MAHA Clinical File
Rx Only

Department of Health and Human Services | Food and Drug Administration

MEDWATCH

The FDA Safety Information and Adverse Event Reporting System

Form 3500-MAHA

Form Approved: Not Applicable

Serious
FDA MedWatch adverse event report infographic showing a U.S. map with measles outbreak markers and a SERIOUS stamp

Section A

Patient Information

1. Patient IdentifierUnited States of America
2. Age at Time of Event250 years
3. SexN/A (nation-state)
4. Weight330 million (population)
5. EthnicityAll of them

Section B

Adverse Event or Product Problem

January 2025

Childhood vaccine schedule reduced from 17 to 11 recommended vaccines.

January 2025

CDC Advisory Committee on Immunization Practices (ACIP) fired and reconstituted with Kennedy's picks.

February 2025

Kennedy endorses Trump executive order boosting glyphosate production, after years calling it a carcinogen.

March 2025

Federal judge rules vaccine schedule changes "probably illegal" and Kennedy "likely broke the law."

March 2025

1,300+ measles cases in 2025 (93% in unvaccinated individuals).

March 2025

The Lancet editorial: "The destruction that Kennedy has wrought in one year might take generations to repair."

March 2025

Robert Malone angrily quits CDC panel, cites "weaponized leaking, sabotage."

March 2025

Acting CDC Director Bhattacharya publicly supports measles vaccine, breaking from Kennedy.

March 2025

26 states reject CDC vaccine guidance.

Section C

Suspect Product(s)

1. NameMake America Healthy Again (MAHA)
[Ref: Doc 01 - Methylene Blue]
2. ManufacturerRobert F. Kennedy Jr.
3. NDC#None (not FDA approved)
4. Dose, FrequencyUnlimited executive authority, administered daily
5. RouteExecutive order, press conference, X.com, Joe Rogan Experience
6. Date StartedJanuary 2025
7. Date StoppedOngoing
8. Event Abated After Use Stopped?N/A (use has not stopped)
9. Lot#2025-2026
10. Expiration DateMidterm elections, November 2026

Section D

Suspect Medical Device

Not applicable. Patient implementation of national policy objectives occurs without reliance on approved medical hardware.

Section E

Reporter Information

Sources
The LancetThe AtlanticNPRThe New York TimesProPublicaArs TechnicaPoliticoThe Daily BeastUSA Today
Reporter Type
Healthcare Professional (The Lancet)Consumer (330 million of them)Media

All reporters independently confirmed adverse events.

Outcome Assessment

Outcomes Attributed to Adverse Event

Death
Life-threatening
Hospitalization (initial or prolonged)
Disability or permanent damage
Required intervention to prevent permanent impairment (federal court order)
Congenital anomaly/birth defect
Other serious (important medical events)

Loss of measles elimination status pending PAHO review. DTaP coverage dropped from 95% to 92.1%. 42% of Americans cannot name who runs the FDA.

Relevant Tests / Laboratory Data

Including Dates

Public Trust Polling

42%

of Americans cannot name the FDA commissioner.

Politico, March 2025

DTaP Coverage

95.0%92.1%

Declined from 95% (2019-20) to 92.1% (2024-25). Below herd immunity threshold.

Measles Incidence

1,300+

cases in 2025, on top of 2,200+ in 2024. Highest in three decades.

State Compliance

26

states rejected CDC vaccine guidance in the past year.

Personnel Status: Casey Means

Surgeon General Nomination

Confirmation stalled in Senate.

Pending

Personnel Status: Vinay Prasad

FDA Role

Leaving FDA end of April after “tumultuous tenure.”

Departing

This form has been filed by the available evidence. No response is expected. No response has been forthcoming.

This page is satire formatted as a pharmaceutical document. It is not medical advice. The pharmacology, however, is real.