What to know
An accurate temperature history that reflects actual vaccine temperatures is critical for ensuring vaccine quality and potency. Routine temperature monitoring helps verify proper storage conditions and identify any shifts in temperature trends that may require corrective action.
Vaccine Temperature Monitoring
Regular temperature checks also provide an opportunity to inspect the storage unit, reorganize misplaced vaccines, and remove expired vaccines.
☑ 🖍 At the start of each workday, check and record minimum and maximum temperatures.
If the TMD does not read minimum/maximum temperatures, check and record the current temperature a minimum of two times per workday (at the start and end of the workday).
If a reading is missed, leave a blank entry in the log.
Record:
- Minimum/maximum temperature
- Date
- Time
- Name of person who checked and recorded the temperature
- Any actions taken if a temperature excursion occurred
Some TMDs require resetting minimum/maximum temperatures to start tracking new readings for the next temperature check. Always follow the manufacturer's instructions for proper use.
☑ 🖍 Keep temperature logs for 3 years to track trends and recurring issues.
VFC providers and others who administer vaccines purchased with public funds should contact their immunization program for state-specific requirements related to record keeping.
Temperature Excursions
Temperature excursions or inappropriate storage conditions for any immunization product require immediate action. Any temperature reading outside the recommended range in the manufacturer's package insert or EUA factsheet is a temperature excursion. In general, manufacturers analyze information about the magnitude of the temperature excursion and the total amount of time that temperatures were out of range, as well as information about the vaccine in question, to determine whether a vaccine is likely to still be viable.
Vaccine Administration and Temperature Excursions
- Vaccines stored at inappropriate temperatures should not be administered unless the manufacturer provides guidance that vaccine safety and effectiveness have not been compromised. For guidance regarding whether the exposed vaccines remain viable, contact the vaccine manufacturer or the immunization program at the state or local health department.
- If vaccines exposed to inappropriate temperatures are inadvertently administered, the doses generally need to be repeated. For guidance on timing and spacing of revaccination, contact CDC at nipinfo@cdc.gov.
☑ 🖍 Perform the following steps in the event of a temperature excursion:
Any staff member who hears an alarm or notices a temperature excursion on the TMD should immediately notify the primary or backup vaccine coordinator, or report the problem to their supervisor.
Label exposed vaccines "DO NOT USE—TEMPERATURE EXCURSION" and move them to the correct storage conditions. Place them in a separate container apart from other vaccines in the unit. Do not discard these vaccines.
The vaccine coordinator or other appropriate staff person should begin to document information about the event:
- Date and time of the temperature excursion
- Storage unit temperature as well as room temperature, if available (including minimum/ maximum temperatures during the time of the event, if available)
- Name of the person completing the report
- Description of the event:
- The length of time vaccine may have been affected, if using a DDL
- Inventory of affected vaccines, including lot numbers and whether purchased with public (e.g., VFC) or private funds
- List of items in the unit other than vaccines, including water bottles in the refrigerator and/or frozen cooler packs in the freezer
- Any problems with the storage unit or affected vaccines before the event
- Other relevant information, such as a cracked door seal in the affected unit, or extreme room temperature fluctuations in the storage unit area
Implement the facility SOPs to adjust unit temperature to the appropriate range. At a minimum, check the TMD to make sure it is appropriately placed in the center of the vaccines.
Contact the state or local health department's immunization program or the vaccine manufacturers per SOPs to determine if it is safe and effective to use the impacted vaccines. Be prepared to provide documentation of the event (e.g., temperature log data) for the best guidance.
Complete documentation of the event, including
- Action taken
- What happened to the affected vaccine, and how long it took to act
- Who was contacted, and what instructions were received
- What prevention measures were implemented to avoid a similar event
- Results
- Final disposition of affected vaccines (e.g., shortened expiration date per manufacturer, discarded, or returned)
CDC's Vaccine Storage Troubleshooting Worksheet, located in the toolkit's Resources section, can be used to document these steps.
VFC Reminder
VFC providers and others who administer vaccines purchased with public funds should contact their immunization program for state-specific requirements related to vaccine temperature monitoring.