1. ANTHRAX VACCINE 14 Sep 09 Introduction Department of Defense
Individual’s Briefing
ANTHRAX VACCINE
The purpose of this briefing is to introduce individuals to the Anthrax Vaccine Immunization Program (AVIP).
It remains the Department of Defense’s top priority to continue this vaccination program for your personal protection, the protection of your unit, and to help ensure the success of your military mission.
14 Sep 09

2. Policy, Threat and Disease Vaccine Facts and Safety
Briefing Outline
Key Messages
Policy, Threat and Disease
Vaccine Facts and Safety
Exemptions and Pregnancy
Adverse Event Reporting
This briefing will outline the AVIP’s key messages, information relating to current policy, threat and disease; facts about the anthrax vaccine and its safety; exemptions and pregnancy guidelines for anthrax vaccination; and adverse event reporting.

3. Your health and safety is our # 1 concern
Key Messages
Your health and safety is our # 1 concern
Receiving the vaccination is the only round-the-clock protection available to protect service members against this very real threat
The Food and Drug Administration say the anthrax vaccine protects against all forms of anthrax disease and is safe
Vaccination protects you, your unit, and your mission
Please remember these key messages about the DoD Anthrax Vaccine Immunization Program.
First, preserving the health and safety of our people is our top concern. What we care most about is helping our service members return home safely.
Second, the anthrax vaccine is the best protective measure against all forms of anthrax. Vaccination is the only around-the-clock protection available for service members against this very real threat.
Third, anthrax attacks would disrupt military missions. It has been extensively evaluated in human safety studies. The scientific evidence for safety and effectiveness has been affirmed by independent civilian panels, the FDA, the CDC, and the National Academy of Sciences. They all conclude that anthrax vaccine effectively protects against anthrax disease.
Finally, vaccination of military personnel is part of our national strategy to safeguard Americans against an anthrax attack. The DoD started this vaccination program based on the threat of weaponized anthrax. What we care about most is protecting our service members from known biologic threats, both natural and man-made, and keeping them healthy.
The purpose of this presentation is to provide you information regarding the danger of anthrax, the threat of anthrax as a biological weapon, and the protection and safety of the anthrax vaccine.

4. Policy History of the AVIP
Dec 97: Secretary of Defense ordered the AVIP
Mar 98: Vaccinations began in Southwest Asia
Aug 98: Vaccinations began in Korea
: Slowdowns due to shortage. After supply restored, program resumed in 2002
Oct 04: Injunction issued against DoD
Jan 05: FDA issues Emergency Use Authorization (EUA)
Dec 05: FDA formally issues Final Rule/Final Order
Oct 06: Deputy Secretary of Defense issued AVIP policy to re-establish a mandatory program for those in higher risk areas and with special roles; policy allows voluntary vaccinations for other groups
Dec 06: Under Secretary of Defense for Personnel and Readiness released DoD implementation guidance for the AVIP policy
Dec 08: Vaccine route and dosing schedule change
Let’s review the policy history of the Anthrax Vaccine Immunization Program (AVIP), because there have been several changes over the years.
In December 1997, the Secretary of Defense ordered the start of the AVIP. Vaccinations began in Southwest Asia in March 1998 and then expanded to Korea in August 1998.
A vaccine shortage caused slowdowns in 2000 and The AVIP fully resumed in Fall 2002, after the supply of FDA-licensed anthrax vaccine was restored.
A federal judge ordered an injunction in October 2004 temporarily stopping immunizations. In January 2005, vaccinations resumed under a special program called an Emergency Use Authorization (EUA).
On 19 December 2005, after extensive evaluation of the scientific literature and assessment of public comments, the FDA issued a Final Order stating that anthrax vaccine protects against all routes of anthrax exposure.
In October 2006, after a lengthy assessment of the biological threat and the vaccination program, the Deputy Secretary of Defense announced that DoD would resume mandatory anthrax vaccinations for certain groups based upon location or mission.
This new policy allows for voluntary vaccinations for those who have received one or more previous anthrax shots and wish to continue the series.
In December 2006, the Under Secretary of Defense for Personnel and Readiness released DoD implementation guidance for the AVIP policy.
And in December 2008, the FDA approves changes to route of administration and number of initial series doses of anthrax vaccine.

