← MMWR reports

mm7039e4 — Anomalies

Compared to the v-safe dataset: additional-dose serious events, “no reasons” claim, deaths, and MedDRA gaps. Hause AM et al., MMWR 2021;70(39):1379–1384.

DOI: https://doi.org/10.15585/mmwr.mm7039e4

Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12–September 19, 2021

Central finding #

Paper (Results): “Medical care was sought by 401 (1.8%) registrants, and thirteen (0.1%) were hospitalized. Reasons for receiving medical care or hospitalization were not identified in the v-safe survey; however, registrants who indicate that medical attention was sought after vaccination are contacted by VAERS staff and encouraged to complete a VAERS report.”
Paper (closing): voluntary v-safe reports found “no unexpected patterns of adverse reactions after an additional dose”; “most of these adverse reactions were mild or moderate.”

This additional-dose safety brief publishes checkbox rates for medical care and hospitalization, then tells readers that v-safe surveys do not identify why people sought care. That claim is false as to the data people actually entered. In the same cohort, free-text fields and MedDRA codes record diagnoses and narratives—including myocarditis/pericarditis, blood clots, inpatient admissions, and death.

The serious-event story stops at “1.8% / 0.1%” while coded and free-text seriousness is left unused—under a headline that nothing unexpected appeared.

Cohort: additional dose 12 Aug–19 Sep 2021 with ≥1 day-0–7 check-in after mRNA primary (dose 3) or Janssen primary (dose 2, no dose 3)—about 25,237 people (paper 22,191; later freeze). Care-seeking rates match; the gaps are reasons, coding, cardiac/clot silence, and omitted deaths. Full write-up: vsafe-analysis/mmwr/mm7039e4/anomalies_report.md.

A. “Reasons … were not identified” — contradicted #

Paper (Results): “Reasons for receiving medical care or hospitalization were not identified in the v-safe survey…”

When a registrant checks Hospitalization or medical care and types a reason—or when MedDRA codes that reason—v-safe has recorded a reason. Free text and codes in this cohort include “suspected myocarditis,” “pericarditis diagnosis,” blood-clot narratives, “Hospitalized NOW,” and death/clot language.

Why this matters: A paper that concludes there were “no unexpected patterns” after an additional dose simultaneously tells the public that v-safe cannot speak to why people were hospitalized—while enrollees typed myocarditis, clots, and death into the same system. That is a misrepresentation of surveillance capability, not a true empty field.

All day-0–7 hospitalization responses in the reconstructed cohort.

Free-text rows mentioning myocarditis, pericarditis, clots, death, or admission language.

B. Hospitalization checkboxes heavily under-coded #

Paper (Methods): registrants who report medical attention “are contacted by VAERS staff…”

Day-0–7 hospitalization responses: 18 / 14 registrants. Only 5 (~28%) carry MedDRA Hospitalisation; 4 (~22%) have no MedDRA at all. Roughly seven in ten hospitalization-flagged responses lack the standard hospitalisation preferred term—even when free text describes admission from the ER, myocarditis/pericarditis, heart-failure workups, or surgery.

Call-center / GDIT outcomes among hospitalization reporters are roughly Successful 7 vs Unsuccessful 7—half not Successful.

Same hospitalization grid as above (filter on Hosp PT = N).

C. Emergency visits under-coded #

ER checkbox responses: 75 (62 registrants). Only 13 (~17%) carry an emergency-care– or hospitalisation-like MedDRA term; 30 (~40%) have no MedDRA row at all.

ER responses without an ER-like preferred term.

D. Cardiac / clotting signals unpublished #

Paper: “no unexpected patterns… most… mild or moderate.”

v-safe Results never publish myocarditis, pericarditis, thrombosis, or chest-pain MedDRA counts for this window. In the coding window for this cohort: 148 Chest pain, 6 Thrombosis, 3 Myocarditis, 3 Pericarditis, plus intensive-care and anaphylaxis codes. Weak dumps are large too (461 Unevaluable event; 1,019 No adverse event)—including clot-like free text coded only as Unevaluable.

Why this matters: These are not chart-confirmed diagnoses, but they are in-window coded signals the Results never mention beyond care checkboxes, while the abstract reassures readers that reactions were mild or moderate.

Myocarditis / pericarditis MedDRA.

Thrombosis-class MedDRA.

Chest pain MedDRA (up to 250 / all 148).

Serious free text coded Unevaluable (sample).

E. Deaths reported in v-safe — never mentioned #

Paper: Does not discuss deaths at all. Safety conclusion is reactogenicity-only (“no unexpected patterns”).

Under inclusion, MedDRA through 31 October 2021 shows 3 registrants coded Death, including first-person clot/death free text (X2G-31533-65804), a CMML-related death narrative (NR2-32968-17075), and a son reporting his mother’s death on the account (ESC-28107-36307).

Caveats: MedDRA is not a death certificate; causality is unknown; one row is clearly a relative’s death. Even so, Death-coded reports sit inside the paper’s inclusion window and are omitted while the MMWR concludes nothing unexpected appeared.

F. Call-center follow-up vs paper wording #

Paper: registrants who indicate medical attention “are contacted by VAERS staff and encouraged to complete a VAERS report.”

Among people who checked needed medical care (~453), call-center / GDIT outcomes are roughly Successful 150 vs Unsuccessful 277—Unsuccessful exceeds Successful. The Methods sentence sounds like a functioning safety net; for a large share of medical-care reporters, follow-up did not land as Successful.

Summary #

Bottom line: Compared to the v-safe dataset, additional-dose checkbox rates verify—but the MMWR tells readers v-safe cannot record why people sought care even when they typed myocarditis, clots, and death; leaves cardiac and clotting codes unpublished beside a “mild or moderate / no unexpected patterns” conclusion; under-codes hospitalisations; and omits three in-cohort Death-coded registrants entirely.