Table 1 Summary of the characteristics of the included studies with evidence on new-onset and relapsed liver diseases post-COVID-19 vaccination (n = 118 studies), 2021–2022

Acute cellular rejection of the liver

Hughes et al. 2022 [34], United States

Retrospective case report, single centre

65

1 (100)

1 White (Caucasian)

2

1 Cryptogenic cirrhosis

1 Liver transplant recipient

1 Coronary artery disease

1 Diabetes mellitus

1 Hyperlipidaemia

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Extremity weakness

1 Paraesthesia ascending to bilateral hands

1 Hyporeflexia

1 Loss of pinprick sensation

1 Difficulty with walking

1 Bilateral cranial nerve 7 palsies

1 Acute inflammatory demyelinating polyneuropathy

1 Raised liver enzymes

1 Raised bilirubin

1 Thrombocytopenia

1 Raised white blood cells

1 High CRP

Mild acute rejection in his graft

Innumerable new bilobar lesions [n = 1]

1 IVIG

1 Steroid

(NOS, moderate)

1 survived

Sarwar et al. 2022 [69], United States

Retrospective case-series, single centre

Median (IQR), 54 (51–66)

4 (80)

5 White (Caucasian)

Mean (SD), 11.6 (4.6)

5 Liver transplant recipients

3 Non-alcoholic steatohepatitis-related cirrhosis

2 Alcohol-related cirrhosis

2 History of acute cellular rejection

Moderna, dose 1 and dose 2 [n = 3]

Pfizer-BioNTech, dose 1 and dose 2 [n = 2]

New-onset [n = 3]

Relapsed [n = 2]

Not reported [n = 5]

3 Raised liver enzymes

4 Raised bilirubin

Typical features of T cell-mediated ACRL including portal inflammation of predominantly mixed activated lymphocytes, portal vein phlebitis and bile duct injuries [n = 5]

Not performed [n = 5]

9 Steroid

1 Everolimus

2 Tacrolimus

1 Cyclosporine

1 Mycophenolate mofetil

(NOS, moderate)

5 survived

Valsecchi et al. 2022 [29], Italy

Retrospective case report, single centre

58

0 (0)

1 White (Caucasian)

44

1 Autoimmune cirrhosis

1 Grade II encephalopathy

1 Refractory ascites

1 End-stage liver disease

1 Liver transplant recipient

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Worsened neurologic status

1 Vaccine-induced immune thrombotic thrombocytopenia

1 Graft-versus-host disorder

1 Transplantation-mediated alloimmune thrombocytopenia

1 Low Hb

1 Thrombocytopenia

1 High INR

1 High D-dimer

1 Raised liver enzymes

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Small millimetric high density area on the occipital lobe [n = 1]

1 Heparin

1 Fondaparinux

1 IVIG

1 Steroid

(NOS, moderate)

1 survived

Vyhmeister et al. 2021 [82], United States

Retrospective case report, single centre

64

0 (0)

1 White (Caucasian)

11

1 Cirrhosis

1 Hepatitis C virus

1 Hepatocellular carcinoma

1 Liver transplant recipient

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Dark urine

1 Fatigue

1 Malaise

1 Raised liver enzymes

Typical features of ACRL including mixed portal inflammation, bile duct injury, and endotheliitis [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

1 Mycophenolate mofetil

1 Anti-thymocyte globulin

(NOS, moderate)

1 survived

Acute hepatic failure

Barary et al. 2022 [128], Iran

Retrospective case report, single centre

35

1 (100)

1 Persian

8

1 Psychological problems

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Generalized weakness

1 Abdominal pain

1 Jaundice

1 Fever

1 Headache

1 Vomiting

1 Loss of appetite

1 High D-dimer

1 Thrombocytopenia 1 Low fibrinogen

1 Raised liver enzymes

1 Raised bilirubin

1 DIC

1 High INR

Not performed [n = 1]

Grade I fatty liver disease [n = 1]

Mild effusion in subdiaphragmatic space [n = 1]

1 Steroid

1 IVIG

1 Rivaroxaban

(NOS, moderate)

1 died

Efe et al. 2022 [45], Turkey

Retrospective case report, single centre

53

1 (100)

1 White (Caucasian)

10

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Erythematous skin eruption

1 Pruritus

1 Hypersensitivity reaction

1 Myalgia

1 Fatigue

1 Jaundice

1 Vaccine-induced immune-mediated liver injury

1 Hepatic encephalopathy

1 Fulminant liver failure

1 Raised liver enzymes

1 Raised bilirubin

1 High INR

1 Elevated IgG

Portal inflammation with interface

activity and significant lobular necroinflammatory

activity, hepatocellular rosette formation and emperipolesis [n = 1]

Not performed [n = 1]

1 Antihistamines

1 Steroid

1 Plasma exchange

1 Liver transplantation

(NOS, high)

1 survived

Hieber et al. 2022 [35], Germany

Retrospective case report, single centre

24

0 (0)

1 White (Caucasian)

10

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Fatigue

1 Chills

1 Weakness

1 Nausea

1 Painful cervical and supraclavicular bilateral lymphadenopathy 1 Hemophagocytic lymphohistiocytosis

1 Acute liver failure

1 Reduced white blood cells

1 Raised liver enzymes

1 High LDH

1 Positive ANAs

1 High ferritin

Unremarkable [n = 1]

Splenomegaly [n = 1]

Enlarged cervical and supraclavicular lymph nodes [n = 1]

1 Steroid

1 IVIG

1 Anakinra

(NOS, moderate)

1 survived

Sohrabi et al. 2022 [78], Iran

Retrospective case report, single centre

34

1 (100)

1 Persian

1

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Nausea

1 Dizziness

1 Abdominal pain

1 Myalgia

1 Yellow eyes

1 Petechiae

1 Gastrointestinal haemorrhage

1 DIC

1 Acute hepatic failure

1 Raised liver enzymes

1 Raised bilirubin

1 High D-dimer

1 High PT

1 High INR

1 Raised white blood cells

1 High APTT

1 High CRP

Liver massive infarction [n = 1]

Massive emboli in portal-vein to the splenic with blockage of the hepatic artery by a thrombus [n = 1]

1 Steroid

1 Antibiotics

1 PRBCs

(NOS, moderate)

1 died

Acute liver injury

Alqarni et al. 2021 [113], Saudi Arabia

Retrospective case report, single centre

14

0 (0)

1 Arab

3

1 No medical history

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Epigastric pain

1 Epigastric tenderness

1 Diarrhea

1 Nausea

1 Vomiting

1 Jaundice

1 Leukopenia

1 Neutropenia

1 Lymphopenia

1 High PT

1 High APTT

1 High INR

Not performed [n = 1]

Minimal rim of free fluid in the pelvic cavity [n = 1]

1 IV fluids

1 N-acetylcysteine

1 Lactulose

1 Vitamin K

1 Intubation

(NOS, low)

1 survived

Dumortier 2021 [99], France

Retrospective case report, single centre

46

0 (0)

1 White (Caucasian)

12

1 Alcohol-associated liver disease

1 Liver transplant recipient

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

Not reported [n = 1]

1 Raised liver enzymes

1 Raised bilirubin

Not performed [n = 1]

Unremarkable [n = 1]

No treatment [n = 1]

(NOS, moderate)

1 survived

Ghorbani et al. 2022 [44], Iran

Retrospective case report, single centre

62

1 (100)

1 Persian

3

1 Hypertension

1 Diabetes mellitus

Sinopharm COVID-19 vaccine, dose 2 [n = 1]

New-onset [n = 1]

1 Weakness

1 Jaundice

1 Weight loss

1 Itching

1 Yellow eyes

1 Yellow skin

1 Raised liver enzymes

1 Raised bilirubin

Not performed [n = 1]

Hepatitis pattern of injury [n = 1]

Portal and lobular inflammation and marked eosinophils infiltration [n = 1]

1 Ursodeoxycholic acid

(NOS, moderate)

1 survived

Kawasaki et al. 2022 [122], Japan

Retrospective case report, single centre

15

0 (0)

1 Asian

1

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Headache

1 Raised liver enzymes

1 Leukopenia

1 Thrombocytopenia

1 High LDH

Not performed [n = 1]

Unremarkable [n = 1]

1 IV fluids

(NOS, moderate)

1 survived

Mann et al. 2021 [12], United States

Retrospective case report, single centre

61

0 (0)

1 White (Caucasian)

9

1 Irritable bowel disease

1 Cholecystectomy

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Generalized weakness

1 Pain

1 Vomiting

1 Yellow eyes

1 Abdominal tenderness

1 Tachycardia

1 Raised liver enzymes

1 Raised bilirubin

1 Raised white blood cells

Minimal pallor suggesting slight oedema along with scattered inflammatory cells [n = 1]

