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Proper vaccine preparation, site and route selection, needle length, and injection Improperly
techniques are essential to the appropriate administration of vaccines. Being
administered
ready to handle rare reactions is essential.
injections may
Overview of this section:
Best Practices Checklist: Vaccine Administration result in injuries or
Five "Rights" to Avoid Medication Wrongs prevent vaccines
Don't Hesitate to Vaccinate from providing
Preparing the Shot optimal protection.
Giving the Shot
After the Shot
Key Resources for Vaccine Administration Who to Call
Centers for Disease
Control and Prevention
800-232-4636
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 147
Best Practices Checklist: Vaccine Administration
The information in this checklist will be covered in more detail throughout this section.
148 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
emember these five "rights" of medication administration to avoid making Five "Rights"
R medication errors when you vaccinate patients: to Avoid
1. Right patient – including proper age; check the package insert. Medication
2. Right dose – check the package insert for directions. Wrongs
3. Right vaccine/diluent – follow indications and contraindications.
4. Right route – use the proper needle length and site (intramuscular, subcuta-
neous, nasal, or oral).
5. Right time – check the age indications and minimum intervals between doses.
Following these five "rights" will not only keep you in line with best practices but
also will greatly reduce wasted vaccine and adverse events.
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 149
Preparing the Proper preparation assures the vaccine isn't wasted and the patient is protected.
Shot yy Open only one multi-dose vial of a specific vaccine at a time.
yy Never combine vaccines in a syringe unless it is specifically recommended in
the package insert.
yy Check the vaccine label three times: when pulling vaccine from the container,
when withdrawing the vaccine, and before replacing it on the shelf or
disposing of the empty container.
yy Check the label three times; when you remove the vaccine from storage, when
you draw it up, and when you dispose of the syringe or place the vial back into
storage.
yy Be familiar with each vaccine's storage and handling information provided in
the package insert; see Guide to Receiving, Storing, and Handling Vaccines
on pages 19-25.
Multi-dose vials of vaccine Don't pre-fill syringes: Too much can go wrong
contain a bacteriostatic yy The practice of pre-filling syringes for more than one patient at a time is a
agent and once opened, quality control and patient safety issue.
can be used until the
expiration date on the vial, yy Pre-filling syringes is a violation of medication administration practice
unless contaminated. standards, which state that you should only administer vaccine you have
personally prepared and drawn up.
yy You cannot be sure of the composition and sterility of the dose you are
administering if you haven't prepared it.
yy Bacteria can contaminate and grow in syringes pre-filled from single-dose
vials, because these vials do not contain bacteriostatic agents.
yy Once vaccine is inside the syringe, it is difficult to tell which vaccine is which;
this may lead to administration errors.
yy Bulk plastic syringes, as opposed to manufactured pre-filled glass syringes,
are designed for immediate administration and not for vaccine storage.
yy No stability data are available for vaccines stored in plastic syringes. Vaccine
components may interact with the plastic over time and affect vaccine potency.
yy Pre-filling may lead to wasting vaccine, because you will have to discard any
vaccine you are unable to use within the reconstituted shelf life or work day.
150 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Most reconstituted
Reconstituted Vaccine: Diluents and Shelf Life vaccines should be
Vaccine Diluent* Reconstituted shelf life used immediately after
ActHIB 24 hours when stored in reconstitution - within
sanofi pasteur 0.4% saline
(Hib) refrigerator 30 minutes.
Hiberix 24 hours when stored in
GSK 0.9% saline
(Hib) refrigerator
Imovax sanofi pasteur distilled
30 minutes
(Rabies) sterile water
M-M-R II 8 hours when protected from
Merck sterile water
(Measles, mumps, rubella) light and stored in refrigerator
MenHIbrix GSK 0.9% saline 30 minutes
(Meningococcal C/Y-Hib)
Single-dose vials - sanofi
pasteur distilled sterile water 30 minutes for single-dose vial
Menomune
(Meningococcal) Multi-dose vials - sanofi
pasteur distilled sterile water 35 days when stored in multi-
dose vial in refrigerator
with thimerosal
8 hours at or below room
Menveo MenCWY conjugate temperature, 68º to 77ºF
(Meningococcal)
(20º to 25ºC)
Pentacel sanofi pasteur DTaP-IPV 30 minutes
(DTaP-IPV-Hib)
ProQuad 30 minutes when protected
(Measles, mumps, rubella, Merck sterile water from light and stored in
varicella) refrigerator
RabAvert Novartis sterile water 30 minutes
(Rabies)
Rotarix GSK calcium carbonate, 24 hours when stored in
(Rotavirus) sterile water, and xanthane refrigerator
Varivax 30 minutes when protected
Merck sterile water
(Varicella) from light
YF-VAX
sanofi pasteur saline 60 minutes
(Yellow fever)
Zostavax 30 minutes when protected
Merck sterile water
(Zoster) from light
*Use only the diluent provided by the manufacturer because it is a component of the
vaccine.
