re: FDA staff recommends watching for Bell's palsy in Moderna and Pfizer vaccine recipients

But but but it’s SAAAAAAFE

quote:

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I think it is safe and won't cause bells, but the FDA obviously thinks enough of the incidents to at least take notice and make a specific comment on bell's.

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When I go back to the office I can try and take a picture of all the other incidents the FDA noted in the guidance they sent over

May have to make multiple posts to cover then all. And there are some where over 100s of recepients experienced the same sickness, not just 4

It is not just Bell’s palsy they noted. It’s just to Bell’s palsy that the media noted....

quote:

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Reports of lymphadenopathy were imbalanced with notably more cases in the vaccine group
(64) vs. the placebo group (6), which is plausibly related to vaccination. Bell’s palsy was
reported by four vaccine participants and none in the placebo group. These cases occurred at 3,
9, 37, and 48 days after vaccination. One case (onset at 3 days postvaccination) was reported
as resolved with sequelae within three days after onset, and the other three were reported as
continuing or resolving as of the November 14, 2020 data cut-off with ongoing durations of 10,
15, and 21 days, respectively. The observed frequency of reported Bell’s palsy in the vaccine
group is consistent with the expected background rate in the general population, and there is no
clear basis upon which to conclude a causal relationship at this time, but FDA will recommend
surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations.
There were no other notable patterns or numerical imbalances between treatment groups for
specific categories (system organ class or preferred term) of non-serious adverse events,
including other neurologic, neuro-inflammatory, and thrombotic events, that would suggest a
causal relationship to BNT162b2 vaccine.

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No doubt you monitor for 100 different things, but this statement is why the bell's stands out.

Back in 06, I got Shingles out of nowhere. Why the body wash I was using gave it to me is still a mystery.