Adverse Event¶

Use adverse-event commands for safety surveillance across four source-backed paths:

OpenFDA FAERS drug adverse-event reports,
CDC WONDER VAERS aggregate vaccine adverse-event summaries,
recall notices,
device events.

Vaccine searches default to combined OpenFDA FAERS + CDC VAERS when the query resolves to a vaccine and the active filters are VAERS-compatible. Non-vaccine searches stay FAERS-only in practice. --source vaers is aggregate-only, accepts only the vaccine query and --limit, and rejects --reaction, --outcome, --serious, --date-from, --date-to, --suspect-only, --sex, --age-min, --age-max, --reporter, --count, --offset, recall classification, and device fields.

Search FAERS reports¶

By drug:

biomcp search adverse-event --drug pembrolizumab --limit 5

Serious reports only:

biomcp search adverse-event --drug pembrolizumab --serious --limit 5

Reaction-focused filter:

biomcp search adverse-event --drug pembrolizumab --reaction pneumonitis --limit 5

The reaction summary labels each percentage as a share of returned reports: the numerator is the number of returned-page FAERS reports containing that reaction and the denominator is the number of reports on that returned page. The page is only a sample of all matching reports. These spontaneous-report shares are not incidence in treated or exposed patients and do not establish causality.

biomcp drug adverse-events <name> instead uses an aggregate OpenFDA count and labels the percentage as a share of matching reports. Its denominator is all matching FAERS reports. JSON identifies these meanings in summary.percentage_context, including the exact divisor and explicit false values for incidence and causality.

FAERS counts are FAERS-only and therefore require --source faers; count operations require offset zero:

biomcp search adverse-event --drug pembrolizumab --source faers --count reaction --limit 10

For --count, Percent of Shown Count divides each bucket by the sum of the shown bucket counts. That sum is not a count of distinct reports because one report can contribute to multiple buckets. Count-mode JSON remains the raw bucket contract and does not contain calculated percentages or percentage_context.

Search vaccine events with VAERS¶

Combined FAERS + VAERS for vaccine queries:

biomcp search adverse-event "COVID-19 vaccine" --source all --limit 5

VAERS-only aggregate summary:

biomcp search adverse-event "MMR vaccine" --source vaers --limit 5

VAERS summaries are aggregate-only. They surface the matched vaccine display name, CDC WONDER code, CVX code(s) when the query resolves through the CDC CVX/MVX bridge, serious vs non-serious counts, age distribution, and top reaction counts. --limit bounds the number of top reaction rows.

--source only applies to --type faers; recall and device searches keep their existing source-specific paths.

Search recall notices¶

biomcp search adverse-event --type recall --drug metformin --limit 5

Classification filter:

biomcp search adverse-event --type recall --drug metformin --classification "Class I" --limit 5

Search device events (MAUDE)¶

biomcp search adverse-event --type device --device "insulin pump" --limit 5

Manufacturer filter:

biomcp search adverse-event --type device --manufacturer Medtronic --limit 5

Product-code filter:

biomcp search adverse-event --type device --product-code PQP --limit 5

--manufacturer and --product-code are valid only with --type device.

Device seriousness is typed: bare --serious and --serious any select Death or Injury and render as death_or_injury, --serious death selects Death only, and --serious injury selects Injury only. FAERS seriousness values such as hospitalization are rejected on the device route.

Get a report by ID¶

biomcp get adverse-event 10222779

Report resolution is source-aware and returns the corresponding markdown format.

Request report sections¶

Section	Description
`reactions`	Adverse reactions reported
`outcomes`	Reaction outcomes (death, hospitalization, etc.)
`concomitant`	Concomitant medications
`guidance`	Safety guidance and labeling
`all`	Include all sections

biomcp get adverse-event 10222779 reactions outcomes
biomcp get adverse-event 10222779 all

Helper commands¶

There is no direct adverse-event <helper> family. Use biomcp drug adverse-events <name> when you want the inbound drug pivot into this safety surface.

JSON mode¶

biomcp --json get adverse-event 10222779

Combined-source outcomes¶

JSON from search adverse-event <query> --source all includes independent section_outcomes.faers and .vaers entries while preserving vaers.status. One branch can be unavailable without erasing a healthy result from the other; empty means that source completed successfully with no matching evidence. A successful VAERS branch credits both CDC CVX identity resolution and CDC VAERS evidence. When --source all includes FAERS-only filters or a nonzero offset, vaers.status explains the skip and its section outcome remains not_requested because no VAERS fetch ran. Device-search JSON includes the effective query summary, including the selected seriousness meaning.

Practical tips¶

Include drug generic names for better FAERS recall.
Use plain vaccine names, family names, or common brand names when you want the VAERS path.
Treat FAERS rows and VAERS aggregate counts as signal, not incidence estimates.
Validate serious findings through full source documents when needed.