1. Site Care

2. Site Care Education Goals Review normal reactions after vaccination Provide site care instructions (oral and written) Provide contact information for concerns

3. Site Care Education Goals (2) Provide successful vaccination “take” reading date and location information

4. Vaccination Site Reaction Day 4 Day 7 Day 14 Day 21

5. Normal, expected local reactions Usually seen ~1 week after vaccination Soreness at vaccination site Intense erythema surrounding the vaccination site Lymphadenopathy (local): 25% – 50%

6. Normal, expected systemic symptoms – usually occur ~1 week after vaccination Headache Myalgia Chills Nausea Fatigue 0.3 – 37.0%

7. Normal, expected systemic symptoms usually seen ~1 week after vaccination Malaise Fever –  100º F: 17% –  101º F: 7% –  102º F: 1.4%

8. Normal variant responses & symptoms Local satellite lesions Lymphangitis Local edema Viral cellulitis Mild rashes

9. Local Satellite Lesions 1 or more additional lesions near vaccine site

10. Lymphangitis Inflammation of the lymphatic vessels characterized by red streaks or patches in the skin

11. Local edema Fluid accumulation in the vaccination area

12. Site Care Clinical Issues Vaccinia virus may be cultured from the site of a vaccination from 2-3 days after vaccination until the scab separates Care must be taken to prevent the spread of the virus to other parts of the body or other persons

13. Dressing Keep covered with 2x2 gauze and tape at all times until scab separates Semi-permeable occlusive bandage over 2x2 dressing for HCW at work Use waterproof covering during shower

14. Dressing Changes Wash hands with soap and water before and after every contact with the vaccination site or any materials (dressing, clothing, etc). Change dressing every 1-2 days

15. Dressing Changes (2) HCW may change own dressing at home Place used dressing in zip bag and discard in trash Vary position of tape over gauze

16. Comfort Measures Acetaminophen and ibuprofen for pain DO NOT scratch—may use oral antihistamines for itching DO NOT apply anything (ointments, salves or antibiotic band-aids) to the vaccine site DO NOT apply heat or cold to the vaccine site

17. At-work Issues Cover dressing with semi-permeable membrane, e.g., Opsite Wear long-sleeves over dressing HCW do not need to be furloughed Have dressing assessed on work days before beginning shift

18. At-home Issues Use normal laundering (hot water) to wash clothes, towels or sheets that have touched the vaccination site Keep family members from touching your vaccination site (keep site covered)

19. At-home Issues (2) Wear long sleeves to bed Wash hands first thing in the morning Dispose of scab in zip bag and discard in trash

20. Additional Clinic Roles

21. Vaccination Assistants May assist vaccine administrator with all aspects of pre and post vaccination activities May set up/break down vaccination stations

22. May assure area is available for vaccinees having reactions May replenish vaccine station supplies May apply bandages to vaccination site Vaccination Assistants (2)

23. Data Entry Staff MDCH intends to provide data entry staff Vaccination not required Data entry discussion to follow

24. Entry/Exit Monitors Maintain clinic flow May answer questions related general vaccine clinic operations (entrances, exits, parking, bathroom locations etc.) May be clerical staff or volunteers Vaccination not needed

25. Security Assure clinic parking is adequate, close and protected Provide telephone numbers for police, fire, utilities, facility owner/manager

26. Security (2) Assure facility is secure, well lighted and functional Vaccination not indicated

27. Supply Issues

28. Supplies Provided by MDCH 4X4 Tegederms $50.00 per vaccinee for other supplies Copies of CDC vaccination packets (as requested in January by each region) Color brochures for each vaccinee to be handed out during site care instruction

29. Supplies Provided by MDCH Vaccination card for vaccinee Vaccine Information Statements Consent forms

30. Additional Clinic Supplies Detailed supply checklist provided in Handout #4

31. Section V: Data Issues

32. Data System MCIR –Modifications: age restrictions, assessment, adverse event tracking, cost, time to develop, and daily extract to CDC of the data –May be available for Stage 2

33. Data System Pre-Event Vaccination System (PVS) –Written by CDC –Web-based application –Digital certificates used for security

34. Smallpox Vaccination Form— Data Flow Matches clinic flow Printed in triplicate Top sheet used for data entry and sent to MDCH Second sheet sent to clinic responsible for reading the “Take” response Third sheet given to the vaccinee

35. Greeter & Smallpox Vaccination Form Greeter gives form to vaccinee Vaccinee completes –Patient Information –Vaccination History

36. Nurse Screener & the Form The nurse screener completes –Referring Organization –Current Vaccination Questions –Disposition once the patient signs the form giving consent to be vaccinated Record the PVN on each copy of the form

37. Vaccinator/Vaccination Assistant & the Form After vaccination, nurse vaccinator or vaccination assistant will –Document the date of administration and sign the form –Fill in the vaccine, diluent and batch information

