Compared to the v-safe dataset: second-booster serious events in adults ≥50, omitted deaths, cardiac/clot codes, and hospital under-coding. Hause AM et al., MMWR 2022;71(30):971–976.

DOI: https://doi.org/10.15585/mmwr.mm7130a4

Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29–July 10, 2022

Central finding #

Paper (Results): “Hospitalization was reported by 81 (0.03%) registrants; 39 (48.1%) indicated that the hospitalization was unrelated to vaccination, 28 (34.6%) were unreachable or unwilling to provide additional information, and 14 (17.3%) completed a VAERS report.”
Paper (Summary): “serious adverse events are uncommon.”

v-safe Results publish checkbox rates and a three-way disposition of the 81 hospitalizations—then stop. Compared to the v-safe dataset for the same second-booster cohort, that leaves out Death-coded free text and MedDRA (23 Death; 31 including cardiac arrest), 662 Chest pain codes, dozens of MI/stroke/PE/thrombosis codes, and the fact that most hospitalization checkboxes never receive the standard Hospitalisation preferred term.

The public message is “serious events are uncommon”; the active-surveillance extract still contains the serious narratives.

Cohort: second mRNA booster 29 Mar–10 Jul 2022, ≥120 days after prior booster, age ≥50 bands, mRNA for all doses— about 308,324 people (paper 286,380). Care-seeking rates match. Full write-up: vsafe-analysis/mmwr/mm7130a4/anomalies_report.md.

A. Hospitalizations under-coded #

Paper (Results): 81 hospitalizations with unrelated / unreachable / VAERS dispositions.

Day-0–7 hospitalization responses: 119 / 92 registrants (paper 81). Only 26 (~22%) carry MedDRA Hospitalisation; 28 (~24%) have no MedDRA at all. Roughly four in five hospitalization-flagged responses lack the standard hospitalisation preferred term—even when free text describes clots, cardiac events, or inpatient care.

Call-center / GDIT among these reporters: roughly Successful 51 vs Unsuccessful 39.

B. Emergency visits under-coded #

ER checkbox responses: 316 (290 registrants). Only 66 (~21%) carry an emergency-care– or hospitalisation-like MedDRA term; 77 (~24%) have no MedDRA row at all.

Sample of under-coded ER responses (250).

C. Cardiac / clot / chest pain — unpublished under “serious AEs are uncommon” #

Paper: “serious adverse events are uncommon.” Myocarditis appears as a VAERS case-finding exercise.

In this cohort’s coding window: 662 Chest pain, 74 Myocardial infarction, 76 Cerebrovascular accident, 49 Pulmonary embolism, 77 Thrombosis, 13 Pericarditis, 5 Myocarditis—none published in v-safe Results.

Why this matters: For adults ≥50 receiving a second booster, the MMWR reassures readers that serious events are uncommon while leaving hundreds of chest-pain codes and dozens of MI/stroke/PE codes off the page— next to a VAERS death and myocarditis narrative.

Myocarditis / pericarditis MedDRA.

MI / PE / CVA / thrombosis MedDRA sample (250).

Chest pain MedDRA sample (250 of 662).

Serious free text coded Unevaluable.

D. Deaths reported in v-safe — omitted while VAERS deaths are reviewed #

Paper (VAERS): among serious reports, clinical impressions include Death (52; 11.8% of serious).

Under inclusion, MedDRA through 15 August 2022 shows 23 registrants coded Death and 10 Cardiac arrest (31 in the death/arrest union)—including PE/cardiac-arrest free text, “respiratory failure deceased,” and spouse “passed away” narratives. The paper never states that any death was reported through v-safe.

Caveats: MedDRA is not a death certificate; many entries are proxy notes; some cite cancer, trauma, or later dates. Even so, dozens of Death-coded reports sit inside the inclusion window and are omitted while 52 VAERS deaths are reviewed.

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

Paper: of 81 hospitalizations, 28 (34.6%) were unreachable or unwilling; Methods say medical-care reporters “are contacted.”

For hospitalization reporters in this reconstruction, GDIT Unsuccessful (39) is substantial next to Successful (51). The paper itself acknowledges a large unreachable share—yet still closes with “serious adverse events are uncommon” without publishing the Death-coded and cardiac-coded v-safe content above.

Summary #

Bottom line: Compared to the v-safe dataset, second-booster checkbox rates for adults ≥50 verify—but the MMWR tells readers serious events are uncommon while leaving Death-coded v-safe reports unpublished beside a VAERS death review, burying hundreds of chest-pain and dozens of MI/stroke/PE codes, and under-coding most hospitalization checkboxes.