COVID-19 Vaccine Provider Guide

INFORMATION FOR HANDLING AND ADMINISTERING COVID-19

VACCINE
Updated 3/22/2024

The COVID-19 vaccine response can change periodically. Please make sure you have the most current version of
this document, which can be found at COVID-19 Vaccine Providers
(www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html).

Contents
COVID-19 Vaccine Provider Guide ................................................................................................................................ 1
Background............................................................................................................................................................... 2
Use of this guide ....................................................................................................................................................... 2
Training requirements.......................................................................................................................................... 2
COVID-19 vaccine ordering and distribution............................................................................................................ 2
COVID-19 vaccine products and recommendations ................................................................................................ 2
COVID-19 vaccination guidance for people NOT moderately or severely immunocompromised ...................... 4
COVID-19 vaccination guidance for people moderately or severely immunocompromised .............................. 4
COVID-19 vaccination guidance for people 65 years and older NOT moderately or severely
immunocompromised .......................................................................................................................................... 4
COVID-19 vaccination guidance for people 65 years and older that are moderately or severely
immunocompromised .......................................................................................................................................... 4
COVID-19 vaccine storage and handling .................................................................................................................. 5
Expiration date and beyond-use date (BUD) ....................................................................................................... 5
Managing out-of-range temperatures (excursions) ................................................................................................. 5
Clinical considerations for authorized vaccines ....................................................................................................... 6
Resources for screening patients before COVID-19 vaccination ......................................................................... 6
Verify patient COVID-19 immunization data ............................................................................................................ 6
COVID-19 vaccine administration ............................................................................................................................ 7
Vaccine information sheets (VISs) and emergency use authorization (EUA) fact sheets ........................................ 7
Vaccine information sheets (VIS) ......................................................................................................................... 7
EUA fact sheets .................................................................................................................................................... 8
COVID-19 vaccine reminders.................................................................................................................................... 8
Post-vaccination care ............................................................................................................................................... 9
Vaccine efficacy .................................................................................................................................................... 9
Post-vaccination instructions ............................................................................................................................... 9
 COVID-19 VACCINE PROVIDER GUIDE

Treatment of post-vaccination symptoms ........................................................................................................... 9

Allergic reaction (anaphylaxis) ............................................................................................................................. 9
Report vaccine adverse events and administration errors ................................................................................ 10
COVID-19 vaccine reporting requirements ............................................................................................................ 11
Billing and reimbursement ..................................................................................................................................... 12
COVID-19 vaccine is no longer supplied by the pandemic federal government response. ............................... 12

Background
In March 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. Immunization with a
safe and effective COVID-19 vaccine is critical to reduce COVID-19-related illnesses, hospitalizations, and deaths.
Initial vaccines were authorized by emergency use authorizations (EUA) from the Food and Drug Administration
(FDA) when enough preliminary data on their effectiveness and safety was collected. In a global health pandemic,
an EUA allows the FDA to review information from a vaccine manufacturer to determine if a vaccine can be
released early. They weigh the benefits of early release against the known and unknown risks of a vaccine.
Information about effectiveness and safety continues to be collected. If at any time vaccine data shows more risk
than benefit, an EUA is re-evaluated.
COVID-19 vaccine is no longer being supplied by the federal government. Private vaccine must be purchased to
administer to persons with insurance. Public vaccine is provided through the Minnesota Vaccines for Children
(MnVFC) program and Un- and Under-insured Adult Vaccine (UUAV) program for eligible persons.

Use of this guide

Anyone who handles and/or administers COVID-19 vaccine should read this guide. Bookmark this guide for easy
reference and check back often for updates.

Training requirements
The vaccine coordinator and back-up coordinator at any site administering COIVD-19 vaccines should read this
COVID-19 vaccine provider guide and watch the CDC’s CDC: COVID-19 Vaccine Training Module
(www2.cdc.gov/vaccines/ed/covid19/) for the most up to date information about COVID-19 vaccines. Other
people storing, handling, and administering COVID-19 vaccines are also highly encouraged to read this guide and
complete the training to strengthen their competency in using these vaccines.

