TABLE 3. Reports of nonserious and serious events to the Vaccine Adverse Event Reporting System for children aged 5–11 years who received a Pfizer-BioNTech COVID-19 booster dose (N = 581) — United States, May 17–July 31, 2022.
| Reported events | No. (%) |
|---|---|
|
Nonserious VAERS reports
|
578 (100) |
|
Symptom, sign, diagnostic result, or condition (MedDRA PT*)
| |
| Product preparation issue |
145 (25.1) |
| Incorrect dose administered |
128 (22.2) |
| No adverse event† |
105 (18.2) |
| Product administered to patient of inappropriate age |
55 (9.5) |
| Product preparation error |
53 (9.2) |
| Expired product administered |
46 (8.0) |
| Fever |
45 (7.8) |
| Pain in extremity |
38 (6.6) |
| Fatigue |
28 (4.8) |
| Headache |
22 (3.8) |
| Injection site pain |
22 (3.8) |
| Product storage error |
22 (3.8) |
| Vomiting |
22 (3.8) |
| Chills |
18 (3.1) |
| Dizziness |
18 (3.1) |
|
Serious VAERS reports
§,¶
|
3 (100)
|
|
Clinical impression
| |
| Generalized pain, fatigue, and malaise requiring hospitalization |
1 (33.3) |
| New onset type 1 diabetes |
1 (33.3) |
| Facial swelling | 1 (33.3) |
Abbreviations: MedDRA PT = Medical Dictionary for Regulatory Activities preferred terms; VAERS = Vaccine Adverse Event Reporting System.
* Signs and symptoms in VAERS reports are assigned MedDRA PTs by VAERS staff members. Each VAERS report might be assigned more than one MedDRA PT and can include normal diagnostic findings. A MedDRA PT does not represent a medical diagnosis made or confirmed by a provider or clinical reviewer.
† All reports classified as no adverse event were accompanied by at least one report of vaccine error (e.g., product preparation issue, incorrect dose administered, product preparation error, product administered to patient of inappropriate age, expired product administered, or product storage error). A total of 413 reports were classified as vaccine errors; the most common specific errors are listed in the table. Of the 413 reports of vaccine error, 105 included the MedDRA PT “no adverse event,” 63 listed an adverse health event, and the remaining reports only indicated that a vaccine error occurred.
§ VAERS reports are classified as serious if any of the following are reported: hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death.
¶ Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression. The clinical impression of the event does not establish a causal role with vaccination. https://www.meddra.org/how-to-use/basics/hierarchy