COVID-19 vaccines, SARS-CoV-2 infections after vaccination, flares and adverse events in patients with inflammatory and non-inflammatory RMDs
| Inflammatory RMDs | Non-inflammatory RMDs | All patients | ||
| Vaccine | mRNA/nucleic acid (Pfizer/BioNTech) | 3218 (70) | 382 (74) | 3600 (70) |
| mRNA/nucleic acid (Moderna) | 398 (7) | 30 (6) | 428 (8) | |
| Viral vector (AstraZeneca/Oxford) | 759 (16) | 96 (19) | 855 (17) | |
| Viral vector (Janssen/Johnson & Johnson) | 45 (1) | 5 (1) | 50 (1) | |
| Viral vector (Sputnik V) | 5 (<1) | 1 (<1) | 6 (<1) | |
| Inactivated vaccine (CoronaVac/Sinovac) | 53 (1) | 1 (<1) | 54 (1) | |
| Other | 4 (<1) | 4 (<1) | ||
| Unknown/missing | 110 (2) | 2 (<1) | 112 (2) | |
| Vaccine combination (Pfizer/BioNTech and AstraZeneca/Oxford) | 11 (<1) | 11 (<1) | ||
| Vaccine combination (Pfizer/BioNTech and CoronaVac/Sinovac) | 1 (<1) | 1 (<1) | ||
| Vaccine doses | One | 1149 (25) | 132 (26) | 1281 (25) |
| Two | 3406 (74) | 384 (74) | 3790 (74) | |
| Three | 46 (1) | 1 (<1) | 47 (1) | |
| Unknown/missing | 3 (<1) | 3 (<1) | ||
| SARS-CoV-2 infection after vaccination | Yes | 42 (1) | 4 (1) | 46 (1) |
| No | 4380 (95) | 490 (95) | 4870 (95) | |
| Unknown/missing | 182 (4) | 23 (4) | 205 (4) | |
| Vaccination status | Fully vaccinated cases | 2622 (57) | 270 (52) | 2892 (56) |
| Partially vaccinated cases | 1982 (43) | 247 (48) | 2229 (44) | |
| SARS-CoV-2 infection after vaccination, according to vaccination status (vaccination status is the denominator) | Fully vaccinated cases | 18/2622 (1) | 3/270 (1) | 21/2892 (1) |
| Partially vaccinated cases | 24/1982 (1) | 1/247 (<1) | 25/2229 (1) | |
| Flare following vaccination (only applicable to patients with inflammatory RMD; n=4604) | Yes | 204 (4) | – | – |
| No | 3706 (81) | – | – | |
| Unknown/missing | 694 (15) | – | – | |
| Type of flare (data presented as percentage of total number of inflammatory RMD cases (n=4604)) | Fever | 18 (<1) | – | – |
| Weight loss | 1 (<1) | – | – | |
| Increase in fatigue | 30 (1) | – | – | |
| Increase in dryness | 4 (<1) | – | – | |
| Enlarged lymph nodes | 4 (<1) | – | – | |
| Polyarthralgia | 83 (2) | – | – | |
| Arthritis flare | 95 (2) | – | – | |
| Cutaneous flare | 16 (<1) | – | – | |
| Pulmonary flare | 3 (<1) | – | – | |
| Renal flare | 1 (<1) | – | – | |
| Neurological flare | 2 (<1) | – | – | |
| Muscular flare | 15 (<1) | – | – | |
| Cardiac flare | 3 (<1) | – | – | |
| Gastro-intestinal flare | 1 (<1) | – | – | |
| Haematological flare | 3 (<1) | – | – | |
| Other | 17 (<1) | – | – | |
| Unknown/missing | 7 (<1) | – | – | |
| Severity of flare (data presented as percentage of total number of inflammatory RMD cases (n=4604)) | Mild/minor | 69 (2) | – | – |
| Moderate | 98 (2) | – | – | |
| Severe/major without hospitalisation | 20 (<1) | – | – | |
| Severe/major with hospitalisation | 9 (<1) | – | – | |
| Unknown/missing | 8 (<1) | – | – | |
| New medication or dosage increase due to flare | 68 (1) | – | – | |
| Vaccine-related AEs | Yes | 1688 (37) | 206 (40) | 1894 (37) |
| No | 2916 (63) | 311 (60) | 3227 (63) | |
| Early AEs | Pain at injection site | 881 (19) | 75 (15) | 956 (19) |
| Redness at injection site | 70 (2) | 4 (1) | 74 (1) | |
