mm7031e1 — Anomalies

Central finding #

Paper (Discussion): “A small number of v-safe participants reported they were hospitalized after vaccination; however, v-safe does not record reason for hospitalization, and it cannot be determined whether hospitalization was related to vaccination.”

This adolescent safety paper’s serious-event story is VAERS myocarditis (hundreds of listings; ACIP risk-benefit) plus 14 VAERS deaths. v-safe is used mainly for reactogenicity and care-seeking rates.

The claim that v-safe “does not record reason for hospitalization” is false as to the data people actually entered. In the same 12–15 cohort, free-text fields and MedDRA codes record reasons including “Diagnosed with myocarditis,” “Hospitalized for myocarditis,” appendectomy, and pancreatitis. The MMWR chose not to use those fields—while telling readers the system cannot speak to why teens were hospitalized.

Cohort: Pfizer doses 14 Dec 2020–16 Jul 2021, age band 12-15, ≥1 day-0–7 check-in (~63,480 dose-1 / ~38,987 dose-2). Table 3 rates match; the gaps are reasons, coding, myocarditis/chest-pain silence, and an omitted v-safe Death. Full write-up: vsafe-analysis/mmwr/mm7031e1/anomalies_report.md.

A. “v-safe does not record reason for hospitalization” — contradicted #

Paper (Discussion): “…v-safe does not record reason for hospitalization, and it cannot be determined whether hospitalization was related to vaccination.”

When a parent checks Hospitalization and types a reason (or when MedDRA codes that reason), v-safe has recorded a reason. Free text in this cohort includes “Hospitalized for myocarditis,” “Diagnosed with myocarditis,” inpatient pancreatitis, and emergency appendectomy.

Why this matters: In a paper whose SAE focus is myocarditis, telling the public that v-safe cannot record hospitalization reasons—while free text says “Diagnosed with myocarditis”—is a misrepresentation of the surveillance system, not a true technical limit. It keeps v-safe silent exactly where VAERS is loud.

Tables below: all day-0–7 hospitalization responses (ages 12–15), and free-text rows that mention myocarditis / pericarditis.

Myocarditis / pericarditis free text (4 registrants).

B. Hospitalization checkboxes heavily under-coded #

Paper (Methods): “Enrollees who report seeking medical care are contacted by CDC’s v-safe call center…”

Day-0–7 hospitalization responses (ages 12–15): 36 responses / 26 registrants. Only 5 (~14%) carry MedDRA Hospitalisation; 14 (~39%) have no MedDRA codes at all. Roughly six in seven hospitalization-flagged responses lack the standard hospitalisation preferred term.

Among these 26 hospitalization reporters, call-center / GDIT outcomes are roughly Successful 6 vs Unsuccessful 20—majority not Successful, next to Methods language that medical-attention reports prompt follow-up.

Same hospitalization grid as above (filter on Hosp PT = N to see under-coded rows).

C. Emergency visits under-coded #

ER checkbox responses (12–15): 155. Only 26 (~17%) carry an emergency-care– or hospitalisation-like MedDRA term; 49 (~32%) have no MedDRA row at all.

Sample of ER responses without an ER-like preferred term.

D. Myocarditis / chest pain in v-safe — unpublished next to VAERS #

Paper (Results): “Myocarditis was listed among 4.3% (397) of all VAERS reports.”

The public SAE narrative is VAERS myocarditis. v-safe Results never publish myocarditis or chest-pain MedDRA counts for adolescents. In the 12–15 coding window: 334 Chest pain, 6 Myocarditis, 1 Pericarditis, 1 Troponin increased.

Free text mentioning myocarditis/pericarditis: 4 registrants; 3 receive a myocarditis/pericarditis PT. Missed coding example: T6B-24019-82630 — “Random Chest pains (pericarditis like)” → Chest pain only (no Pericarditis).

Why this matters: Omitting these codes (and 334 Chest pain) while claiming v-safe cannot speak to hospitalization reason—when free text says “Diagnosed with myocarditis”—is a clear reporting gap.

Myocarditis / pericarditis MedDRA rows.

Chest pain MedDRA sample (up to 250 registrants).

E. Anaphylaxis in v-safe (unpublished) #

6 registrants coded Anaphylactic reaction and 1 Anaphylaxis treatment in the 12–15 window—not discussed (paper’s SAE focus is VAERS myocarditis/death).

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

Paper (Results): “CDC reviewed 14 reports of death after vaccination…”

Under inclusion (Pfizer, window, age 12–15, day-0–7 cohort), MedDRA through 15 August 2021 shows 1 registrant coded Death: 8LN-82934-37637 (free text “Death”). No Successful GDIT closeout in the follow-up extract. The paper never states that any death was reported through v-safe.

Caveats: MedDRA is not a death certificate; free text is a single word; causality unknown. Still, a Death-coded v-safe report exists inside the paper’s age/vaccine/date inclusion and is omitted while 14 VAERS adolescent deaths are reviewed at length.

Summary #

• Misrepresentation: claim that v-safe does not record reason for hospitalization — free text/MedDRA include myocarditis, appendectomy, pancreatitis
• Major omission: 1 v-safe registrant (12–15) coded MedDRA Death under inclusion — never mentioned (only 14 VAERS deaths)
• Coding failure: only ~14% of Hospitalization responses get PT Hospitalisation; ~39% have no MedDRA
• Coding failure: ER→emergency-like PT on only ~17% of ER responses; “pericarditis like” free text → Chest pain only
• Reporting gap: 6 Myocarditis + 334 Chest pain (12–15) unpublished next to VAERS myocarditis deep-dive
• Anomaly: GDIT Successful 6 vs Unsuccessful 20 among 12–15 hospitalization reporters
• OK: Table 3 12–15 care-seeking / reactogenicity rates match the v-safe dataset

Bottom line: Compared to the v-safe dataset, adolescent care-seeking rates check out—but the MMWR tells readers v-safe cannot record why teens were hospitalized even when parents typed “myocarditis,” leaves chest-pain/myocarditis codes unpublished beside a VAERS myocarditis story, under-codes hospitalisations, and omits an in-cohort Death-coded v-safe registrant while reviewing 14 VAERS deaths in full.