5. Current Policy Implementation
Mandatory and Voluntary Vaccinations
Vaccinations are mandatory for DoD service members, emergency essential designated civilians, and contractor personnel performing mission-essential services assigned to:
Central Command area of responsibility, the Korean Peninsula, and the Horn of Africa for 15 or more consecutive days
Special units with biowarfare or bioterrorism related missions
Specialty units with approved exception to policy
Vaccinations shall begin, to the extent feasible, up to 120 days prior to deployment or arrival in higher threat areas
We will now discuss the two groups covered by the AVIP policy announced by the Deputy Secretary of Defense in October Some people are subject to mandatory anthrax vaccinations and some may receive the vaccine voluntarily.
Currently, the mandatory policy applies to individuals assigned to the CENTCOM area of responsibility, the Korean peninsula, and the Horn of Africa for 15 or more consecutive days. This includes all service members, emergency essential designated civilians, contractor personnel performing mission-essential services (with the provision in their contract), some Naval Forces afloat, and civilian and contract Mariners (under Commander, Military Sealift Command).
The program is also mandatory for some personnel outside of the geographic regions of the CENTCOM AOR and the Korean peninsula – these include certain special-mission units that have a bio-warfare mission or have an approved exception to policy. These are listed in the Under Secretary of Defense for Personnel and Readiness December 2006 implementation guidance.
Vaccinations should begin, to the extent feasible, up to 120 days prior to deployment or arrival in higher threat areas to provide the greatest protection.

6. Current Policy Implementation
Vaccinations are voluntary for DoD service members who are not in the mandatory groups and have received at least one dose of Anthrax Vaccine Adsorbed during or after 1998
Vaccinations are voluntary for DoD civilians and adult family members; contractors and their accompanying US citizen family members:
Residing in Central Command area of responsibility, the Korean Peninsula, and the Horn of Africa for 15 or more consecutive days
DoD Civilian Personnel Management Service concluded notification to national unions on 12 Jan 07
The second group covered by this policy are those that may receive anthrax vaccinations voluntarily. Voluntary resumption (or continuation) of anthrax vaccine immunization is permitted for service members who received at least one previous dose of anthrax vaccine since the start of the program in 1998.
This is designed to allow individuals to continue the vaccinations on schedule when they are no longer in the designated mandatory population.
Vaccinations are voluntary for non-emergency essential DoD civilians; contractors not performing mission-essential services and accompanying US citizen family members who reside in the CENTCOM area of responsibility, Korean Peninsula, and the Horn of Africa for 15 or more consecutive days.
On 12 January 2007, the DoD Civilian Personnel Management Service provided notice to the national unions about the new civilian requirements outlined in the policy.

7. Anthrax spores are the most likely bioweapon
Threat
Inhalation anthrax is 99% lethal if unprotected, unvaccinated, or untreated
Anthrax spores are the most likely bioweapon
Relatively easy and cheap to produce
Extremely stable – can withstand harsh environmental conditions and remain dormant up to 50 years
Can be aerosolized and delivered in a variety of methods
Odorless, colorless, tasteless, difficult to detect
Why is the anthrax vaccine an important part of our biological weapon protection plan? Because the threat of anthrax is deadly and real.
Anthrax bacteria have several unique characteristics that make them effective biological weapons:
The bacteria can be produced in large quantities using a basic knowledge of biology and relatively unsophisticated equipment. The spores can then be stored in a bioweapons arsenal for decades without loss of lethality.
The bacteria form spores with tough protective coats that allow them to survive in harsh environmental conditions for decades.
Anthrax spores can be easily dispersed into the air by missiles, rockets, artillery shells, aerial bombs, sprayers from aircraft, trucks, hand-held devices, and virtually any other delivery system, including mailed packages.
Weaponized anthrax spores are odorless, colorless, tasteless, and it remain very difficult to detect.
Once symptoms of anthrax develop, even if a person receives antibiotic treatment, 45-80% of those infected will die. If an adversary succeeds in dispersing enough anthrax spores in the air, death approaches 100% in unprotected, unvaccinated personnel.

