What the pattern is #
v-safe check-ins let families mark Emergency room or emergency department visit. Coders may
attach symptom preferred terms and—when the setting is coded—an emergency-care-style term such as
Emergency care. The recurring failure: the ER checkbox is checked, but the
response has no emergency-care-style preferred term (sometimes no MedDRA at all).
Why missing ER-related PT_NAME matters #
1. ER checkboxes are the urgent-care signal in v-safe
If that signal exists only as a survey flag and never as a preferred term, PT-centric reviews undercount urgent care.
2. Symptom PTs without an ER-setting PT look less severe than the checkbox
Chest pain; Costochondritis or Syncope without Emergency care can be skimmed as outpatient coding while the checkbox said ED.
3. Empty MedDRA on an ER checkbox is worse than soft coding
Some ER-checkbox responses have no preferred terms at all—nothing for a MedDRA search to find.
4. “Serious adverse events are rare” sits next to uncoded urgent visits
Reassurance next to incomplete coded evidence of emergency evaluation.
5. Same registrant can show hospital + ER under-coding together
Example: LH6-45059-75313 in mm7109e2 (appendectomy pathway).
Lead example: adolescent booster ER rows (mm7109e2) #
In the reconstructed 12–15 booster cohort for mm7109e2, there are 14
day-0–7 ER/ED check-ins; only one received Emergency care
(FY8-11778-30167). The juxtaposed block for mm7109e2 below lists the under-coded rows next to
the paper’s Table 1 / Results language.
Cross-paper counts #
| Paper | Title | Distinct registrants | Response rows | With any MedDRA PT | With free text |
|---|---|---|---|---|---|
| mm7008e3 | First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021 | 200 | 200 | 200 | 200 |
| mm7018e2 | Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021 | 66 | 66 | 66 | 66 |
| mm7031e1 | COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021 | 121 | 121 | 75 | 9 |
| mm7039e4 | Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12–September 19, 2021 | 50 | 62 | 32 | 4 |
| mm705152a1 | COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021 | 54 | 54 | 34 | 4 |
| mm7107e1 | Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021–February 6, 2022 | 289 | 300 | 231 | 126 |
| mm7109e2 | Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years — United States, December 9, 2021–February 20, 2022 | 13 | 13 | 10 | 2 |
| mm7128a3 | Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years With Presumed Immunocompromise Status — United States, January 12–March 28, 2022 | 12 | 13 | 11 | 1 |
| mm7130a4 | Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29–July 10, 2022 | 231 | 250 | 173 | 51 |
| mm7133a3 | Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022 | 2 | 3 | 3 | 0 |
| mm7135a3 | COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18–August 21, 2022 | 26 | 27 | 15 | 4 |
| mm7202a5 | Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5–11 Years — United States, October 12–January 1, 2023 | 4 | 4 | 2 | 1 |
| mm7223a2 | Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023 | 6 | 7 | 3 | 1 |
Total under-coded ER response rows: 1120 (of 1134 ER rows examined).
Paper quotes ↔ registrant examples #
Left: MMWR verbatim. Right: under-coded ER registrant examples. Use Show more / Show less when one column is much taller than the other.
mm7109e2 — Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years — United States, December 9, 2021–February 20, 2022 #
Anomaly report: mm7109e2. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “One (0.03%) adolescent received care at a hospital during the week after booster dose vaccination for treatment of a new onset migraine; whether hospitalization was the result of vaccination could not be determined.” Paper (Table 1): lists a small number of emergency visits after the booster among adolescents. Paper (Results): “Sixty-four preliminary reports of myocarditis were received, among which 47 were considered serious; 32 (68.1%) of these reports were confirmed… All 32 reports were among adolescent boys…” Paper (Results): “No deaths were reported to VAERS.” |
|
mm705152a1 — COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021 #
Anomaly report: mm705152a1. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “Approximately 1% of parents reported seeking medical care in the week after vaccination… Fourteen (0.02%) children reportedly received care at a hospital; information regarding reason for hospitalization was available for five children… Parents and guardians of all hospitalized children were contacted; two parents completed VAERS reports, and one revealed hospitalization was reported in error.” Paper (VAERS): 100 serious reports including troponin increased (15), chest pain (12), and 15 preliminary myocarditis reports (11 meeting CDC case definition); two deaths under review with “no evidence… suggested a causal association.” Paper (Discussion / Summary cues): Findings similar to trials; local/systemic reactions mostly mild–moderate; counseling tone that vaccine is safe for this age group. Paper (Results): Fourteen hospital reports; reasons for five (appendicitis ×2, vomiting/dehydration, respiratory infection, retropharyngeal cellulitis); all parents contacted; two VAERS; one hospitalization “reported in error.” |
|
mm7031e1 — COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021 #
Anomaly report: mm7031e1. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