COVID-19 vaccine ordering and distribution

COVID-19 2023-2024 vaccine should be ordered through your routine vaccine ordering process. Providers enrolled
in MnVFC or UUAV will order COVID-19 2023-2024 vaccine in MIIC.

COVID-19 vaccine products and recommendations

Several COVID-19 vaccines are currently available. Having multiple products makes COVID-19 vaccine more
accessible, but it also increases the risk of medication errors and can lead to vaccine waste. Sites are encouraged
to only store and administer one COVID-19 mRNA vaccine product. Double check the product specific EUA
provider fact sheet or package insert for age indication, route, dosage, and storage and handling requirements.
The currently FDA-approved or FDA-authorized COVID-19 vaccines are summarized below. None of the current

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vaccines are live-virus vaccines or contain any preservatives. Any COVID-19 vaccine can be used when indicated.
Refer to FDA: COVID-19 Vaccines (www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-
2019-covid-19/covid-19-vaccines) for links to the package inserts and EUA fact sheets for providers for the
currently approved or authorized vaccines.
Pfizer-BioNTech-COVID-19 2023-2024 vaccines
Description Yellow cap Blue cap Gray cap
Age indication 6 months-4 years 5-11 years 12 years and older
Dose and route 0.3 mL (3 mcg) IM 0.3 mL (10 mcg) IM 0.3 mL (30 mcg) IM
Amount of diluent* needed per vial 1.1 mL NO DILUTION NO DILUTION
Doses per vial 3-dose multi-dose vial single dose vial single dose vial
Pfizer-BioNTech-COVID-19 2023-2024 vaccines storage conditions
Storage Conditions Yellow cap Blue cap Gray cap
ULT Freezer (-90°C to -60°C/-130°F to -76°F) Until the expiration date Until the expiration date Until the expiration date
Freezer (-25°C to -15°C/-13°F to 5°F) DO NOT STORE DO NOT STORE DO NOT STORE
Refrigerator (2°C to 8°C/35°F to 46°F) 10 weeks or until 10 weeks or until 10 weeks or until
expiration date expiration date expiration date
Room Temperature (8°C to 25°C/46°F to 12 hours (including thaw 12 hours (including thaw 12 hours (including thaw
77°F) time time) time)
After First Puncture (2°C to 25°C/36°F to Discard after 12 hours Discard after 12 hours Discard after 12 hours
77°F)
Moderna COVID-19 2023-2024 vaccines
Description Blue cap/green label Blue cap/blue label
Age indication 6 months through 11 years 12 years and older
Dose and route 0.25mL (25mcg) 0.5ml (50mcg)
Amount of diluent* needed per vial NO DILUTION NO DILUTION
Doses per vial Single dose vial Single dose vial
*Diluent sterile 0.9% Sodium Chloride Injection USP. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.

Moderna COVID-19 2023-2024 vaccines storage conditions

Storage Conditions Blue cap/green label Blue cap/blue label
Freezer (-25°C to -15°C/-13°F to 5°F) Until expiration date Until expiration date
Refrigerator (2°C to 8°C/35°F to 46°F) 30 days or until expiration date 30 days or until expiration date
Room Temperature (8°C to 25°C/46°F to 77°F) Up to 24 hours (unpunctured vials) Up to 24 hours (unpunctured vials)
After First Puncture (2°C to 25°C/36°F to 77°F) Discard after 8 hours Discard after 12 hours
Comments Do not refreeze Do not refreeze
Novavax COVID-19 2023-2024 vaccines
Description Blue cap/blue label
Age indication 12 years and older
Dose and route 0.5ml (50mcg)
Amount of diluent* needed per vial NO DILUTION
Doses per vial 5-dose multi-dose vial
Novavax COVID-19 2023-2024 vaccine storage conditions
Storage Conditions Blue cap/blue label
Freezer (-25°C to -15°C/-13°F to 5°F) Do not store
Refrigerator (2°C to 8°C/35°F to 46°F) Until expiration date
Room Temperature (8°C to 25°C/46°F to 77°F) 12 hours
After First Puncture (2°C to 25°C/36°F to 77°F) Discard after 12 hours
Comments Do not refreeze

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COVID-19 vaccination guidance for people NOT moderately or severely

immunocompromised
CDC recommends that people ages 6 months and older receive at least one 2023-2024 COVID-19 vaccine. The
number of doses varies by age, vaccine, previous COVID-19 vaccines received, and the presence of moderate or
severe immune compromise. Refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Guidance
for people who are not moderately or severely immunocompromised (www.cdc.gov/vaccines/covid-19/clinical-
considerations/interim-considerations-us.html) for detailed schedules.

