Table 3.
Clinical events during vaccination at T1 (3–4 weeks) and T2 (8 weeks after fist vaccination) in SARS-CoV-2 unexposed persons/patients of the DIA-Vacc pure vaccination cohort.
| Variable | Category | MP T1 | DP T1 | KTR T1 | MP T2 | DP T2 | KTR T2 |
|---|---|---|---|---|---|---|---|
| Number | evaluable | 148 | 1304 | 376 | 148 | 1304 | 376 |
| Vaccination side effects | n /% | 37 / 25 | 126 / 9.7 | 112 / 29.8 | 59 / 39.9 | 315 / 24.2 | 119 / 31.6 |
| Arm pain | n /% | 26 / 17.6 | 88 / 6.7 | 94 / 25 | 33 / 22.3 | 183 / 14 | 78 / 20.7 |
| Joint pain | n /% | 4 / 2.7 | 6 / 0.5 | 7 / 1.9 | 14 / 9.5 | 43 / 3.3 | 10 / 2.7 |
| Fever | n /% | 3 / 2 | 9 / 0.7 | 5 / 1.3 | 18 / 12.2 | 50 / 3.8 | 14 / 3.7 |
| Shivering | n /% | 3 / 2 | 5 / 0.4 | 7 / 1.9 | 15 / 10.1 | 81 / 6.2 | 6 / 1.6 |
| Severe allergic reaction | n /% | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| others | n /% | 13 / 8.8 | 38 / 2.9 | 29 / 7.7 | 30 / 20.3 | 147 / 11.3 | 73 / 19.4 |
| hospitalization due to vaccination | n /% | 0 / 0 | 5 / 0.4 | 3 / 0.8 | 0 / 0 | 5 / 0.4 | 6 / 1.6 |
| Asymptomatic COVID-19 disease | n /% | 0 / 0 | 0 / 0 | 0 / 0 | 3 / 2 | 35 / 2.7 | 4 / 1.1 |
| Symptomatic COVID-19 disease with | n /% | 0 / 0 | 17 / 1.3 | 0 / 0 | 1 / 0.7 | 3 / 0.2 | 4 / 1.1 |
| Cough | n /% | 0 / 0 | 10 / 0.8 | 0 / 0 | 1 / 0.7 | 0 / 0 | 2 / 0.5 |
| headache | n /% | 0 / 0 | 5 / 0.4 | 0 / 0 | 1 / 0.7 | 1 / 0.1 | 2 / 0.5 |
| Fever | n /% | 0 / 0 | 8 / 0.6 | 0 / 0 | 0 / 0 | 0 / 0 | 3 / 0.8 |
| Dyspnoe | n /% | 0 / 0 | 4 / 0.3 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Dysgeusia/smelling disorder | n /% | 0 / 0 | 1 / 0.1 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Rash | n /% | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Diarrhoe | n /% | 0 / 0 | 0 / 0 | 0 / 0 | 1 / 0.7 | 0 / 0 | 1 / 0.3 |
| Hospitalization necessary | n /% | 0 / 0 | 10 / 0.8 | 0 / 0 | 0 / 0 | 0 / 0 | 1 / 0.3 |
| Intensive care necessary | n /% | 0 / 0 | 3 / 0.2 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Mechanical ventilation necessary | n /% | 0 / 0 | 1 / 0.1 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Death due to/with COVID-19 | n /% | 0 / 0 | 5 / 0.4 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| SARS-Cov-2 transmission likely due to | n /% | 0 / 0 | 16 / 1.2 | 0 / 0 | 1 / 0.7 | 3 / 0.2 | 4 / 1.1 |
| Medical personnel | n /% | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Patients | n /% | 0 / 0 | 3 / 0.2 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| carpool | n /% | 0 / 0 | 2 / 0.2 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Private domain | n /% | 0 / 0 | 3 / 0.2 | 0 / 0 | 1 / 0.7 | 3 / 0.2 | 4 / 1.1 |
| unknown | n /% | 0 / 0 | 8 / 0.6 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
T0 = before first vaccination; T1 = 3–4 weeks after first vaccination; T2 = 8 weeks after first vaccination.
For this evaluation, all participants with previous asymptomatic* or documented symptomatic** COVID-19 disease before vaccination (T0) were excluded and de novo COVID-19 cases during vaccination up to T2 were assessed. Symptomatic COVID-19 disease was documented for SARS-CoV-2 PCR positive patients with clinical symptoms between T1 and T0 as well as between T2 and T1. Asymptomatic COVID-19 disease was assessed by participants without knowledge or symptoms of COVID-19 disease, but de novo IgG-antibody reaction to the nucleocapsid subunit of the SARS-CoV-2 virus independent on other measures.
*Asymptomatic COVID-19 disease definition - neither knowledge nor symptoms of COVID-19 disease, but IgG-antibody reaction to nucleocapsid (T0, T1 or T2) or to the Spike protein subunit S1 (only T0) of the SARS-CoV-2 virus is positive.
**Symptomatic COVID-19 disease definition - SARS-CoV-2 PCR positive patients with clinical symptoms.