This case involves a male journalist who went to a local facility to receive immunizations before traveling abroad for work. A senior member of the facility staff mistakingly administered an anthrax vaccine and allegedly administered a significantly larger dose than what would be recommended. After receiving the vaccination, he fainted and began to convulse. The staff managed his care and he recovered in the emergency room. While on his trip abroad, the patient became increasingly lethargic and needed to return home. Upon his return, he was diagnosed with chronic fatigue syndrome. It was alleged that the anthrax vaccine caused the journalist to suffer from CFS. An infectious disease expert familiar with this condition was sought to review the case.
Question(s) For Expert Witness
- 1. When is it appropriate to give the anthrax vaccination? What is the appropriate dosage?
- 2. What are the possible adverse effects of over vaccination?
Expert Witness Response E-139356
My specialty is infectious diseases and the experience I have with vaccines and any potential complications is working in the industry at a large pharmaceutical company, where they manufacture a number of vaccines. I am pro-vaccination and my experience is learning a lot about vaccine and reactions, and affecting the adolescent age group. Experience in launch of HPV vaccine in adolescents – we have many reports of fainting and seizure-like activity. My initial thought was that it was not a true seizure response but could have been a vaso vagal response, and what one thinks promoted this specific response.
Most practitioners would not have experience with anthrax vaccine in particular, and I have no idea how someone would have received this by accident. This is more of a military vaccine. I don’t know too many civilian physicians who would have experience and routine travel clinics would not have experience with this. Normally when testing and developing they do dose ranging and we want to see what gives the best immune response and make sure we don’t give too high or low a response. Ultimately the design sent to market has a lower dose to make sure it is safe. My suggestion is to get from the manufacturer what concentrations have been studied to determine dosage – they might have studies that show that level of dose is potential safe or otherwise.
I always roll my eyes when people say chronic fatigue. On occasion, it’s possible to have a detrimental response. Many patients come to me with a diagnosis or a misdiagnosis of chronic fatigue. It’s a grab bag category because there are no hard and fast rules about it. CDC has tried to refine it to make it more credible. A few decades ago where many people were saying they had CFS the way people say they are gluten free – it was trendy to say you had it. There is not one thing people can put their finger on and then say they have CFS. I have seen in my entire career 2 cases where I actually believed people had a dramatic fatiguing illness. Is those cases it was a viral infection that set people off. People were normal, no underlying conditions. CFS is so vague and trendy. In package inserts for anthrax, fatigue is listed as an issue, but this is not chronic fatigue.
Expert Witness Response E-138842
My expertise is in infectious diseases and vaccine development. I have published and lectured on vaccine efficacy for several viral diseases, but not for anthrax. I do have one publication on anthrax disease, but not in a vaccination setting. Common symptoms of anthrax vaccination are pain, soreness, redness, swelling, and itching at the injection site. Fever, muscle pain, headaches, and short-lived fatigue are also common symptoms. This is a very complex situation. Most of the anthrax vaccine data are from adults, so little is known about the effect of the vaccine. Also, the route of vaccination (intramuscular or subcutaneous) matters in what side effects occur, as does the dose. Other pertinent information would be the medical history of the patient, and if other vaccines were administered at the same time. There have been connections made between the anthrax vaccine and chronic fatigue syndrome, but there are not proven scientifically. On one hand, there are some rulings by the veteran’s administration that patients suffering from chronic fatigue syndrome after receiving the anthrax vaccine are entitled to service connection. Additionally, there are some studies suggesting a link between anthrax vaccination and Gulf War Syndrome, which has some similar symptoms as chronic fatigue syndrome. However, there are more studies that have not found a link. Overall, there are no proven links between anthrax vaccination and chronic fatigue syndrome, but I think it’s fair to say further research is necessary. Additional information on the patient would be useful in this case.