient recipient (30 days)

y in an immunodeficient recipient (6 months)

y in a vaccine-associated community case (interval - not applicable)

B. Vaccine-strain polio viral infection 

y in a non-immunodeficient recipient (30 days)

y in an immunodeficient recipient (6 months)

y in a vaccine-associated community case (interval - not applicable)

C. Any acute complication or sequelae (including death) of above events (interval - not applicable)

Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)
D

Appendix D

Appendix D-6

Vaccine/Toxoid Event and Interval ** from Vaccination

Inactivated Polio in any 

combination: IPV, DTaP-IPV, 

DTaP-IPV/Hib, DTaP-HepB-IPV

A. Anaphylaxis or anaphylactic shock (7 days)

B. Shoulder Injury Related to Vaccine Administration (7 days)

C. Vasovagal syncope (7 days)

D. Any acute complication or sequelae (including death) of above events (interval - not applicable)

E. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Hepatitis B in any combination: 

HepB, HepA-HepB, DTaPHepB-IPV, Hib-HepB

A. Anaphylaxis or anaphylactic shock (7 days)

B. Shoulder Injury Related to Vaccine Administration (7 days)

C. Vasovagal syncope (7 days)

D. Any acute complications or sequelae (including death) of above events (interval - not applicable)

E. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Haemophilus influenzae type b 

in any combination (conjugate): 

Hib, Hib-HepB, DTaP-IPV/Hib, 

Hib-MenCY

A. Shoulder Injury Related to Vaccine Administration (7 days)

B. Vasovagal syncope (7 days)

C. Any acute complication or sequelae (including death) of above events (interval - not applicable)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Varicella in any combination: 

VAR, MMRV

A. Anaphylaxis or anaphylactic shock (7 days)

B. Disseminated varicella vaccine-strain viral disease 

y Vaccine-strain virus identified (time interval unlimited)

y If strain determination is not done or if laboratory testing is inconclusive (42 days)

C. Varicella vaccine-strain viral reactivation (time interval unlimited)

D. Shoulder Injury Related to Vaccine Administration (7 days)

E. Vasovagal syncope (7 days)

F. Any acute complication or sequelae (including death) of above events (interval - not applicable)

G. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Rotavirus (monovalent or 

pentavalent) RV1, RV5

A. Intussusception (21 days)

B. Any acute complication or sequelae (including death) of above events (interval - not applicable)

C. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Pneumococcal conjugate 

(7-valent or 13-valent) PCV7, 

PCV13

A. Shoulder Injury Related to Vaccine Administration (7 days)

B. Vasovagal syncope (7 days)

C. Any acute complication or sequelae (including death) of above events (interval - not applicable)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Hepatitis A in any combination: 

HepA, HepA-HepB

A. Shoulder Injury Related to Vaccine Administration (7 days)

B. Vasovagal syncope (7 days)

C. Any acute complication or sequelae (including death) of above events (interval - not applicable)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Seasonal influenza (trivalent 

inactivated influenza, quadrivalent inactivated influenza, live 

attenuated influenza): IIV, IIV3, 

IIV4, RIV3, ccIIV3, LAIV4

A. Anaphylaxis or anaphylactic shock (7 days)

B. Shoulder Injury Related to Vaccine Administration (7 days)

C. Vasovagal syncope (7 days)

D. Guillain-Barré Syndrome (42 days) 

E. Any acute complication or sequelae (including death) of above events (interval - not applicable)

F. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)
D

Appendix D

Appendix D-7

Vaccine/Toxoid Event and Interval ** from Vaccination

Meningococcal: MCV4, MPSV4, 

Hib-MenCY, MenACWY, MenB

A. Anaphylaxis or anaphylactic shock (7 days)

B. Shoulder Injury Related to Vaccine Administration (7 days)

C. Vasovagal syncope (7 days)

D. Any acute complication or sequelae (including death) of above events (interval - not applicable)

E. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Human Papillomavirus (quadrivalent, bivalent, or 9 valent): 

9vHPV, 4vHPV, 2vHPV

A. Anaphylaxis or anaphylactic shock (7 days)

B. Shoulder Injury Related to Vaccine Administration (7 days)

C. Vasovagal syncope (7 days)

D. Any acute complication or sequelae (including death) of above events (interval - not applicable)

E. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

Any new vaccine recommended 

by the Centers for Disease 

Control and Prevention for 

routine administration to 

children.