Increased echogenicity within the liver compatible with fatty infiltrates [n = 1]

1 Antibiotics

(NOS, moderate)

1 survived

Shroff et al. 2021 [13], United States

Retrospective case-series, multicenter

Median (IQR), 63 (49.2–69.5)

6 (37.5)

Not reported

Mean (SD), 25.9 (12.3)

6 Chronic liver disease

4 AIH

3 Cirrhosis

1 Hepatitis C virus

1 Drug-induced liver injury

Pfizer-BioNTech, dose 1 and dose 2 [n = 12]

Moderna, dose 1 and dose 2 [n = 4]

New-onset [n = 11]

Relapsed [n = 5]

16 Liver injuries

3 Acute liver injuries

1 Primary sclerosing cholangitis

16 Raised liver enzymes

12 Raised bilirubin

7 High INR

5 Positive ANAs

4 Positive ASMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Portal inflammation [n = 10]

Severe cholestasis [n = 1]

Not performed [n = 6]

New severe sclerosing cholangitis [n = 1]

Hepatic steatosis [n = 1]

Solitary HCC [n = 1]

Unremarkable [n = 2]

Not performed [n = 2]

8 Steroid

2 N-acetylcysteine

1 Biliary dilatation

(NOS, high)

16 survived

Autoimmune hepatitis

Avci et al. 2021 [112], Turkey

Retrospective case report, single centre

61

0 (0)

1 White (Caucasian)

30

1 Hashimoto’s thyroiditis

1 Hypertension

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Malaise

1 Fatigue

1 Anorexia

1 Nausea

1 Yellow eyes

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Positive ASMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

gallbladder was filled with many millimetric stones [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Boettler et al. 2022 [127], Germany

Retrospective case report, single centre

52

1 (100)

1 White (Caucasian)

14

1 Hypothyroidism

Pfizer-BioNTech, dose 1 and dose 2 [n = 1]

New-onset [n = 1]

1 Acute mixed hepatocellular/cholestatic hepatitis [after 1^st dose]

1 Severe hepatitis [after 2^nd dose]

1 Pruritus

1 Nausea

1 Fatigue

1 Loss of appetite

1 Jaundice

1 Fatigue

1 Highly activated cytotoxic CD8 T-cell infiltrate

1 Raised liver enzymes

Histopathological findings consistent with AIH [n = 1]

Infiltrates consisting of T-cells, macrophages, B-cells, plasma cells and granulocytes in the liver [n = 1]

1 Steroid

1 Ursodeoxycholic acid

(NOS, moderate)

1 survived

Bril et al. 2021 [6], United States

Retrospective case report, single centre

35

0 (0)

1 White (Caucasian)

7

1 Pregnancy

1 Hypertension

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Pruritus

1 Dark urine

1 Jaundice

1 Hepatomegaly

1 Raised liver enzymes

1 Raised bilirubin

1 Raised ammonium

1 Positive ANAs

1 Positive ds-DNA antibodies

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, high)

1 survived

Camacho-Domínguez et al. 2022 [37], Colombia

Retrospective case report, single centre

79

1 (100)

1 Hispanic

15

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Jaundice

1 Pruritus

1 Acholia

1 Choluria

1 Yellow skin

1 Abdominal tenderness

1 Esophagitis

1 Gastritis

1 Raised liver enzymes

1 Raised bilirubin

1 Lymphopenia

1 Elevated IgG

1 Positive ANAs

1 Positive ASMAs

Histopathological findings consistent with AIH [n = 1]

Edema of the gallbladder walls with a pattern described in acute hepatitis [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Cao et al. 2021 [110], China

Retrospective case report, single centre

57

0 (0)

1 Asian

2

1 No medical history

Sinovac-CoronaVac, dose 2 [n = 1]

New-onset [n = 1]

1 Dark urine

1 Acholic stools

1 Pruritus

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

1 Positive ANAs

1 Positive anti–Sjögren syndrome antigen A

1 Positive anti–major centromere autoantigen B

1 Positive anti–Sjögren syndrome antigen B

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Ursodeoxycholic acid

1 Steroid

1 Azathioprine

(NOS, high)

1 survived

Clayton-Chubb et al. 2021 [101], Australia

Retrospective case report, single centre

36

1 (100)

1 Arab

26

1 Hypertension

1 Laser eye surgery

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Pruritus

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

3 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Mild peri-portal oedema [n = 1]

1 Steroid

(NOS, high)

1 survived

Efe et al. 2022 [126], Multicounty

Retrospective case-series, multicenter

Median (IQR), 48 (18–79)

32 (36.8)

Not reported

Median (IQR), 15 (3–65)

13 Diabetes mellitus

13 Hypertension

12 Pre-existing liver disease

7 NAFLD

1 Primary biliary cholangitis

1 Hepatitis C infection

1 Liver transplant

1 Breast cancer

1 Pemphigus vulgaris

1 Polycythemia vera

Pfizer-BioNTech, dose not reported [n = 51]

Moderna, dose not reported [n = 16]

Oxford Uni-AstraZeneca, dose not reported [n = 20]

New-onset [n = 48]

Not reported [n = 39]

65 Fatigue

55 Nausea

34 Jaundice

21 Abdominal pain

10 Itching

7 Rash

7 Fever

56 Positive ANAs

15 Positive ASMAs

5 Positive AMAs

53 Elevated IgG

1 Anti-SLA

1 Positive LC-1

7 Raised liver enzymes

Histopathological findings consistent with AIH [n = 34]

Not reported [n = 87]

46 Steroid

9 Azathioprine

2 Mycophenolate mofetil

9 Plasma exchange

1 IVIG

1 Liver transplantation

(NOS, moderate)

87 survived

Erard et al. 2021 [99], France

Retrospective case reports, single centre

Median (IQR), 73 (68–73)

0 (0)

3 Whites (Caucasians)

Mean (SD), 17 (6.1)

1 Not reported

Pfizer-BioNTech, dose 2 [n = 1]

Moderna, dose 2 [n = 1]

Oxford Uni-AstraZeneca, dose 3 [n = 1]

New-onset [n = 3]

2 Fatigue

3 Pruritus

3 Jaundice

1 Hepatic encephalopathy

1 Liver failure

1 Sepsis

3 Raised liver enzymes

3 Raised bilirubin

1 High INR

3 Positive ANAs

Histopathological findings consistent with AIH [n = 3]

Unremarkable [n = 1]

2 Steroid

(NOS, moderate)

2 survived

1 died

Fimiano et al. 2022 [68], Italy

Retrospective case report, single centre

63

0 (0)

1 White (Caucasian)

54

1 Postmenopausal hypothyroidism

1 Family history of 1st-degree relative with coeliac disease

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Nausea

1 Hyperchromic urines

1 Jaundice

1 Hypoechoic stools

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ATA

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Garrido et al. 2021 [7], Portugal

Retrospective case report, single centre

65

0 (0)

1 White (Caucasian)

14

1 Polycythemia vera

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Dark urine

1 Abdominal pain

1 Hepatomegaly

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

3 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Hepatomegaly [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Ghielmetti et al. 2021 [102], Switzerland

Retrospective case report, single centre

63

1 (100)

1 White (Caucasian)

7

1 Diabetes mellitus

1 Ischemic heart disease

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Fatigue

1 Anorexia

1 Hepatomegaly

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Goulas et al. 2021 [97], Greece

Retrospective case report, single centre

52

0 (0)

1 White (Caucasian)

14

1 No medical history

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Malaise

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 High CRP

1 High ESR

1 Positive ANAs

1 Positive ASMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Hasegawa et al. 2022 [124], Japan

Retrospective case report, single centre

82

0 (0)

1 Asian

7

1 Hepatitis C infection

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Fatigue

1 Loss of appetite

1 Severe liver injury

1 Positive ANAs

1 Elevated IgG

1 Raised liver enzymes

1 Raised bilirubin

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Kang et al. 2022 [123], Republic of Korea

Retrospective case report, single centre

27

0 (0)

1 Asian

14

1 No medical history

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Hepatomegaly

1 Nausea

1 Vomiting

1 Headache

1 Fever

1 Dark urine

1 Enteritis

1 Diarrhea

1 Elevated IgG

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

Histopathological findings consistent with AIH [n = 1]

Splenomegaly [n = 1]

Gallbladder wall thickening [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Lasagna et al. 2022 [120], Italy

Retrospective case report, single centre

52

0 (0)

1 White (Caucasian)

10

1 Lung adenocarcinoma with bone metastases

1 Hepatitis B infection

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Hepatitis

1 Colitis

1 Diarrhea

1 Raised liver enzymes

1 High LDH

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Lee et al. 2022 [119], Republic of Korea

Retrospective case report, single centre

57

0 (0)