People who are unvaccinated and get Novavax 2023-2024 vaccine need 2 doses given 3-8 weeks apart.

Children 6 months through 4 years should get the same brand of vaccine for their primary series when possible.
But if that vaccine is unavailable or it is unknown what previous doses were given, it is acceptable to use the
brand you have. Don’t miss opportunities to vaccinate kids.

COVID-19 vaccination guidance for people moderately or severely

immunocompromised
People who are immunocompromised should have three doses with at least one of the doses being the new
2023-2024 COVID-19 vaccine. They may also receive additional 2023-2024 COVID-19 vaccine doses based on their
clinical situation at least two months following the last 2023-2024 COVID-19 vaccine dose. Refer to: CDC: Interim
Clinical Considerations for Use of COVID-19 Vaccines: Guidance for people who are moderately or severely
immunocompromised (www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-
us.html#immunocompromised) for more specific information on this population.

COVID-19 vaccination guidance for people 65 years and older NOT moderately
or severely immunocompromised
All people ages 65 years and older should receive 1 additional dose of any 2023–2024 COVID-19 vaccine
at least 4 months following the previous dose of 2023–2024 COVID-19 vaccine. For initial vaccination
with Novavax COVID-19 Vaccine, the 2-dose series should be completed before administration of the
additional dose. Refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Guidance for people
who are not moderately or severely immunocompromised (www.cdc.gov/vaccines/covid-19/clinical-
considerations/interim-considerations-us.html) for more specific information.

COVID-19 vaccination guidance for people 65 years and older that are
moderately or severely immunocompromised
All people ages 65 years and older who are moderately or severely immunocompromised should receive
1 additional dose of any 2023–2024 COVID-19 vaccine at least 2 months after the last dose of 2023–
2024 COVID vaccine indicated. Further additional doses may be administered, informed by the clinical
judgement of a healthcare provider and personal preference and circumstances. Any further additional
doses should be administered at least 2 months after the last 2023–2024 COVID-19 vaccine dose. CDC:
Interim Clinical Considerations for Use of COVID-19 Vaccines: Guidance for people who are moderately or severely
immunocompromised (www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-
us.html#immunocompromised) for more specific information on this population.

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COVID-19 vaccine storage and handling

COVID-19 vaccine products are temperature-sensitive, must be stored, and handled correctly to ensure efficacy
and maximize shelf life. Proper storage and handling practices are critical to minimize vaccine loss and limit risk of
administering COVID-19 vaccine with reduced effectiveness.
Storage and handling requirements for COVID-19 vaccine products vary. Follow specific shipping, storage, and
handling requirements for each vaccine product in their respective package insert or EUA fact sheet for health
care providers at FDA: COVID-19 Vaccines (www.fda.gov/emergency-preparedness-and-response/coronavirus-
disease-2019-covid-19/covid-19-vaccines).
Vaccine must be stored in dedicated refrigeration/freezer units. Find more information on CDC’s storage and
handling recommendations at Vaccine Storage and Handling Toolkit
(www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html). Storing vaccine in the freezer of a combination
household unit is not recommended. If your facility provides frozen vaccine, you must have a separate freezer.
Providers new to vaccine storage and handling, should view CDC’s, You Call the Shots module. Learn more at CDC:
CE Instructions for WB4417: Immunization: You Call the Shots-Module Ten-Storage and Handling—2021
(www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp).