A. Shoulder Injury Related to Vaccine Administration (7 days)

B. Vasovagal syncope (7 days)

C. Any acute complication or sequelae (including death) of above events (interval - not applicable)

D. Events described in manufacturer’s package insert as contraindications to additional doses of 

vaccine (interval - see package insert)

* Effective date: March 21, 2017. The Reportable Events Table (RET) reflects what is reportable by law (42 USC 300aa-25) to the

Vaccine Adverse Event Reporting System (VAERS) including conditions found in the manufacturer package insert. In addition,

healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the 

vaccine caused the event) for any vaccine, whether or not it is listed on the RET. Manufacturers are also required by regulation

(21CFR 600.80) to report to the VAERS program all adverse events made known to them for any vaccin

Note that the RET differs from the Vaccine Injury Table (VIT) regarding timeframes of adverse events. Timeframes listed on the

RET reflect what is required for reporting, but not what is required for compensation. To view timeframes for compensation,

please see the VIT at https://www.hrsa.gov/sites/default/files/vaccinecompensation/vaccineinjurytable.

**Represents the onset interval between vaccination and the adverse event. For a detailed explanation of terms, see the

Vaccine Injury Table at https://www.hrsa.gov/sites/default/files/vaccinecompensation/vaccineinjurytable.
D

Appendix D

Appendix D-8

07/09/2021 CS 322033-A

A vaccine administration error is any preventable event that may cause or lead to inappropriate medication use or patient harm.1 Vaccine 

administration errors can have many consequences, including inadequate immunological protection, possible injury to the patient, cost, 

inconvenience, and reduced confidence in the health care delivery system. Take preventive actions to avoid vaccine administration errors 

and establish an environment that values reporting and investigating errors as part of risk management and quality improvement.

Vaccine administration errors may be due to causes such as:

1. National Coordinating Council for Medication Error Reporting and Prevention, https://www.nccmerp.org/about-medication-errors

Error(s) Possible Preventive Actions

Wrong vaccine, 

route, site, or 

dosage (amount); 

or improperly 

prepared.

Circle important information on the packaging to emphasize the difference between the vaccines.

Include the brand name with the vaccine abbreviation whenever possible (e.g., PCV13 [Prevnar13]) in 

orders, medical screens, etc.

Separate vaccines into bins or other containers according to type and formulation. Use color-coded 

identification labels on vaccine storage containers.

Store look-alike vaccines in different areas of the storage unit (e.g., pediatric and adult formulations of 

the same vaccine on different shelves in the unit). 

Do not list vaccines with look-alike names sequentially on computer screens, order forms, or medical 

records, if possible.

Consider using "name alert" or "look-alike" stickers on packaging and areas where these vaccines 

are stored.

Consider purchasing products with look-alike packaging from different manufacturers, if possible.

Establish "Do NOT Disturb" or no-interruption areas or times when vaccines are being prepared or 

administered.

Prepare vaccine for one patient at a time. Once prepared, label the syringe with vaccine name.

Do not administer vaccines prepared by someone else.

Triple-check work before administering a vaccine and ask another staff member to check.

Keep reference materials on recommended sites, routes, and needle lengths for each vaccine used in 

your facility in the medication preparation area.

Clearly identify diluents if the manufacturer's label could mislead staff into believing the diluent is the 

vaccine itself.

Integrate vaccine administration training into orientation and other appropriate education 

requirements.

Provide education when new products are added to inventory or recommendations are updated.

Use standing orders, if appropriate.

 Lack of standardized protocols

 Patient misidentification

 Using nonstandard or error-prone abbreviations

 Easily misidentified products 

(e.g. DTaP, DT, Tdap, Td)

If an error occurs, determine how the error occurred and take the appropriate actions to put strategies in place to prevent it from 

happening in the future. The following table outlines common vaccine administration errors and possible preventive actions you 

can take to avoid errors.

 Insufficient staff training

 Distraction

 Changes in recommendations

Vaccine Administration: 

Preventing Vaccine 

Administration Errors
D

Appendix D

Appendix D-9

07/09/2021 CS 322033-A

U.S.Department of 

Health and Human Servic

Centers for Disease

Control and Prevention

Vaccine Administration: Preventing Vaccine Administration Errors

Error(s) Possible Preventive Actions

Wrong patient Verify the patient's identity before administering vaccines.

Educate staff on the importance of avoiding unnecessary distractions or interruptions when staff is 

administering vaccine.