If you have drawn up vaccine for a patient who changes their mind: TAKE ACTION
T
1. Mark the syringe with the date and time it was drawn up, the vaccine type,
and the lot number.
2. Use within the same eight-hour work day or within the proper reconstituted
shelf life.
3. If the vaccine isn't used within the same eight-hour work day or recon-
stituted shelf life, whichever is shorter, discard it using proper disposal
procedures. See Disposing of Vaccine on page 27.
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 151
Preparing the Shot
152 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Give all vaccines in the same visit: Simultaneous administration Giving the
All vaccines, whether live or inactivated, can be given at the same visit. However, Shot
if not administered at the same visit, follow these simple rules (based on ACIP
General Recommendations, Table 3 Guidelines for spacing of live and inactivated
antigens, page 96):
yy Two or more inactivated vaccines can be given at same visit or at any interval
between doses.
yy Inactivated and live vaccines can be given at the same visit or at any interval
between doses.
yy Two or more live intranasal or injectable vaccines must be given at least four
weeks apart if not given at the same visit.
yy Live oral vaccines: Can be given at the same visit or at any interval before or
after inactivated or live injectable vaccines.
Live vaccines:
yy Influenza: LAIV, intranasal
yy Measles, mumps, rubella
yy Measles, mumps, rubella, varicella
yy Rotavirus, oral
yy Typhoid, oral
yy Varicella
yy Yellow fever
yy Zoster
Inactivated vaccines:
yy DTaP, DT, Td, TT, Tdap
yy Haemophilus influenzae type b
yy Hepatitis A
yy Hepatitis B
yy Human papillomavirus
yy Influenza: TIV, injectable
yy Japanese encephalitis
yy Meningococcal, conjugate and polysaccharide
yy Pneumococcal, conjugate and polysaccharide
yy Polio, injectable
yy Rabies
yy Typhoid, injectable
Selecting the injection site (IM or SQ)
yy Intramuscular (IM) injections are generally recommended for inactivated
vaccines and vaccines that contain an adjuvant or preservative; see How to
Administer IM Injections on page 171.
yy Subcutaneous (SQ) injections are generally recommended for live vaccines
and other vaccines that may cause fewer local reactions; see How to
Administer SQ Injections on page 172.
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 153
Giving the Shot
yy When giving injections use only the muscle site identified for the patient's age
group, usually the vastus lateralis for infants and toddlers and the deltoid for
older children, adolescents, and adults.
yy Don’t use the gluteal area (buttocks) to administer vaccine. It is covered by a
significant layer of subcutaneous fat that can prevent the needle from reaching
the muscle. In young children, an IM injection in the gluteal area has the
potential to damage the sciatic nerve.
Vaccine given by the wrong route?
yy If a vaccine is administered by the wrong route, e.g., SQ rather than IM,
the injection usually does not need to be repeated. Hepatitis B and rabies
vaccinations are the exception to this rule. If hepatitis B or rabies vaccine is
improperly administered, SQ rather than IM, the dose should be repeated.
yy Keep in mind that improperly administered IM vaccines may cause a local
reaction (e.g., irritation, redness, swelling, or necrosis). Make sure to advise
the patient/parent of possible local reactions.
Administering more than one vaccine at the same site
If multiple vaccines are being administered at a single visit, try to give each
vaccine at a different site. However, if two or more injections are given in a single
limb follow these rules:
For infants and younger children:
yy Use the vastus lateralis muscle
yy Separate injections by 1 inch or more
For older children and adults:
yy Use the deltoid muscle
yy Separate injections by 1 inch or more
For simultaneous administration of a vaccine and an immune globulin (e.g.,
hepatitis B and hepatitis B immunoglobulin [HBIG]), use different limbs for each
injection.
