GRADE 1 (Mild) Transient (goes away after a short time) or mild discomfort; no limitation in activity; no medical intervention/therapy required.
GRADE 2 (Moderate) Your daily activity is affected mild to moderately – some assistance might be needed; no or minimal medical intervention/therapy required.
GRADE 3 (Severe) Your daily activity is markedly reduced – some assistance usually required; medical intervention/therapy required, hospitalisation or hospice care possible.
GRADE 4 (Potentially life threatening) Extreme limitation to daily activity, significant assistance required; significant medical intervention/therapy, hospitalisation or hospice care very likely.
I don’t know about using these grades specifically for the COVID vaccine. Grade 3--my daily activity was “markedly reduced”—I stayed in bed all day for one day because I felt blah, but there was never a question of whether I needed a medical intervention or hospitalization. I’d had a similar reaction to some flu vaccines before. (Hospice care? Is the linked website written this way because it focuses on HIV/AIDS?)
I would not interpret your case as severe according to this grade. The specification “some assistance usually required” seems like they mean your reaction is so bad you need help eating/washing/using the toilet, which I assume was not the case for you. While—especially for a young healthy person—staying in bed all day is a “marked reduction” of activity, there’s still quite some room for further worsening before you’re at a point where it’s life threatening.
While the wording could be more clear, if my interpretation is correct I would agree this is an OK grading to use.
Er, yes, I do think I’m saying that we should use something else besides the linked standard.
Object level: Feeling blah for a day and staying in bed doesn’t strike me as “severe” or “horrible”. I’m deeply confused by the fact that you seem to be arguing in favor of standards that would say that staying in bed for a day is “horrible” or “severe”.
I’m not trained in this area, but just for comparison, “Common Terminology Criteria for Adverse Events v3.0” https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf has a “grade 3/severe” category for most types of adverse effects, and includes hypertension requiring two drugs to treat; hypotension requiring more that 24 hours’ treatment; insomnia so bad that it interferes with your ADLs; and a weight gain of 20% or more from baseline. The “fatigue” I experienced would be a 2/moderate at best under their standard (page 11), but more likely a 1 as I had no actual trouble with ADLs.
Meta level: I think you should give serious, possibly overwhelming, consideration to how such data would get reported. Vaccine-hesitant people will hear about the study results through popular media: “30% of recipients reported ‘severe’ side effects!” and will never see or hear what “severe” means in the study’s context. They will assume that “severe” means whatever they think “severe” means. If I were one such person, I would be expecting side effects far worse than I experienced.
If someone wants to run a mirror of Aalla’s poll side effect grades might provide for a better result (https://i-base.info/guides/side/how-side-effects-are-graded):
I don’t know about using these grades specifically for the COVID vaccine. Grade 3--my daily activity was “markedly reduced”—I stayed in bed all day for one day because I felt blah, but there was never a question of whether I needed a medical intervention or hospitalization. I’d had a similar reaction to some flu vaccines before. (Hospice care? Is the linked website written this way because it focuses on HIV/AIDS?)
I would not interpret your case as severe according to this grade. The specification “some assistance usually required” seems like they mean your reaction is so bad you need help eating/washing/using the toilet, which I assume was not the case for you. While—especially for a young healthy person—staying in bed all day is a “marked reduction” of activity, there’s still quite some room for further worsening before you’re at a point where it’s life threatening.
While the wording could be more clear, if my interpretation is correct I would agree this is an OK grading to use.
This is a bit like saying: “I know that the vaccine is horrible given the general standards, so we should use something else”.
Novavax does manage a low amount of grade 3 side effects.
There’s another question about whether there are long term side effects that also interesting.
Er, yes, I do think I’m saying that we should use something else besides the linked standard.
Object level: Feeling blah for a day and staying in bed doesn’t strike me as “severe” or “horrible”. I’m deeply confused by the fact that you seem to be arguing in favor of standards that would say that staying in bed for a day is “horrible” or “severe”.
I’m not trained in this area, but just for comparison, “Common Terminology Criteria for Adverse Events v3.0” https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf has a “grade 3/severe” category for most types of adverse effects, and includes hypertension requiring two drugs to treat; hypotension requiring more that 24 hours’ treatment; insomnia so bad that it interferes with your ADLs; and a weight gain of 20% or more from baseline. The “fatigue” I experienced would be a 2/moderate at best under their standard (page 11), but more likely a 1 as I had no actual trouble with ADLs.
Meta level: I think you should give serious, possibly overwhelming, consideration to how such data would get reported. Vaccine-hesitant people will hear about the study results through popular media: “30% of recipients reported ‘severe’ side effects!” and will never see or hear what “severe” means in the study’s context. They will assume that “severe” means whatever they think “severe” means. If I were one such person, I would be expecting side effects far worse than I experienced.