8. Recognized as an illness for centuries
Anthrax Infections
Recognized as an illness for centuries
Once common where livestock were raised, now controlled using vaccine for livestock
Human infection from direct contact with infected animals, animal products, or anthrax spores
Still a problem in Asia and Africa
Terror attacks via US mail in Fall 2001
Now, let’s talk about the background of the disease. Anthrax has been documented for thousands of years, perhaps as early as the Egyptian plagues in 1500 BC. In the Middle Ages, people called anthrax the “Black Bane,” because it nearly destroyed cattle herds in Europe. In the late 1800s, scientists, such as Louis Pasteur, focused on this disease and developed the first man-made vaccine for animals.
Animals normally inhale or swallow the spores while grazing. If they inhale or swallow enough spores to become infected, they develop anthrax and eventually die. Naturally occurring anthrax has been controlled throughout the world by animal vaccination and other preventive measures, although outbreaks still occur in regions where animals are not routinely vaccinated.
In a non-Biological Warfare environment, humans become infected through agricultural or industrial exposure to contaminated animal products. This includes handling contaminated carcasses, hides, wool, hair and bones, or ingesting contaminated meat.
While cases of human anthrax infections in the U.S. have become rare, anthrax remains a problem in certain areas of Asia and Africa.
In 2006 a New York artist who created African drums from imported animal hides was diagnosed and treated for inhalation anthrax.
In 2001 the U.S. was a target of an anthrax attack via the US mail system. Eleven inhalation and eleven cutaneous case were reported in 5 states.

9. Spore enters through broken skin, gastrointestinal tract, or the lungs
Pathogenesis
Spore enters through broken skin, gastrointestinal tract, or the lungs
Collected by white blood cells
Transported to nearest lymph nodes
Bacteria multiply in lymph nodes
Produce deadly toxins
Toxins cause swelling, bleeding and death of the tissue and organs (lungs, brain, GI tract)
To become infected, the spore of the bacteria must enter an opening in the body, either through a break in the skin, through ingestion into the GI tract or through inhalation into the lungs.
Once in the body, the body’s defense system or white blood cells collect the bacterium and bring it to the nearest lymph nodes. Before the body can destroy the bacterium it begins to rapidly multiply and then begins releasing a deadly toxin. This toxin causes swelling, bleeding and eventually death of the tissue and the body’s organs.
The death of an unvaccinated person from inhalation can occur in as little as 72 hours after exposure to the spores.

10. Three types of Anthrax infection
Infections
Three types of Anthrax infection
Cutaneous Anthrax (Skin)
Gastrointestinal Anthrax (GI tract)
Inhalational Anthrax (lungs)
There are three types of anthrax infection: Cutaneous, gastrointestinal and inhalation.

11. Incubation period: 1-5 days
Cutaneous Anthrax
Cutaneous: Contact with spore-infected animal hides or products through a break in the skin
Incubation period: 1-5 days
Symptoms: Papule forms in 1-2 days; changes to vesicle; ruptures to form ulcer and develops black eschar (scab); lasts 2-3 weeks
Cutaneous anthrax is the most common form of the disease seen in humans.
Infection with cutaneous anthrax often occurs when a person is exposed to spores on animal products or hides, which enter through breaks in the skin. The first sign of the disease often occurs within 1-5 days after exposure. It begins as a small bump, and progresses to a larger blister followed by a black scab called an eschar (“ESS-car”). Death is rare if treated with antibiotics, but if left untreated 5-20% of those infected may die.
The lesion is usually painless but may be itchy, with varying amounts of redness and swelling around the edges of the scab. Treatment can prevent the spread but not evolution of skin stages. The area will still develop the black eschar before it can heal. If left untreated, a blood infection may also occur. The black eschar separates after 2-3 weeks, leaving a scar.