1 Asian

14

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Weakness

1 Fatigue

1 Raised liver enzymes

1 Positive ANAs

1 Positive AMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Ursodeoxycholic acid

(NOS, moderate)

1 survived

Lodato et al. 2021 [105], Italy

Retrospective case report, single centre

43

0 (0)

1 White (Caucasian)

15

1 Hyperlipidemia

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Itching

1 Abdominal pain

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 N-acetylcysteine

(NOS, high)

1 survived

Londoño et al. 2021 [108], Spain

Retrospective case report, single centre

41

0 (0)

1 White (Caucasian)

7

1 Premature ovarian failure

1 Substitutive hormonal therapy

Moderna, dose 2 [n = 1]

New-onset [n = 1]

1 Epigastric pain

1 Nausea

1 Vomiting

1 Dark urine

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Positive ASMAs

1 Positive LC-1

1 Elevated IgG

1 Anti-SLA

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, high)

1 survived

Mahalingham et al. 2022 [43], United Kingdom

Retrospective case report, single centre

32

0 (0)

1 White (Caucasian)

21

1 Liver transplant recipient

1 Autoimmune hepatitis

Pfizer-BioNTech, dose 3 [n = 1]

Relapsed [n = 1]

Asymptomatic

1 Raised liver enzymes

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

McShane et al. 2021 [107], Ireland

Retrospective case report, single centre

71

0 (0)

1 White (Caucasian)

4

1 Cholecystectomy

1 Left total hip replacement

1 Osteoarthritis of the knees

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

1 Positive ASMAs

Histopathological findings consistent with AIH [n = 1]

Distal common bile duct dilation consistent with prior cholecystectomy [n = 1]

1 Steroid

(NOS, high)

1 survived

Mekritthikrai et al. 2022 [118], Thailand

Retrospective case report, single centre

52

0 (0)

1 Asian

7

1 Hypertension

1 Dyslipidemia

Sinovac-CoronaVac, dose 2 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Fatigue

1 Yellow eyes

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Positive ASMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Liver cirrhosis [n = 1]

1 Steroid

1 Azathioprine

(NOS, high)

1 survived

Nyein et al. 2022 [117], Singapore

Retrospective case report, single centre

34

1 (100)

1 Asian

14

1 No medical history

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Pruritus

1 Fever

1 Jaundice

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

1 Positive ANAs

1 Positive AMAs

1 Acute hepatitis

1 Acute cholestasis

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Ursodeoxycholic acid

(NOS, high)

1 survived

Palla et al. 2022 [87], Greece

Retrospective case report, single centre

40

0 (0)

1 White (Caucasian)

30

1 Sarcoidosis

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

Asymptomatic

1 Raised liver enzymes

1 Positive ANAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, high)

1 survived

Rela et al. 2021 [104], India

Retrospective case reports, single centre

38 and 65

1 (50)

2 Indians

Mean (SD), 18 (2.8)

1 Hypothyroidism

1 Diabetes mellitus

1 Jaundice

Covishield, dose 1 [n = 2]

New-onset [n = 1]

Relapsed [n = 1]

2 Fever

1 Anorexia

1 Fatigue

2 Jaundice

1 Altered sensorium

1 Leg edema

1 Dark urine

2 Raised liver enzymes

2 Raised bilirubin

2 High INR

1 Elevated IgG

1 Positive ANAs

Histopathological findings consistent with AIH [n = 2]

Unremarkable [n = 1]

Hepatomegaly [n = 1]

Inter-bowel free fluid [n = 1]

2 Steroid

1 Exchange transfusion

(NOS, moderate)

1 survived

1 died

Rigamonti et al. 2022 [42], Italy

Retrospective case-series, multicenter

Median (IQR), 62 (32–80)

6 (50)

12 Whites (Caucasians)

48 for [dose 1]

10 for [dose 2]

3 Thyroiditis

2 Rheumatoid arthritis

1 Systemic lupus erythematosus

Pfizer-BioNTech, dose not reported [n = 7]

Moderna, dose not reported [n = 2]

Oxford Uni-AstraZeneca, dose not reported [n = 3]

Not reported [n = 12]

8 Jaundice

10 Raised liver enzymes

8 Raised bilirubin

6 Positive ANAs

1 Positive ASMAs

1 Liver/kidney microsome type 1 antibodies

Histopathological findings consistent with AIH [n = 11]

Not reported [n = 12]

Not reported [n = 12]

(NOS, moderate)

12 outcome was not reported

Rocco et al. 2021 [106], Italy

Retrospective case report, single centre

80

0 (0)

1 White (Caucasian)

7

1 Hyperlipidemia

1 Hashimoto’s thyroiditis

1 Acute glomerulonephritis

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Jaundice

1 Dark urine

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Enlarged reactive hilar lymph nodes [n = 1]

1 Steroid

(NOS, high)

1 survived

Romero-Salazar et al. 2022 [41], Spain

Retrospective case report, single centre

76

1 (100)

1 White (Caucasian)

Not reported

1 Liver cirrhosis

1 Primary biliary cholangitis

Pfizer-BioNTech, dose 3 [n = 1]

New-onset [n = 1]

Not reported [n = 1]

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

1 Positive ANAs

Histopathological findings consistent with AIH [n = 1]

Not reported [n = 1]

1 Ursodeoxycholic acid

1 Obeticholic acid

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Shahrani et al. 2022 [115], Malaysia

Retrospective case reports, single center

Median (IQR), 63 (59–63)

0 (0)

3 Asians

Median (IQR), 12 (10–12)

1 Dyslipidemia

1 Ulcerative colitis

1 Primary sclerosing cholangitis

1 No medical history

Oxford Uni-AstraZeneca, dose 2 [n = 2]

Pfizer-BioNTech, dose 3 [n = 1]

New-onset [n = 3]

3 Jaundice

3 Raised liver enzymes

3 Raised bilirubin

3 Elevated IgG

1 Positive ANAs

1 Positive AMAs

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 3]

3 Steroid

(NOS, high)

2 survived

1 died

Suzuki et al. 2021 [84], Japan

Retrospective case reports, single centre

Median (IQR), 78 (75–78)

0 (0)

3 Asians

Median (IQR), 7 (4–7)

1 Gastroesophageal reflux esophagitis

1 Hyperlipidemia

1 Primary biliary cholangitis

Pfizer-BioNTech, dose 2 [n = 2]

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 3]

1 Jaundice

1 Dark urine

1 Fever

1 Malaise

3 Liver injury

3 Raised liver enzymes

3 Raised bilirubin

3 Positive ANAs

3 Elevated IgG

2 High INR

Histopathological findings consistent with AIH [n = 3]

Peripheral edema [n = 2]

3 Steroid

(NOS, high)

3 survived

Tan et al. 2021 [8], Singapore

Retrospective case report, single centre

56

0 (0)

1 Asian

42

1 Hyperlipidemia

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Anorexia

1 Jaundice

1 Yellow eyes

1 Raised liver enzymes

1 Raised bilirubin

1 Elevated IgG

1 Positive ANAs

1 Positive ASMAs

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, high)

1 survived

Torrente et al. 2021 [86], Spain

Retrospective case report, single centre

46

0 (0)

1 White (Caucasian)

21

1 Hypothyroidism

1 Hypertransaminasemia

1 Anaemia

Oxford Uni-AstraZeneca, dose 1 [n = 1]

Relapsed [n = 1]

Asymptomatic

1 Raised liver enzymes

1 Low Hb

1 Positive ANAs

1 Low ferritin

1 Positive HLA-DRB1*03 and 04

1 Positive HLA DQ2 and DQ8

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Tun et al. 2021 [85], United Kingdom

Retrospective case report, single centre

47

1 (100)

1 White (Caucasian)

3 for [dose 1]

18 for [dose 2]

1 No medical history

Moderna, dose 1 and dose 2 [n = 1]

New-onset [n = 1]

1 Malaise

1 Jaundice

1 Hepatomegaly

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Elevated IgM

1 Elevated IgG

1 High PT

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, high)

1 survived

Vuille-Lessard et al. 2021 [103], Switzerland

Retrospective case report, single centre

76

0 (0)

1 White (Caucasian)

2

1 Hashimoto’s thyroiditis

1 Urothelial carcinoma

1 Low blood pressure

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Dark urine

1 Weight loss

1 Fatigue

1 Yellow eyes

1 Hepatomegaly

1 Raised liver enzymes

1 Raised bilirubin

1 Positive ANAs

1 Positive ASMAs

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Slightly enlarged and hyperechogenic liver [n = 1]

1 Steroid

1 Azathioprine

(NOS, moderate)

1 survived

Zhou et al. 2021 [80], Germany

Retrospective case report, single centre

36

0 (0)

1 White (Caucasian)

11

1 Primary sclerosing cholangitis

1 Ulcerative colitis

1 Pruritus

Moderna, dose 1 [n = 1]