Expiration date and beyond-use date (BUD)

In certain conditions vaccines must be used before the actual expiration date. This is referred to as the beyond-
use date (BUD). The BUD is determined based on the storage conditions and the time a vial is first punctured for
COVID-19 vaccines. The person that performs the step in the administration process that changes the BUD (e.g.,
punctures the vial, reconstitutes it, moves it from the freezer to refrigerator, etc.) must document the new BUD
on a label. BUD tracker labels are available on CDC’s website.

Check expiration dates and beyond-use dates closely. Discard the vaccine based on the earliest date, whether
that is the manufacturer’s labeled expiration date or the BUD.
Example: Pfizer vaccine can be stored for 10 weeks in the refrigerator. If it was placed in the refrigerator on
December 20, its BUD is February 28. However, if the vaccine vial’s expiration date is February 8, then it needs
to be discarded at the end of the day on February 8.

Keep in mind that COVID-19 vaccine products do not contain any preservative and therefore can’t be used after a
certain number of hours after the vial is first punctured. Carefully read and follow the EUA fact sheet for health
care providers and/or manufacturers’ package inserts or websites for each vaccine product regarding expiration
and beyond-use dates.

Managing out-of-range temperatures (excursions)

As with all vaccines, if COVID-19 vaccines are exposed to out-of-range temperatures, take immediate action. Mark
the vaccine “do not use” until its usability is determined. If vaccine thaws, do not re-freeze.
Contact MDH’s Immunization Program Monday through Friday between 8:00 a.m. and 4:30 p.m. at 651-201-5414
to determine your next steps. Make sure to have specific information about temperatures, duration of excursion,
etc. available. Refer to Storage and Handling Mishap Checklist
(www.health.state.mn.us/people/immunize/hcp/mnvfc/vaxchklst.pdf) for steps to take and a form to document
actions taken.
Contact information for vaccine manufacturers:

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▪ Moderna:
Phone: 1-866-MOD-ERNA or 1-866-663-3762
Email: excursions@modernatx.com
▪ Pfizer:
Pfizer U.S. Medical Information
Phone: 1-800-438-1985
▪ Novavax:
Phone: 1-844-668-2829
Email: Fill out our contact form (www.novavax.com/contact-us/email-us)
Some vaccine manufacturers have online temperature excursion tools you may use:
▪ Moderna: Storage & temperature excursion for Moderna COVID-19 vaccine
(https://tools.modernamedinfo.com/en-US/excursion/introduction-landing-page).

Contact MDH even if you have contacted the vaccine manufacturer or used their online temperature excursion
tool and the issue was resolved.

Clinical considerations for authorized vaccines

ACIP has issued interim recommendations for the use of COVID-19 vaccines for the prevention of COVID-19. These
recommendations are published in CDC: Use of COVID-19 Vaccines in the United States
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html). A summary of recent
changes and the date they were last updated is at the top of the webpage.

Resources for screening patients before COVID-19 vaccination

▪ Template: COVID-19 Vaccine Screening and Agreement on COVID-19 Vaccine Providers
(www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html).
▪ CDC: Prevaccination Checklist for COVID-19 Vaccines (www.cdc.gov/vaccines/covid-19/downloads/pre-
vaccination-screening-form.pdf).

Verify patient COVID-19 immunization data

Prior to administering a dose of COVID-19 vaccine, please review the patient’s immunization history. The primary
source of COVID-19 vaccine administration data should be the Minnesota Immunization Information Connection
(MIIC). If the data for a patient is not in MIIC, other acceptable sources include:
1. Their CDC vaccination card.
2. An official document from a health care provider or another state’s Immunization Information System (IIS)
with day, month, year, and product administered as well as the patient’s name and date of birth.
3. Electronic documentation from a health care provider or another state’s Immunization Information System
(IIS) such as the MyChart app or another consumer access application (app) that includes day, month, year,
and product administered as well as the patient’s name and date of birth.
4. A patient’s U.S. Department of State’s Vaccination Documentation form DS-3025 that includes a patient’s
verified past immunizations.

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Verbal presentations of data are not acceptable. Please enter immunization data from these acceptable sources
her

For more information, review MIIC user guidance for looking up a client at Client Search and Printing
Immunization Records (www.health.state.mn.us/people/immunize/miic/train/clientsearch.html) and entering
immunization data at Adding Immunizations Not Using Inventory
(www.health.state.mn.us/people/immunize/miic/train/addnoinv.html).

