TABLE 3. Events* reported to the Vaccine Adverse Event Reporting System for persons aged ≥12 years† after receipt of a bivalent Pfizer-BioNTech or Moderna COVID-19 vaccine booster dose — United States, August 31–October 23, 2022.
| Adverse events | Vaccine, no. reporting (%) |
||
|---|---|---|---|
| Pfizer-BioNTech | Moderna | Total§ | |
|
Total
|
2,928
|
2,615
|
5,542
|
|
Vaccination errors¶
|
877 (30.0)
|
1,037 (39.7)
|
1,913 (34.5)
|
| Error without adverse health event |
717 (81.8) |
972 (93.7) |
1,688 (88.2)
|
| Error with adverse health event** |
160 (18.2) |
65 (6.3) |
225 (11.8)
|
| Error with nonserious health event†† |
157 (17.9) |
61 (5.9) |
218 (11.4)
|
| Error with serious health event |
3 (0.3) |
4 (0.4) |
7 (0.4)
|
|
Nonserious reports§§,¶¶
|
2,762 (94.3)
|
2,530 (96.8)
|
5,291 (95.5)
|
| Headache |
343 (12.4) |
285 (11.3) |
628 (11.9)
|
| Fatigue |
318 (11.5) |
257 (10.2) |
575 (10.9)
|
| Fever |
299 (10.8) |
262 (10.4) |
561 (10.6)
|
| Pain |
293 (10.6) |
231 (9.1) |
524 (9.9)
|
| Chills |
254 (9.2) |
205 (8.1) |
459 (8.7)
|
| Pain in extremity |
209 (7.8) |
167 (6.6) |
376 (7.1)
|
| Nausea |
213 (7.7) |
144 (5.7) |
357 (6.8)
|
| Dizziness |
212 (7.7) |
135 (5.3) |
347 (6.6)
|
| Injection site pain |
138 (5.0) |
121 (4.8) |
259 (4.9)
|
| COVID-19 |
169 (6.1) |
89 (3.5) |
258 (4.9)
|
|
Serious reports***,††† |
166 (5.7)
|
85 (3.3)
|
251 (4.5)
|
| Allergic reaction/Anaphylaxis |
6 |
2 |
8
|
| Appendicitis |
4 |
1 |
5
|
| Arrythmia |
8 |
5 |
13
|
| Atrial fibrillation |
5 |
4 |
9
|
| Atrioventricular node block, second or third degree |
2 |
0 |
2
|
| Supraventricular tachycardia |
0 |
1 |
1
|
| …Other |
1 |
0 |
1
|
| COVID-19 |
14 |
6 |
20
|
| Death§§§ |
27 |
9 |
36
|
| Dyspnea |
4 |
1 |
5
|
| Fall |
1 |
6 |
7
|
| Guillain-Barré syndrome |
2 |
0 |
2
|
| Hypertension, acute |
7 |
3 |
10
|
| Pericarditis¶¶¶ |
1 |
3 |
4
|
| Pneumonia |
6 |
1 |
7
|
| Seizure |
6 |
0 |
6
|
| Thrombotic event |
20 |
11 |
31
|
| Stroke or transient ischemic attack |
12 |
5 |
17
|
| Pulmonary embolism |
5 |
5 |
10
|
| Other |
3 |
1 |
4
|
| Chest pain, not otherwise specified |
9 |
3 |
12
|
| Myocardial infarction |
5 |
3 |
8
|
| Myocarditis**** | 3 | 2 | 5 |
Abbreviations: MedDRA PT = Medical Dictionary for Regulatory Activities preferred term; 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, which can include normal diagnostic findings. A MedDRA PT does not indicate a medically confirmed diagnosis.
† On August 31, 2022, the Food and Drug Administration authorized bivalent formulations of Moderna and Pfizer-BioNTech COVID-19 vaccines for use as a single booster dose ≥2 months after completing primary or booster vaccination, Pfizer-BioNTech for persons aged ≥12 years and Moderna for adults aged ≥18 years.
§ One report was for a person who received both Moderna and Pfizer-BioNTech bivalent booster doses at the same visit and did not experience an adverse health event.
¶ Vaccine administration or handling errors.
** The most common MedDRA PTs among reports of vaccination error included incorrect product formulation administered, incorrect dose administered, underdose, and wrong product administered.
†† Adverse health events coded for reports with nonserious vaccination errors included arthralgia, headache, injection site erythema, injection site swelling, fever, pain, and pain in extremity.
§§ Excluding vaccination error MedDRA PTs.
¶¶ Includes the top 10 most frequently coded MedDRA PTs among nonserious reports.
*** 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 preliminary clinical impressions. https://www.meddra.org/how-to-use/basics/hierarchy
††† Because of the small number of serious reports, percentages are not provided for serious report events. Other clinical impressions included acute pancreatitis, acute respiratory failure, aneurysm, arm pain, arthralgia, aseptic meningitis, bilateral pleural effusion, cellulitis, chronic anemia, compression fracture, confusion, contact dermatitis, costochondritis, erythema nodosum, fever, glaucoma, hearing loss, leukocytoplastic vasculitis, lower extremity weakness, lymphadenopathy, migraine, myalgia, pancreatitis, pericardial and pleural effusions, pericardial tamponade, pylephlebitis, rhabdomyolysis, unspecified bradycardia, unspecified tachycardia, transverse myelitis, vertigo, and vision loss.
§§§ For reports of death, cause of death was available for four reports: cardiac arrest, dementia, metastatic prostate cancer, and myocardial infarction.
¶¶¶ All four reports of pericarditis have been verified by medical record review.
**** Three of the five reports of myocarditis have been verified by medical record review.