Relapsed [n = 1]

Asymptomatic except for minor muscle aches

1 Raised liver enzymes

1 Raised bilirubin

1 High INR

1 Positive ANAs

1 Positive ds-DNA antibodies

1 Elevated IgG

Histopathological findings consistent with AIH [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Azathioprine

(NOS, high)

1 survived

Hepatic porphyria

Jud et al. 2021 [92], Austria

Retrospective case report, single centre

34

0 (0)

1 White (Caucasian)

4

1 Hashimoto’s thyroiditis

1 Appendectomy

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Pinprick sensation in her chest and thoracic spine

1 Dizziness

1 Abdominal pain

1 Dark urine

1 SIADH

1 Vomiting

1 Loose stool

1 Pollakisuria

1 dysuria

1 Hypertension

1 Leg dysesthesia

1 Hyponatremia

1 High creatinine

1 Thrombocytopenia

1 High urine porphyrins

1 High urine 5-aminolevulinic acid

1 High urine porphobilinogen

Not performed [n = 1]

Unremarkable [n = 1]

1 Hemin

1 Metamizole

1 Butylscopolamine bromide

1 Crystalloid fluid

1 Antibiotic

1 Piritramide

1 Furosemide

1 Urapidil

(NOS, moderate)

1 survived

Hepatomegaly

Cory et al. 2021 [100], United Kingdom

Retrospective case report, single centre

36

0 (0)

1 White (Caucasian)

9

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal tenderness

1 Pleuritic pain

1 Pericardial rub

1 Hepatomegaly

1 Splenomegaly

1 Pericarditis

1 Thrombocytopenia

1 High ferritin

1 High CRP

1 High LDH

Reactive picture [n = 1]

Hepatomegaly [n = 1]

Splenomegaly [n = 1]

Pleural effusions [n = 1]

Pericarditis [n = 1]

1 Antibiotics

1 Steroid

1 IVIG

1 IV fluids

1 Analgesics

(NOS, low)

1 survived

Manzo et al. 2021 [88], Italy

Retrospective case report, single centre

69

0 (0)

1 White (Caucasian)

1

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Pain in the shoulder and pelvis

1 Stiffness

1 Fatigue

1 Fever

1 Polymyalgia rheumatica

1 High CRP

1 High ESR

Not performed [n = 1]

Mild hepatomegaly [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Patil and Patil 2021 [24], India

Retrospective case report, single centre

22

0 (0)

1 Indian

10

1 Infective jaundice

Covishield, dose 2 [n = 1]

New-onset [n = 1]

1 Pain in right knee

1 Fever

1 Polyarthralgia

1 Bipedal edema

1 Cutaneous rash over fingertips

1 Petechiae over lower limb

1 Left cervical lymph node

1 Mild liver enlargement

1 Systemic lupus erythematosus

1 Positive ANAs

1 Positive anti-double strand deoxyribonucleic acid

1 Elevated IgG

1 Low Hb

1 Pancytopenia

1 Thrombocytopenia

1 Raised white blood cells

1 High leukocytes

1 High ESR

1 High LDH

1 High D-dimer

1 High APTT

Not performed [n = 1]

Bilateral cervical lymphadenopathy [n = 1]

Mild hepatomegaly [n = 1]

1 Steroid

1 HCQ

1 Mycophenolate mofetil

1 Furosemide

1 Telmisartan

1 Folic acid

1 Calcium

1 Vitamin D3

(NOS, moderate)

1 survived

Jaundice

Al Aoun and Motabi 2021 [75], Saudi Arabia

Retrospective case report, single centre

45

0 (0)

1 Arab

3

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 SOB

1 Palpitations

1 Dark urine

1 Fatigue

1 Tachycardia

1 Jaundice

1 Pallor

1 High reticulocyte count

1 Low Hb

1 High LDH

1 Raised bilirubin

Not performed [n = 1]

Unremarkable [n = 1]

1 PRBCs

1 Rituximab

(NOS, moderate)

1 survived

Al-Ahmad et al. 2021 [71], Kuwait

Retrospective case report, single centre

37

1 (100)

1 Arab

10

1 Smoking

1 Polycythemia

1 Venesection

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Dizziness

1 Fatigue

1 headache

1 SOB

1 Palpitation

1 Acquired haemolytic anaemia

1 Dark urine

1 Tachycardia

1 Jaundice

1 Pallor

1 Purpuric eruptions on extremities

1 Fragmented erythrocytes

1 Thrombocytopenia

1 Low Hb

1 High reticulocyte count

1 Thrombocytopenia

1 High LDH

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Rituximab

1 Plasma exchange

(NOS, moderate)

1 survived

Guri et al. 2022 [125], Switzerland

Retrospective case report, single centre

53

1 (100)

1 White (Caucasian)

2

1 Benign recurrent intrahepatic cholestasis

1 Family history of benign recurrent intrahepatic cholestasis

Pfizer-BioNTech, dose 1 [n = 1]

Relapsed [n = 1]

1 Jaundice

1 Pruritus

1 Fever

1 Fatigue

1 Nausea

1 Acute kidney injury

1 Raised liver enzymes

1 Raised bilirubin

Histopathological findings consistent with benign recurrent intrahepatic cholestasis [n = 1]

Not performed [n = 1]

1 Colestyramine

1 Ursodeoxycholic acid

1 Rifampicin

1 Phototherapy

(NOS, high)

1 survived

Lensen et al. 2021 [90], The Netherlands

Retrospective case report, single centre

82

0 (0)

1 White (Caucasian)

3

1 Alzheimer’s disease

1 Hepatitis C infection

1 Hepatitis B infection

1 Diabetes mellitus

1 Hypertension

1 Osteoarthritis

1 Portal hypertension

1 Oesophageal varices

1 Hepatic cirrhosis

1 Thrombocytopenia

1 Allergy to wasp sting

Pfizer-BioNTech, dose 1 [n = 1]

Relapsed [n = 1]

1 Jaundice

1 Somnolence

1 Chills

1 Yellow eyes

1 Decreased consciousness

1 Abdominal pain

1 Coma

1 Raised liver enzymes

1 Raised bilirubin

1 High CRP

Not performed [n = 1]

Not performed [n = 1]

Not reported [n = 1]

(NOS, moderate)

1 died

Peralta-Amaro et al. 2022 [74], Mexico

Retrospective case report, single centre

18

1 (100)

1 Hispanic

22

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Headache

1 Diarrhoea

1 Conjunctival injection

1 Skin lesions on the thorax and hands

1 Sudden pain

1 Cyanosis

1 Leg coolness

1 Numbness

1 Rash

1 Palmar erythema with superficial scaling

1 Cracked and erythematous lips

1 Strawberry tongue

1 Jaundice

1 Cervical lymphadenopathy

1 Acute arterial insufficiency of the right foot and leg

1 High CRP

1 Raised liver enzymes

1 Hypoalbuminemia

1 Raised bilirubin

1 High LDH

1 Thrombocytopenia

1 High PT

1 High APTT

1 High leukocytes

1 High creatinine

Not performed [n = 1]

Arterial thrombosis of the right leg [n = 1]

1 IVIG

1 Acetylsalicylic acid

(NOS, high)

1 survived

Pérez‐Lamas et al. 2021 [73], Spain

Retrospective case report, single centre

57

0 (0)

1 White (Caucasian)

2

1 Cold agglutinin disease

1 Anaemia

Pfizer-BioNTech, dose 1 and dose 2 [n = 1]

New-onset [n = 1]

1 Chills

1 Weakness

1 SOB

1 Lumbar pain

1 Jaundice

1 Paleness

1 Autoimmune haemolytic anaemia

1 Hemoglobinuria

1 High reticulocyte count

1 Low Hb

1 Raised bilirubin

1 High ferritin

1 High D-dimer

1 Positive ANAs

Not performed [n = 1]

Not performed [n = 1]

1 Steroid

(NOS, high)

1 survived

Wong et al. 2021 [81], United States

Retrospective case report, single centre

61

0 (0)

1 White (Caucasian)

5

1 Breast cancer

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Generalized cutaneous hypersensitivity reaction

1 Fever

1 Fatigue

1 Generalized myalgia

1 Jaundice

1 Rash

1 Nausea

1 Headache

1 Acute hepatitis

1 Raised liver enzymes

1 Raised bilirubin

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Yoshida et al. 2022 [72], Japan

Retrospective case report, single centre

57

1 (100)

1 Asian

7

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Anorexia

1 Fatigue

1 Jaundice

1 Acquired haemolytic anaemia

1 Anaphylactic shock

1 Respiratory distress

1 Fragmented erythrocytes

1 Thrombocytopenia

1 ITP

1 Acute hepatitis

1 Low Hb

1 Raised white blood cells

1 High reticulocyte count

1 Raised liver enzymes

1 Raised bilirubin

1 High creatinine

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

1 Rituximab

1 Plasma exchange

1 FFP

1 Epinephrine

(NOS, moderate)

