The FDA generally would only review the summaries, not the full patient information. A lot of those 450,000 pages are careful patient documentation that simply

The FDA generally would only review the summaries, not the full patient information. A lot of those 450,000 pages are careful patient documentation that simply isn't necessary when you already have the total side effect counts. At most the FDA might review the clinical history of the patients with severe side effects. They aren't going to be reading the notes about every Bob Smith reporting fatigue after getting a COVID-19 vaccine.