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Adverse Events Following Smallpox Vaccination with ACAM2000 in a Military Population

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Adverse Events Following Smallpox Vaccination with ACAM2000 in a Military Population OBSERVATION Adverse Events Following Smallpox Vaccination With ACAM2000 in a Military Population Thomas M. Beachkofsky, MD; Scott C. Carrizales, MD; Jeffrey J. Bidinger, MD; David E. Hrncir, MD, MPH; Darren E. Whittemore, DO; Chad M. Hivnor, MD, FAAD Background: Generalized vaccinia and benign exan- polymerase chain reaction confirmed generalized vac- thems are 2 adverse events that have been associated with cinia. The remaining 7 patients presented with unusual, the smallpox vaccination. Accurate incidence and preva- painful, and pruritic papulovesicular eruptions occur- lence rates of each are not readily available, but these ring on the extensor surfaces of their upper and lower events are thought to be uncommon. To our knowl- extremities without systemic symptoms. Histologic find- edge, this is the first case series to provide clinical as well ings revealed 2 general patterns, including a dermal hy- as pathologic descriptions of multiple papulovesicular persensitivity reaction with lymphocytic vasculitis and eruptions occurring after receiving the second- a vesicular spongiotic dermatitis with eosinophils. generation smallpox vaccine, ACAM2000 (Acambis, Can- ton, Massachusetts), among a vaccinia-naïve military Conclusions: We present the first confirmed case of gen- population. In addition, we report the first confirmed case, eralized vaccinia following immunization with the second- to our knowledge, of generalized vaccinia following ad- generation smallpox vaccine ACAM2000. In addition, we ministration of the ACAM2000 vaccine. describe 7 cases of benign, acral, papulovesicular erup- tions thought to be associated with ACAM2000 admin- Observations: All patients received primary smallpox immunization as well as 1 to 3 concurrent or near- istration. Further research is needed to discern the patho- concurrent (within the preceding 21 days) immuniza- genesis of these benign eruptions as well as their incidence tions for typhoid, anthrax, hepatitis B, and/or seasonal and prevalence and that of generalized vaccinia with influenza. One patient presented with a flulike pro- ACAM2000. drome and diffuse vesiclopustules covering the face, neck, chest, back, and upper and lower extremities. Vaccinia Arch Dermatol. 2010;146(6):656-661 WING TO THE ONGOING pregnancy, and seizure. No other SAEs his- threat of bioterrorism, torically associated with the smallpox vac- limited vaccine supply cine were observed, including generalized availability, and unfavor- vaccinia (GV), ocular vaccinia, postvac- able production meth- cinia encephalitis, progressive vaccinia, ery- Oods for the older smallpox vaccine, Dryvax thema multiforme, or eczema vaccinatum. (Wyeth Pharmaceutical Inc, Philadelphia, Generalized vaccinia and benign cuta- Pennsylvania), a new smallpox vaccine, was neous eruptions are known adverse events developed. ACAM2000 (Acambis, Can- following immunization with the old ton, Massachusetts), the successor of smallpox vaccine, Dryvax. The incidence Dryvax, was developed via a clone from the of GV is unknown; however, it is thought Dryvax vaccine that was plaque purified and to be a rare adverse event that has often amplified in cell culture.1 After clinical trials, been overreported owing to lack of adher- the US Food and Drug Administration ap- ence to the guidelines required for diag- proved ACAM2000 in August 2007 for nosis.5,6 Lesions typically occur within a people at high risk for smallpox exposure, week of vaccination and evolve from and the US military completely transi- vesicles to pustules to scars.5 Typically, tioned to using the new vaccine by Febru- cases are self-limited and resolve without Author Affiliations: Wilford ary 2008.2,3 It was found to be similar in specific intervention and the use of vac- Hall Medical Center safety and efficacy to Dryvax, based on non- cinia immune globulin is not indicated. (Dr Beachkofsky), Departments clinical and clinical trials.4 Serious adverse Clinical descriptions of the varied cu- of Dermatology (Drs Carrizales, events (SAEs) were observed in less than 1% taneous morphologic reactions from pre- Bidinger, and Hivnor) and Pathology (Dr Whittemore), of the 2983 patients vaccinated during clini- vious cases noted following the use of and Vaccine Healthcare Center cal trials. Reported SAEs included myocar- Dryvax include exanthematous, urti- (Dr Hrncir), Lackland Air Force ditis, pericarditis, atrial fibrillation, atypi- carial, morbilliform, vesicular, pustular, Base, Texas. cal chest pain, coronary artery disease, and Stevens Johnson–like syndrome.5-8 Re- (REPRINTED) ARCH DERMATOL/ VOL 146 (NO. 6), JUNE 2010 WWW.ARCHDERMATOL.COM 656 ©2010 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 ports from the 1960s note that most benign eruptions tend thema of his right knee, and the development of a small to occur 4 to 10 days after vaccination.9,10 However, more erythematous-based pustule in his right axilla and left groin. recent reports describe eruptions occurring as late as 12 He was diagnosed as having cellulitis of his right knee and to 19 days following vaccination.8,11,12 The clearance time was prescribed trimethoprim-sulfamethoxazole and clin- for these benign eruptions varies widely in the litera- damycin. The following day (PVD 13) the patient was seen ture. Early data suggested resolution within 2 to 4 days11,13; in clinic for follow-up and noted to have a heart rate of 110 however, subsequent studies report a delay of 10 to 20 beats per minute, a temperature of 101.7°F, and was ex- days.11,12 No specific treatment is required, although an- periencing pain at a level of 7 on a 10-point scale. Find- tihistamines, nonsteroidal anti-inflammatory drugs ings from a skin examination were documented as un- (NSAIDs), and topical or oral steroids have been re- changed. Subsequently, the patient was sent home with ported to provide some degree of symptomatic relief. Vac- acetaminophen for treatment of his fever. cinia immune globulin is not recommended as treat- The following day (PVD 14) the patient was seen in ment for these cutaneous reactions.6 the emergency department with subsequent develop- ment of generalized pustules on his scalp, trunk, and up- METHODS per and lower extremities. He was then started on intra- venous clindamycin and vancomycin and transferred to the intensive care unit (ICU) (on PVD 15) for further We reviewed 8 cases of cutaneous reactions that occurred fol- monitoring and treatment of GV and cellulitis. At that lowing smallpox vaccination with ACAM2000 that took place from July 2008 through July 2009. During that time, more than time, the dermatology consultant noted that all lesions 150 000 members of the US military were vaccinated (data from were in a similar morphologic state (J. Schwartz, D.O, T. Vactor, June 17, 2009, contained in an e-mail forwarded from oral communication [telephone], July 9, 2009). Labora- M. Hartshorn, MSHP, CMPE, on June 18, 2009). Patients were tory evaluation revealed a nonspecific elevation in in- identified through multiple sources within Wilford Hall Medi- flammatory markers (erythrocyte sedimentation rate, C- cal Center, Lackland Air Force Base, Texas, to include the Vac- reactive protein) and pancytopenia that was attributed cine Healthcare Center (2 cases), emergency department to viral bone marrow suppression. The following day (PVD (2 cases), and pathology department (1 case). Additional cases 16, ICU day 2) the patient was noted to have the inter- throughout the military were identified using the Army Medi- val development of a vesicle on his left ulnar, distal up- cal Department teledermatology system (3 cases). A derma- per extremity and subsequent resolution of the right knee tologist (C.M.H.) was involved in the immediate care (either directly or via the teledermatology system) of all patients. Clini- erythema, induration, warmth, and tenderness. cal photographs were taken of all but 1 patient, and at least Laboratory studies, including blood and a wound cul- 1 punch or shave biopsy specimen was obtained from each pa- tures from a representative distal lesion, were negative tient. Laboratory studies were neither standardized nor con- for bacterial growth. A viral culture from a representa- sistent among patients; however, studies included the follow- tive distal lesion yielded a nonspecified virus that was ing: vaccinia polymerase chain reaction (PCR), viral culture, negative on direct fluorescent antibody testing for the fol- bacterial culture, IgG/IgM assays for Varicella zoster virus (VZV), lowing: adenovirus, influenza virus, parainfluenza vi- and IgG assays for herpes simplex virus (HSV) 1 and 2. All speci- rus, respiratory syncitial virus, HSV, VZV, and cytomega- mens were examined by the same dermatopathologist with lovirus. Initial vaccinia PCR testing at Brook Army Medical hematoxylin-eosin staining, while a few were additionally ana- Center confirmed the presence of vaccinia virus, which lyzed with Giemsa, Fite method, and Tzanck stains. Immuno- histochemical analysis for various substrates, including C3, was later confirmed by the Pox Virus Branch at the Cen- C5b-9, fibrinogen, IgG, IgM, IgA, HSV, and VZV were also per- ters for Disease Control and Prevention. A punch bi- formed in select cases. opsy specimen from a vesicle on the right wrist revealed superficial epidermal necrosis with a mixed pustular/ vesicular spongiotic dermatitis, including scattered neu- REPORT OF A CASE trophils and eosinophils (Figure 1). Owing to the patient’s overall
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