Freedom of Information Act

Defending The Republic’s FOIA Case Against The FDA

Uncovers New Data on Adverse Events

Defendant the Republic (DTR) has just obtained another set of documents from the Food and Drug Administration (FDA) relating to the agency’s approval of Moderna’s COVID-19 vaccine “Spikevax.” DTR received these Moderna files as a result of its ongoing Freedom of Information Act (FOIA) lawsuit against the FDA. They are available for download below.

The new records include a listing of adverse events for thousands of clinical participants who received doses of Moderna’s COVID-19 vaccine. The adverse events, many of which started mere days after vaccination, include: elevated blood pressure, swollen lymph nodes, high fevers and fatigue, rashes, and vertigo.

These are just some of the adverse reactions that clinical trial participants had to Moderna’s COVID-19 vaccine. In July of 2023, DTR released the initial set of Moderna documents – the first significant release of data from Moderna’s COVID-19 clinical trials – which revealed serious adverse events following the company’s vaccine, including death and neurological disorders.

Also released are: summaries of the duration of days that passed from the date of injection (for both the first and second shots) and the onset of adverse reactions; Moderna responses to FDA comments concerning vaccine effectiveness; and other FDA comments to Moderna concerning the clinical results.

Before the end of the year, DTR anticipates the FDA, in compliance with its FOIA obligations, will produce thousands more pages of Moderna records. We will summarize and release those records to the public once available.

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Moderna 2nd Batch Documents and Spreadsheets Links Below:

S39 M5 Tavares 2013

S20 M1 Thera Area User Guide For Vaccines

S9 M1 Rsp FDA Cmts Clin 17 SEP 2021 IR2

S21 M1 Rsp FDA Cmts Clin 03 NOV 2021

S11 M5 T14030104010401

S11 M5 T14030104010402

S21 M5 Table IR15b-14-2-1-1-2-1-4-1

S21 M5 Table IR15c-14-2-1-1-2-1-4-1

S21 M5 Table IR15d-14-2-1-1-2-1-4-1

FDA CBER 2022 908-0014279 to -0014363 125752 S0009 M1 Listing 16-2-7-42

FDA CBER 2022-908-0014364 to -0014370 125752 S0039 M1 CMQ Autoimmune Meddra v23-0