Prepare and administer vaccines to one patient at a time. If more than one patient needs vaccines 

during the same clinical encounter (e.g., parent with two children), assign different providers to each 

patient, if possible. Alternatively, bring only one patient's vaccines into the treatment area at a time, 

labeled with vaccine and patient name.

Documentation 

errors

Do not use error-prone abbreviations to document vaccine administration (e.g., use intranasal route

[NAS] to document the intranasal route—not IN, which is easily confused with IM). 

Use ACIP vaccine abbreviations.

Change the appearance of look-alike names or generic abbreviations on computer screens, if possible.

Improperly stored 

and/or handled 

vaccine administered 

(e.g., expired 

vaccine given)

Integrate vaccine storage and handling training based on manufacturer guidance and/or 

requirements.

Rotate vaccines so those with the earliest expiration dates are in the front of the storage unit. Use 

these first.

Remove expired vaccines/diluents from storage units and areas where viable vaccines are stored.

Isolate vaccines exposed to improper temperatures and contact the state or local immunization 

program and/or the vaccine manufacturer.

Scheduling errors 

(e.g., vaccine 

doses in a series 

administered 

too soon)

Use standing orders, if appropriate.

Create procedures to obtain a complete vaccination history using the immunization information 

system (IIS), previous medical records, and personal vaccination records.

Integrate vaccine administration training, including timing and spacing of vaccines, into orientation 

and other appropriate education requirements.

For children, especially infants, schedule immunization visits after the birthday.

Post current immunization schedules for children and adults that staff can quickly reference in clinical 

areas where vaccinations may be prescribed and administered.

Post reference sheets for timing and spacing in your medication preparation area. CDC has vaccine 

catch-up guidance for DTaP, Tdap, Hib, PCV13, and polio vaccines to assist health care personnel in 

interpreting the catch-up schedule for children.

Counsel parents and patients on how important it is for them to maintain immunization records.

* At this time, COVID-19 vaccination has additional VAERS reporting requirements, including required reporting of vaccine 

 administration errors. Please see https://vaers.hhs.gov/faq.html for more information. 

Adapted with appreciation from Table 11-2, Medication Errors, 2nd ed, by Cohen, Michael. Washington D.C: American Pharmacists Association; 2007.

Healthcare providers are strongly encouraged to report vaccine administration errors to 

Vaccine Adverse Event Reporting System (VAERS).* To file an electronic report, please see the 

VAERS website at https://vaers.hhs.gov/reportevent.html 
D

Appendix D

Appendix D-10

Vaccine Injury Compensation Program (VICP)

The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims. It was

established as part of the National Childhood Vaccine Injury Act of 1986, after lawsuits against vaccine 

manufacturers and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates. It

provides compensation to people found to be injured by certain vaccines

The VICP is administered jointly by the U.S. Department of Health and Human Services (HHS), the U.S. Co

of Federal Claims (the Court), and the U.S. Department of Justice (DOJ.  The VICP is located in the HH

Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Vaccine Injury 

Compensation

Who can file a petition? 

According to the Health Resources and Services Administration of HHS, a person may file a petition if they:

y received a vaccine covered by the VICP and believe that they have been injured by this vaccine

y are a parent or legal guardian of a child or disabled adult who received a covered vaccine and who they 

believe was injured by this vaccine

y are the legal representative of the estate of a deceased person who received a covered vaccine and who 

they believe was injured by the vaccine and/or whose death they believe resulted from the vaccine injury

You may file a petition regardless of age and United States citizenship. The covered vaccine must have been

given in the United States or its territories with few exceptions. To learn more about exceptions, see the VICP

website (https://www.hrsa.gov/vaccine-compensation/eligible/index.ht

In addition, to be eligible to file a claim, the effects of the person’s injury must have: 

1.  lasted for more than 6 months after the vaccine was given; 

2.  resulted in a hospital stay and surgery; o

3.  resulted in deat

What vaccines are covered?

The Vaccine Injury Table makes it easier for some people to get compensation. The Table lists and explains

injuries and conditions that are presumed to be caused by vaccines. It also lists time periods in which the first

symptom of these injuries and conditions must occur after receiving the vaccine. If the first symptom of these

injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the 

injury or condition unless another cause is found. For example, if a patient received the tetanus vaccine and had

a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the 

tetanus vaccine caused the injury, if no other cause is found

If an injury or condition is not on the Table or if it did not occur within the time period on the Table, the petitioner 

must prove that the vaccine caused the injury or condition

A copy of the Vaccine Injury Table is on the following page or can be found online at https://www.hrsa.gov/site

default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf. A comprehensive explanation of terms used i

the table accompanies the online version

How can a petition be filed? 

