Sex: M
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. The subject of this report is a 35 year old male who presents for evaluation of multiple rashes and new onset joint pains involving the left elbow and right hip. He referred himself due to continued medical problems and a desire for a second opinion. The patient's history and records reflect a temporal association of some of his medical complaints onset with immunizations including anthrax and smallpox, however, causal association frequently cannot prove or disprove. Vaccine delivery was confirmed by written records and/or documentation in the DOD registry. A detailed clinical summary performed in early 2004 is available as needed for future evaluations. History of present runess: Patient is a 35 year old male on extended active duty who presents for evaluation of multiple rashes and new onset joint pains involving the left elbow and right hip. The patient reports 5 different types of skin manifestations that have occurred since AVA #3. Type 1 Rash: local reaction rash at anthrax vaccine injection site (left arm) without complete resolution after the third injection. Started the week of receiving AVA #3 (unsure of exact day of onset). Developed multiple red papular, non-pruritic bumps on left triceps area covering about 10cm area in the location of the anthrax vaccine injection. Worsens after working out, then improves. Worsens after each subsequent vaccination for 3 days but then improved. All 6 doses of anthrax vaccine were administered in the same site vaccination. Patient has residual skin color changes in the affected area with episodic flares always in the same location. Generally not disabling. With anthrax dose #5, there was severe pain at the injection site associated with lightheadedness, redness/heat like sunburn on the triceps. Pain severity 4.10. Also after AVA #5, within few minutes, patient felt weak and dizzy for 3 days. Had large local reaction in left triceps, red, hot area about 9cm, pain radiated from left shoulder to fingertips, couldn't lift arm above head. Also had multiple bouts of diarrhea, nausea, and fever (temp not taken). Was on quarters for 3 days. Pain in arm and all symptoms resolved within 1 week. Type 2: Eaematoid Rashes: Stated between AVA 5 & 6, 3 months after #5. Intermittent itchy red bumps on legs and back of neck associated with periods of fatigue. Mostly occurs in antecubital spaces and behind knees. Episodes of this rash always linked with flying duty lasting more than 24 hours at one time, or other strenuous exercise/activity/work load. Also occurred with sleep deprivation during new infant's first few months. Rash lasts usually at least 72 hours up to 1 week; treated with topical Elidel; Benadryl is used for itching and sleep relief. Occurs off and on up until the present but always linked situations of fatigue with inadequate sleep in a 24 hour period. Seen by doctor and he did not feel he met the protocol requirements for Eczematoid rashes and anthrax study. Possible diagnosis: miliaria rubra (prickly heat rash). Type 3: Delayed onset Urticaria Rash with Respiratory Symptoms of Anaphylaxis following anthrax vaccine dose #1. Started 6-8 hours after Anthrax vaccine dose #6. Generalized erythematous papular rash all over body; itchy associated with shortness of breath. This rash was the same look as type 2, but was all over the body. Treated in emergency room with steroids, antihistamines, H2 blockers and other medication with complete resolution of chest tightness and erythema, but white papules within rash areas persisted for a week. No recurrence of this type of reaction since. Has never had thus sudden generalized outbreak with respiratory symptoms since. Diagnostic question: Delayed onset but accelerated serum sick like reaction (rather than late phase anaphylaxis). Type 4: Pruritic Papular Rash Variants Worsened by Sunlight and Exertion. Started June 2004 associated with exposure to the sun. 2 types of sun reactions. Rash 4A: Red bumps in patches on trunk and back; could be solar urticaria as they resolve within 24 hours, responds to Benadryl; is associated with fatigue; looks like rash #2 but unlike #2, resolve within 24 hours and are not associated with any changes in superficial skin. 4B: white papules goose pimple type rash (follicular in origin?) from neck to toes; last lest than 24 hours with no changes in superficial skin surface, responds to Benadryl, is associated with fatigue. Last attack was 9/04 - has not occurred in winter sun. Continues to have 4A if severely fatigued, but 4B requires association with sun exposure. Type 5: Macular erythematous rash patches involving back and upper chest as well as other areas, without pruritus. Occurred from September through November 2004. Lasted 2-3 days, may apply Elidel but does not bother him and is not pruritic. Evanescent and without interfering with function. Additional consultations obtained during visit 1/31 to 2/4/05. Dermatological diagnosis: cholinergic urticaria and physical urticaria, Miliaria rubralprofunda/pustulosis, patch testing revealed irritant reaction to Carba Mix and Potassium Dichromate, negative to anthrax vaccine and its components. All lab values WNL, including CBC, UA, C3, C4, CH50, ENA, Raji Cell, ANA, DNA DAYS AB, Ch7, CRP, Lyme, LFTs. Needs biopsy during active flares to further refine treatment plan. Other medical problems briefly reviewed during this visit: Fall 2004: onset of left elbow and right hip pains with stiffness, worsening post strenuous exercise (running 6-8 miles, lifting 225 pound weight training); denies generalized joint pains or joint redness, heat or swelling. Recommendations: x-ray right hip, early DID of the right hip, x-ray of left elbow, no fracture or acute change visualized, possible calcific body at tip of olecranon process; if symptoms persist further evaluate with either repeat lateral view or CT examination, physical medicine and rehab/physical therapy consultation to address exercise program that reduces joint trauma and exercise induced injury while maintaining fitness plan. (OMIC)