Sex: M
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Fatigue, Hypokinesia, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. It is quite clear that the anthrax vaccine that I was given is unsafe and unproven. Attached is a summary of my experience with the anthrax vaccine including some pictures. One picture was taken 6 hours after my sixth anthrax shot. this rash was all over my body, caused trouble breathing, and required a trip to the ER to get stabilized. I have some type of autoimmune problem that will not go away. I believe every lot should be pulled and tested for unlicensed components and the program's history to be investigated. I believe I've developed a number of medical problems that are all related to the Anthrax vaccine. The following symptoms are listed in the order of their severity: skin rashes, joint pain and muscle pain, fatigue, sleep disturbances and memory loss. Individually, these symptoms could all be considered part of the aging process. Collectively, they are some of the classic symptoms of GWS. I am a military veteran of a number of campaigns. My first two-week deployment was FEB 1989. My second deployment was June-November 1991. On these deployments, I did not have any Anthrax vaccination or other preventative medications. Other than a broken thumb from a volleyball game, I came away from these deployments without any health issues. On 6/19/99, I started the mandatory Anthrax vaccination program. I was told the program was perfectly safe and proven and the vaccine was licensed. I was also told there was absolutely no squalene in the vaccine even though I did not know what squalene was or why the medical staff was making the statement. I was not given any list of side effects nor was I given a letter of informed consent to sign. I had 4 anthrax vaccinations in 1999, and then AVIP was put on hold. On 7/14/99, I had my third anthrax shot from lot FAV038 (lot FAV038 has tested positive for squalene). Shortly afterwards, I developed multiple red papular non-pruritic bumps (2-4 mm diameter) on left tricep area in the location of the anthrax vaccination injection. This rash worsens after sweating or exercise and never completely resolved. All 6 anthrax shots were in my left arm. During the winter of 1999, I noticed I could not ski or snowboard a full day as I could in 1998, because of fatigue. I also noticed aches and pains in the muscles and joints the next day that I had not experienced in previous ski seasons. I just considered this part of the aging process since I had turned 30 that year. On 2/21/03, I was involuntarily activated. During this two year activation, I was grounded from flying for a cumulative period of 9 months because of unexplained skin rashes. Other symptoms of GWS became more pronounced during this 2-year period that I had earlier attributed to getting older, but I now believe were all caused by the mandatory anthrax vaccinations. Reviewing my medical history, it will show a pattern of a damaged autoimmune system. The AVIP program was started again and I had my fifth anthrax shot on 4/15/03. This shot made me sick for 3 days and grounded me from flying. In June 2003, I started to developed unexplained skin rashes. The medical department gave me a number of reasons on why I was getting skin rashes. They include: "You must be using a new soap or deodorant. You're taking showed that are too hot. You are older and naturally allergic to new things in the air. you could be allergic to your dog." On 11/17/03, I had my sixth anthrax shot. 6 hours after this shot, I broke out in a body rash from head to toe and had trouble breathing. I went to the ER and was given 4 different drugs to control the rash. Treatment included multiple visits to specialist at two hospitals from 1/30/05 to 2/5/05 for testing related to the rash. Urticaria was still unresolved and the last bad breakout was 2/27/05. The medical department has prescribed various histamine blockers to prevent my immune system from going into overdrive, which appears to be a chief cause of the skin rashes. Medications prescribed include: Loratadine, Zyrtec, Montelukast, Ranitidine, Prednisone, Benadryl, and Allegra. Topical creams prescribed include Elidel, Erythomocine and Amcinonide. I started to experience mild joint and muscle pain during the winter of 1999. This was after my first 4 anthrax vaccinations. This pain would occur 24 hours after exercising for more than an hour and after any sports. It was most noticeable after snow skiing, snowboarding or wake boarding. I considered it a mild discomfort and part of the natural aging process. In July 2004, I started to experience more joint and muscle pain after exercise. I started to have chronic pain in the right hip and left elbow. This pain was on a level on a 4 out of 10 and would worsen about 24 hours after exercise. Initially, I did not seek medical attention