COVID-19 vaccine administration

Based on their scope of practice, all people who administer vaccines should receive comprehensive, competency-
based staff training and education, including the “rights of vaccine administration,” patient care before, during,
and after vaccine administration, vaccine preparation, and skill validation.
Vaccine administration resources for all people who vaccinate, including staff who are new to vaccination and
staff who need a refresher:
▪ CDC: Immunization Education and Training (www.cdc.gov/vaccines/ed/index.html)
▪ CDC: COVID-19 Vaccination Training Programs and Reference Materials (www.cdc.gov/vaccines/covid-
19/downloads/COVID-19-Clinical-Training-and-Resources-for-HCPs.pdf)
▪ CDC: You Call the Shots (www.cdc.gov/vaccines/ed/youcalltheshots.html)
Watch the “Vaccine Administration” e-Learn.
▪ CDC: Epidemiology and Prevention of Vaccine-Preventable Diseases
(www.cdc.gov/vaccines/pubs/pinkbook/index.html)
Known as the “Pink Book”.
▪ How to Administer IM (Intramuscular) Injections (www.health.state.mn.us/people/immunize/hcp/admim.pdf)
▪ Intramuscular (IM) Injection: Sites (https://youtu.be/PqSuCPnPeYE)
▪ Preparing COVID-19 Vaccines for Administration
(www.health.state.mn.us/diseases/coronavirus/vaccine/adminprep.pdf)
▪ Preparing to Vaccinate Young Children: COVID-19
(www.health.state.mn.us/diseases/coronavirus/vaccine/pedstips.html)
▪ COVID-19 Vaccine Trainings for Health Professionals
(www.health.state.mn.us/diseases/coronavirus/vaccine/training.html#supp)
Immunization Basic Principles supplemental on-demand training for vaccine providers.
▪ COVID-19 PPE and Source Control Grids (www.health.state.mn.us/diseases/coronavirus/hcp/ppegrid.pdf)
▪ One & Only Campaign (www.cdc.gov/injectionsafety/one-and-only.html)

Vaccine information sheets (VISs) and emergency use authorization

(EUA) fact sheets
Vaccine information sheets (VIS)
Vaccines licensed through the FDA and added to the vaccine injury table are required to have a vaccine
information sheet (VIS). Federal law requires that patients receive a VIS prior to administration of a licensed
vaccine. For recipients who are 12 or older receiving Pfizer or Moderna vaccine, a provider may use the COVID-19

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VIS found at CDC: Vaccine Information Statement (www.cdc.gov/vaccines/hcp/vis/current-vis.html). As more

COVID-19 vaccines are licensed new VIS will be developed.

EUA fact sheets

EUA fact sheets for vaccination providers are product-specific information sheets that replace the usual package
insert. The fact sheet for vaccine recipients is similar to a licensed product’s VIS.
The EUA fact sheet for vaccine recipients explains the vaccine risks and benefits, specific vaccine product
information and its use, and information from clinical trials that support the FDA’s emergency use authorization.
▪ You are legally required to give an EUA fact sheet to each recipient/parent/legal representative prior to
vaccination. Be prepared to answer questions about the vaccine.
EUA fact sheets for providers and recipients are available on FDA, CDC, MDH, and vaccine manufacturer websites.
Translated fact sheets in multiple languages are on the FDA website.
▪ FDA: Fact Sheet for Recipients and Caregivers about Pfizer COVID-19 Vaccine (2023-2024) in Individuals 6
months Through 11 Years of Age (www.fda.gov/media/167209/download?attachment).
▪ FDA: Fact Sheet for Recipients and Caregivers About Moderna COVID-19 Vaccine (2023-2024) in Individuals 6
Months Through 11 Years of Age (www.fda.gov/media/167209/download?attachment).
▪ FDA: Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) Fact Sheet for Recipients and Caregivers
(www.fda.gov/media/159898/download?attachment).

