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The US Health and Human Services VAERS FAQ for COVID-19 says (emphasis in original):

What adverse events should healthcare providers report to VAERS after COVID-19 vaccination?

[...] Healthcare providers who administer COVID-19 vaccines are required by law to report to VAERS the following after vaccination:

[...]

  • Serious AEs regardless of causality. Serious AEs per FDA are defined as:

    • Death

    • [...]

I want to understand this legal requirement to report deaths. In particular, is there an associated time limit after vaccination?

For example, if someone receives a vaccine dose and then dies non-violently the next day, and their healthcare provider is aware of both facts, I believe the provider is required by this law (which law?) to report it to VAERS. But what if they die non-violently six months later? What about six years? (I'm excluding violent deaths on the assumption they are clearly not related to vaccination, and hence exempt from this requirement.)

That page has a blurb about time periods and a link to a table:

What are healthcare providers required to report to VAERS?

Healthcare providers are required by law to report to VAERS:

The linked document mentions numerous vaccines and toxoids, but COVID-19 vaccines are not listed. The seemingly closest is "Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children" (which is not true of COVID-19 vaccines, but I assume will be at some point), which says "[...] C. Any acute complication or sequelae (including death) of above events (interval - not applicable) [...]". This seems to say there is no applicable limit in that case, but surely there's some other requirement like a suspicion of a connection to the vaccine, right? Otherwise every non-violent death of someone who was vaccinated as a child would require a VAERS report. And anyway I'm interested in the COVID-19 vaccines.

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The VAERS guideline has this:

What are healthcare providers required to report to VAERS?

Healthcare providers are required by law to report to VAERS:

Healthcare providers are strongly encouraged to report:

  • Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
  • Vaccine administration errors

Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.

The link to that table is:

https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf

...and in that table, the days required are listed individually by vaccine. The default is seven (7) days, and in no case does the table indicate a reporting time greater than forty-two (42) days. Because the COVID vaccines are not expressly listed, one would assume that the legal reporting requirement was seven days, the default as listed for the final entry in the table.

Vaccine/Toxoid Event and interval** from vaccination
Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children A. Shoulder Injury Related to Vaccine Administration (7 days)
B. Vasovagal syncope (7 days)
C. Any acute complication or sequelae (including death) of above events (interval - not applicable)
D. Events described in manufacturer’s package insert

NOTE: VAERS reporting for the COVID-19 vaccine is NOT required in certain circumstances, as quoted below.

VAERS reporting is not required for the following situations:

  • If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
  • Mixing and matching of booster doses (as of October 21, 2021, mixing and matching of booster doses is allowed)

Full details HERE.


More information regarding the vaccine guidelines can be found via the information packaged with it. This may be difficult to find online, but the following site seems to have some of it.

https://vaxopedia.org/2020/12/09/where-are-the-covid-19-package-inserts/

More information, on a per-vaccine/vaccine maker basis, can be found via the FDA information, such as the following:

Moderna https://www.fda.gov/media/144637/download

Janssen https://www.fda.gov/media/146304/download

Comirnaty and Pfizer-BioNTech (US formulation) https://www.fda.gov/media/153713/download

Comirnaty and Pfizer-BioNTech (alternative, non-US formulation) https://www.fda.gov/media/153715/download

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    Those are the resources I linked and quoted in my question. You're saying you think they mean the limit is 7 days? But the final entry applies "for routine administration to children", and in any case says "interval - not applicable" regarding death. Dec 1 '21 at 6:33
  • @ScottMcPeak That "interval - not applicable" is said to apply to the "above events," which are, namely, shoulder injury and vasovagal syncope (temporary loss of consciousness due to fainting or low blood pressure). In other words, those would be things that would have to occur immediately subsequent to or during the administration of the vaccine, which is why the time interval is inapplicable.
    – Polyhat
    Dec 1 '21 at 6:40
  • Ok, that makes sense regarding N/A. But I still don't see how that table row applies to COVID-19 vaccines, nor to death generally. Dec 1 '21 at 6:56
  • @ScottMcPeak I think, technically, you're right--it doesn't apply because the COVID-19 vaccines are not part of the "routine" for administration to children. But schools do, now, routinely require them for admittance--at least, where I am they do, including elementary schools. So there is some gray area here, and probably their rules need to be updated to clarify it. In any case, it would be hard to make a legal case against a medical professional who failed to report an adverse effect after the standard 7-day reporting period.
    – Polyhat
    Dec 1 '21 at 7:07
  • You say 7 days is "standard". Is that based on the table we have been discussing or on some other source? Dec 1 '21 at 7:36

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