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Site Care
Site Care Education Goals
• Review normal reactions after vaccination
• Provide site care instructions (oral and written)
• Provide contact information for concerns
Site Care Education Goals (2)
• Provide successful vaccination “take” reading date and location information
Vaccination Site Reaction
Day 4
Day 7
Day 14
Day 21
Normal, expected local reactions
Usually seen ~1 week after vaccination
• Soreness at vaccination site
• Intense erythema surrounding the vaccination site
• Lymphadenopathy (local):
25% – 50%
Normal, expected systemic symptoms – usually occur ~1 week
after vaccination
• Headache
• Myalgia
• Chills
• Nausea
• Fatigue
0.3 – 37.0%
Normal, expected systemic symptoms usually seen ~1 week
after vaccination• Malaise
• Fever 100º F: 17% 101º F: 7% 102º F: 1.4%
Normal variant responses & symptoms
• Local satellite lesions
• Lymphangitis
• Local edema
• Viral cellulitis
• Mild rashes
Local Satellite Lesions
1 or more additional lesions near vaccine site
Lymphangitis
Inflammation of the lymphatic vessels characterized by red streaks or patches in the skin
Local edema
Fluid accumulation in the vaccination area
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
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
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
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
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
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
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)
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
Additional Clinic Roles
Vaccination Assistants
• May assist vaccine administrator with all aspects of pre and post vaccination activities
• May set up/break down vaccination stations
• May assure area is available for vaccinees having reactions
• May replenish vaccine station supplies
• May apply bandages to vaccination site
Vaccination Assistants (2)
Data Entry Staff
• MDCH intends to provide data entry staff
• Vaccination not required
• Data entry discussion to follow
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
Security
• Assure clinic parking is adequate, close and protected
• Provide telephone numbers for police, fire, utilities, facility owner/manager
Security (2)
• Assure facility is secure, well lighted and functional
• Vaccination not indicated
Supply Issues
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
Supplies Provided by MDCH
• Vaccination card for vaccinee
• Vaccine Information Statements
• Consent forms
Additional Clinic Supplies
• Detailed supply checklist provided in Handout #4
Section V: Data Issues
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
Data System
• Pre-Event Vaccination System (PVS)
– Written by CDC
– Web-based application
– Digital certificates used for security
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
Greeter & Smallpox Vaccination Form
• Greeter gives form to vaccinee
• Vaccinee completes
– Patient Information
– Vaccination History
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
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
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
Site Care Educator & the Form
• Site care educator will record the date and location where the “take” response should be read
Data Entry Staff
• The completed form is then given to the data entry staff for entry into the PVS
“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
“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
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
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
Section VI: Evaluating Vaccine
“Take”
Evaluating Vaccination Site for “Take”
• Major response
• Equivocal response
• No response
Major “Take” Response
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
Equivocal Response
• Any other reaction
• May result from
– A person being sufficiently immune to suppress viral replication
– Sub-potent vaccine or improper technique
Equivocal Reaction (2)
• May result from (cont.)
– Hypersensitivity reaction to components of the vaccine
• Do not confuse with reaction to tape
No Response
• No signs of major or equivocal reaction to vaccine
Re-vaccination
• Indicated for
– Equivocal response
– No response
• Vaccination repeated using vaccine from another vial when possible
Re-vaccination (2)
• After 2 vaccinations without major reaction, seek medical consultation
• O.K. to re-vaccinate in same (non-dominant) arm
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
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
“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
“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”
Section VII: Reporting Adverse
Events
True Adverse Reactions
• Focus for monitoring
• Rare
• Can be serious
• May require specific therapy
True adverse reactions
• Extensive body rashes (erythema multiforme)
• Bullous erythema multiforme• Bacterial infection of site• Inadvertent autoinoculation • Contact inoculation
True adverse reactions (2)
• Generalized vaccinia
• Eczema vaccinatum
• Progressive vaccinia • Post-vaccinial Encephalitis
Extensive body rashes (erythema multiforme)
Bullous erythema multiforme (aka Stevens-Johnson syndrome)
Bacterial infection of site
Inadvertent autoinoculation and contact inoculation
Generalized Vaccinia
Eczema vaccinatum
Progressive Vaccinia
Post-Vaccinial Encephalitis
• Rare
• Believed to result from autoimmune or allergic reaction
• No specific therapy
• VIG is not effective and is not recommended
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
Adverse Events Summary
• Some local & systemic reactions are common & expected
• Variations of normal “takes” occur
• Some responses are dramatic, but self-limited
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
Section VIII: MDCH Role
MDCH Role
• Assistance with training as requested
• Assistance with data system and data issues
• Assistance with evaluating adverse events
For More Information…
• Additional smallpox information available at
– http://www.michigan.gov/mdch
– http://www.bt.cdc.gov
Michigan Dept of Community Health
P. O. Box 30195
Lansing, MI 48909
517/335-8159
517/335-9855 (fax)
Contact: Nancy Fasano, [email protected]
http://www.michigan.gov/mdch