COVID-19 vaccine reminders

Most people aged 5 years and older now only need one dose of the 2023-2024 COVID-19 vaccine. For those
under 5 years old or who are immunocompromised and need more than one dose for a primary series, it is
important that people receive all doses, and that doses are the same vaccine product. Try to keep doses within
the recommended interval. If the interval is missed, the dose should be given as soon as possible, and the series
does not need to be restarted. Providers should refer to: CDC Interim Clinical Considerations for Use of COVID-19
Vaccines: Overview of COVID-19 vaccination (www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-
considerations-us.html#covid-vaccines) to understand the schedule for situations that require more than one
dose.
Vaccination reminders are critical to ensure compliance with vaccine dosing intervals and to achieve optimal
vaccine effectiveness. Use these tips for COVID-19 vaccine reminders:
▪ Make sure each person getting vaccinated knows if they need additional doses and schedule an appointment
for the next dose.
▪ If the patient has a smartphone, ask them to enter the date when the next vaccine is due into their electronic
calendar.
Using Minnesota Immunization Information Connection (MIIC) for vaccine reminders:
▪ Record all vaccinations in MIIC within 7 days after vaccine administration.
▪ Pull lists of people overdue/recommended for COVID-19 vaccine using the MIIC client follow-up functionality
in MIIC. Information on client follow-up is available at Client Follow-Up
(www.health.state.mn.us/people/immunize/miic/train/followup.html).
▪ Partner with MDH to text your clients who are overdue or recommended for vaccines, including COVID
routine doses, Zoster, or routine child/adolescent immunizations. This program is free to the participating

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provider and is easy to set up. For more information, email the MIIC Texting Program at
health.miictexting@state.mn.us. For more information on this project visit Reminder/Recall Using Text
Messages (www.health.state.mn.us/diseases/coronavirus/vaccine/remindrecall.pdf).
▪ Look at your electronic health record or vaccine management tool to identify if there is a next dose reminder
function already built in (e.g., patient portal).
▪ Use other methods, such as text messaging, phone calls, email, and mail.

Post-vaccination care
Vaccine efficacy
All COVID-19 vaccines currently approved or authorized in the United States (Pfizer-BioNTech, Moderna and
Novavax) are effective at preventing severe disease, hospitalizations, and death from COVID-19.

Post-vaccination instructions
Preparing people for what to expect after vaccination and when to follow up with a health care provider is a best
practice and expectation. Patient instructions should include information specific to the product they are
receiving. This information should include:
▪ Common side effects (listed in the VIS and EUA fact sheet).
▪ When to contact their health care provider (such as signs of an allergic reaction or medical concerns that may
or may not be related to vaccination).
▪ For vaccine(s) requiring more than one dose, the importance of receiving all recommended dose(s) of vaccine
to build an adequate immune response.
▪ What it means to be up to date with your COVID-19 Vaccines refer to: CDC: Stay Up to Date with Your COVID-
19 Vaccines (www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html).

Treatment of post-vaccination symptoms

After receiving a COVID-19 vaccine dose, over the counter fever, or pain medication (e.g., acetaminophen, non-
steroidal anti-inflammatory drugs) may be used for local or systemic symptoms, if medically appropriate. Refer to
the applicable EUA fact sheet for recipients to view side effects listed for each vaccine product.

It is not recommended to routinely take over-the-counter fever or pain medication prior to vaccination to
prevent symptoms following vaccination.

Allergic reaction (anaphylaxis)

Anaphylactic reactions in people receiving the COVID-19 vaccine outside of clinical trials have been reported.
While rare, these events highlight the importance of a quick and competent response. Antihistamines should not
be taken before vaccination to prevent allergic reactions, as they do not prevent anaphylaxis and might mask
cutaneous (skin) symptoms. Refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines:
Contraindications and precautions (www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-
us.html) for more information regarding adverse reactions.

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Appropriate medical treatment used to manage immediate allergic reactions (e.g., epinephrine) must be
immediately available in the event an acute anaphylactic reaction occurs following administration of the
vaccine.