154 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Giving the Shot
Preparing patients for injections
Each age presents its own set of challenges when preparing to give shots. To
deliver the shot in the quickest and most comfortable position for the patient,
parent, and you, first ask the patient (and parent!) to relax. Also give parents a
copy of Be There for Your Child During Shots on page 163.
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 155
Giving the Shot
Positioning for injections
When positioning an infant, toddler, or young child keep in mind that they will
instinctively jerk away from the source of pain. Warn parents about this if they are
holding them.
156 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Guidance following vaccination After the Shot
yy Observe the patient for 15 minutes after vaccination.
yy Advise the parent/patient on the use of a non-aspirin pain reliever.
yy Give the patient a copy of their immunization record (e.g., MIIC immunization
record, Minnesota “Gold Card”).
yy Schedule their next immunization appointment before they leave the clinic.
yy Document immunizations in the medical record. Refer to Documenting
Shots on page 181 for more information on immunization documentation
requirements.
yy Be familiar with the treatment of vaccine reactions; see Guidelines for
Managing Possible Immediate Reactions table on page 158.
yy Document any adverse reaction and submit a VAERS report; see pages 175-179.
Managing vaccine reactions
Read this section carefully. Don’t be stuck trying to read information on how to
manage a reaction while it is happening! All staff involved with immunizing should
familiarize themselves with the material in this section before they have to deal
with any sort of reaction to a vaccine. Review your facility's anaphylaxis policy/
protocol every year and hold annual staff meetings to review this material.
Vaccine reactions can be as mild as local injection-site discomfort or as severe
or life-threatening as anaphylaxis. Staff should be prepared to handle all types of
reactions. The Guidelines for Managing Possible Immediate Reactions on page
158 describes management of such reactions.
What is anaphylaxis?
Anaphylaxis is a potentially life-threatening allergic reaction to a foreign substance.
It is extremely rare after immunization. When it occurs, it usually begins within
minutes following the injection, although delayed reactions are possible. Early
recognition and treatment of anaphylaxis is vital. All staff should feel confident to
manage the situation properly. Personnel administering vaccines need to be able
to distinguish symptoms of anaphylaxis from vasovagal syncope (fainting).
Prepare in advance for an anaphylactic episode
yy Have a written policy/protocol in place for medical emergencies and
anaphylaxis.
yy Know where your policy/protocol is; review, revise, and have your medical
director sign it annually.
yy Assemble an anaphylaxis kit that contains epinephrine, syringes, needles,
CPR mask or barrier, stethoscope, and a blood pressure cuff.
yy Know where these emergency materials are located and how to use them.
yy Have detailed prescriptions for what medications should be given. Typically,
epinephrine and diphenhydramamine (Benadryl) are the medications used.
yy Periodically conduct practice drills using your policy/protocol (e.g., review how
to draw up medications from ampules, use an EpiPen, start oxygen, and use
your CPR barrier mask).
yy Check epinephrine expiration dates each quarter as well as the oxygen level
of your tank, if you have one.
yy Make sure a phone is accessible at immunization clinic sites.
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 157
After the Shot
158 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
After the Shot
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 159
After the Shot
Pregnancy Registry
Health care providers are encouraged to report any instances of prenatal exposure to a varicella containing
vaccine (Varivax, ProQuad, or Zostivax) or human papillomavirus vaccine (Gardasil or Cervarix). Both
Merck and GlaxoSmithKline maintain a surveillance registry on pregnancy outcomes and newborn health
status outcomes following vaccination with these vaccines.
yy Merck vaccines (Varivax, ProQuad, Zostivax, and Gardasil): 800-986 8999
www.merckpregnancyregistries.com/home.html
yy GlaxoSmithKline vaccine (Cervarix): 888-452 9622
160 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Key Resources yy Be There For Your Child During Shots (MDH)
A brochure for parents to help prepare their child for shots, including what they
for Vaccine can do before, during, and after the shots. Brochure can be ordered using the
Administration Immunization Materials for Use with the Public order form: www.health.state.
mn.us/divs/idepc/immunize/ordermat.html.
