TABLE 1. Most frequently reported adverse reactions reported* to v-safe for children aged 5–11 years who received homologous Pfizer-BioNTech COVID-19 booster vaccination† (N = 3,249), by severity§ and dose — United States, May 17–July 31, 2022.
| Reported event | % Reporting event |
||
|---|---|---|---|
| Dose 1 | Dose 2 | Dose 3 | |
|
Injection site pain
|
60.7
|
66.1
|
66.7
|
| Mild |
50.1 |
50.7 |
44.9 |
| Moderate |
10.2 |
14.9 |
20.8 |
| Severe |
0.3 |
0.6 |
1.0 |
|
Fatigue
|
22.9
|
29.9
|
28.9
|
| Mild |
15.0 |
17.5 |
15.1 |
| Moderate |
7.2 |
11.6 |
12.0 |
| Severe |
0.7 |
0.8 |
1.7 |
|
Headache
|
15.2
|
20.6
|
19.9
|
| Mild |
10.5 |
13.1 |
11.4 |
| Moderate |
4.4 |
7.1 |
7.5 |
| Severe |
0.2 |
0.4 |
1.0 |
|
Myalgia
|
7.1
|
10.2
|
13.9
|
| Mild |
4.8 |
6.0 |
7.2 |
| Moderate |
2.1 |
4.0 |
6.3 |
| Severe |
0.2 |
0.2 |
0.4 |
|
Chills
|
3.8
|
7.6
|
7.4
|
| Mild |
2.6 |
4.6 |
4.1 |
| Moderate |
1.1 |
3.0 |
2.9 |
| Severe |
0.1 |
0.1 |
0.4 |
|
Fever¶
|
1.4
|
3.9
|
5.1
|
| Mild |
0.9 |
2.2 |
2.7 |
| Moderate |
0.4 |
1.0 |
1.4 |
| Severe |
0.1 |
0.6 |
0.9 |
| Very severe | 0.03 | 0.1 | 0.1 |
* Percentage of registrants who reported a reaction or health impact at least once during days 0–7 after vaccination.
† Includes only persons who received Pfizer-BioNTech COVID-19 vaccine for primary series and first booster dose and completed at least one survey after their booster dose and at least one survey after a previous vaccine dose.
§ Includes the most severe episode reported during the day 0–7 window for each event. Parents and guardians who participate in v-safe use the following definitions to describe the severity of a child’s symptoms: mild (noticeable, but not problematic), moderate (limit normal daily activities), or severe (make daily activities difficult or impossible). The odds of reporting a moderate or severe symptom after booster dose and previous doses were compared using a multivariable generalized estimating equations model that accounted for repeated measures among doses reported by each registrant; statistical significance was defined by p<0.05. All booster dose and dose 1 comparisons were statistically significant (p<0.01). All booster dose and dose 2 comparisons were statistically significant (p<0.05) except “chills” (p = 0.38).
¶ Includes those who reported a temperature and met the definition for fever (≥100.4°F [≥38.0°C]) during days 0–3. If information was available, fever was classified further as mild (100.4°F–101.1°F [38.0°C–38.3°C]), moderate (101.2°F–102.0°F [38.4°C–38.9°C]), severe (102.1°F–104.0°F [39.0°C–40.0°C]), or very severe (>104.0°F [>40°C]). Because few registrants reported a temperature that met the definition for fever, statistics were not estimated for this variable.