← MMWR reports

mm7133a3 — Anomalies

Compared to the v-safe dataset: Pfizer boosters ages 5–11 — the “no hospitalizations” claim, chest pain, and under-coding. Hause AM et al., MMWR 2022;71(33):1047–1050.

DOI: https://doi.org/10.15585/mmwr.mm7133a3

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022

Central finding #

Paper (Results): “No children received care at a hospital after third dose vaccination.”
Paper (VAERS): “Three (0.5%) reports were considered serious; no reports of myocarditis or death were received.” “Reports of serious adverse events were rare.”

The MMWR’s safety pitch for 5–11 boosters is reactogenicity plus an essentially empty serious-event cupboard: zero v-safe hospitalizations, zero VAERS myocarditis, zero VAERS deaths.

Compared to the v-safe dataset under the same inclusion rules, that absolute hospitalization claim does not hold: at least one registrant checked Hospitalization (with ER) the day after dose 3, was coded for chest pain / dyspnea / tachycardia, and call-center follow-up closed as Unsuccessful—with no Hospitalisation preferred term. Separately, 13 children have Chest pain MedDRA, never mentioned next to the “no myocarditis” reassurance.

Cohort: homologous Pfizer dose 3, 17 May–31 Jul 2022, ≥150 days after dose 2, age 05-11— about 5,455 (paper 3,249; later freeze). Rates roughly match. Full write-up: vsafe-analysis/mmwr/mm7133a3/anomalies_report.md.

A. “No children received care at a hospital” — contradicted #

Paper (Results / Table 2): Hospitalization after dose 3 = 0.

Under reconstruction, registrant DQ6-14633-25689 (dose 3 on 29 Jun 2022; 191 days after dose 2) checked ER + Hospitalization on day 1. MedDRA: Chest pain; Dyspnoea; Heart rate increased— no Hospitalisation PT. GDIT: Unsuccessful.

Why this matters: An absolute “none” claim is easy for parents and clinicians to remember. Even a single in-cohort hospitalization with cardiac-symptom coding—and failed call-center closeout—breaks that claim.

B. Emergency visits in week 1 #

ER checkbox responses (day 0–7): 4 (3 registrants). One is the hospitalization case above. Others include COVID-related ER care and neck-pain coding.

C. Chest pain unpublished next to “no myocarditis” #

Paper: VAERS received no myocarditis reports; serious AEs rare.

In the coding window: 13 Chest pain. Free text includes heart palpitations with chest pain, a minute-long seizure, and “heart inflammation” after COVID (Carditis). A later Hospitalisation PT (sepsis admission ~day 42) also sits in-cohort but outside the week-1 checkbox count.

Why this matters: Leaving these codes off the v-safe Results page understates what active surveillance recorded next to an absolute “no hospital / no myocarditis” message.

Chest pain MedDRA (all 13).

Serious free-text narratives.

Hospitalisation MedDRA in coding window.

D. Deaths in v-safe — none under inclusion #

Paper (VAERS): no reports of death were received.

This reconstruction shows no MedDRA Death or Cardiac arrest codes through 31 August 2022. That aligns with the paper’s VAERS “no death” statement as far as v-safe coding goes. The gaps are the hospitalization contradiction and chest-pain silence—not a hidden death tally.

E. Call-center follow-up #

Paper (Methods): “CDC’s v-safe call center contacts parents who indicate that medical care was sought…”

Among ~65 medical-care reporters, GDIT outcomes are roughly Successful 44 / Unsuccessful 21. The sole week-1 hospitalization reporter is Unsuccessful—so the child who contradicts the “no hospital” claim was not successfully closed out in the follow-up extract.

Summary #

Bottom line: Compared to the v-safe dataset, this 5–11 Pfizer booster brief gets reactogenicity roughly right—but its claim that no child was hospitalized after dose 3 is false under inclusion, and it leaves chest-pain free text unpublished beside a “no myocarditis / serious events rare” message while failing to code or successfully follow up the hospital case it missed.