Daniel Boyle, LCSW, MPH

Vaccine Injury Support Project

1718 Sherman Ave. Suite 208
Evanston, IL 60201
danielboyle@me.com
March 20, 2015
National Vaccine Program Office
Office of the Assistant Secretary for Health
Department of Health and Human Services
200 Independence Avenue SW.
Room 733G
Washington, DC 20201
ATTN: Rebecca Fish
Email: Rebecca.Fish@hhs.gov
I am submitting the following comments in response to Federal
Register Notice 2015-02481 regarding the Draft National Adult
Immunization Plan (NAIP).
I am commenting from the perspective of a person who was injured by
vaccines. I consented to the vaccines under coercion from my
employer and received two flu vaccines (seasonal and H1N1) in
December of 2009. Soon after I received the immunizations I
developed symptoms of brachial neuritis or neuralgic amyotrophy (NA).
I also experienced other less acute adverse effects over the course of
the next month and a half.
I continue to live with the effects of the NA. When I notified the
provider who administered the vaccine (the employee health
department of the healthcare facility where I was employed) of my
injury that office did not report to VAERS. I accessed the Vaccine
Adverse Event Reporting System (VAERS) on my own. I also filed a
claim with the National Vaccine Injury Compensation Program (VICP)
with the help of an attorney. I filed my claim almost three years after
my injury, when neurologist who specializes in NA diagnosed additional
neuromuscular effects. Only with the information from that
consultation did it become apparent to me that I was eligible to file
under the VICP. My claim was settled with the VICP in 2014.
I was not notified by my employer/provider, that the VICP or the
Countermeasures Injury Compensation Program (CICP) existed. (The

2009 H1N1 vaccine was covered only by the CICP.) Also, my employer
did not support my Workers Compensation claim.
Since my vaccine injury I am advocating for the right of full informed
consent for all medical procedures, including immunization, without
coercion, for all persons. I am also advocating for additional support for
persons injured by vaccines, including proactive measures to identify
the vaccine injured.1
My comments and recommendations follow, organized in relation to
the Goals and Objectives of the Draft NAIP listed below in italics.
Goal 1: Strengthen the Adult Immunization Infrastructure
A strong public health surveillance system to evaluate vaccines
must also include a strong surveillance system to detect vaccine
injuries. Designing a comprehensive system of surveillance that
better monitors Adverse Events Following Immunizations (AEFIs),
and vaccine caused injuries and deaths will contribute to
improved quality outcomes for vaccine campaigns, and safer
vaccines.
Objective 1.2: Enhance current vaccine safety monitoring systems and
develop new methods to accurately and more rapidly assess vaccine
safety and efficacy in adult populations (e.g., pregnant women).
Primary care providers do not easily recognize vaccine injuries.
We do not have a workable estimate of the distribution,
incidence or prevalence of vaccine injuries. Without basic
epidemiology of vaccine injuries we cannot design a truly qualitybased vaccine system. And without this important data we
cannot know if we are improving vaccine quality from the point
of view of reducing injuries and deaths from vaccines. It is
important that any plan for improving the use, safety and
efficacy of vaccines includes a plan to establish this basic
epidemiology of vaccine caused injury and mortality.
Where vaccines are mandated by employers or other entities
additional active monitoring for adverse effects by independent
entities is needed. It is needed to offset the encroachment on
individual rights, and the added risk carried by those receiving
immunizations under those circumstances.
1 http://vaccineinjurysupport.weebly.com/read-up-on-it.html

Pharmacists, a group increasingly responsible for administering

vaccines, need to be integrated into active surveillance systems
to detect AEFIs.2 And, as the private, commercial sector becomes
more prominent in the vaccine distribution system, and profits
from it, they need to contribute resources to improving the
overall system to make vaccines safer for their customers.3

Objective 1.3 Continue to analyze claims filed as part of the National

Vaccine Injury Compensation Program (VICP) to identify potential
causal links between vaccines and adverse events.
The claims to the VICP are the very top of the tip of an iceberg.
Without basic surveillance and detection systems, and applied
epidemiology to determine the distribution, prevalence and
incidence of vaccine caused injuries it will be more difficult to
develop the motivation to fund research into the mechanism of
these events.
If we cannot detect these events we cannot study them further.
In my specific injury the differential diagnosis included a number
of other shoulder and neurological conditions. A false negative
conclusion regarding vaccine causation is too easily arrived at
without enhanced primary care provider awareness of vaccine
adverse effects, and without basic research into the
epidemiology and causation of these injuries. For example, a
condition such as NA /brachial neuritis (which is included in the
Vaccine Injury Table for injuries related to receipt of Tetanus
vaccine, but not for Influenza vaccine) is more prevalent than is
currently assumed. 4
Analysis of VICP claims must also include vaccine injury claims
under the Countermeasures Injury Compensation Program
(CICP). Persons receiving vaccines covered under the
Countermeasures Injury Compensation Program (CICP) also must
be informed at the time they receive the vaccine that they are
eligible for compensation under this program if injured.
In addition to in depth analyses of the VICP claims it is equally
important to enhance the VAERS system to improve its ability to
glean information from those reporting, and offer persons
2 https://www.ncbi.nlm.nih.gov/pubmed/17138470
3 http://smartretailingrx.com/patient-care-counseling/vaccinations-a-shot-in-the-arm-forcommunity-pharmacies/
4 http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=2901