To learn how to file a petition, see the VICP website at https://www.hrsa.gov/vaccine-compensation/how-to-file/index.h

For more information, visit the VICP website at https://www.hrsa.gov/vaccine-compensation/index.h
D

Appendix D

Appendix D-11

National Childhood Vaccine Injury Act: Vaccine Injury Table

This table, supplemented with definitions and other explanatory material, can be found on the National Vaccine 

Injury Compensation Program’s website at https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.

Vaccine Illness, disability, injury

 or condition covered

Time period for first symptom or 

manifestation of onset or 

of significant aggravation after 

vaccine administration

I. Vaccines containing tetanus 

toxoid (e.g., DTaP, DTP, DT, Td, 

or TT)

A. Anaphylaxis ≤4 hours

B. Brachial Neuritis 2-28 days (not less than 2 days and not 

more than 28 days)

C. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

D. Vasovagal syncope ≤1 hour

II. Vaccines containing whole cell 

pertussis bacteria, extracted or 

partial cell pertussis bacteria, 

or specific pertussis antigen(s) 

(e.g., DTP, DTaP, P, DTP-Hib)

A. Anaphylaxis ≤4 hours

B. Encephalopathy or encephalitis ≤72 hours

C. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

D. Vasovagal syncope ≤1 hour

III. Vaccines containing measles, 

mumps, and rubella virus or 

any of its components (e.g.,

MMR, MM, MMRV)

A. Anaphylaxis ≤4 hours

B. Encephalopathy or encephalitis 5-15 days (not less than 5 days and not 

more than 15 days)

C. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

D. Vasovagal syncope ≤1 hour

IV. Vaccines containing rubella 

virus (e.g., MMR, MMRV)

A. Chronic arthritis 7-42 days (not less than 7 days and 

not more than 42 days)

V. Vaccines containing measles 

virus (e.g., MMR, MM, MMRV)

A. Thrombocytopenic purpura 7-30 days (not less than 7 days and 

not more than 30 days)

B. Vaccine-Strain Measles Viral Infection 

in an immunodeficient recipient: 

y Vaccine-strain virus identified

Not applicable

Vaccine-Strain Measles Viral Infection 

in an immunodeficient recipient: 

y If strain determination is not done or if 

laboratory testing is inconclusive

≤12 months
D

Appendix D

Appendix D-12

Vaccine Illness, disability, injury

 or condition covered

Time period for first symptom or 

manifestation of onset or 

of significant aggravation after 

vaccine administration

VI. Vaccines containing polio 

live virus (OPV)

A. Paralytic Polio 

y in a non-immunodeficient recipient ≤30 days

Paralytic Polio 

y in an immunodeficient recipient ≤6 months

Paralytic Polio 

y in a vaccine associated community case Not applicable

B. Vaccine-Strain Polio Viral Infection

y in a non-immunodeficient recipient ≤30 days

Vaccine-Strain Polio Viral Infection

y in an immunodeficient recipient ≤6 months

Vaccine-Strain Polio Viral Infection

y in a vaccine associated community case Not applicable

VII. Vaccines containing polio 

inactivated virus (e.g., IPV)

A. Anaphylaxis ≤4 hours

B. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

C. Vasovagal syncope ≤1 hour

VIII. Hepatitis B vaccines

A. Anaphylaxis ≤4 hours

B. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

C. Vasovagal syncope ≤1 hour

IX. Haemophilus influenzae

type b (Hib) vaccines

A. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

B. Vasovagal syncope ≤1 hour

X. Varicella vaccines

A. Anaphylaxis ≤4 hours

B. Disseminated varicella vaccine-strain 

viral disease:

y Vaccine-strain virus identified

Not applicable

Disseminated varicella vaccine-strain 

viral disease:

y If strain determination is not done or 

if laboratory testing is inconclusive

7-42 days (not less than 7 days and 

not more than 42 days)

C. Varicella vaccine-strain viral reactivation Not applicable

D. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

E. Vasovagal syncope ≤1 hour

XI. Rotavirus vaccine A. Intussusception 1-21 days (not less than 1 day and not 

more than 21 days)

