| Systemic reactions in persons aged 12-15 years, Pfizer-BioNTech COVID-19 vaccine and placebo Table 6 | c Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea |
|---|---|
| No grade 4 local reactions were reported | 8 a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain |
Serious Adverse Events The proportions of participants who reported at least 1 serious adverse event were 0.
| Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients | 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 |
|---|---|
| Data on local reactions were not solicited from persons aged 16-17 years | 2 0 0 20 1 |
Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination.
23| 2 0 0 8 0 | No other systemic grade 4 reactions were reported |
|---|---|
| Food and Drug Administration FDA as possibly related to vaccine: shoulder injury possibly related to vaccine administration or to the vaccine itself, and lymphadenopathy involving the axilla contralateral to the vaccine injection site | Local reactions in persons aged 18-55 years, Pfizer-BioNTech COVID-19 vaccine and placebo Table 1 |
Fatigue, headache, chills, and new or worsened muscle pain were most common.
1