1 0 0 3 0 | Fever was more common after the second dose and in the younger group 15 |
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bMild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe pain at the injection site | Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination |
Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 3 days after either dose and lasted a median duration of 1 to 2 days | Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups |
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4 0 Grade 4 0 0 0 0 Any systemic event 877 77 | Unsolicited Adverse Events Reports of lymphadenopathy were imbalanced with 6 more cases in the vaccine group 7 than the placebo group 1 ; lymphadenopathy is plausibly related to the vaccine |
For both age groups, fatigue, headache and new or worsened muscle pain were most common.
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