| Swelling at injection site | 75 (2) | 1 (<1) | 76 (1) | |
| Generalised muscle pain | 302 (7) | 41 (8) | 343 (7) | |
| Generalised joint pain | 163 (4) | 26 (5) | 189 (4) | |
| Headache | 293 (6) | 36 (7) | 329 (6) | |
| Fever | 331 (7) | 44 (9) | 375 (7) | |
| Chills | 130 (3) | 16 (3) | 146 (3) | |
| Fatigue | 531 (12) | 65 (13) | 596 (12) | |
| Vomiting | 58 (1) | 4 (1) | 62 (1) | |
| Diarrhoea | 38 (1) | 4 (1) | 42 (1) | |
| Unknown | 5 (<1) | 5 (<1) | ||
| AEs of special interest | Cardiovascular – arterial hypertension | 4 (<1) | 2 (<1) | 6 (<1) |
| Cardiovascular – arrhythmia | 3 (<1) | 3 (<1) | ||
| Cardiovascular – coronary artery disease | 2 (<1) | 2 (<1) | ||
| Cardiovascular – myocarditis and pericarditis | 1 (<1) | 1 (<1) | ||
| Dermatologic – eczema, nodes and plaques | 4 (<1) | 4 (<1) | ||
| Dermatologic – pruritus, injection site reaction, redness and burning | 3 (<1) | 2 (<1) | 5 (<1) | |
| Gastrointestinal – liver injury | 3(<1) | 3 (1) | 6 (<1) | |
| General conditions – hot flush, anxiety, lowered body temperature, loss and lack of appetite and night sweats | 8 (<1) | 1 (<1) | 9 (<1) | |
| Haematological – peripheral deep vein thrombosis | 2 (<1) | 2 (<1) | ||
| Haematological – haemorrhagic disease | 1 (<1) | 1 (<1) | ||
| Haematological – thrombocytopenia | 1 (<1) | 1 (<1) | ||
| Haematological – stroke | 1 (<1) | 1 (<1) | ||
| Immunological – anaphylaxis | 3 (<1) | 3 (<1) | ||
| Immunological – arthritis | 4 (<1) | 5 (1) | 9 (<1) | |
| Immunological – skin and mucosal | 8 (<1) | 1 (<1) | 9 (<1) | |
| Immunological – vasculitides | 1 (<1) | 2 (<1) | 3 (<1) | |
| Lymphadenopathy | 4 (<1) | 2 (<1) | 5 (<1) | |
| Malaise, fatigue and insomnia | 5 (<1) | 1 (<1) | 6 (<1) | |
| Neurological – anosmia and ageusia | 1 (<1) | 1 (<1) | ||
| Neurological – drowsiness, vertigo, dizziness, nausea, tinnitus, migraine and hallucination | 21 (<1) | 7 (1) | 21 (<1) | |
| Other possible cardiac symptoms – ankle oedema, dyspnoea and dry cough | 7 (<1) | 2 (<1) | 9 (<1) | |
| Pain/pain syndromes | 2 (<1) | 2 (<1) | 4 (<1) | |
| Tendons and joints – tendinopathy, frozen shoulder and carpal tunnel syndrome | 4 (<1) | 2 (<1) | 6 (<1) | |
| Viral infection – herpes, herpes zoster and shingles | 9 (<1) | 1 (<1) | 10 (<1) | |
| Viral infection – influenza, flu-like episodes, rhinitis, cough and cold | 7 (<1) | 1 (<1) | 8 (<1) | |
| Other | 3 (<1) | 3 (1) | 6 (<1) | |
| Total of adverse events of special interest | 112 (2) | 37 (7) | 149 (3) | |
| AE seriousness | Non-serious | 90 (2) | 25 (5) | 115 (2) |
| Serious – important medical event | 8 (<1) | 8 (2) | 16 (<1) | |
| Serious - hospitalisation (or prolongation of existing hospitalisation) | 6 (<1) | 2 (<1) | 8 (<1) | |
| Serious – life threatening | 3 (<1) | 3 (<1) | ||
| Unknown/missing | 4 (<1) | 4 (<1) | ||
| AE outcome | Ongoing/continuing | 21 (<1) | 6 (1) | 27 (1) |
| Recovered/resolved without sequelae | 75 (1) | 25 (5) | 100 (2) | |
| Recovered/resolved with sequelae | 6 (<1) | 2 (<1) | 8 (<1) | |
| Unknown/missing | 9 (<1) | 1 (<1) | 10 (<1) | |
All values are n (%) unless stated otherwise.
AEs, adverse events; RMDs, rheumatic and musculoskeletal diseases.