Table 3

COVID-19 vaccines, SARS-CoV-2 infections after vaccination, flares and adverse events in patients with inflammatory and non-inflammatory RMDs

Inflammatory RMDsNon-inflammatory RMDsAll patients
VaccinemRNA/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)
Other4 (<1)4 (<1)
Unknown/missing110 (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 dosesOne1149 (25)132 (26)1281 (25)
Two3406 (74)384 (74)3790 (74)
Three46 (1)1 (<1)47 (1)
Unknown/missing3 (<1)3 (<1)
SARS-CoV-2 infection after vaccinationYes42 (1)4 (1)46 (1)
No4380 (95)490 (95)4870 (95)
Unknown/missing182 (4)23 (4)205 (4)
Vaccination statusFully vaccinated cases2622 (57)270 (52)2892 (56)
Partially vaccinated cases1982 (43)247 (48)2229 (44)
SARS-CoV-2 infection after vaccination, according to vaccination status (vaccination status is the denominator)Fully vaccinated cases18/2622 (1)3/270 (1)21/2892 (1)
Partially vaccinated cases24/1982 (1)1/247 (<1)25/2229 (1)
Flare following vaccination (only applicable to patients with inflammatory RMD; n=4604)Yes204 (4)
No3706 (81)
Unknown/missing694 (15)
Type of flare (data presented as percentage of total number of inflammatory RMD cases (n=4604))Fever18 (<1)
Weight loss1 (<1)
Increase in fatigue30 (1)
Increase in dryness4 (<1)
Enlarged lymph nodes4 (<1)
Polyarthralgia83 (2)
Arthritis flare95 (2)
Cutaneous flare16 (<1)
Pulmonary flare3 (<1)
Renal flare1 (<1)
Neurological flare2 (<1)
Muscular flare15 (<1)
Cardiac flare3 (<1)
Gastro-intestinal flare1 (<1)
Haematological flare3 (<1)
Other17 (<1)
Unknown/missing7 (<1)
Severity of flare (data presented as percentage of total number of inflammatory RMD cases (n=4604))Mild/minor69 (2)
Moderate98 (2)
Severe/major without hospitalisation20 (<1)
Severe/major with hospitalisation9 (<1)
Unknown/missing8 (<1)
New medication or dosage increase due to flare68 (1)
Vaccine-related AEsYes1688 (37)206 (40)1894 (37)
No2916 (63)311 (60)3227 (63)
Early AEsPain at injection site881 (19)75 (15)956 (19)
Redness at injection site70 (2)4 (1)74 (1)
Swelling at injection site75 (2)1 (<1)76 (1)
Generalised muscle pain302 (7)41 (8)343 (7)
Generalised joint pain163 (4)26 (5)189 (4)
Headache293 (6)36 (7)329 (6)
Fever331 (7)44 (9)375 (7)
Chills130 (3)16 (3)146 (3)
Fatigue531 (12)65 (13)596 (12)
Vomiting58 (1)4 (1)62 (1)
Diarrhoea38 (1)4 (1)42 (1)
Unknown5 (<1)5 (<1)
AEs of special interestCardiovascular – arterial hypertension4 (<1)2 (<1)6 (<1)
Cardiovascular – arrhythmia3 (<1)3 (<1)
Cardiovascular – coronary artery disease2 (<1)2 (<1)
Cardiovascular – myocarditis and pericarditis1 (<1)1 (<1)
Dermatologic – eczema, nodes and plaques4 (<1)4 (<1)
Dermatologic – pruritus, injection site reaction, redness and burning3 (<1)2 (<1)5 (<1)
Gastrointestinal – liver injury3(<1)3 (1)6 (<1)
General conditions – hot flush, anxiety, lowered body temperature, loss and lack of appetite and night sweats8 (<1)1 (<1)9 (<1)
Haematological – peripheral deep vein thrombosis2 (<1)2 (<1)
Haematological – haemorrhagic disease1 (<1)1 (<1)
Haematological – thrombocytopenia1 (<1)1 (<1)
Haematological – stroke1 (<1)1 (<1)
Immunological – anaphylaxis3 (<1)3 (<1)
Immunological – arthritis4 (<1)5 (1)9 (<1)
Immunological – skin and mucosal8 (<1)1 (<1)9 (<1)
Immunological – vasculitides1 (<1)2 (<1)3 (<1)
Lymphadenopathy4 (<1)2 (<1)5 (<1)
Malaise, fatigue and insomnia5 (<1)1 (<1)6 (<1)
Neurological – anosmia and ageusia1 (<1)1 (<1)
Neurological – drowsiness, vertigo, dizziness, nausea, tinnitus, migraine and hallucination21 (<1)7 (1)21 (<1)
Other possible cardiac symptoms – ankle oedema, dyspnoea and dry cough7 (<1)2 (<1)9 (<1)
Pain/pain syndromes2 (<1)2 (<1)4 (<1)
Tendons and joints – tendinopathy, frozen shoulder and carpal tunnel syndrome4 (<1)2 (<1)6 (<1)
Viral infection – herpes, herpes zoster and shingles9 (<1)1 (<1)10 (<1)
Viral infection – influenza, flu-like episodes, rhinitis, cough and cold7 (<1)1 (<1)8 (<1)
Other3 (<1)3 (1)6 (<1)
Total of adverse events of special interest112 (2)37 (7)149 (3)
AE seriousnessNon-serious90 (2)25 (5)115 (2)
Serious – important medical event8 (<1)8 (2)16 (<1)
Serious - hospitalisation (or prolongation of existing hospitalisation)6 (<1)2 (<1)8 (<1)
Serious – life threatening3 (<1)3 (<1)
Unknown/missing4 (<1)4 (<1)
AE outcomeOngoing/continuing21 (<1)6 (1)27 (1)
Recovered/resolved without sequelae75 (1)25 (5)100 (2)
Recovered/resolved with sequelae6 (<1)2 (<1)8 (<1)
Unknown/missing9 (<1)1 (<1)10 (<1)
  • All values are n (%) unless stated otherwise.

  • AEs, adverse events; RMDs, rheumatic and musculoskeletal diseases.