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.” Paper (Results): Myocarditis appears among serious VAERS findings; “Myocarditis was listed among 4.3% (397) of all VAERS reports.” Table 2 lists myocarditis as 40.3% of serious reports (n = 863)—a figure that does not reconcile cleanly with 397 if all those myocarditis reports were serious (397/863 ≈ 46%). Whatever the bookkeeping, the public SAE narrative is VAERS myocarditis. Paper (Results): “CDC reviewed 14 reports of death after vaccination…” with clinical impressions (PE, suicide, ICH, heart failure, HLH/infection, unknown/pending). States no VAERS death was determined to result from myocarditis. Paper (v-safe Results): never states that any death was reported through v-safe, and gives no v-safe death count. |
|
mm7135a3 — COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18–August 21, 2022 #
Anomaly report: mm7135a3. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “Approximately 741 (2%) reported seeking medical care in the week after either dose… Four children received care at a hospital after vaccination; two respondents indicated the hospitalization was unrelated to vaccination, one was unwilling to provide further information, and one completed a VAERS report…” Paper (Abstract / VAERS): “No reports of myocarditis after vaccination were reported.” “These initial safety findings are consistent with those from preauthorization clinical trials… and that serious adverse events are rare.” Paper (Results): “Four children received care at a hospital after vaccination; two respondents indicated the hospitalization was unrelated to vaccination, one was unwilling to provide further information, and one completed a VAERS report (Table 3).” Paper (VAERS / Abstract): “Nineteen serious events were reported to VAERS. Eight reports were for seizure…” “No reports of myocarditis after vaccination were reported.” “serious adverse events are rare.” |
|
mm7144a3 — Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years — United States, August 31–October 23, 2022 #
Anomaly report: mm7144a3. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “Receipt of medical care was reported by 0.8% of registrants… Hospitalization was reported by 55 (0.03%) registrants. Among 45 registrants with information about the hospitalization available from the v-safe call center or free text message response, 29 indicated that the hospitalization was unrelated to vaccination, 13 completed a VAERS report, and three did not wish to complete a VAERS report.” Paper (Table 2): Hospitalization row printed as 0 / 0 / 0 / 0 / 0 for every age group and the total. Paper (Abstract): “Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses.” Paper (Table 2): Hospitalization = 0 for ages 12–17, 18–49, 50–64, ≥65, and Total. |
No under-coded rows in this extract for this paper. |
mm7008e3 — First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021 #
Anomaly report: mm7008e3. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Summary / Discussion): “No unusual or unexpected reporting patterns were detected.” / “The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events.” Paper (Methods): “Enrollees who report seeking medical care are contacted, and a VAERS report is completed if clinically indicated.” Paper (v-safe Results): publish only reactogenicity frequencies (Figure / Table 2)—no hospitalization or medical-care tallies from v-safe. Paper: Uses v-safe Results only for common local/systemic symptoms; emergency care from v-safe is not quantified. |
|
mm7107e1 — Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021–February 6, 2022 #
Anomaly report: mm7107e1. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Discussion): “V-safe does not capture diagnoses associated with hospitalization; however, registrants can include supplemental text for each health check-in.” Paper (VAERS Results): frames adult booster seriousness mainly through VAERS—3,004 serious reports; 37 myocarditis cases meeting the case definition; one myocarditis-associated death under investigation. Paper (Results / Discussion): Myocarditis appears as a VAERS finding—37 reports meeting the case definition after booster among adults; Table 2 manufacturer headers are Pfizer 18 + Moderna 18 = 36, which does not reconcile cleanly with the text’s 37. Whatever the bookkeeping, the public SAE narrative is VAERS myocarditis. Paper (Discussion): “One death was reported [to VAERS among myocarditis cases]; investigation is ongoing…” |
|
mm7018e2 — Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021 #
Anomaly report: mm7018e2. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Discussion): “A rare but serious adverse event occurring primarily in women, blood clots in large vessels accompanied by a low platelet count, was rapidly detected by the U.S. vaccine safety monitoring system.” Paper (v-safe Results): “Only 1.4% of enrollees reported seeking any form of medical care in the 7 days after vaccination.” — with no v-safe discussion of clotting codes, TTS-like free text, or deaths. Paper (Methods): “Enrollees who report seeking medical care are contacted by CDC’s v-safe call center and encouraged to complete a VAERS report, if indicated.” Paper (Table 3): reports a small hospitalization percentage after Janssen (about 0.04% of enrollees). |
|
mm7039e4 — Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12–September 19, 2021 #
