Becoming a COVID-19 Vaccine Provider
Part 4: COVID-19 Vaccine Reporting Requirements
Helpful topics to consider when you are reviewing the COVID-19 vaccine reporting requirements.
In this section you will find:
Within 24 hours of administering a dose of COVID-19 vaccine:
- Report in NMSIIS (New Mexico Statewide Immunization Information System)
- Data can be reported to NMSIIS via Data Exchange, manual entry, or the NM Registration App
- NMSIIS Help Desk 833-882-6454
Vaccine Finder Reporting: Inventory Reporting
COVID-19 Providers are required to report inventory DAILY in VaccineFinder
- Each provider has to log into the Vaccine Provider website: https://covid.locating.health/login
- Need to enter daily report on aggregate doses on hand for each COVID-19 Vaccine
Any temperature reading outside the manufacturer’s recommended range is considered a temperature excursion and requires IMMEDIATE action by site staff.
1.Any staff who hears an alarm or becomes aware of a temperature excursion must IMMEDIATELY initiate the COVID-19 Troubleshooting process, following the steps on page one of the COVID-19 Vaccine Troubleshooting Record (TSR) – this form is accessible on NMSIIS Reports.
2.Quarantine and label exposed vaccines “DO NOT USE” (do not discard these vaccines) and begin the process of contacting manufacturers for viability determination.
Pfizer: 800-438-1985 or www.PfizerMedInfo.com
Adverse Event Reporting: VAERS
All adverse events or reactions must be reported in the Vaccine Adverse Events Reporting System (VAERS): https://vaers.hhs.gov/
Healthcare providers are required to report to VAERS the following adverse events after COVID-19 vaccination [under Emergency Use Authorization (EUA)], and other adverse events if later revised by CDC:
- Vaccine administration errors, whether or not associated with an adverse event (AE)
- Serious AEs regardless of causality. Serious AEs per FDA are defined as: Death; A life-threatening AE; Inpatient hospitalization or prolongation of existing hospitalization; A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; A congenital anomaly/birth defect; An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
- Cases of Multisystem Inflammatory Syndrome
- Cases of COVID-19 that result in hospitalization or death
Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.
Also report any additional select AEs and/or any revised safety reporting requirements per FDA’s conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 vaccine being authorized under an Emergency Use Authorization (EUA).