Appendix I. Clinical Evaluation Tool for Smallpox Vaccine Adverse Reactions, Ophthalmologic Reactions/Eye Splash, or Other Potential Exposure to Vaccinia Virus (Text Description)
www.bt.cdc.gov/agent/smallpox/vaccination/clineval (03-25-2003 Version)
A flow chart with notes provides a clinical evaluation tool for smallpox vaccine adverse reactions, ophthalmologic reactions/eye splash, or other potential exposure to vaccinia virus. The flow chart begins with a box that says, "History of potential inadvertent exposure to vaccinia virus in or near the eye(s). No lesions or inflammation present." This box is connected to one below that says, "History of known risk factors for smallpox vaccine adverse reactions?"
If the answer to that question is yes, the provider is directed to a box at the right that says: "Consult with State/local health department and Centers for Disease Control and Prevention (CDC) to obtain clinical guidance and to report inadvertent exposure to vaccinia virus contained in smallpox vaccine. Management of the adverse reactions discussed in this Tool may be different when risk factor(s) are present. Refer to Consultation and Reporting Information, listed at the bottom of the chart. Vaccine recipients or close contacts with risk factor(s) should be reported, whether or not an adverse event develops. The following risk factors are listed:
- Atopic dermatitis/eczema (including severe atopic blepharitis).
- Acute exfoliative dermatitis.
- Immunocompromised including/HIV+.
- Pregnancy.
- Topical ocular steroid use.
The following adverse reactions (potential/reported historically) are listed:
- Eczema vaccinatum.
- Inadvertent inoculation.
- Progressive vaccinia/generalized vaccinia (severe form).
- Fetal vaccinia and potential unknown risks to fetus.
- Autoinoculation to the eye.
If the answer to the question about history of known risk factors is no, the provider is directed to "report incident of possible inadvertent inoculation in or near eye from laboratory setting or direct splash from smallpox vaccine" and to refer to Consultation and Reporting Information.
The provider is then asked if it has been less than 7-10 days since exposure. If the answer is no, this is a considered a situation with low morbidity and mortality risk and the instruction box says, "Close observation. No immediate treatment indicated. Obtain ophthalmology consultation if symptoms develop."
If the answer is yes (it has been less than 7-10 days since exposure), this is a considered a situation with moderate morbidity and mortality risk. The provider is told to "consider immediate gentle irrigation of affected eye with sterile water or saline if exposure occurred within a few hours of presentation" and to "avoid irrigation under high pressure to prevent iatrogenic corneal abrasions." The chart then splits into three branches.
The branch on the left shows two stacked boxes that describe clinical presentations that indicate high morbidity and mortality risk and the action to be taken. The first box says, "Possible inadvertent inoculation in or near eye from high-risk vaccinia strain in laboratory setting (e.g., splash to eye). Laboratory vaccinia strains may be of higher concentration and greater virulence."
The second box says, "Request vaccinia immune globulin (VIG) consultation (refer to Consultation and Reporting Information at bottom of chart). Begin topical antiviral prophylaxis. Close observation. Obtain immediate baseline ophthalmology consultation to assist in evaluation, management, and followup." A footnote says: "Topical antiviral prophylaxis: trifluridine eye drops 5 times/day up to 5 days. Discontinue if no evidence of vaccinial infection is present after 5 days. Trifluridine may cause some eye redness/irritation with use. Close followup by ophthalmology indicated while on trifluridine to evaluate treatment.
The branch in the middle shows two stacked boxes that describe a clinical presentation that indicates moderate morbidity and mortality risk and the actions to be taken. The first box says, "Possible inadvertent inoculation in or near eye from vaccinia in smallpox vaccine (e.g., splash to eye). Vaccinia in smallpox vaccine is in lower concentration and less virulent than lab strains."
The second box says, "VIG not indicated. Recommend topical antiviral prophylaxis up to 5 days [as described above]. Close observation. Obtain immediate baseline ophthalmology consultation to assist in evaluation, management, and followup."
The branch on the right begins with two stacked boxes that describe another clinical presentation that indicates moderate morbidity and mortality risk and the actions to be taken. The first box says, "Possible inadvertent inoculation in or near eye from vaccinia lesion in vaccine recipient or close contact (e.g., contact with vaccine site followed by rubbing in or near eye). Obtain history of exposure to assess potential risk." The second box asks, "Does clinician feel there is significant risk of inadvertent inoculation?" If the answer is yes, this is considered a situation with moderate morbidity and mortality risk and the instruction box says, "VIG not indicated. Consider topical antiviral prophylaxis [as described above]. Close observation. Obtain baseline ophthalmology consultation to assist in evaluation, management, and followup." If the answer is no, this is considered a situation with low morbidity and mortality risk and the instruction box says, "Close observation. No immediate treatment indicated. Obtain ophthalmology consultation if signs/symptoms develop."
The following "Consultation and Reporting Information" (as referenced throughout the description above) appears at the bottom of the chart: "Civilian health care providers who need clinical consultation with or without release of vaccinia immune globulin (VIG) (first line agent) or cidofovir (second line agent) for potential smallpox
vaccine adverse reactions should contact their State/local health department or the CDC Clinician Information Line at (877) 554-4625. Military health care providers (or civilian providers treating a
DoD healthcare beneficiary) requesting clinical consultation should call (866) 210-6469, and if requesting VIG release should call (888) USA-RIID or (301) 619-2257. Health care providers should
report smallpox vaccine adverse events to their State/local health department and to the Vaccine Adverse Event Reporting System (VAERS) at http://www.vaers.org/ or (800) 822-7967."
"Please call (888) 246-2675 (Español (888) 246-2857, TTY (866) 874-2646) or visit http://www.bt.cdc.gov/agent/smallpox/index.asp for general public information about smallpox vaccination.
Persons experiencing urgent or life-threatening medical events should seek immediate medical assistance."
The following disclaimer appears at the bottom of the chart, below the Consultation and Reporting Information:
"Disclaimer: The CDC and its partners in the Clinical Immunization Safety Assessment (CISA) network have developed Clinical Evaluation Tools to help health care providers manage patients with potential adverse reactions from smallpox vaccination in the absence of circulating
smallpox virus (pre-event setting). These Tools are based on studies conducted before routine US childhood smallpox vaccination was discontinued in 1972 and on expert opinion; they are not entirely evidence-based. The Tools may not apply to all patients with smallpox vaccine
adverse reactions and are not intended to substitute for evaluation by a trained clinician. This Tool was last updated on 3-25-03. Please direct feedback on these Tools to spoxtool@cdc.gov."
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