1 survived

Portal vein thrombosis

Aladdin et al. 2021 [67], Saudi Arabia

Retrospective case report, single centre

36

0 (0)

1 Arab

14

1 Diabetes mellitus

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Convulsions

1 Weakness

1 Fever

1 Vomiting

1 Headache

1 Tachycardia

1 Brisk deep tendon reflexes

1 Babinski sign

1 Hypotension

1 DIC

1 Acute kidney injury

1 Lactic acidosis

1 Multi-organ failure

1 Cardiac arrest

1 Worsening of the neurological state

1 Low Hb

1 Raised white blood cells

1 Raised liver enzymes

1 High D-dimer

1 High INR

1 High PT

1 High APTT

1 Thrombocytopenia

1 Low fibrinogen

1 High creatinine

Not performed [n = 1]

Extensive portal vein thrombosis [n = 1]

Superior mesenteric vein thrombosis [n = 1]

Splenic and hepatic infarction [n = 1]

1 Heparin

1 Antibiotics

1 Antivirals

1 Intubation

1 MV

1 Ionotropic support

1 PRBCs

1 Hemodialysis

(NOS, moderate)

1 died

Asif et al. 2021 [66], United States

Retrospective case report, single centre

28

1 (100)

1 White (Caucasian)

10

1 No medical history

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Nausea

1 Vision changes

1 Photophobia

1 Cerebral venous sinus thrombosis

1 Pulmonary emboli

1 Thrombocytopenia

1 Positive for antibodies directed against (PF4) antibodies

1 High D-dimer

1 Positive heparin-induced thrombocytopenia

Not performed [n = 1]

Multiple acute pulmonary emboli [n = 1]

Right hepatic vein thrombosis [n = 1]

1 Anticoagulant

1 IVIG

1 Argatroban

1 Acetazolamide

1 Apixaban

(NOS, moderate)

1 survived

Asmat et al. 2021 [65], United Kingdom

Retrospective case report, single centre

47

0 (0)

1 White (Caucasian)

10

1 Migraine

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Photophobia

1 Periorbital pain

1 Neck stiffness

1 Back pain

1 Vaccine-associated thrombocytopenia

1 Heparin-induced thrombocytopenia

1 Abdominal pain

1 Chest pain

1 Thrombocytopenia

1 Raised liver enzymes

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

1 Positive heparin-induced thrombocytopenia

Not performed [n = 1]

Pulmonary embolism [n = 1]

Completely occluded portal vein [n = 1]

Acute thrombosis extending into the superior mesenteric vein and splenic vein [n = 1]

1 Sumatriptan

1 IVIG

1 Fondaparinux

1 Apixaban

(NOS, moderate)

1 survived

Bersinger et al. 2021 [111], France

Retrospective case report, single centre

21

0 (0)

1 White (Caucasian)

9

1 Migraine

1 Smoking

1 Contraception

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Seizure

1 Fall

1 Dislocation of right knee

1 Right-sided hemiplegia

1 Expressive aphasia

1 Thrombocytopenia

1 Positive for antibodies directed against (PF4) antibodies

1 Positive sensitized serotonin release assay

Not performed [n = 1]

Thrombosis in the deep and superficial cerebral veins [n = 1]

Thrombosis of the left jugular vein [n = 1]

Left frontoparietal venous haemorrhagic infarction [n = 1]

Pulmonary embolism [n = 1]

Hepatic and external iliac venous thrombosis [n = 1]

1 Heparin

1 Intubation

1 MV

1 Sedation

1 Anticoagulant

1 IVIG

1 Fondaparinux

1 Cranioplasty

(NOS, moderate)

1 survived

Centonze et al. 2021 [109], Italy

Retrospective case report, single centre

32

0 (0)

1 White (Caucasian)

11

1 DBD donor

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

Not reported [n = 1]

1 Thrombocytopenia

1 High D-dimer

1 High APTT

1 Low fibrinogen

Not performed [n = 1]

Hepatic veins thrombosis [n = 1]

Cerebral venous sinus thrombosis [n = 1]

Not reported [n = 1]

(NOS, moderate)

1 died

Ciccone et al. 2021 [64], Italy

Retrospective case-series, multicenter

Median (IQR), 48 (36.7–54.7)

0 (0)

4 Whites (Caucasians)

Mean

(SD), 3.7 (2.6)

1 Factor II mutation

1 Contraception

2 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 4]

New-onset [n = 4]

2 Fever

4 Headache

1 Nausea

2 Vomiting

4 High D-dimer

3 High INR

4 Thrombocytopenia

Not performed [n = 1]

Suprahepatic vein thrombosis [n = 1]

Portal and mesenteric veins thrombosis [n = 1]

Aortic arch, thoracic aorta, portal, suprahepatic, right coronary, pulmonary and basilar arteries thrombosis [n = 1]

Pulmonary thromboembolism, portal vein and inferior cava thrombosis [n = 1]

3 Heparin

3 Mannitol

1 Thrombectomy

2 Craniectomy

3 Steroid

1 Plasmapheresis

1 Fresh frozen plasma

2 Fondaparinux

(NOS, high)

3 in a coma

1 died

Curcio et al. 2022 [63], Italy

Retrospective case report, single centre

68

1 (100)

1 White (Caucasian)

13

1 Hypertension

1 Euthyroid nodular goitre

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Leg edema

1 Leg pain

1 Weakness

1 Dizziness

1 Dyspnoea

1 Tachypnea

1 Thrombocytopenia

1 High D-dimer

1 High LDH

1 High CRP

1 Low Hb

1 High INR

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Massive bilateral pulmonary artery embolism

thrombosis [n = 1]

Right intrahepatic portal thrombosis [n = 1]

1 Steroid

1 IVIG

1 Anticoagulant

1 Implanted inferior caval vein filter

1 Fondaparinux

(NOS, moderate)

1 survived

D'agostino et al. 2021 [62], Italy

Retrospective case report, single centre

54

0 (0)

1 White (Caucasian)

12

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 DIC

1 Acute cerebrovascular accident

1 Worsening of the neurological state

1 Thrombocytopenia

1 Low Hb

1 High PT

1 High D-dimer

1 High APTT

Not performed [n = 1]

Filling defects at the level of left portal branch and at the level of right suprahepatic vein [n = 1]

1 Plain old balloon angioplasty of the right coronary artery was performed

1 Antiplatelet

(NOS, high)

1 died

De Michele et al. 2021 [61], Italy

Retrospective case reports, single centre

57 and 55

0 (0)

2 Whites (Caucasians)

7 and 9

2 Hypothyroidism

1 Breast cancer

1 Left-sided hemiplegia

1 Gaze deviation

1 Dysarthria

1 Left neglect

Oxford Uni-AstraZeneca, dose 1 [n = 2]

New-onset [n = 2]

1 Worsening of the neurological state

1 ARDS

1 Abdominal pain

1 Aphasia

1 Right hemiparesis

1 Seizures

1 Coma

1 Anaemia

2 Thrombocytopenia

1 High D-dimer

1 Low Hb

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Extensive pulmonary artery and portal vein thrombosis [n = 2]

1 Mechanical thrombectomy

1 PRBCs

1 Decompressive craniectomy

2 Steroid

2 IVIG

1 Plasma exchange

1 Fondaparinux

1 Intubation

(NOS, high)

1 survived

1 died

Fanni et al. 2021 [98], Italy

Retrospective case report, single centre

58

0 (0)

1 White (Caucasian)

13

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Diarrhea

1 Vomiting

1 Hepatic failure

1 Renal failure

1 Thrombocytopenia

1 Low fibrinogen

1 High D-dimer

1 High INR

1 High PT

1 High APTT

1 Low Hb

Voluminous fibrin thrombi in the branches of the portal vein [n = 1]

Portal vein thrombosis [n = 1]

Splenic vein thrombosis [n = 1]

Superior mesenteric vein thrombosis [n = 1]

Not reported [n = 1]

(NOS, moderate)

1 died

Graça et al. 2021 [96], Portugal

Retrospective case report, single centre

62

0 (0)

1 White (Caucasian)

1

1 Obesity

1 Asthma

1 Rhinitis

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Nausea

1 Vomiting

1 Fever

1 Epigastric tenderness

1 Iliac fossa tenderness

1 Low Hb

1 Thrombocytosis

1 High leucocytes

1 High CRP

1 Raised liver enzymes

1 Raised bilirubin

Not performed [n = 1]

Total occlusion at the hepatic and splenic arteries [n = 1]

1 Antibiotics

1 PRBCs

1 Heparin

1 Anticoagulant

(NOS, moderate)

