Table 6

Adverse events of special interest possibly/probably related to COVID-19 vaccination among patient with inflammatory RMDs

AE type	Seriousness of AE	Outcome of AE	COVID-19 vaccine	RMD	RMD medication*	Medication held or reduced
Cardiovascular – arterial hypertension	Non-serious	Recovered/resolved without sequelae	Moderna	axSpA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	AZ	RA	HCQ+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	MTX+GC	No
	Serious (important medical event)	Recovered/resolved without sequelae	Pfizer	pSpA	GC	No
Cardiac – arrhythmia	Non-serious	Recovered/resolved without sequelae	Pfizer	SLE	HCQ+AZA+GC	No
	Non-serious	UNK	Pfizer	RA	GC	Yes
	Non-serious	Ongoing/continuing	Pfizer	EDS	None	NA
Cardiac – coronary artery disease	Serious (life threatening)	Recovered/resolved without sequelae	Pfizer	RA	ABA+MTX+GC	No
Cardiac – coronary artery disease	Serious (life threatening)	Recovered/resolved with sequelae	Pfizer	RA	RTX+LEF+GC	No
Cardiac – myocarditis and pericarditis	Non-serious	Recovered/resolved without sequelae	Pfizer	SLE	None	NA
Dermatological – eczema, nodes and plaques	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	ABA	No
	Non-serious	Recovered/resolved without sequelae	Moderna	SjS	HCQ+GC	Yes
	Non-serious	Ongoing/continuing	AZ	PsA	Apremilast	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	pSpA	TNFi	No
Dermatological – pruritus, injection site reaction, redness and burning	Non-serious	Recovered/resolved without sequelae	Pfizer	pSpA	LEF+GC	No
	Non-serious	Ongoing/continuing	Pfizer	RA	MTX+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	PMR	HCQ+GC	No
Gastrointestinal – liver injury	Non-serious	Recovered/resolved without sequelae	Pfizer	GCA	MTX	Yes
	Non-serious	Ongoing/continuing	Pfizer	RP	AZA+GC	No
	Serious (life threatening)	Recovered/resolved with sequelae	Pfizer	SLE	HCQ+GC	No
General conditions – hot flush, anxiety, lowered body temperature, loss and lack of appetite and night sweats	Non-serious	Recovered/resolved without sequelae	Pfizer	SSc	MMF+GC	No
	Non-serious	Recovered/resolved without sequelae	AZ	axSpA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	IL-6	UNK
	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-17	Yes
	Non-serious	Recovered/resolved without sequelae	Pfizer	GCA	None	NA
	Non-serious	Recovered/resolved without sequelae	AZ	RA	ABA+MTX	No
	Non-serious	Recovered/resolved without sequelae	Moderna	RA	None	NA
	Non-serious	Ongoing/continuing	AZ	axSpA	TNFi	No
Haematological – peripheral deep vein thrombosis	Non-serious	Ongoing/continuing	Pfizer	axSpA	IL-17	No
Haematological – peripheral deep vein thrombosis	Serious (hospitalisation)	Ongoing/continuing	Pfizer	AAV	AZA+GC	No
Haematological – haemorrhagic disease	Non-serious	Recovered/resolved without sequelae	AZ	RA	HCQ+GC	No
Haematological – stroke	Serious (Hospitalisation)	Recovered/resolved with sequelae	Pfizer	PMR	IL-6+GC	No
Haematological – thrombocytopenia	Non-serious	Recovered/resolved without sequelae	AZ	mCTD	None	NA
Immunological – anaphylaxis	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	SSc	Sildenafil	No
	Non-serious	Recovered/resolved without sequelae	AZ	Other vasculitis	GC	Yes
Immunological – arthritis	Non-serious	Recovered/resolved without sequelae	AZ	SjS	HCQ	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	PMR	HCQ+GC	No
	Non-serious	UNK	AZ	GCA	IL-6+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	SLE	HCQ+Belimumab	No
Immunological – skin or mucosal	Non-serious	Recovered/resolved without sequelae	Pfizer	SLE	AZA+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	SSZ+GC+NSAIDs	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	Myositis	HCQ+MTX+GC	No
	Non-serious	Ongoing/continuing	Moderna	SjS	None	NA
	Serious (hospitalisation)	Recovered/resolved without sequelae	Pfizer	PsA	None	NA
	Serious (important medical event)	Recovered/resolved without sequelae	Pfizer	RA	ABA+HCQ	No
	Serious (important medical event)	Recovered/resolved without sequelae	AZ	u-CTD	HCQ	No
	Serious (important medical event)	Ongoing/continuing	Pfizer	PsA	TNFi	No
Immunological – vasculitides	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-17	Yes
Lymphadenopathy	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-17+MTX	No
	Non-serious	Recovered/resolved without sequelae	Moderna	mCTD	None	NA
	Non-serious	Recovered/resolved without sequelae	Pfizer	Other vasculitis	None	NA
	Non-serious	Ongoing/continuing	Pfizer	RA	MTX	No
Malaise, fatigue and insomnia	Non-serious	Recovered/resolved without sequelae	AZ	PMR	MTX+GC	No
	Non-serious	Recovered/resolved with sequelae	AZ	Monogenic AIS	Colchicine	No
	Serious (important medical event)	Ongoing/continuing	Pfizer	SSc	MMF	Yes
	UNK	UNK	Pfizer	PsA	None	NA
	UNK	UNK	Pfizer	PsA	TNFi+NSAIDs	No
Neurological – anosmia and ageusia	Non-serious	Recovered/resolved without sequelae	Pfizer	SjS	MTX	No
Neurological – drowsiness, vertigo, dizziness, nausea, tinnitus, migraine, hallucination and hemiparesis	Non-serious	Ongoing/continuing	Pfizer	Sarcoidosis	HCQ	No
	Non-serious	Recovered/resolved without sequelae	Unknown	Other IA	HCQ+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	pSpA	Apremilast	No
	Non-serious	Recovered/resolved without sequelae	AZ	pSpA	IL-17	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-17	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	IL-17	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	SjS	MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	MTX	No
	Non-serious	Recovered/resolved without sequelae	Moderna	RA	SSZ	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	Non-systemic JIA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	TNFi	Yes
	Non-serious	Recovered/resolved without sequelae	Moderna	pSpA	None	NA
	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-12/23	No
	Non-serious	Ongoing/continuing	AZ	PsA	None	NA
	Non-serious	Recovered/resolved without sequelae	AZ	RA	SSZ	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	MTX	Yes
	Non-serious	Recovered/resolved without sequelae	Pfizer	SSc	Unknown	NA
	Serious (important medical event)	Ongoing/continuing	Pfizer	SSc	HCQ+MMF	No (HCQ), UNK (MMF)
Other possible cardiac symptoms – ankle oedema, dyspnoea and dry cough	Non-serious	Recovered/resolved without sequelae	Pfizer	PsA	IL-17	No
	Non-serious	Recovered/resolved without sequelae	Moderna	RA	IL-6	No
	Non-serious	Recovered/resolved with sequelae	Pfizer	AAV	Benralizumab	No
	Non-serious	Ongoing/continuing	Moderna	RA	RTX+GC	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	JAKi +GC	Yes (GC), No (JAKi)
	Serious (important medical event)	Recovered/resolved without sequelae	Pfizer	SjS	HCQ	No
	UNK	UNK	Pfizer	RA	TNFi	No
Pain/pain syndromes	Non-serious	UNK	Pfizer	SjS	None	NA
Pain/pain syndromes	Non-serious	Recovered/resolved without sequelae	Pfizer	PMR	GC	UNK
Tendons and joints – tendinopathy, frozen shoulder and carpal tunnel syndrome	Non-serious	UNK	Pfizer	RA	ABA+MTX	No
	Non-serious	Ongoing/continuing	Moderna	uCTD	None	NA
	Non-serious	Ongoing/continuing	Pfizer	PMR	GC	No
	UNK	UNK	AZ	RA	MTX	No
Viral infections – herpes, herpes zoster and shingles	Non-serious	Ongoing/continuing	Pfizer	SjS	HCQ	No
	Non-serious	Ongoing/continuing	Moderna	RA	JAKi	No
	Non-serious	Ongoing/continuing	Pfizer	RA	JAKi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	TNFi	No
	Non-serious	Ongoing/continuing	Pfizer	PMR	GC	No
	Non-serious	Recovered/resolved with sequelae	AZ	RA	TNFi	No
	Serious (hospitalisation)	Recovered/resolved without sequelae	Pfizer	RA	JAKi	Yes
	Serious (hospitalisation)	UNK	Pfizer	RA	MTX+GC	Yes (MTX), No (GC)
	Serious (important medical event)	Recovered/resolved without sequelae	Pfizer	RA	MTX+GC	No
Viral infections – influenza, flu-like episodes, rhinitis, cough and cold	Non-serious	Recovered/resolved without sequelae	Pfizer+AZ	GCA	IL-6	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	Myositis	MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	RTX+MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	axSpA	TNFi	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	CRMO	TNFi+MTX	No
	Non-serious	Recovered/resolved without sequelae	Pfizer	SjS	None	NA
Other – GORD	Non-serious	Recovered/resolved without sequelae	Pfizer	RA	LEF	No
Other – neck swelling	Serious (hospitalisation)	Recovered/resolved without sequelae	Pfizer	RA	LEF	No
Other (UNK)	Non-serious	UNK	Pfizer	RA	JAKi+LEF+GC	No

