(SE13) Neurologic disease, severe:

Possible diagnoses include:

• Peripheral neuropathy, nonfocal
• Encephalopathy
• Guillain-Barré syndrome
• Progressive focal neurologic disease (see also SE 14)

Assumes no other etiologic factor

• Consult with neurology for diagnosis and treatment.
• Some cases may benefit from rapid treatment with high-dose intravenous immunoglobulin.
• Contact VHC Network for case management requirements.

• Give temporary exemption, pending consultation with neurology.

• Submit VAERS report.
• Consider risk for recurrent reaction before administering additional doses.
• Permanent exemption may be required.

• Apply high-potency topical corticosteroid cream or ointment at least 2 to 3 times per day until reaction has resolved. Rarely requires oral corticosteroids (e.g., prednisone at 1 mg/kg or 50 to 60 mg per day for 3 to 4 days, tapering off by 10 to 20 mg per day over the next 2 to 4 days). Avoid unprotected sun exposure at the treated sites and use sunscreen aggressively.
• Avoid unprotected sun exposure at the treated site for at least 1 to 2 weeks and use sunscreen aggressively. For at least 3 to 4 days, avoid strenuous exercise using the arm that has received the vaccination.
• If itching/pruritus is present, use second-generation antihistamines such as fexofenadine (Allegra®) 180 mg daily (if a child or < 60 kg body weight, use 60 mg twice daily) or cetirizine (Zyrtec®) 5-10 mg daily. If not available, use first-generation antihistamines, recognizing sedating side effects.
• If swelling extends below elbow, a sling may be useful. Some vaccine recipients may benefit from an ice pack within first 24 hours. Consider cellulites or lymphangitis in evaluation.
  

• If localized itching was a dominant feature, pretreat with a second-generation antihistamine such as fexofenadine (Allegra®) 180 mg daily (if a child or < 60 kg body weight, use 60 mg twice daily) or cetirizine (Zyrtec®) 5-10 mg daily. Start at least 24 hours prior to vaccine administration. If not available, use first-generation antihistamines, recognizing sedating side effects. Continuing for 48 to 72 hours after the injection (longer if injection-site reaction persists or reflares).
• Avoid unprotected sun exposure at the treated sites, use sunscreen aggressively and avoid strenuous exercise as above.

Comment: Some vaccine recipients will tolerate these types of reactions less well than others, and may be apprehensive about the health risk from the next injection. Careful education and/or willingness to consult with specialists may prevent unnecessary polarization or potential refusal of subsequent vaccinations. Because most of these vaccine recipients can receive additional doses safely, it is important to avoid unnecessary indefinite exemptions, considering the threat and mortality risk of weaponized anthrax.

Symptomatic treatment to prevent recurrence of adverse events has been very effective for many vaccines, including anthrax vaccine.

• Acetaminophen 650-1000 mg orally every 4-6 h or ibuprofen 600-800 mg every 8 h for pain/headache at time of shot or 1 h prior to shot.
• Additional treatment for nausea and other symptoms as indicated.

The Vaccine Healthcare Centers Network may be contacted via the following methods:

Mailing address:
PO BOX 59606
Washington, DC 20012-0606

Telephone: 202-782-0411/DSN 662-0411
Fax: 202-782-4658
Email: askVHC@na.amedd.army.mil
Web site: www.vhcinfo.org

DoD Vaccine Call Center: 1-866-210-6469

"At this time, ACIP cannot recommend changes in vaccine administration because of the preliminary nature of this information. However, the data in this report do support some flexibility in the route and timing of anthrax vaccination under special circumstances. As with other licensed vaccines, no data indicate that increasing the interval between doses adversely affects immunogenicity or safety. Therefore, interruption of the vaccination schedule does not require restarting the entire series of anthrax vaccine or the addition of extra doses."

Regarding immunogenicity considerations in individualizing medical treatment: "Because of the complexity of a six-dose primary vaccination schedule and frequency of local injection-site reactions (see Vaccine Safety), studies are under way to assess the immunogenicity of schedules with a reduced number of doses and with intramuscular (IM) administration rather than subcutaneous administration. Immunogenicity data were collected from military personnel who had a prolonged interval between the first and second doses of anthrax vaccine in the U.S. military anthrax vaccination program. Antibody to PA was measured by enzyme-linked immunosorbent assay (ELISA) at 7 weeks after the first dose. Geometric mean titers increased from 450 mcg/mL among those who received the second vaccine dose 2 weeks after the first (the recommended schedule, n = 22), to 1,225 for those vaccinated at a 3-week interval (n = 19), and 1,860 for those vaccinated at a 4-week interval (n = 12). Differences in titer between the routine and prolonged intervals were statistically significant (p < 0.01)."

Regarding immunogenicity and safety considerations in individualizing medical treatment: "..a small randomized study was conducted among military personnel to compare the licensed regimen (subcutaneous injections at 0, 2, and 4 weeks, n = 28) and alternate regimens (subcutaneous [n = 23] or intramuscular [n=22] injections at 0 and 4 weeks). Immunogenicity outcomes measured at 8 weeks after the first dose included geometric mean IgG concentrations and the proportion of subjects seroconverting (defined by an anti-PA IgG concentration of > 25 mcg/mL). In addition, the occurrence of local and systemic adverse events was determined. IgG concentrations were similar between the routine and alternate schedule groups (routine: 478 mcg/mL; subcutaneous at 0 and 4 weeks: 625 mcg/mL; intramuscular at 0 and 4 weeks: 482 mcg/mL). All study participants seroconverted except for one of 21 in the intramuscular (injections at 0 and 4 weeks) group. Systemic adverse events were uncommon and similar for the intramuscular and subcutaneous groups. All local reactions (i.e., tenderness, erythema, warmth, induration, and subcutaneous nodules) were significantly more common following subcutaneous vaccination. Comparison of the three vaccination series indicated no significant differences between the proportion of subjects experiencing local reactions for the two subcutaneous regimens but significantly fewer subcutaneous nodules (p < 0.001) and significantly less erythema (p = 0.001) in the group vaccinated intramuscularly (P. Pittman, personal communication, USAMRIID, Ft. Detrick, MD)."

See Also:

Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR 2002;51(RR-2):1-35. (2002 Feb 8)

Info Paper

Eye Notes