yy Vaccine Product Summary (MDH)
Summary chart showing each vaccine's generic and brand names,
manufacturer, licensed age groups, dosing information, and administration
route.
www.health.state.mn.us/divs/idepc/immunize/hcp/vaxprodsum.pdf
yy How to Administer an Intramuscular (IM) or Subcutaneous (SQ)
Injections (MDH)
Illustrated guide to giving IM and SQ vaccinations for infants, children, and
adults. Includes injection site, needle length and size, and angle of needle
insertion.
www.health.state.mn.us/divs/idepc/immunize/hcp/admim.pdf
yy Immunization Site Map (California Department of Public Health,
Immunization Branch)
Illustrated site maps for giving vaccinations to infants, toddlers, and adults.
www.eziz.org/PDF/IMM-718.pdf and www.eziz.org/PDF/IMM-718adult.pdf
yy VAERS Table of Reportable Events Following Vaccination
Listing of post-vaccination adverse events by vaccine.
http://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_
Following_Vaccination.pdf
yy VAERS Report Form
Photocopy-ready, pre-addressed, postage-paid VAERS report form for
reporting any adverse event.
http://vaers.hhs.gov/esub/index
yy Immunization Techniques: Best Practices with Infants, Children, and
Adults (Video by the California Department of Public Health)
Not included in this section, but a good resource guide to vaccine administration
techniques. Focuses on the skills and techniques needed for vaccine
administration. Use it for training and orientation, or as a refresher for more
experienced staff. Available for purchase on DVD (25 minutes) from the
Immunization Action Coalition. Order from www.immunize.org/shop/toolkit_
iztechdvd.asp
July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - VACCINE ADMINISTRATION www.health.state.mn.us/immunize 161
162 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Be there for your child during shots.
www.health.state.mn.us/immunize
Reprinted with permission from the California Department of Health Services, Immunization Branch
163
164 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
Vaccine Product Summary
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5503, 1-800-657-3970
www.health.state.mn.us/immunize
www.health.state.mn.us/immunize Page 1 of 5 (10/13)
165
166
Vaccine Product Summary
www.health.state.mn.us/immunize
Adult: 19 years and older 1.0 mL
Agriflu (IIV3) NOV 18 years and older 0.5 mL IM • Not currently on the market.
• Age 6 months through 35 months: 0.25 mL dose
Fluzone • Age 3 years and older: 0.5 mL dose
SP 6 months and older See note IM
(IIV3 or IIV4) • Follow ACIP’s two-dose recommendation for children age
6 months through 8 years
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MDH, Immunization Program Page 3 of 5 (10/13)
167
168
Vaccine Product Summary
www.health.state.mn.us/immunize
• Give at the same time as varicella and/or PPD or any
Measles, mumps, other live virus vaccine (i.e., yellow fever)
rubella M-M-R II MSD 1 year and older ~0.5 mL SQ • If not given at the same time as varicella and/or PPD wait
(MMR) at least 28 days
• Administer entire reconstituted volume
• Protect from light and use within 8 hours of reconstitution
Measles, mumps,
rubella, varicella Proquad MSD 12 months through 12 years 0.5 mL SQ • Must use within 30 minutes of reconstitution
(MMRV)
• Reconstitute with saline diluent (0.6 mL) to make 0.5 mL
Meningococcal C/Y –
Menhibrix GSK 6 weeks through 18 months 0.5 mL IM dose
Hib
• No ACIP recommendations for use as of 7/2012
Menactra SP 9 months through 55 years 0.5 mL IM • Covers types A, C, Y, and W-135
Meningococcal
conjugate • Covers types A, C, Y, and W-135
(MCV) Menveo NOV 2 months through 55 years 0.5 mL IM • Mix liquid MenA with powder C, Y, W-135
• Must use within 8 hours of reconstitution
Meningococcal • Give to at risk persons for whom MCV4 is not licensed
polysaccharide Menomune SP 2 years and older 0.5 mL SQ (i.e., persons 56 years and older with risk factors)
Adapted from MDH Standing Orders for Routine Immunizations and Gloria Tobias’ (Countryside Public Health) Vaccine Cheat Sheet.
www.health.state.mn.us/immunize
MDH, Immunization Program Page 5 of 5 (10/13)
169
170 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
How to Administer IM (Intramuscular) Injections
Administer DTaP, DT, Td, Tdap, Hib, hepA, hepB, HPV, TIV, MCV, PCV, and rabies vaccines via IM (intramuscular) route.
