05-18-2020, 11:09 AM
I just looked up the AE grading system used for vaccines, which is available from the FDA here:
https://www.fda.gov/media/73679/download
An AE of grade 3 erythema is > 10 cm, which would probably be acceptable if that were the only thing they saw.
Grade 3 systemic symptoms is a bit vague, but here are the definitions from the FDA of various vital signs:
Fever of 102.1 to 104
Tacycardia to > 130
Hypotension to < 80 mmHg
Respiratory rate to > 25
Most symptoms would need to impair daily activities to qualify as grade 3. It would require narcotics for treatment of a headache, or IV hydration for nausea and vomiting.
In other words, a grade 3 AE for a vaccine is no joke.
BC
https://www.fda.gov/media/73679/download
An AE of grade 3 erythema is > 10 cm, which would probably be acceptable if that were the only thing they saw.
Grade 3 systemic symptoms is a bit vague, but here are the definitions from the FDA of various vital signs:
Fever of 102.1 to 104
Tacycardia to > 130
Hypotension to < 80 mmHg
Respiratory rate to > 25
Most symptoms would need to impair daily activities to qualify as grade 3. It would require narcotics for treatment of a headache, or IV hydration for nausea and vomiting.
In other words, a grade 3 AE for a vaccine is no joke.
BC