Anomaly report: mm7039e4. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
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 (Summary / 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.” Paper: “no unexpected patterns… most… mild or moderate.” Paper: Does not discuss deaths at all (no VAERS death review; no v-safe death count). Safety conclusion is reactogenicity-only. |
|
mm7130a4 — Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29–July 10, 2022 #
Anomaly report: mm7130a4. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
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 / closing): local and systemic reactions are expected after a second booster; “serious adverse events are uncommon.” Seriousness is framed mainly through VAERS (442 serious reports; 52 deaths among serious impressions; myocarditis case-finding). Paper: “serious adverse events are uncommon.” Myocarditis appears as a VAERS case-finding exercise; v-safe Results never publish myocarditis, pericarditis, chest-pain, MI, or thrombosis MedDRA counts for second boosters. Paper (VAERS): among serious reports, clinical impressions include Death (52; 11.8% of serious). Death certificates reviewed when available; causes listed for six with sufficient information (CHF, aortic dissection, etc.). |
|
mm7128a3 — Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years With Presumed Immunocompromise Status — United States, January 12–March 28, 2022 #
Anomaly report: mm7128a3. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “Two registrants reported receiving care at a hospital during the week after dose 4 vaccination. The v-safe call center contacted both these registrants; one completed a VAERS report, and the other indicated the report was accidental or unrelated to vaccination.” Paper (Summary / closing): “Serious adverse events after mRNA booster (dose 4) are rare… safety findings were consistent with those previously described among nonimmunocompromised persons.” Seriousness is framed mainly through VAERS (17 serious reports; one manufacturer death with pulmonary fibrosis / respiratory failure; one preliminary myocarditis under review). Paper (Results): both hospital reporters “were contacted”; one completed VAERS; the other said the report was accidental/unrelated. Paper (Summary): “Only 17 serious adverse events were reported to VAERS.” “Serious adverse events after mRNA booster (dose 4) are rare.” |
|
mm7133a3 — Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022 #
Anomaly report: mm7133a3. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “Approximately 1.0% of parents reported seeking medical care for their child after third dose vaccination… No children received care at a hospital after third dose vaccination.” Paper (Abstract / VAERS): “Three (0.5%) reports were considered serious; no reports of myocarditis or death were received.” “Reports of serious adverse events were rare.” Paper (Results / Table 2): Hospitalization after dose 3 = 0. Paper: VAERS received no myocarditis reports; serious AEs rare; findings consistent with the trial. |
|
mm7202a5 — Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5–11 Years — United States, October 12–January 1, 2023 #
Anomaly report: mm7202a5. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “…most commonly in an outpatient clinic (37; 1.1%); no children received hospital care. Of the 64 reports of medical care sought, 37 had additional information available; parents or guardians of 35 children reported that seeking care was unrelated to vaccination.” Paper (Abstract): “There were no reports of myocarditis or death after bivalent booster vaccination.” “…adverse events… are consistent with those reported after a monovalent booster dose; serious adverse events are rare.” “Preliminary safety findings… are reassuring.” Paper (Results / Table 2): Hospitalization = 0 (—) for Pfizer, Moderna, and Total. Prose: “no children received hospital care.” Paper (Results): Of 37 medical-care reports with more information, 35 said seeking care was unrelated to vaccination. |
|
mm7223a2 — Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023 #
Anomaly report: mm7223a2. Left: MMWR wording. Right: under-coded registrant rows from the v-safe dataset (viewer links).
| MMWR verbatim | Registrant examples |
|---|---|
Paper (Results): “90 (3.0%) parents reported seeking medical care for their child. Among these… one child was hospitalized for pneumonia; 43 (48.0%) had additional information available from the v-safe call center. Parents of 30 children indicated that medical care was unrelated to vaccination, 11 parents completed a VAERS report, and two parents indicated that the report was made in error.” Paper (Abstract / VAERS): “…most reactions reported after a third dose… were mild and transient and that serious adverse events are rare.” Eight VAERS serious reports (including Kawasaki disease, new-onset afebrile seizure ×2, pneumonia, diabetic ketoacidosis); “no evidence suggested that these reported events were related to vaccination.” Paper (Results / Table 1): Hospitalization = 1 (0.03%); prose: “one child was hospitalized for pneumonia.” Paper (Results): Of those with call-center information, 30 said medical care was unrelated, 11 completed VAERS, 2 said the report was in error. Infection signs in 34 of 90 medical-care reports. |
|
Searchable evidence grid #
Filter paper = mm7109e2 to match the adolescent booster ER table.