Table 3.
Reported health events within seven days after vaccination or previous seven days among unvaccinated and vaccinated individuals with autoimmune diseases.
| Variable | Unvaccinated Group N = 1,286 |
Influenza Vaccine Alone N = 491 |
mRNA COVID-19 Vaccine Alone N = 2,986 |
mRNA COVID-19 and Influenza Vaccine Co-administered N = 1,743 |
|---|---|---|---|---|
| Local symptomsa | ||||
| Injection site reaction | NA | 197 (40%) | 1,880 (63%) | 1,025 (59%) |
| Common Systemic symptomsb | ||||
| General | ||||
| Unwellc | 57 (4.4%) | 21 (4.3%) | 242 (8.1%) | 140 (8.0%) |
| Fever (≥38▫C) | 12 (0.9%) | 7 (1.4%) | 61 (2.0%) | 49 (2.8%) |
| GI symptomsd | 27 (2.1%) | 9 (1.8%) | 98 (3.3%) | 54 (3.1%) |
| Joint pain/stiffness | 32 (2.5%) | 12 (2.4%) | 127 (4.3%) | 68 (3.9%) |
| Runny nose | 33 (2.6%) | 12 (2.4%) | 55 (1.8%) | 59 (3.4%) |
| Nasal congestion | 52 (4.0%) | 15 (3.1%) | 67 (2.2%) | 74 (4.2%) |
| Earache/pain | 9 (0.7%) | 4 (0.8%) | 16 (0.5%) | 17 (1.0%) |
| Sore throat | 39 (3.0%) | 10 (2.0%) | 52 (1.7%) | 47 (2.7%) |
| Neurological | ||||
| Headache | 33 (2.6%) | 16 (3.3%) | 179 (6.0%) | 110 (6.3%) |
| Dizziness | 15 (1.2%) | 4 (0.8%) | 54 (1.8%) | 40 (2.3%) |
| Paresthesia | 6 (0.5%) | 0 (0%) | 17 (0.6%) | 12 (0.7%) |
| Fainting | 1 (<0.1%) | 1 (0.2%) | 4 (0.1%) | 3 (0.2%) |
| Difficult to walk | 4 (0.3%) | 1 (0.2%) | 15 (0.5%) | 4 (0.2%) |
| Loss of taste/smell | 5 (0.4%) | 3 (0.6%) | 9 (0.3%) | 8 (0.5%) |
| Impaired or lost vision | 0 (0%) | 1 (0.2%) | 5 (0.2%) | 3 (0.2%) |
| Sudden unilateral | 0 (0%) | 0 (0%) | 1 (<0.1%) | 0 (0%) |
| facial weakness/paralysis | ||||
| Seizure or convulsion | 0 (0%) | 0 (0%) | 1 (<0.1%) | 0 (0%) |
| Neurological symptomse | 1 (<0.1%) | 2 (0.4%) | 12 (0.4%) | 7 (0.4%) |
| Cardio-respiratory | ||||
| Palpitation | 7 (0.5%) | 1 (0.2%) | 23 (0.8%) | 12 (0.7%) |
| Breathing difficulty | 9 (0.7%) | 0 (0%) | 22 (0.7%) | 22 (1.3%) |
| Chest tightness | 11 (0.9%) | 1 (0.2%) | 25 (0.8%) | 28 (1.6%) |
| Cough | 36 (2.8%) | 10 (2.0%) | 54 (1.8%) | 58 (3.3%) |
| Allergic-like | ||||
| Face or lip swelling | 1 (<0.1%) | 0 (0%) | 2 (<0.1%) | 0 (0%) |
| Eyelid swelling | 3 (0.2%) | 0 (0%) | 6 (0.2%) | 4 (0.2%) |
| Itchy eyes | 9 (0.7%) | 7 (1.4%) | 23 (0.8%) | 14 (0.8%) |
| Red eyes | 2 (0.2%) | 1 (0.2%) | 10 (0.3%) | 6 (0.3%) |
| Throat/tongue swelling | 1 (<0.1%) | 2 (0.4%) | 4 (0.1%) | 3 (0.2%) |
| Rash or hives | 4 (0.3%) | 0 (0%) | 14 (0.5%) | 4 (0.2%) |
| Anaphylaxis | 0 (0%) | 0 (0%) | 1 (<0.1%) | 1 (<0.1%) |
| Coagulation symptomsf | 2 (0.2%) | 1 (0.2%) | 6 (0.2%) | 1 (<0.1%) |
aAll participants were asked about injection site reactions (Redness, pain or swelling at injection site/above and below in the immunized arm). bOnly those who indicated a health event that led to school/work absenteeism, a medical consultation and/or prevention of daily activities were asked to provide details and participants could report more than one symptom. ctiredness, weakness, muscle aches, fatigue, or chills. dnausea, vomiting, diarrhea, or stomach pain. eweakness or paralysis of the arms or legs/confusion/change in personality/behavior or difficulty with urination or defecation; fSymptoms of blood clot or bleeding: swelling/pain in legs.