1 survived

Graf et al. 2021 [3], Germany

Retrospective case report, single centre

29

1 (100)

1 White (Caucasian)

9

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Abdominal pain

1 Abdominal cramps

1 Vomiting

1 Hematemesis

1 Multilocular thrombosis

1 Seizures

1 Intracranial hemorrhage

1 Aphasia

1 Apraxia

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Extensive thrombosis of the mesenteric and portal vein [n = 1]

1 IVIG

1 Argatroban

(NOS, high)

1 survived

Greenhall et al. 2021 [95], United Kingdom

Retrospective case reports, single centre

Median (IQR), 34 (21–63)

11 (85)

13 Whites (Caucasians)

Median (IQR), 10 (7–18)

13 DBD donors

Oxford Uni-AstraZeneca, dose 1 [n = 13]

New-onset [n = 13]

12 Intracranial haemorrhages

7 Cerebral venous sinus thrombosis

6 Extra-cranial thrombosis

4 Thrombocytopenia

5 High D-dimer

Not reported [n = 1]

Thrombosis of the portal veins [n = 2]

Splenic vein thrombosis [n = 1]

Not reported [n = 13]

(NOS, high)

13 died

Kadam et al. 2022 [91], United Kingdom

Retrospective case reports, single centre

55

0 (0)

1 White (Caucasian)

14

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Confusion

1 Abdominal pain

1 Reduced GCS

1 Reduced muscle power bilaterally

1 Dysphasia

1 Thrombocytopenia

1 Raised liver enzymes

1 Raised bilirubin

1 High PT

1 High INR

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not reported [n = 1]

Thrombosis of the portal and hepatic veins and multiple infarcts of the liver, left kidney and lingular segment of the partially imaged lungs [n = 1]

1 IVIG

1 Fresh frozen plasma

1 Anticoagulant

1 Exchange transfusion

(NOS, moderate)

Outcome was not reported

Kulkarni et al. 2021 [59], India

Retrospective case report, single centre

46

1 (100)

1 Indian

7

1 Budd-Chiari syndrome

1 JAK2 positive myeloproliferative neoplasm

1 DIPS

1 Hypertension

1 Diabetes mellitus

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

Not reported [n = 1]

Not performed [n = 1]

No flow in the DIPS stent [n = 1]

Completely thrombosed portal vein, splenic vein, and DIPS stent [n = 1]

1 Thrombolysis

1 Venoplasty

1 Heparin

1 Dabigatran

(NOS, moderate)

1 survived

Lin et al. 2021 [58], Taiwan

Retrospective case report, single centre

42

0 (0)

1 Asian

5

1 Budd-Chiari syndrome

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Headache

1 Abdominal pain

1 Legs edema

1 Raised liver enzymes

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

No flow in the right hepatic vein [n = 1]

Thrombosis and occlusion in her right hepatic vein [n = 1]

1 IVIG

1 Anticoagulants

1 Steroid

(NOS, moderate)

1 survived

Major et al. 2022 [57], United States

Retrospective case report, single centre

50

1 (100)

1 White (Caucasian)

21

1 Obesity

1 Alcoholic cirrhosis

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Abdominal distension

1 Fatigue

1 Dark urine

1 Thrombocytopenia

1 Raised liver enzymes

1 Raised bilirubin

1 High INR

1 High D-dimer

1 High creatinine

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Cirrhotic liver disease [n = 1]

Complete thrombosis of the right portal vein [n = 1]

Partial thrombus in the main portal vein [n = 1]

1 Argatroban

1 IVIG

1 Steroid

1 Bivalirudin

1 Rituximab

1 TIPS procedure

1 Plasma exchange

1 Fondaparinux

(NOS, moderate)

1 survived

Öcal et al. 2021 [4], Germany

Retrospective case reports, single centre

41

0 (0)

1 White (Caucasian)

11

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Abdominal pain

1 Hypovolaemic shock

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Massive thrombosis of the entire portal venous system [n = 1]

Splenomegaly [n = 1]

1 Anticoagulant

1 Analgesics

1 IVIG

1 Emergent laparotomy

(NOS, high)

1 survived

Premkumar et al. 2021 [56], India

Retrospective case-series, single centre

Median (IQR), 53 (48–53)

2 (66.7)

3 Indians

Not reported [n = 3]

1 NAFLD

1 Hepatitis C infection

1 Alcoholic cirrhosis

1 Diabetes mellitus

Oxford Uni-AstraZeneca, dose 1 [n = 2]

Oxford Uni-AstraZeneca, dose 2 [n = 1]

New-onset [n = 3]

1 Pain

2 Ascites

Not reported [n = 3]

Not performed [n = 3]

Portal vein thrombosis [n = 2]

Superior mesenteric vein thrombosis [n = 1]

1 Heparin

1 Dabigatran

1 Variceal eradication

(NOS, moderate)

2 survived

1 died

Ramdeny et al. 2021 [55], United Kingdom

Retrospective case report, single centre

54

1 (100)

1 Indian

21

1 Rare congenital limb malformation

1 Strong family history of a rare congenital limb deformity

1 Thrombophlebitis of the right leg

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Bruising

1 Unilateral right calf swelling

1 High D-dimer

1 Thrombocytopenia

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Extensive cerebral venous sinus thrombosis [n = 1]

Concurrent venous thrombosis in the portal vein [n = 1]

1 IVIG

1 Danaparoid

1 DOAC

(NOS, moderate)

1 survived

Repp et al. 2022 [116], United States

Retrospective case report, single centre

34

0 (0)

1 White (Caucasian)

5

1 Polycystic ovarian syndrome

1 Hypothyroidism

1 Smoking

1 Contraception

1 Family history of deep vein thrombosis

Moderna, dose 2 [n = 1]

New-onset [n = 1]

1 SOB

1 Abdominal pain

1 Dyspnea

1 Nausea

1 Diarrhea

1 Fever

1 Lightheadedness

1 Headache

1 Pruritus

Not reported [n = 1]

Portal vein thrombosis [n = 1]

Unremarkable [n = 1]

1 Analgesics

1 Ondansetron

1 IV fluids

1 Antacids

1 Rivaroxaban

(NOS, moderate)

1 survived

Schultz et al. 2021 [49], Norway

Retrospective case reports, single centre

32

1 (100)

1 White (Caucasian)

7

1 Asthma

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Back pain

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Thrombosis of several branches of the portal vein with occlusion of the left intrahepatic portal vein and left hepatic vein [n = 1]

Thrombosis of the splenic vein, the azygos vein, and the hemiazygos vein [n = 1]

1 Platelet concentrate

1 IVIG

1 Steroid

1 Dalteparin

1 Warfarin

(NOS, high)

1 survived

Scully et al. 2021 [54], United Kingdom

Retrospective case-series, multicenter

Median (IQR), 54 (30–54)

1 (33.3)

3 Whites (Caucasians)

Mean (SD), 9.7 (3.5)

1 Deep vein thrombosis

1 Contraception

Oxford Uni-AstraZeneca, dose 1 [n = 3]

New-onset [n = 3]

Not reported [n = 3]

3 Thrombocytopenia

1 High PT

3 High APTT

3 Low fibrinogen

2 High D-dimer

3 Positive for antibodies directed against (PF4) antibodies

Thrombosis in many

small vessels, especially vessels in the lungs and intestine, cerebral veins, and venous sinuses [n = 1]

Extensive intracerebral hemorrhage [n = 1]

Cerebral venous thrombosis [n = 1]

Portal vein thrombosis [n = 3]

Pulmonary embolisms [n = 1]

Middle cerebral artery infarcts [n = 1]

Not reported [n = 3]

(NOS, high)

1 survived

2 died

See et al. 2021 [53], United States

Retrospective case-series, multicenter

18–39 (n = 1)

and

 ≥ 40 (n = 1)

0 (0)

2 Whites (Caucasians)

8 and 13

1 Obesity

1 Contraception

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 2]

New-onset [n = 2]

2 Headache

2 Abdominal pain

1 Vomiting

1 Nausea

1 Myalgia

1 Chills

1 Fever

1 Back pain

1 Bruising

1 Malaise

2 Thrombocytopenia

2 High D-dimer

1 High APTT

1 High INR

2 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 2]

Portal vein thrombosis [n = 2]

Pulmonary embolus [n = 1]

Intracerebral hemorrhage [n = 1]

Retroperitoneal, intraperitoneal, and pelvic hemorrhage [n = 1]

Thrombosis of the splenic vein [n = 1]

Thrombosis of the right hepatic vein [n = 1]

Thrombosis of the distal superior

mesenteric vein [n = 1]

1 Aspirin

1 Paracetamol

1 Caffeine

1 Argatroban

1 IVIG

(NOS, high)