because I still considered it part of the aging process and did not connect it to the anthrax vaccination or the unexplained rashes. While at the hospital in 2/05, I had them investigate the pain in my left elbow and right hip. Initial recommendation was early DJD of right hip and possible calcific body of olecranon process on left elbow. This pain still exists today and has spread to my left hip. In the last 6 months, I have changed my work out schedule to lessen the joint and muscle pain. I lift lighter weights every third or fourth day instead of 3 days on and one day off. I've also changed to lower impact aerobics instead of running. None of this has helped my pain in the left elbow or hips. I started to have mild fatigue problems during the winter of 1999. I did not have energy levels as the previous years, but considered this part of the aging process. In June of 2003, the fatigue started to get worse, which I attributed to my activated, wartime flight schedule. We would regularly fly 24-26 hour crew duty days with only 6-8 hours of sleep between missions. It was common for every crew member to feel fatigued all the time. In June 2004, I was grounded from flying any overseas missions because of the chronic urticaria. I basically became a desk jockey and was on a regular sleep cycle. 9 months after flying my last augmented crew duty day, I still have days of extreme fatigue even after sleeping 8 hours. I have found no trigger for when this happens and no cure. When I have a day of no energy or extreme fatigue, I will not exercise for the day and try to get an afternoon nap. I have not sought medical attention for the fatigue. I started to have sleep problems in July 2003, which is common because of our flight schedule. Sometimes I could sleep only 5-6 hours after being up for 24. Other nights I could not get to sleep at all. While at home from trips, I would wake up at 2:00 AM and not be able to get back to sleep. I attributed this to the poor scheduling of our trips. Our schedule would consist of being on 1 hour alert for up to 5 days, and then get alerted at 1:00 AM to fly a 24-26 hour mission. It was also common to fly up to 5 back-to-back 24 hour crew duty days in a 10 day period. This would effectively be 5 nights of sleep in a 10 day period. Changing 11 time zones in a single mission is common. I have my flight logs to prove this schedule. The command's answer to this erratic flight schedule was to prescribe Ambien on a limited basis to help flight crews sleep. The Ambien does work very well for me with no side effects that I have noticed. Once again, I still have a problem 9 months since my last augmented, 24-hour crew duty day overseas. The typical problem is I wake up at 4:00 AM for no apparent reason. I am not having any nightmares or post traumatic stress. I eat well, exercises on a regular basis, and get to sleep between 10-10:30 PM every evening. I usually fall asleep within 5 minutes. On average, once a week, I'll wake up at 4:00 AM and cannot return to sleep. Once I get in a cycle of 2-3 days in a row of a sleep problem, I will take an Ambien in the evening to reset my body clock. This usually works for a 7-10 day period before I have another sleep disturbance. I only take Ambien 3-4 times a month now to help me sleep. I have experienced short term memory loss since 2000. I know this is subjective and can be part of the aging process. I feel my memory is average when it was once outstanding. I have a very good track record for testing in my military career. It was common for me to score 95% or better on all of my written exams. I could reproduce from memory the electrical diagrams of planes. I was awarded a number of honors at my formal military schools, which relied heavily on academics. Today, these classes would be very difficult for me. My last formal school was officer school, which I finished through correspondence in December 2004. I barely passed all 4 exams. It would take me five days to study for one exam that would normally take me only two days. I've experienced simple loss of thought by walking into a room and forgetting why I went into the room. Sometimes I will go to work and forget to bring some of my required equipment. During the 2-year activation, I lost a camera battery charger, a CD player, a case of 35 music CDs, an MP3 player and a jacket. These items were lost on separate trips. I just forgot where I put them. Is this normal for a 35 year old male who exercises on a regular basis and eats a healthy balanced diet? It is my uneducated conclusion (I am not a doctor) that the anthrax vaccine is causing most if not all of these medical problems. I believe there is enough information here to warrant an investigation into the anthrax vaccine. I believe they should investigate the connection between the anthrax vaccine and GWS and either prove or disprove the connection. (OMIC)