XII. Pneumococcal

conjugate vaccines

A. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

B. Vasovagal syncope ≤1 hour

XIII. Hepatitis A vaccines

A. Shoulder Injury Related to Vaccine 

Administration ≤48 hours

B. Vasovagal syncope ≤1 hour
D

Appendix D

Appendix D-13

Vaccine Illness, disability, injury

 or condition covered

Time period for first symptom or 

manifestation of onset or 

of significant aggravation after 

vaccine administration

XIV. Seasonal influenza vaccines

A. Anaphylaxis ≤4 hours

B. Shoulder Injury Related to Vaccine 

Administration

<48 hours

C. Vasovagal syncope ≤1 hour

D. Guillain-Barré Syndrome 3-42 days (not less than 3 days and not 

more than 42 days)

XV. Meningococcal vaccines A. Anaphylaxis ≤4 hours

B. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

C. Vasovagal syncope ≤1 hour

XVI. Human papillomavirus 

(HPV) vaccines

A. Anaphylaxis ≤4 hours

B. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

C. Vasovagal syncope ≤1 hour

XVII. Any new vaccine 

recommended by the Centers 

for Disease Control and 

Prevention for routine administration to children, after 

publication by the Secretary 

of a notice of coverage

A. Shoulder Injury Related to Vaccine 

Administration

≤48 hours

B. Vasovagal syncope ≤1 hour

(Applies Only to Petitions for Compensation Filed under the National Vaccine Injury Compensation Program 

on or after March 21, 2017)

Last revised January 2021
D

Appendix D

Appendix D-14

Countermeasures Injury Compensation Program (CICP) 

The Countermeasures Injury Compensation Program (CICP) is a Federal program that provides benefits for 

serious injuries that occur as a result of the administration or use of a covered countermeasure. Countermeasures

are vaccines, antivirals, drugs, biologics, or medical devices used to diagnose, prevent, or treat, a declared 

pandemic, epidemic, or security threat. The Secretary of the United States Department of Health and Human

Services (the Secretary) declares specific countermeasures under CICP

This Program was established by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act), 

42 U.S.C. § 247d-6e. The PREP Act also confers broad liability protections covering the manufacture, testi

development, distribution, or use of the designated covered countermeasure

Some examples of covered public health threats are:

y COVID-19

y Ebola

y Pandemic Influenza A

y Smallpox

y Anthrax.

Who is eligible? 

The following may be eligible:

y The injured countermeasure recipient

y Certain survivor(s) of a deceased injured countermeasure recipient

y The estate of a deceased injured countermeasure recipient

How can a claim be filed?

Individuals have one year from the date the vaccine or other covered countermeasure was administered or used 

to request compensation benefits. If their injury is added to a Countermeasures Injury Table, then they may

also have one year from the effective date of the Table addition to file. To file a claim, individuals must submit

a Request for Benefits Form and the Authorization for Use or Disclosure of Health Information Form to request 

medical records from each health care provider who treated the injured person. In addition, medical records from

one year before the injury to the present time must be submitted

For more detailed instructions, visit the CICP website at https://www.hrsa.gov/cicp/filing-benefi

Eligible individuals may be compensated for certain reasonable and necessary medical expenses and for lost 

employment income at the time of the injury. Death benefits may be paid to certain survivors of covered

countermeasures recipients who have died as a direct result of the covered countermeasure injury. The U

Department of Health and Human Services is the payer of last resort. Therefore, payments are reduced by those

of other third-party payers

Contact Information 

Website: http://www.hrsa.gov/cic

E-mail: CICP@hrsa.go

Phone: 1-855-266-CICP (2427) Updated January 2021
D

Appendix D

Appendix D-15

Additional Resources for Vaccine Safety

Below is a list of additional resources for Vaccine Information Statements (VISs) as recommended

General Vaccine Safety

y Vaccine Safety: https://www.cdc.gov/vaccinesafety/index.h

y Vaccine Safety Information for Healthcare Providers: https://www.cdc.gov/vaccinesafety/hcproviders/index.h

Safety Monitoring Systems

y Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov/index.h

y Vaccine Safety Datalink (VSD): https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.h

Clinical Immunization Safety Assessment (CISA) Project: 

y https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.h

Compensation Programs

y Countermeasures Injury Compensation Program (CICP): https://www.hrsa.gov/ci

y National Vaccine Injury Compensation Program (VICP): https://www.hrsa.gov/vaccine-compensation/index.h
D

Appendix D

Appendix D-16