1. User's Guide
  2. Transmit and Monitor Reports
  3. Schedule Reports
  4. Follow-up eVAERS Reports

Follow-up eVAERS Reports

If an eVAERS report is manually scheduled or automatically scheduled for the same reporting Destination, system either schedules Initial or Follow-up report based on the same logic (product license type and status of previously scheduled report) that is currently existing for E2B reports.

If the case was previously submitted to a Reporting Destination in VAERS PDF format and if the same reporting destination is configured for sending eVAERS report:

  1. System schedules the next eVAERS as a follow-up report and displays the follow-up numbering in the Case Form ' Regulatory Reports ' Seq field by considering the previously reported VAERS.
  2. If any Follow-up reports are scheduled to the same destination at a later point of time, system schedules a follow-up report by populating Follow-up<##> in Case Form Regulatory Reports Seq column.
  3. System uses Case Number (as printed in the Manufacturer Control Number (that is listed in Box 24) of the previously submitted VAERS report) in data elements C.1.1. and C.1.8.1.

If a reporting destination is configured for eVAERS and VAERS reports and if the previous report was sent in eVAERS format and if the subsequent report is scheduled in VAERS PDF format to the same destination:

  1. System schedules an initial report by populating Initial' in the Case Form Regulatory Reports Seq column.
  2. If any Follow-up reports are scheduled to the same destination at a later point of time, system schedules a follow-up report by populating Follow-up<##> in Case Form Regulatory Reports Seq column.
  3. System does not use (C.1.1) from the previously submitted eVAERS report as the Manufacturer Control Number of VAERS report.

Note:

If user tries to generate eVAERS and VAERS in parallel for a Case, then system has different MCN for eVAERS and VAERS reports for the same case.

Downgrade report is scheduled automatically if the Significant F/UP version does not satisfy the Regulatory Reporting Rules defined for eVAERS for a case was submitted in eVAERS.

System auto-schedules Amendment report instead of a follow-up report for a Reporting Destination configured with eVAERS profile, when:

a. eVAERS report was previously submitted to the same Reporting Destination for the same license type

b. if the latest record in the 'Amendment / Follow-up section' of Case Form ' General is an Amendment and the Amendment record was created for previously submitted eVAERS report

System auto-schedules a Nullification report instead of follow-up report for a Reporting Destination configured with eVAERS, under the same conditions ( Case deletion and manually scheduling Nullification from Reports Compliance Submitted Reports Schedule Nullification) as per current functionality on Nullification reports for E2B profiles.

When Nullification report is generated, following data element items have updated values from the previous report.

  • N.1.2 batchmessagenumb
  • N.1.5 batchmessagedate
  • N.2.r.4 messagecreationdate
  • C.1.2 transmissiondater3
  • C.1.11.1 casenullification
  • C.1.11.2 nullificationreason

Parent topic: Schedule Reports