12. Gastrointestinal Anthrax
Gastrointestinal: Ingesting poorly- or undercooked infected meat
Incubation period: 2-5 days
Symptoms: Fever, abdominal pain, nausea, vomiting of blood, and bloody diarrhea
Mortality up to 50% due to late diagnosis, GI hemorrhage, massive fluid retention
Oropharyngeal anthrax -> compromised airway
Gastrointestinal anthrax often occurs following the consumption of raw or undercooked contaminated meat.
Symptoms begin 2-5 days after spore exposure and may include fever, abdominal pain, nausea, vomiting of blood, and bloody diarrhea. Death occurs in up to 50% of those infected due to late diagnosis, massive GI bleeding and fluid retention.
This is associated with severe abdominal distress followed by fever and signs of infection. An anthrax infection of the throat may lead to a compromised airway and cause difficulty breathing. Involvement of the mouth usually includes lesions at the base of the tongue, sore throat, fever, and swollen lymph nodes.
Gastrointestinal anthrax is a very rare disease and there have been no documented cases in the US in the 20th century.

13. Incubation period: 1-6 days Symptoms:
Inhalation Anthrax
Inhalation: Spores enter lungs, collected by white blood cells, travel to lymph nodes. Spores rapidly multiply and produce toxins
Incubation period: 1-6 days
Symptoms:
Initially flu-like: Mild fever, myalgias and malaise, cough, chest discomfort, 2-4 days
Slight improvement, hours to days
Severe respiratory distress quickly progresses to shock and death in hours to days
Toxins cause destruction of pulmonary and thoracic tissues, result in multiple organ failure
Inhalation anthrax occurs when spores enter the body through the lungs. Just one breath of spores is enough to cause infection. Disease occurs when anthrax spores enter the lungs, travel to the lymph nodes, multiply, and produce toxins.
The toxins cause bleeding and destruction of the brain or vital organs in the chest, ultimately resulting in death.
These symptoms develop within 1-6 days and resemble the common cold or flu: sore throat, mild fever, muscle aches, and tiredness. Often the person will begin to feel better but then develop respiratory distress and quickly progress to shock and eventually death. Even when treated aggressively in a state-of-the-art medical facility, 45-80% of unvaccinated patients could die. If left untreated, the death rate exceeds 99%.
It is important to remember inhalation anthrax is not contagious. To become infected you must be directly exposed to the spores.

14. Chest Autopsy of Lethal Case of Inhalation Anthrax
Lung
Heart
This is an autopsy photo of the chest cavity of someone exposed to anthrax through inhalation.
The heart and lungs have turned black from internal bleeding, swelling, and tissue death as a result of the toxins inside the victim’s chest.

15. Brain Autopsy of Lethal Case of Inhalation Anthrax
In this case, the person’s skull has been removed and you are looking at the human brain. This photo shows encephalitis (swelling of the brain).
Again, notice the blackened color of the brain from internal bleeding inside the skull.

16. Chest X-ray of Inhalation Anthrax
Chest X-Ray in Anthrax
In a normal chest X-ray, the lung area should be mostly black, representing air, like the picture on the left.
The picture on the right is a chest X-ray of someone infected with inhalation anthrax. Notice the enlarged internal organs (heart and lymph nodes in the center of the chest) and fluid in the lungs, represented by the white areas.
Normal Chest X-ray
Chest X-ray of Inhalation Anthrax
Victim