38. Vaccinator/Vaccination Assistant & the Form (2) After vaccination, nurse vaccinator or vaccination assistant will –Complete the vaccine record card for vaccinees to have for their records

39. Site Care Educator & the Form Site care educator will record the date and location where the “take” response should be read

40. Data Entry Staff The completed form is then given to the data entry staff for entry into the PVS

41. “Take” Response Readers The “take” response should be recorded in the appropriate section at the bottom of the form The form will be sent to MDCH for data entry

42. “Take” Response Readers (2) The “take” response should also be recorded on the vaccinee’s vaccine record card An additional form will be developed for use at sites where the “take” response will be read in case the original form is not available

43. Data Reminders Use of the PVN is key to tracking the individual and linking any follow-up activity back to the same individual MDCH plans to supply staff for data entry at clinics depending on the number of clinics occurring simultaneously

44. Data Reminders (2) CDC expects us to account for every dose of vaccine administered and have a “take” reading done on every person receiving the vaccine

45. Section VI: Evaluating Vaccine “Take”

46. Evaluating Vaccination Site for “Take” Major response Equivocal response No response

47. Major “Take” Response

48. Major “Take” Response (2) Need to see one of the following 6-10 days after vaccination: –Clear-cut pustule OR –Area of definite induration or congestion around a central lesion, e.g., an ulcer or a scab

49. Equivocal Response Any other reaction May result from –A person being sufficiently immune to suppress viral replication –Sub-potent vaccine or improper technique

50. Equivocal Reaction (2) May result from (cont.) –Hypersensitivity reaction to components of the vaccine Do not confuse with reaction to tape

51. No Response No signs of major or equivocal reaction to vaccine

52. Re-vaccination Indicated for –Equivocal response –No response Vaccination repeated using vaccine from another vial when possible

53. Re-vaccination (2) After 2 vaccinations without major reaction, seek medical consultation O.K. to re-vaccinate in same (non- dominant) arm

54. Coordinating “Take” Evaluation for HCRT Regional vaccination coordinator and hospital site facility coordinator identify a plan to evaluate “takes” Plan will need to be communicated to the vaccination clinic manager “Take” response reading date must be given to each vaccinee

55. Coordinating “Take” Evaluation for PHRT Regional vaccination coordinator identifies plan to evaluate “takes” for public health staff Plan communicated to PHRT members “Take” response reading date given to each vaccinee

56. “Take” Evaluation Process Vaccine “takes” evaluated by someone trained in “take” evaluation Schedule “take” evaluation 6-10 days after vaccination Record vaccine “take” on form & on vaccinee’s vaccination card

57. “Take” Evaluation Process (2) Employer follow-up is needed for vaccinees who miss appointments for “take” evaluation Refer for medical consultation after 2 unsuccessful “takes”

58. Section VII: Reporting Adverse Events

59. True Adverse Reactions Focus for monitoring Rare Can be serious May require specific therapy

60. True adverse reactions Extensive body rashes (erythema multiforme) Bullous erythema multiforme Bacterial infection of site Inadvertent autoinoculation Contact inoculation

61. True adverse reactions (2) Generalized vaccinia Eczema vaccinatum Progressive vaccinia Post-vaccinial Encephalitis

62. Extensive body rashes (erythema multiforme)

63. Bullous erythema multiforme (aka Stevens-Johnson syndrome)

64. Bacterial infection of site

65. Inadvertent autoinoculation and contact inoculation

66. Generalized Vaccinia

67. Eczema vaccinatum

68. Progressive Vaccinia

69. Post-Vaccinial Encephalitis Rare Believed to result from autoimmune or allergic reaction No specific therapy VIG is not effective and is not recommended

70. Management and Reporting: Role of the HAP Designated “Hospital-Assigned Physician” Evaluates and manages reactions Consults with state and national resources as necessary Reports adverse reactions to VAERS Indicates PVN on VAERS report

71. Adverse Events Summary Some local & systemic reactions are common & expected Variations of normal “takes” occur Some responses are dramatic, but self- limited

72. Adverse Events Summary (2) Severe reactions can occur but are rare Monitoring to focus on serious reactions Careful screening can minimize occurrence of serious reactions

73. Section VIII: MDCH Role

74. MDCH Role Assistance with training as requested Assistance with data system and data issues Assistance with evaluating adverse events

75. Questions? Questions may be –Faxed to 517/335-9855 –E-mailed to fasanon@michigan.gov

76. For More Information… Additional smallpox information available at –http://www.michigan.gov/mdch –http://www.bt.cdc.gov

77. Michigan Dept of Community Health P. O. Box 30195 Lansing, MI 48909 517/335-8159 517/335-9855 (fax) Contact: Nancy Fasano, fasanon@michigan.gov http://www.michigan.gov/mdch