Table 2.
Vaccine Safety/Tolerability
| Factor |
MS/NID N(%) |
Control N (%) |
p |
|
Vaccine Typea Pfizer/BioNTech Moderna AstraZeneca Johnson & Johnson Not Sure/Clinical Trial |
357 (56.3) 267 (42.1) 0 (0.0) 9 (1.4) 1 (0.2) |
169 (50.6) 148 (44.3) 2 (0.6) 13 (3.9) 2 (0.6) |
0.009 |
|
Side effects with the 1stdose of a 2-dose vaccine?: Yes No |
256 (42.2) 350 (57.8) |
141 (45.3) 170 (54.7) |
0.410b |
|
Side effect type: Arm soreness Fevers, chills, aches, flu-like Allergic Reaction Neurologic complications Fatigue Headache Otherc |
225 (37.1) 72 (11.8) 6 (0.9) 1 (0.2) d 18 (2.9) 35 (5.7) 36 (5.9) |
127 (40.8) 38 (12.2) 6 (1.9) 0 (0) 15 (9.3) 6 (1.9) 11 (3.5) |
0.345 0.948 0.237 0.555 0.214 0.022 0.170 |
|
Side effect timing: Within 1 week 1-4 weeks 2-6 months >6 months |
244 (95.3) 7 (2.7) 0 (0) 0 (0) |
136 (96.5) 4 (2.8) 0 (0) 0 (0) |
1.0 |
|
Side effects with 2nddose of a 2-dose vaccine? Yes No |
246 (67.0) 121 (33.0) |
114 (64.8) 62 (35.2) |
0.672b |
|
Side effect type: Arm soreness Fevers, chills, aches, flu-like Allergic Reaction Neurologic complications Fatigue Headache Otherc |
191 (52.0) 150 (40.9) 2 (0.5) 6 (1.6)d 34 (9.2) 30 (8.1) 27 (7.4) |
97 (55.1) 85 (48.3) 1 (0.6) 1 (0.6) 13 (7.4) 3 (1.7) 8 (4.5) |
1.0 0.454 1.0 0.280 0.455 0.006 0.229 |
|
Side effect timing: Within 1 week 1-4 weeks 2-6 months >6 months |
243 (98.8) 2 (0.8) 1 (0.4) 0 (0) |
110 (96.5) 3 (2.6) 0 (0) 0 (0) |
0.330 |
|
Side effects with a 1-dose vaccine? Yes No |
6 (46.2) 7 (53.8) |
8 (66.7) 4 (33.3) |
0.310b |
|
Side effect type: Arm soreness Fevers, chills, aches, flu-like Allergic Reaction Neurologic complications Fatigue Headache Other c |
4 (30.8) 3 (23.1) 0 (0) 0 (0) 1 (16.7) 1 (16.7) 1 (16.7) |
5 (38.5) 4 (30.8) 0 (0) 0 (0) 2 (25) 3 (37.5) 2 (25) |
0.176 0.236 1.0 1.0 0.593 0.322 0.593 |
|
Side effect timing: Within 1 week 1-4 weeks 2-6 months >6 months |
6 (100) 0 (0) 0 (0) 0 (0) |
8 (100) 0 (0) 0 (0) 0 (0) |
0.593 |
Comparison of patient-reported side effects following all doses of vaccination against SARS-CoV-2 are reported here. p-values represent comparison between the NID and control group. There were no significant differences in reported side effect rates between the groups. However, when adjusting for age, comorbidities, and vaccine type, there was a higher rate of side effects reported after the second dose of the mRNA vaccines. The only difference in side effect type between groups was an increase in headaches reported by the NID group after the mRNA vaccines.
Vaccine types included: Pfizer/BioNTech sponsored (BNT162b2), Moderna sponsored (mRNA-1273), Johnson & Johnson/Janssen sponsored (Ad26.COV2.S), and AstraZeneca sponsored (ChAdOx1 nCoV-19).
When adjusting for age, comorbidities, BMI, and vaccine type there was no difference in side effect rate between NID and controls with the first dose (p=0.205) or second dose (p=0.846) of the 2-dose mRNA vaccines. When adjusting for age, comorbidities, BMI and vaccine type there was no difference in side effect rate with the 1-dose viral-vector vaccines (p=0.393). .
“Other” free text responses for all vaccine doses fell into the categories of: lymphadenopathy, joint pain, myalgias, chest pain, light-headedness/dizziness and rash. There were no differences between sub-categories of “other” responses between NID and control.
Neurologic complications listed by the MS/NID group in free text form who indicated a neurologic complication as side effect of a 2-dose vaccine series included “worsening of numbness and coordination”, “worsening of MS symptoms - weakness of muscles and loss of balance”, and “mental pain related to MS.” The remaining participants (n=1 first dose, and n=4 second dose) did not specify.