17. Anthrax Vaccine Facts Licensed by the Federal government since 1970
Administered in US to at-risk veterinarians, laboratory workers, and livestock handlers
Over 9 million doses to more than 2.3 million people since Mar 98
Vaccine primes immune system to fight anthrax
Manufactured in US by Emergent BioSolutions
“AVA,” BioThraxTM. Package insert with each vial.
Official name: Anthrax Vaccine Adsorbed
The best countermeasure against this deadly biological warfare threat is anthrax vaccine.
The Federal government licensed the current anthrax vaccine in Anthrax vaccine has been administered and proven effective when vaccinating at-risk veterinarians, laboratory workers, and livestock handlers. Over 9 million doses have been administered to more than 2.3 million people since March 1998.
This vaccine contains no whole or live anthrax bacteria; therefore, it is impossible to contract the disease from it.
Like some other vaccines, it contains aluminum hydroxide as an adjuvant to enhance its ability to stimulate antibody production, as well as benzethonium chloride as a preservative and formaldehyde as a stabilizer.
Emergent BioSolutions, formerly BioPort Corporation, is the sole manufacturer of the FDA-approved anthrax vaccine in the United States. It is not unusual that anthrax vaccine is only manufactured by one company. More than half of FDA-licensed vaccines are produced by only one manufacturer. As with all vaccines, the DoD policy is to adhere to the FDA-licensed dosing schedule as closely as possible.
Currently there is no other product that is approved by FDA to prevent anthrax before exposure.
This vaccine contains no whole or live anthrax bacteria;
therefore, it is impossible to contract the disease from it.

18. Immunization Schedule
5 doses over 18 months
Do not compress schedule
Adjust schedule for individual delays
Do not “restart” series if it has been interrupted
; annual booster
4 weeks
6 months
12 months
18 months
150 days days days
30 days
Dose
As with all vaccines, the DoD policy is to adhere to the FDA-approved dosing schedule as closely as possible.
For anthrax vaccine, the approved immunization schedule is a dose on day 0, 4 weeks later, then at 6, 12 and 18 months after the first dose. The minimum interval between each dose is shown on the slide.
This initial five-dose series is then followed with annual boosters to maintain immunity.
Each dose of vaccine adds to protection cumulatively. The full series is needed to obtain maximum and ongoing protection.
If circumstances prevent adherence to the FDA schedule, longer intervals between doses are not expected to adversely affect antibody response.
You cannot shorten the stated time intervals between each dose. Your body needs time to build antibodies. If you get the doses too close together, you will not get the protective value of the vaccine. Don’t fall behind schedule. If you do, get vaccinated right away and get back on schedule.
Do NOT “restart” series if it has been interrupted. Even if only one dose was given or if they started many years ago, you should not restart. This recommendation follows national guidelines by the Advisory Committee on Immunization Practices (ACIP). The next dose should be given as soon as possible, with the series adjusted to conform to the standard intervals in the schedule.

19. Injection Site Reactions
Many may experience temporary pain and swelling after the shot
Mild side effects such as redness and tenderness at the site of vaccination are common
For both genders, IM administration significantly reduces adverse events at injection sites
Monitoring of all adverse events
Burning
Soreness
Redness
Itching
Swelling
Local pain at the injection site
Since March 1998, over 2.3 million people have received over 9 million doses of anthrax vaccine in the DoD program.
As with most vaccines, many may experience temporary pain and swelling after the shot. Mild side effects such as redness and tenderness at the site of vaccination are common. Differences in severity of side effects between men and women have been reported with anthrax vaccine; but this is consistent with differences also reported with influenza and pertussis vaccines. For both genders, intramuscular (IM) administration significantly reduces adverse events at injection sites.
Some may also experience burning, soreness, redness, itching, swelling, or local pain at the injection site. These side effects are typically not serious and should not prevent people from performing normal duties.
If your injection site reaction does not resolve in several days, you should see your healthcare provider. As with any vaccine, acute allergic reactions occur about once per 100,000 doses.
Adverse events after vaccination should be reported, especially before receiving any additional vaccinations. While most events require no treatment, some may need further evaluation, therapy and/or exemption from additional vaccinations.

