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Showing content from https://vaers.hhs.gov/reportevent.html below:

The vaccination provider must report all serious* adverse events following administration of JYNNEOS or ACAM2000 vaccine and vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html.

The vaccination provider is responsible for mandatory reporting of the following listed events following JYNNEOS or ACAM2000 vaccination to VAERS:

• Vaccine administration errors whether or not associated with an adverse event(AE)
• Serious* adverse events (irrespective of attribution to vaccination)
• Cases of cardiac events, including myocarditis and pericarditis
• Cases of thromboembolic events and neurovascular events

*Serious adverse events 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

Providers are encouraged to also report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.

As of August 9, 2022, FDA issued an Emergency Use Authorization (EUA) for JYNNEOS monkeypox vaccine. It authorizes the vaccine to be administered in one of two ways:

1. Intradermally (between the layers of the skin) on the inner aspect of the forearm, and
2. Subcutaneously (under the skin) in the upper arm above the elbow

These are considered routes of vaccination. When submitting a VAERS report, ensure that you document the Route in Section 17 of the VAERS form, by choosing “intradermal” or “subcutaneous” from the selection menu.

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