FDA authorizes Pfizer vaccine for kids age 12 to 15

Re:FDA authorizes Pfizer vaccine for kids age 12 to 15 by pseudalopex on Tuesday May 11, 2021 @07:03PM (#27124725)

The question is what substantial means. I believe hvac's credible source over your forceful assertion.

Serious adverse events have to be reported to VAERS. I think the FDA would notice if Pfizer lied about there being no pattern.

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Re:FDA authorizes Pfizer vaccine for kids age 12 to 15 by timr on Tuesday May 18, 2021 @04:27PM (#27200562)

I quoted directly from the approval document on the FDA website. The other poster is linking to some unrelated thing about VAERS.

https://www.fda.gov/media/144413/download

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Re:FDA authorizes Pfizer vaccine for kids age 12 to 15 by pseudalopex on Thursday May 20, 2021 @01:27AM (#27217737)

You quoted the part of the fact sheet about reporting serious adverse events to VAERS. The University of Iowa page is about the same thing exactly. They quoted the same definition. The only differences were they abbreviated adverse event and gave examples.

"A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; e.g. symptoms that preclude patient from attending work, school or perform their typical daily activities"

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