1 survived

1 died

Strobel et al. 2021 [5], Germany

Retrospective case report, single centre

29

1 (100)

1 White (Caucasian)

14

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Headache

1 Skin petechia

1 High D-dimer

1 Thrombocytopenia

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Thrombosis of the portal vein [n = 1]

Thrombosis of the splenic vein [n = 1]

Thrombosis of the superior mesenteric vein [n = 1]

1 Steroid

1 Argatroban

1 IVIG

1 Apixaban

(NOS, moderate)

1 survived

Thaler et al. 2021 [52], Austria

Retrospective case-series, multicenter

40 and 63

2 (100)

2 Whites (Caucasians)

7 and 17

2 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 2]

New-onset [n = 2]

1 Abdominal pain

1 Headache

1 Chills

1 Fever

1 Photophobia

1 Petechiae

1 Hematomas

2 High D-dimer

2 Thrombocytopenia

2 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 2]

Thrombosis of the portal- and hepatic vein [n = 1]

Thrombosis of the splenic-, and mesenteric vein [n = 1]

1 Rivaroxaban

1 IVIG

1 Fondaparinux

1 Steroid

1 Apixaban

(NOS, moderate)

2 survived

Tiwari et al. 2022 [31], India

Retrospective case report, single centre

24

0 (0)

1 Indian

18

1 Contraception

1 Menstrual irregularities

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Nausea

1 Vomiting

1 Seizures

1 Brain death

1 Absent brainstem reflexes

1 Positive apnea test

1 Thrombocytopenia

1 High D-dimer

1 High INR

Unremarkable [n = 1]

Venous sinus thrombosis [n = 1]

Portal vein thrombosis [n = 1]

Hemorrhagic transformation [n = 1]

1 Heparin

1 Digital subtraction angiography with thrombus extraction

1 IVIG

1 Intubation

1 MV

(NOS, moderate)

1 died

Tølbøll Sørensen et al. 2021 [51], Denmark

Retrospective case report, single centre

30

0 (0)

1 White (Caucasian)

8

1 Migraine

1 Contraception

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 2]

1 Headache

1 Malaise

1 Ecchymosis

1 Dizziness

1 Thrombocytopenia

1 Raised liver enzymes

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Portal vein thrombosis [n = 1]

1 Tinzaparin

1 Fibrinogen substitution

1 Fondaparinux

1 Rivaroxaban

(NOS, moderate)

1 survived

Umbrello et al. 2021 [76], Italy

Retrospective case report, single centre

36

0 (0)

1 White (Caucasian)

17

1 Fever

1 Asthenia

1 Osteoarticular pain

1 Melena

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Low blood pressure

1 High heart rate

1 Thrombocytopenia

1 Positive for antibodies directed against (PF4) antibodies

1 Low Hb

Not performed [n = 1]

Complete thrombosis of spleno-mesenteric-portal axis [n = 1]

1 Heparin

1 Thrombus aspiration

1 Porto-systemic shunt

1 IV rtPA thrombolysis

1 Argatroban

1 IVIG

1 PRBCs

1 Epinephrine

1 Apixaban

(NOS, moderate)

1 survived

Uzun et al. 2022 [30], Germany

Retrospective case report, single centre

50

0 (0)

1 White (Caucasian)

12

1 Not reported

Johnson & Johnson COVID-19 vaccine, dose not reported [n = 1]

New-onset [n = 1]

1 Vaccine-induced immune thrombotic thrombocytopenia

1 Thrombocytopenia and thrombosis of the cerebral arteries and venous sinuses

1 Brain death

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

1 High creatinine

Hemangioma and a segment with an arterial thrombosis [n = 1]

Intraluminal blood clot was detected in the liver after organ procurement [n = 1]

Occlusion of the middle cerebral artery [n = 1]

Sinus vein thrombosis of the superior sagittal sinus and transverse sinus [n = 1]

1 IVIG

1 Argatroban

(NOS, moderate)

1 died

Raised liver enzymes

Alkindi et al. 2021 [114], Oman

Retrospective case reports, single centre

Median (IQR), 29 (28–29)

3 (100)

3 Arabs

Mean (SD), 5 (1)

1 Avascular necrosis of shoulders

2 Splenectomy

2 Cholecystectomy

2 Acute chest syndrome

1 Tuberculosis of the spine

Oxford Uni-AstraZeneca, dose 1 [n = 3]

New-onset [n = 3]

1 Shoulder pain

2 Back pain

1 Fever

1 Chest pain

1 Tachypnea

1 Tachycardia

2 Low saturation

3 Raised liver enzymes

3 High CRP

1 Raised bilirubin

2 Low Hb

2 Thrombocytopenia

1 Hyponatremia

1 High D-dimer

Not performed [n = 3]

Right-sided infiltrates [n = 1]

Pleural effusion [n = 1]

1 Analgesics

2 Antibiotics

1 PRBCs

1 Heparin

1 Exchange transfusion

1 CPR

1 Oxygen supplementation

1 Thrombolysis

(NOS, low)

2 survived

1 died

Alrashdi et al. 2022 [39], Saudi Arabia

Retrospective case report, single centre

22

0 (0)

1 Arab

7

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Nausea

1 Vomiting

1 Maculopapular rash over extremities

1 Systemic lupus erythematosus

1 Leukopenia

1 Lymphopenia

1 Raised white blood cells

1 Hemolytic anemia

1 Low Hb

1 High reticulocyte count

1 Thrombocytopenia

1 High LDH

1 Raised liver enzymes

1 Raised bilirubin

1 High pancreatic enzymes

1 High ESR

1 Hypocomplementemia

1 Positive ANAs

1 Positive anti-double strand deoxyribonucleic acid

Not performed [n = 1]

Autoimmune pancreatitis [n = 1]

1 Steroid

1 Azathioprine

1 HCQ

(NOS, moderate)

1 survived

Brown et al. 2022 [38], United States

Retrospective case report, single centre

58

1 (100)

1 White (Caucasian)

7

1 Obesity

1 Hypertension

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Headache

1 Nausea

1 Myalgias

1 Fever

1 Chills

1 Sweats

1 Diarrhea

1 Anxiety

1 Encephalopathic

1 Rash

1 Splenomegaly

1 Hypotension

1 NSTEMI (Type 2)

1 Acute interstitial nephritis

1 Acute tubular necrosis

1 Multisystem inflammation syndrome

1 High CRP

1 High ferritin

1 Acute kidney injury

1 Raised liver enzymes

1 Raised bilirubin

1 High hs-cTnT

1 Pancytopenia

1 Low Hb

Not performed [n = 1]

Unremarkable [n = 1]

1 Intubation

1 Steroid

(NOS, moderate)

1 survived

Chai et al. 2022 [9], Denmark

Retrospective case report, single centre

17

1 (100)

1 White (Caucasian)

5

1 No medical history

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Fever

1 Vomiting

1 Myalgia

1 Chest pain

1 Fatigue

1 Multisystem inflammation syndrome

1 Myocarditis

1 Raised liver enzymes

Not performed [n = 1]

Myocarditis [n = 1]

1 Norepinephrine

1 Oxygen supplementation

1 Steroids

1 IVIG

1 Antibiotics

(NOS, moderate)

1 survived

Cirillo et al. 2022 [46], Italy

Retrospective case report, single centre

68

1 (100)

1 White (Caucasian)

9

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Hypoglycemia

1 Malaise

1 Dyspnea

1 Abdominal pain

1 Difficulty with walking

1 Untreatable hypotensive shock

1 Contraction of diuresis

1 Clouding of the sensory

1 Weakness in the four limbs

1 Atrial fibrillation

1 Rhabdomyolysis

1 Kidney injury

1 Respiratory failure

1 Bone marrow failure

1 Multi-organ failure

1 Multi-lineage cytopenia

1 High procalcitonin

1 Increase of myoglobin

1 Raised liver enzymes

1 High D-dimer

1 High LDH

1 High creatine kinase

1 High creatinine

1 High blood urea nitrogen

1 Hyperkalemia

1 Hypocalcemia

1 Lymphopenia

1 High lactic acid

1 Isolation of Pseudomonas aeruginosa from bronchial aspirate

Fiber necrosis with phagocytosis and influx of histiocytes, associated with a significant increase of the vascular component [n = 1]

Severe interstitial pneumopathy [n = 1]

Severe bilateral pleural effusion [n = 1]

1 Steroid

1 Anakinra

1 Eculizumab

1 Beta blockers

1 Hemodialysis

1 Intubation

1 Tracheostomy

1 Meropenem

1 Amphotericin B

1 Tigecycline

1 Fosfomycin

1 Cotrimoxazole

(NOS, high)

1 died

Fritzen et al. 2022 [36], Brazil

Retrospective case report, single centre

60

0 (0)