20. Exemptions from Vaccination
TEMPORARY
PERMANENT
Some people should not get anthrax vaccine
Temporary medical exemptions include
Women who are pregnant, or uncertain if pregnant
Short-term immune suppression
Acute diseases, surgery
Medical evaluation or condition pending
Permanent exemptions can include
Severe allergic reaction or other serious reaction after a previous dose of anthrax vaccine
People with a history of severe latex sensitivity
HIV infection or other chronic immune deficiencies
People who had Guillain-Barré Syndrome (GBS)
Recovery from previous anthrax infection
Some people should not get anthrax vaccine or should wait to get anthrax vaccine. Let’s talk about two groups of exemptions: temporary and permanent.
Women who are pregnant are routinely deferred from most vaccinations. If a woman thinks she could be pregnant, she should get a pregnancy test prior to vaccination. A person is temporarily exempt if they are receiving treatment with certain drugs (e.g., steroid treatment >= 2 weeks), or radiation that inhibits their immune system. If they have a serious acute disease (e.g., febrile illness), or just had surgery, the physician may temporarily defer the vaccination. They may be temporarily deferred if they are currently being evaluated for a medical condition and those results are still pending. Resume vaccinations when temporary issues are resolved.
There are only a few permanent medical reasons why someone would not get anthrax vaccine. A person may be permanently exempt if they had a severe reaction to a previous dose of anthrax vaccine or are allergic to any of its components. The vial stopper contains latex which may contraindicate extraction of a vaccine dose through the stopper. People with a history of latex allergy should be referred to an allergy specialist for evaluation, unless their record provides evidence of prior consultation. Transient injection-site reactions (e.g., soreness, swelling, and nodules) should not be considered evidence of hypersensitivity.
Immunosuppressed individuals, including those who are HIV positive, should not receive the vaccine because they may not develop an adequate immune response. However, if anthrax exposure occurs, they should receive the anthrax vaccine along with antibiotics, since the vaccine would not be expected to harm them.
A permanent exemption may apply if a person has had a condition called Guillain-Barré Syndrome in the past or if there is evidence that someone has immunity to anthrax because of a previous anthrax infection. Do not give to people who have been diagnosed with lupus. They should talk with their physician about whether or not they should be vaccinated, considering the state of their disease, the medications they take, and their personal risk for specific infections. Consult medical specialists as appropriate (e.g., Vaccine Healthcare Centers Network).
Anthrax vaccine is licensed for individuals from 18 to 65 years of age. Data for safety and effectiveness are not yet available for older or younger people. Anyone falling outside of these age limits should not be vaccinated, except under guidance of a physician.
Anthrax vaccine is licensed for individuals
from 18 to 65 years of age

21. Vaccinations routinely deferred during pregnancy
According to the CDC's Advisory Committee on Immunization Practices (ACIP):
“there is no convincing evidence of risk from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids.”
Vaccinations routinely deferred during pregnancy
Before vaccination, ask each woman if she is pregnant or if there is the possibility of trying to become pregnant
No reason to delay conception after vaccination
Anthrax-vaccinated & -unvaccinated women at Fort Stewart (JAMA, 2002): same rates of conception, delivery
Anthrax-vaccinated & -unvaccinated men at fertility clinic: same sperm concentration, rate of pregnancy
Vaccination during pregnancy
Do not vaccinate pregnant women unless potential benefits of vaccination outweigh potential risk to fetus
It is DoD policy to defer routine vaccinations until after pregnancy. While routine pregnancy testing is not indicated before vaccination, respectfully ask each woman about the possibility of pregnancy. Refer women who may be pregnant for further evaluation before vaccination continues. Any woman who wishes to be tested for pregnancy will be provided one.
If a woman becomes pregnant after beginning the vaccine series, suspend the series until she is no longer pregnant. When she is no longer pregnant, the vaccine series can continue. based on a study from Fort Stewart, Georgia, there is no medical reason to delay conception after vaccination. This study contrasted anthrax-vaccinated and -unvaccinated women at Fort Stewart, and found that these groups of women had the same rate of conception and the same rate of delivery.
At the assisted reproductive technology program at Walter Reed Army Medical Center, anthrax-vaccinated and -unvaccinated men had the same sperm concentrations, motility rates, and rates of pregnancy. Regarding vaccination during pregnancy: A study suggests that anthrax vaccine may be linked with birth defects if given during pregnancy. Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination outweigh the potential risk to the fetus.
According to the CDC's Advisory Committee on Immunization Practices (ACIP), “there is no convincing evidence of risk from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids.”

