Liver injury after COVID-19 vaccination: Current status and future perspectives

Table 2 Case series focused on new-onset autoimmune hepatitis associated with coronavirus disease 2019 vaccination, n (%)

Ref.	Clinical presentation	Autoimmune liver disease-related data	Pathology, and/or diagnostic criteria	Therapy	Outcome at the end of follow-up	Rechallenge
[28]	Death: 1 (1.9); life-threatening: 10 (19); hospitalization: 18 (34); ER visit: 14 (26)	NA	NA	NA	Death: 1 (1.9)	NA
[29]	Transaminase > 20 × ULN: 10 (83); jaundice: 8 (67)	ANA+: 6 (50); ASMA+: 1 (8.3); ALKM+: 1 (8.3); median IgG: 1.2 XULN	Histology: n not available: Typical AIH: 8; compatible AIH: 3	IS: n not available	CBR to IS: 58%	NA
[30]1	Symptomatic: 5 (83); asymptomatic: 1 (17)	ANA+: 3 (50); ASMA+: 5 (83); AMA+: 2 (33); Anti-SLA+: 1 (17); elevated IgG: 6 (100)	n = 4 for liver biopsy: Fibrosis: 2 (50) including METAVIR score: 3	Steroid: 3 (50); steroid/azathioprine: 3 (50)	Long-term IS: 3 (50); lost to follow-up: 2 (33); Remission: 1 (17)	NA
[31]	No acute liver failure; one severe acute hepatitis with marked icterus	ANA+: 5 (100); IgG > 1600 mg/dL: 5 (100), HLA-DRB1 (*03:01: 3, *07:01: 2, *11:04: 1, *04: 1, *04:03: 1, *01:03: 1)3	n = 4 for liver biopsy: Simplified IAIHG criteria for the Dx of AIH2: 7-8, CIOMS–RUCAM score2 related to vaccine: 2 (20), 3 (60), 6 (20)	n = 4: Steroid/azathioprine: 3 (75); steroid: 1 (25)	Spontaneous regression: 1 (20); biochemical response to IS: 4 (80)	n = 4 (total 6 additional doses) same: 33; same platform: 13; different platform: 23; no relapse in transaminases

¹Among 76 individuals who developed acute autoimmune hepatitis following at least one coronavirus disease 2019 vaccine dose, six cases occurring within 42 days post-vaccination, with detailed clinical data and a presumed higher likelihood of causal association, were used for analysis.

²Assumed to be applied in the absence of direct citation.

³Data are presented as n.

AIH: Autoimmune hepatitis; ANA: Antinuclear antibody; AMA: Anti-mitochondrial antibody; ALKM: Anti–liver-kidney microsomal antibody; ASMA: Anti-smooth muscle antibody; CBR: Complete biochemical response; CIOMS–RUCAM: Council for International Organizations of Medical Sciences–Roussel Uclaf Causality Assessment Method; COVID-19: Coronavirus disease 2019; Dx: Diagnosis; ER: Emergency room; HLA: Human leukocyte antigen; IAIHG: International Autoimmune Hepatitis Group; IgG: Immunoglobulin G; IS: Immunosuppressants; NA: Not available; SLA: Soluble liver antigen; ULN: Upper limit of normal.