Administer IPV and PPSV vaccines either via IM or SQ (subcutaneous) route.
Patient’s age Site (see illustrations) Needle size* IM site for infants and toddlers (birth to 3 years of age)
Newborn/infant • Anterolateral thigh • 1" needle
(Birth -1 year) • 5/8" in premies or newborns
(0-28 days old) if muscle
mass inadequate¹
• 23-25 gauge needle
www.health.state.mn.us/immunize
651-201-5503 or 1-800-657-3970
www.health.state.mn.us/immunize (5/2011) IC# 141-2380
171
172
How to Administer SQ (Subcutaneous) Injections
Administer MMR, MMRV, MPSV, VAR, and ZOS via SQ (subcutaneous) route.
Administer IPV and PPSV vaccines either via IM (intramuscular) or SQ route.
Patient’s age Site (see illustrations) Needle size* SQ site for infants and toddlers (birth to 3 years of age)
Infants • Fatty area of the thigh • 5/8” needle
(Birth -1 year) • 23-25 gauge
www.health.state.mn.us/immunize
Toddlers • Fatty area of the thigh or • 5/8” needle
(1-3 years) outer aspect of upper arm • 23-25 gauge
Needle insertion
• Insert needle at an 45º angle to the Insert needle at 45º angle into fatty area of anterolateral thigh.
skin. Make sure you pinch up on SQ tissue to prevent injecting into muscle.
• Pinch up on SQ tissue to prevent SQ site for older toddlers, children, adolescents and adults
injecting into muscle.
muscle
elbow
*Red Book 2009, American Academy of Pediatrics (p.19) and CDC General Recommendations on
Immunization, 2011
Immunization Program
P.O. Box 64975 Insert needle at 45º angle into outer aspect of upper arm.
St. Paul, MN 55164-0975 Make sure you pinch up on SQ tissue to prevent injecting into muscle.
651-201-5503 or 1-800-657-3970
www.health.state.mn.us/immunize (5/2011) IC# 141-2380
RT: LT:
RT: LT:
www.health.state.mn.us/immunize
173
Teen and Adult
Immunization Site Map
Create a teen and adult immunization site map for your clinic by indicating which vaccines should be
given at each site. Insert the vaccine name or abbreviation next to the appropriate site.
RD:
Right deltoid (IM)
LD:
RD: Left deltoid (IM)
LD:
RSC:
Right upper arm, subcutaneous tissue
(SC) LSC:
Left upper arm, subcutaneous
tissue (SC)
RSC:
LSC:
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
1-800-657-3970, 651-201-5503
www.health.state.mn.us/immunize
Adapted with permission from the California Department of Public Health, Immunization Branch.
174 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - VACCINE ADMINISTRATION Minnesota Department of Health, July 2011
VAERS Table of Reportable Events Following Vaccination*
A. Paralytic polio
Oral Polio (OPV) o in a non-immunodeficient recipient (30 days)
attenuated influenza‐TIV, LAIV
* Effective date: November 10, 2008. The Reportable Events Table (RET) reflects what is reportable by law (42 USC
300aa-25) to the Vaccine Adverse Event Reporting System (VAERS) including conditions found in the manufacturers
package insert. In addition, healthcare professionals are encouraged to report any clinically significant or unexpected
events (even if you are not certain the vaccine caused the event) for any vaccine, whether or not it is listed on the RET.
Manufacturers are also required by regulation (21CFR 600.80) to report to the VAERS program all adverse events made
known to them for any vaccine.
A list of vaccine abbreviations is attached and is also located at:
http://www.cdc.gov/vaccines/recs/acip/vac‐abbrev.htm
1. State 2. County where administered 3. Date of birth 4. Patient age 5. Sex 6. Date form completed
M F
mm dd yy mm dd yy
7. Describe adverse events(s) (symptoms, signs, time course) and treatment, if any 8. Check all appropriate:
Patient died (date )
mm dd yy
Life threatening illness
Required emergency room/doctor visit
Required hospitalization (________days)
Resulted in prolongation of hospitalization
Resulted in permanent disability
None of the above
9. Patient recovered YES NO UNKNOWN 10. Date of vaccination 11. Adverse event onset
a.
b.