*Immunosuppressive or immunomodulatory medication.
AAV, ANCA-associated vasculitis; ABA, abatacept; AE, adverse event; AIS, autoinflammatory syndrome; axSpA, axial spondyloarthritis; AZ, Oxford/AstraZeneca; AZA, azathioprine; CRMO, chronic recurrent multifocal osteomyelitis; EDS, Ehlers-Danlos syndrome; GC, glucocorticoids; GCA, giant cell arteritis; GORD, gastro-oesophageal reflux disease; HCQ, hydroxychloroquine; IA, inflammatory arthritis; IL-6, interleukin-6; IL-17, interleukin-17; IL-12/23, interleukin-12/23; JAKi, Janus kinase inhibitors; JIA, juvenile idiopathic arthritis; LEF, leflunomide; mCTD, mixed connective tissue disease; MMF, mycophenolate mofetil/mycophenolic acid; MTX, methotrexate; NSAIDs, nonsteroidal anti-inflammatory drugs; PMR, polymyalgia rheumatica; PsA, psoriatic arthritis; pSpA, peripheral spondyloarthritis; RA, rheumatoid arthritis; RMD, rheumatic and musculoskeletal disease; RP, relapsing polychondritis; RTX, rituximab; SjS, Sjogren’s syndrome; SLE, systemic lupus erythematosus; SpA, spondyloarthritis; SSc, systemic sclerosis; SSZ, sulfasalazine; TNFi, tumour necrosis factor; uCTD, undifferentiated connective tissue disease; UNK, unknown/missing.