An allergic reaction to a vaccine can be a life-threatening event. Know the early signs of anaphylaxis: throat
closing sensation, swelling of throat, face or lips, hives or itching, stridor (high-pitched whistling sound), wheezing,
coughing, dizziness, fainting, fast heart rate, low blood pressure, nausea, vomiting, diarrhea, and/or abdominal
pain. CDC has a helpful poster on Recognizing and Responding to Anaphylaxis (www.cdc.gov/vaccines/covid-
19/downloads/recognizing-responding-to-anaphylaxis-508.pdf).
Observation periods following vaccination
Syncope (fainting) might occur in association with any injectable vaccine, especially in adolescents. In accordance
with CDC: General Best Practice Guidelines for Immunization (GBPG) (www.cdc.gov/vaccines/hcp/acip-
recs/general-recs/index.html), vaccination providers, particularly when vaccinating adolescents, should consider
observing vaccine recipients for 15 minutes after vaccination.
Additionally, providers should consider observing people with the following medical histories for 30 minutes after
COVID-19 vaccination to monitor for allergic reactions:
▪ Allergy-related contraindication to a different type of COVID-19 vaccine.
▪ Non-severe, immediate (onset within 4 hours) allergic reaction after a previous dose of COVID-19 vaccine.
▪ Anaphylaxis after non-COVID-19 vaccines or injectable therapies.
Refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Contraindications and precautions
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html)
Emergency preparation
Administer vaccines in settings where staff are trained to recognize and respond to reactions. Immediate systemic
reactions can include fainting (syncope) and severe allergic reaction (anaphylaxis). Learn more about how to
prepare for anaphylactic reactions at CDC: Interim Considerations: Preparing for the Potential Management of
Anaphylaxis after COVID-19 Vaccination (www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-
anaphylaxis.html).

Report vaccine adverse events and administration errors

As with licensed vaccines, vaccines under an Emergency Use Authorization have the same requirements to report
to the Vaccine Adverse Event Report System (VAERS) any situations, including serious adverse events, that
occurred after vaccination. This is regardless of determination of cause. As part of the CDC COVID-19 Vaccination
Program Provider Agreement, vaccination providers are required to report the following to VAERS:
▪ Vaccine administration errors, even if they did not involve an adverse effect.
▪ Serious adverse events:
▪ Death.
▪ A life-threatening adverse event.
▪ An event requiring hospitalization or prolonged hospitalization.
▪ Prolonged impact on a person’s ability to perform daily activities.
▪ A congenital anomaly/birth defect.

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▪ A significant medical event that may cause harm to a person and may require medical or surgical
intervention to prevent one of the outcomes listed above.
▪ Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults.
▪ Cases of myocarditis or pericarditis.
▪ Cases of COVID-19 (including vaccine breakthrough cases) that result in hospitalization or death.
Learn more about VAERS at CDC: Vaccine Adverse Event Reporting System (VAERS): How VAERS works
(www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html). To submit an event, go to VAERS:
Report an Adverse Event (vaers.hhs.gov/reportevent.html). There is a checklist on this page to help gather
information needed when submitting a report (VAERS 2.0 Checklist [vaers.hhs.gov/docs/VAERS
2.0_Checklist.pdf]).
HIPAA permits reporting of vaccine adverse events and medical documentation to VAERS for public health
purposes under 45 CFR, section 164.512(b), as authorized by 42 USC 300aa-25.
Resources to assist clinicians in possible COVID-19 vaccine-related adverse events
Urgent consults: Health care providers can contact the CDC Emergency Operations Center at 770-488-7100 if they
need an urgent COVID-19 vaccine safety consultation. In case of a health emergency, providers should call 911.
Complex health situations following COVID-19 vaccination: For complex vaccine safety questions, health care
providers or health departments in the United States can request a consultation from the CDC: Clinical
Immunization Safety Assessment (CISA) Project
(www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html) COVIDvax clinicians. For non-urgent
concerns, providers may Contact CDC-INFO (wwwn.cdc.gov/DCS/ContactUs/Form).