22. Adverse Event Reporting
When in doubt, report it!
Vaccine Adverse Event Reporting System (VAERS)
FDA and CDC review 100% of adverse-event reports
All VAERS forms reviewed by independent panel of expert civilian physicians for 4 years
DoD requires healthcare workers submit a VAERS Form for
Loss of duty 24 hours or longer
(> 1 duty day)
Hospitalization
Suspected vaccine vial contamination
Other submissions are encouraged
Anyone can submit a VAERS Form
With all vaccines we are concerned about safety surveillance. There are many ways that we monitor the safety of vaccines. One method of safety surveillance is the Vaccine Adverse Event Reporting System, known as VAERS.
If you have an adverse event after receiving a vaccination, you can file a VAERS report. VAERS is a nationwide system initiated in 1990 to monitor vaccine safety trends. This system is managed jointly by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). The FDA and CDC review the adverse events reports submitted either directly to VAERS or through the Department of Defense. VAERS has an important role to play, looking for trends and unexpected reactions to vaccinations.
For the first 4 years of the AVIP, an independent panel of expert, civilian physicians reviewed VAERS reports involving the anthrax vaccine, and consistently concluded that they hadn’t seen anything unusual or unexpected.
DoD encourages reporting of adverse events. At a minimum, DoD requires a VAERS form submission for any adverse event that results in loss of duty for 24 hours or longer, or hospitalization. Also any suspected contamination of vaccine vials must be reported through VAERS. We encourage you to report any reaction you think is important.
Anyone can submit a VAERS form. We encourage you to work together with your healthcare provider when filing a VAERS report, because we tend to get more medical details when a doctor or nurse helps. You may submit one directly. Use the contact information provided here or in the trifold you receive.

23. Reserve Component Adverse Event Guidance
If someone experiences an adverse event in a non-duty status that is possibly associated with a vaccination
Should seek medical evaluation at a DoD, USCG, or civilian medical treatment facility, if necessary
Should Report the event to your unit Commander or designated representative as soon as possible
Should see local medical department or squadron for guidance
Commander will determine Line of Duty and/or Notice of Eligibility status, if required
Submit VAERS for any suspected adverse event
If you’re a member of the Reserve Components (Reservist or Guardsman), I have some specific information for you. Adverse events after DoD- or US Coast Guard-directed vaccinations are line-of-duty conditions.
Any vaccine adverse event occurring in a Reserve Component member should be medically managed just like in the Active Component member.
If a vaccine-associated adverse event occurs in a non-duty status, say, after your drill weekend, the most important thing is that you get the care you need immediately, whether that is at a DoD, USCG, or civilian medical treatment facility. If you don’t have a DoD facility close by, it’s OKAY to go to a civilian facility. There are instructions for you and your civilian physician to ensure payment for that civilian care.
As soon as possible, report the event to your unit Commander or your unit medical or personnel representative.
Your Commander will generate paperwork to initiate a Line of Duty (LOD) and/or Notice of Eligibility (NOE). And then, remember, you, any of your healthcare providers, or your Commander is encouraged to submit a VAERS report.

24. Resources MILVAX Agency www.vaccines.mil www.anthrax.mil
877.GET.VACC
DoD Vaccine Clinical Call Center
Vaccine Healthcare Centers for help with adverse event management
Information for Civilian Healthcare Providers
Call the Military Treatment Facility (MTF) where the member is enrolled OR contact the Military Medical Support Office (MMSO)
if the member is not enrolled to an MTF
USAMMA DOC
Should you need additional information, please refer to the websites or contact information listed here.

25. Closing
This concludes this block of instruction. We hope this presentation has been helpful.