15. Vaccinated at: 16. Vaccine purchased with: 17. Other medications
Private doctor's office/hospital Military clinic/hospital Private funds Military funds
Public health clinic/hospital Other/unknown Public funds Other/unknown
18. Illness at time of vaccination (specify) 19. Pre-existing physician-diagnosed allergies, birth defects, medical conditions (specify)
20. Have you reported No To health department Only for children 5 and under
this adverse event 22. Birth weight 23. No. of brothers and sisters
previously? To doctor To manufacturer __________ lb. _________ oz.
21. Adverse event following prior vaccination (check all applicable, specify) Only for reports submitted by manufacturer/immunization project
Adverse Onset Type Dose no. 24. Mfr./imm. proj. report no. 25. Date received by mfr./imm.proj.
Event Age Vaccine in series
In patient
In brother 26. 15 day report? 27. Report type
or sister Yes No Initial Follow-Up
Health care providers and manufacturers are required by law (42 USC 300aa-25) to report reactions to vaccines listed in the Table of Reportable Events Following Immunization.
Reports for reactions to other vaccines are voluntary except when required as a condition of immunization grant awards.
Form VAERS-1(FDA)
VAERS
P.O. Box 1100
Rockville MD 20849-1100
• Use a separate form for each patient. Complete the form to the best of your abilities. Items 3, 4, 7, 8, 10, 11, and 13 are considered
essential and should be completed whenever possible. Parents/Guardians may need to consult the facility where the vaccine was
administered for some of the information (such as manufacturer, lot number or laboratory data.)
• Refer to the Reportable Events Table (RET) for events mandated for reporting by law. Reporting for other serious events felt to be
related but not on the RET is encouraged.
• Health care providers other than the vaccine administrator (VA) treating a patient for a suspected adverse event should notify the
VA and provide the information about the adverse event to allow the VA to complete the form to meet the VA's legal responsibility.
• These data will be used to increase understanding of adverse events following vaccination and will become part of CDC Privacy
Act System 09-20-0136, "Epidemiologic Studies and Surveillance of Disease Problems". Information identifying the person who
received the vaccine or that person's legal representative will not be made available to the public, but may be available to the
vaccinee or legal representative.
• Postage will be paid by addressee. Forms may be photocopied (must be front & back on same sheet).
SPECIFIC INSTRUCTIONS
Form Completed By: To be used by parents/guardians, vaccine manufacturers/distributors, vaccine administrators, and/or the person
completing the form on behalf of the patient or the health professional who administered the vaccine.
Item 7: Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course,
duration of symptoms, diagnosis, treatment and recovery should be noted.
Item 9: Check "YES" if the patient's health condition is the same as it was prior to the vaccine, "NO" if the patient has not returned
to the pre-vaccination state of health, or "UNKNOWN" if the patient's condition is not known.
Item 10: Give dates and times as specifically as you can remember. If you do not know the exact time, please
and 11: indicate "AM" or "PM" when possible if this information is known. If more than one adverse event, give the onset date and
time for the most serious event.
Item 12: Include "negative" or "normal" results of any relevant tests performed as well as abnormal findings.
Item 13: List ONLY those vaccines given on the day listed in Item 10.
Item 14: List any other vaccines that the patient received within 4 weeks prior to the date listed in Item 10.
Item 16: This section refers to how the person who gave the vaccine purchased it, not to the patient's insurance.
Item 17: List any prescription or non-prescription medications the patient was taking when the vaccine(s) was given.
Item 18: List any short term illnesses the patient had on the date the vaccine(s) was given (i.e., cold, flu, ear infection).
Item 19: List any pre-existing physician-diagnosed allergies, birth defects, medical conditions (including developmental and/or
neurologic disorders) for the patient.
Item 21: List any suspected adverse events the patient, or the patient's brothers or sisters, may have had to previous vaccinations.
If more than one brother or sister, or if the patient has reacted to more than one prior vaccine, use additional pages to
explain completely. For the onset age of a patient, provide the age in months if less than two years old.
Item 26: This space is for manufacturers' use only.