suspected of being harmed by vaccines the opportunity to

participate in research. VAERS needs to be enhanced to allow for
more dialogs with persons reporting, in order to gather more
useful information from them.5,6
Objective 1.4.7 Develop and encourage adoption of standardized
clinical decision support tools for adult vaccination.
In addition to developing clinical decision support tools for
promoting and administering vaccines it is equally important to
develop clinical decision support tools to recognize, identify,
diagnose and treat AEFIs and vaccine caused injuries. I dont
know its scope and practical effectiveness, but the US military on
paper has a national system that provides an integrated clinical
support system to its healthcare personnel.7
Objective 1.6.1 Encourage the development and evaluation of models
to estimate the cost-effectiveness of adult immunization programs.
In order to adequately assess the cost-effectiveness of current
vaccines it is necessary to estimate the burden on those injured
by vaccines. With reliable estimates of incidence and prevalence
of vaccine injuries and deaths it would only then be possible to
approach an estimate of that burden. The NAIP needs to
emphasize the importance of research to identify vaccine caused
morbidity and mortality, and estimate the true costs of
compensation, treatment and rehabilitation.
Objective 1.6.2 Encourage employers to offer and promote adult
immunization using evidence on economic impact
I oppose mandatory vaccination of health care workers and other
populations. Personal safety risks to individuals are of a different
type and order than employers financial and fiduciary risks.
Employers may face financial and other risks as a result of
spread of infectious diseases, but an employer that is an entity,
and not a person, cannot experience a vaccine injury or die as
the result of immunization.

5 http://www.lareb.nl/Publicaties/2014_2_information_regarding_reporting_of_ADR
6 http://link.springer.com/article/10.1007/s40264-014-0205-4/fulltext.html
7 http://www.vaccines.mil/ContactUs - ClinicalServices

However, in the face of the widespread use of these mandates

and restriction of an individuals basic right to full informed
consent, the NAIP must promote the adoption of an ethical and
legal standard for employers who continue to mandate vaccines
as a condition of employment. This would include, at a minimum,
a requirement for employers who mandate immunizations to use
an active universal surveillance program, operated by an
independent organization, to monitor for AEFIs and vaccine
injuries. This would also include an ethical and legal standard to
actively assist employees with the information and resources
needed to access VAERS, the VICP and other benefits available.
Developing a model for such an ethical standard would offset
some of the risks and burdens of vaccine-caused injuries that
employees assume in our current legal and business
environment.
Requirements for an additional duty on employers who mandate
immunizations for their employees would serve as a model for all
employers who promote vaccine use.
Objective 2.3.7 Assess the impact of providing vaccination services in
accessible and complementary settings (e.g., pharmacies and
community health centers) on vaccination coverage, costeffectiveness, and care.
Health care providers maintain independent standards for
administering medications, such as the JCAHO Standards that
include monitoring for response.8. Pharmacies now offer
immunizations and actively market them to the public. They also
need to have standards for monitoring for response, and for
appropriate referral for assessment and treatment of AEFIs.
Include pharmacists in efforts to increase reporting to VAERS,
and any active surveillance programs developed.
Objective 4.1: Develop new vaccines and improve the effectiveness of
existing vaccines for adults.
I advocate that any new vaccines be designed with a mechanism
in place for continued active monitoring and surveillance for
AEFIs. A system designed with quality principles requires that
errors be identified as they occur, and appropriate systems are
8http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?
StandardsFAQId=140&StandardsFAQChapterId=10

put in place for the amelioration of the system to reduce the

errors and to provide care when a person is harmed.
From Table 3. Goal 1: Strengthen the Adult Immunization Infrastructure
Developmental measure: Percentage of adult 17% health care
providers who have identified anadverse event following immunization
andreported it to VAERS.
Active surveillance and monitoring is needed for all
immunizations. VAERS, a passive system is not adequate to
identify rare AEFIs, and is not well known to the general medical
community or to the public. Also, any active national surveillance
program must be coordinated with and collaborate with the
growing global system of pharmacovigilance.9
In summary I believe that a national plan to promote vaccines must
protect the rights of individuals to full informed consent. Where
coercion and legally sanctioned mandates to receive vaccines are
imposed on individuals I believe there is a corresponding duty on the
part of those responsible for the mandates and coercion to actively
monitor for AEFIs. Valid methods and independent entities would need
to perform this surveillance. Also the duty extends to assisting those
injured to help them access resources, appropriate medical care, and
rehabilitation and support services. Efforts and outcomes generated by
responding to such a duty could significantly add to the research
needed to understand the epidemiology of vaccine injuries and to
determine the biological mechanisms involved in them.
Finally, I would like stress that our nation deserves and can afford an
adult immunization system that is of a much higher quality than
currently exists. Technologies for continuous quality improvement exist
in most industries to bring us more reliable and safer products and
services than ever before. This quality philosophy and these
technologies need to be applied in a rigorous way to vaccine
administration. The first step in improvement for me would be a
system that identifies errors, i.e. when a vaccine causes an adverse
outcome for the person receiving it. Right now we just dont have any
idea the extent or full nature of these injuries. Investing in a system
that learns valid rates of AEFIs would be the foundation of making
vaccines safer and more effective. Any national plan to promote the
9 http://www.ncbi.nlm.nih.gov/pubmed/24350637

increased acceptance of vaccines must include this basic

epidemiological research into its very foundation.
I appreciate the opportunity to submit these recommendations and
concerns, and request that they be incorporated into the NAIP.
Respectfully submitted,
Daniel Boyle, LCSW, MPH