COVID-19 vaccine reporting requirements

The Minnesota Immunization Information Connection (MIIC) (www.health.state.mn.us/miic) is a statewide
immunization information system that stores electronic immunization records for Minnesota health service
providers and for the public. MIIC combines immunizations a person has received into a single record, even if the
shots were given by different health care providers in the state.
Become familiar with MIIC. If your organization already submits data to MIIC via one of the following ways, please
implement these steps.
▪ Electronic data exchange: Review your messages to ensure you are sending timely messages and that those
messages contain a CVX/CPT code pair or an NDC code, as well as an MVX code. Verify that your organization
has a process to routinely review rejection (ACK) messages. Confirm your organization has a process for
adding new vaccines in a timely manner to accommodate any new COVID-19 vaccine products that may be
approved or recommended in the future.
▪ Uploaded file via the user interface: Ensure you are submitting a CVX/CPT code pair, as well as the
manufacturer (MVX) code. The current spreadsheet template is available in MIIC, and the latest user guide
can be found at General Immunization Upload Using the Spreadsheet Template
(www.health.state.mn.us/people/immunize/miic/data/spreadsheet.pdf). Please download the template from
MIIC each time you use it. Consider creating an electronic interface with MIIC to reduce staff burden and help
ensure timely data reporting.
▪ Direct data entry in the user interface: Ensure staff are selecting the correct vaccine group and then the
correct option from the “Trade Name” drop-down menu. The COVID Pandemic vaccine group includes the
original formulation(s) through the bivalent booster vaccines. The COVID Routine vaccine group includes

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COVID vaccines starting with the monovalent formulation approved in Fall 2023. Strongly consider using one
of the above reporting methods. Connecting to MIIC for electronic data exchange can reduce staff burden,
especially during high-volume times.
Minnesota Statutes, chapter 144.3351 allows vaccine providers to share immunization data, which is defined in
the statute, with MDH without patient consent. This data includes race and ethnicity. MIIC is a tool that providers
can use to share this information. Find Vaccine Administration Codes from CDC at Data Code Sets
(www.cdc.gov/vaccines/programs/iis/code-sets.html). For more information on entering correct COVID-19
product information into MIIC, please review this resource: Entering COVID-19 Product Information in MIIC
(www.health.state.mn.us/people/immunize/miic/train/entercovidproduct.pdf).

If you have any questions, please contact the MIIC Help Desk at health.miichelp@state.mn.us.

Billing and reimbursement

COVID-19 vaccine is no longer supplied by the pandemic federal government
response.
▪ Insurance plans should reimburse providers for the cost of the vaccine and the administration fee. Vaccine
providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine for the
vaccine recipient.
▪ For patients who have a Minnesota Health Care Plan (MHCP), providers will be reimbursed for the
administration fee. Children with a MHCP should get MnVFC vaccine and not billed for the cost of the vaccine.
Adults with a MHCP should get privately purchased vaccine and bill the MHCP for the cost of the vaccine. As a
reminder, COVID-19 vaccines are exempt from cost-sharing. MHCP also covers vaccine counseling that occurs
during visits and for those COVID-19 vaccines they can administer. For details, refer to the MHCP Provider
Manual: Immunizations and Vaccinations
(www.dhs.state.mn.us/main/idcplg?IdcService=GET_DYNAMIC_CONVERSION&RevisionSelectionMethod=Late
stReleased&dDocName=dhs16_136660). Contact the MHCP Provider Call Center at 651-431-2700 with any
related questions.
▪ Adults 18 years and older without health insurance and adults whose health insurance does not cover all
COVID-19 vaccine costs at an in-network provider can get free updated COVID-19 vaccines through the Bridge
Access Program. This program will end by December 31, 2024. For more details, refer to CDC: Bridge Access
Program (www.cdc.gov/vaccines/programs/bridge/index.html).
Additional resources:
▪ For more information regarding COVID-19 billing, refer to the Centers for Medicare & Medicaid Services:
COVID-19 (www.cms.gov/covidvax-provider).
▪ Find vaccine administration codes from CDC at Data Code Sets (www.cdc.gov/vaccines/programs/iis/code-
sets.html).
Minnesota Department of Health
625 Robert Street North, PO Box 64975
St. Paul, MN 55164-0975
651-201-5000 | health.mn.gov
03/22/2024
To obtain this information in a different format contact health.communications@state.mn.us.

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