1 Hispanic

11

1 Chronic liver disease

1 Portal hypertension

1 Polycythemia vera

1 Hypothyroidism

1 Diabetes mellitus

Oxford Uni-AstraZeneca, dose 2 [n = 1]

New-onset [n = 1]

1 Painful purpuric lesions

1 Palpable papules

1 Leukocytoclastic vasculitis

1 Raised liver enzymes

1 High CRP

1 High leukocytes

1 High APTT

1 High INR

1 High LDH

The histological picture was compatible with leukocytoclastic vasculitis [n = 1]

Not performed [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Gadi et al. 2021 [27], United States

Retrospective case report, single centre

41

0 (0)

1 White (Caucasian)

7

1 Central retinal vein occlusion

1 Hypertension

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Autoimmune hemolytic anemia

1 Fatigue

1 Dark urine

1 Dyspnea

1 Anxiety

1 Thrombocytopenia

1 Low Hb

1 High reticulocyte count

1 Raised white blood cells

1 Raised liver enzymes

1 Raised bilirubin

1 High LDH

1 Positive direct antiglobulin test for IgG

Not performed [n = 1]

Not performed [n = 1]

1 PRBCs

1 Steroid

1 Rituximab

1 Mycophenolate mofetil

1 IVIG

(NOS, moderate)

1 survived

Gaignard et al. 2021 [26], Switzerland

Retrospective case report, single centre

77

1 (100)

1 White (Caucasian)

5

1 No medical history

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Weakness

1 Fatigue

1 SOB

1 Autoimmune hemolytic anemia

1 High reticulocyte count

1 High leukocytes

1 Raised liver enzymes

1 Raised bilirubin

1 High LDH

1 Positive tests for indirect antiglobulin, IgG, complement component 3 and direct antiglobulin

Not performed [n = 1]

Discrete inhomogeneous liver parenchyma [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Hines et al. 2021 [94], United States

Retrospective case report, single centre

26

0 (0)

1 White (Caucasian)

14

1 Irregular menses

1 Contraception

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Rash

1 Bruising

1 Urticaria

1 Thrombocytopenia

1 Raised liver enzymes

Unremarkable [n = 1]

Unremarkable [n = 1]

1 Steroid

1 IVIG

1 N-acetylcysteine

(NOS, moderate)

1 survived

Jawed et al. 2021 [93], United States

Retrospective case report, single centre

47

0 (0)

1 White (Caucasian)

18

1 Hashimoto’s thyroiditis

1 Anaemia

1 Lymphadenopathy

1 ITP

Pfizer-BioNTech, dose 1 [n = 1]

Relapsed [n = 1]

1 Easy bruising

1 Gum bleeding

1 Epistaxis

1 Ecchymosis

1 Petechiae

1 Thrombocytopenia

1 Raised liver enzymes

1 High PT

1 High INR

1 High LDH

1 High reticulocyte count

1 Positive ANAs

1 Positive anti–Sjögren syndrome antigen A

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

1 IVIG

(NOS, moderate)

1 survived

Khajavirad et al. 2022 [33], Iran

Retrospective case report, single centre

70

0 (0)

1 Persian

1

1 Diabetes mellitus

1 Hypertension

1 Coronary artery disease

1 Percutaneous coronary intervention

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Generalized tonic–clonic seizure

1 Lethargy

1 Anaemia

1 Raised liver enzymes

1 High leukocytes

1 High LDH

1 High creatinine

1 High CRP

1 High ESR

1 Thrombocytopenia

1 High D-dimer

1 Low Hb

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Acute infarction in left occipital lobe [n = 1]

1 Paracetamol

1 IVIG

1 Steroid

1 Rivaroxaban

1 Sodium valproate

1 Levetiracetam

1 Anticoagulants

(NOS, moderate)

1 survived

Kishimoto et al. 2022 [70], Japan

Retrospective case report, single centre

46

1 (100)

1 Asian

10

1 Hyperlipidemia

1 Alcohol-associated liver disease

Moderna, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Odynophagia

1 Bilateral anterior neck pain

1 Enlarged thyroid

1 Thyroid tenderness

1 Subacute thyroiditis

1 Low TSH

1 Elevated FT-3

1 Elevated F-T4

1 High CRP

1 Raised liver enzymes

Not performed [n = 1]

Fatty liver [n = 1]

Gallbladder polyps [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Kyungu et al. 2022 [121], Democratic Republic of the Congo

Retrospective case report, single centre

29

1 (100)

1 Black

2

1 No medical history

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Nausea

1 Fever

1 Abdominal pain 1 Dark urine

1 Acute hepatitis

1 Acute cholecystitis

1 High CRP

1 Raised liver enzymes

1 Thrombocytopenia

1 Leukopenia

Not performed [n = 1]

Thickened gallbladder wall without evidence of gallstones [n = 1]

Positive Murphy´s sonographic sign [n = 1]

1 IV fluids

1 Analgesics

1 Antibiotics

1 Rabeprazole

(NOS, moderate)

1 survived

Malayala et al. 2021 [89], United States

Retrospective case report, single centre

60

1 (100)

1 Black

2

1 Hepatitis C infection

1 Chronic kidney disease

1 Hypertension

1 Congestive heart failure

1 Smoking

Moderna, dose 1 [n = 1]

Relapsed [n = 1]

1 Generalized weakness

1 SOB

1 Leg edema

1 Nausea

1 Vomiting

1 Abdominal pain

1 Chest pain

1 Rash

1 High creatinine

1 Thrombocytopenia

1 Raised liver enzymes

1 Raised bilirubin

1 High INR

1 High ferritin

1 High LDH

1 high CRP

Not performed [n = 1]

Liver cirrhosis [n = 1]

1 Antihypertensives

1 Diuretics

(NOS, moderate)

Outcome is unknown

Mücke et al. 2021 [25], Germany

Retrospective case report, single centre

76

1 (100)

1 White (Caucasian)

12

1 Compensated alcoholic liver cirrhosis

1 Heart failure

1 Gastrectomy

1 Gastroesophageal junction cancer

1 Prostatectomy

1 Prostate cancer

1 Indwelling suprapubic catheter

1 Lesions on hands and feet

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Pruritus

1 Swelling

1 Limb swelling

1 Purpuric rash

1 Palpable maculae on both hands, legs and thighs

1 Melaena

1 Diarrhoea

1 Myalgia

1 Fever

1 Hoarseness

1 Fatigue

1 Vaccine-induced cutaneous and gastrointestinal immune complex vasculitis

1 High ESR

1 High interleukin-6 levels

1 High CRP

1 Micro-erythruria

1 Leukocyturia

1 Positive fecal occult test

1 High calprotectin

1 Raised liver enzymes

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

O'Connor et al. 2022 [32], Ireland

Retrospective case report, single centre

45

0 (0)

1 White (Caucasian)

49

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Rash

1 Chills

1 Malaise

1 Conjunctivitis

1 Generalized erythema

1 Sore throat

1 Hoarseness

1 Erythema of the eyelids

1 Edema of the lips

1 Papules and plaques on the face, trunk, and extremities

1 Pustules on the upper lip

1 Edema of the arms and legs

1 Conjunctivitis

1 Erythema of the pharynx

1 Cervical lymphadenopathy

1 Elevated eosinophil

1 High CRP

1 Raised liver enzymes

Drug reaction with eosinophilia and systemic symptoms syndrome [n = 1]

Serositis [n = 1]

Mild fluid in the pleural and peritoneal cavities [n = 1]

1 Levocetirizine

1 Fexofenadine

1 Steroid

(NOS, moderate)

1 survived

Sauret et al. 2022 [23], France

Retrospective case report, single centre

70

1 (100)

1 White (Caucasian)

A few days

1 Not reported

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Headache

1 Hyperesthesia of the scalp

1 Raised liver enzymes

1 High CRP

1 High APTT

Gant cell arteritis [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Sharabi et al. 2021 [79], Israel

Retrospective case report, single centre

56

0 (0)

1 Jew

7

1 Not reported

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 SOB

1 Chest pain

1 Weakness

1 Fever

1 Sore throat

1 Pain

1 Swelling of joints, knees and ankles

1 Tachycardia

1 Dyspnea

1 Rash

1 Raised liver enzymes

1 Raised bilirubin

1 High leukocytes

1 Hypoalbuminemia

1 High hs-cTnT

1 High ferritin

Not performed [n = 1]

Unremarkable [n = 1]

1 Steroid

(NOS, moderate)

1 survived

Sung et al. 2022 [40], Republic of Korea

Retrospective case report, single centre

34

0 (0)

1 Asian

42

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Increased abdominal circumference

1 Pitting oedema of the lower extremities

1 Splenomegaly

1 Ascites

1 Budd-Chiari syndrome

1 Raised liver enzymes

1 High D-dimer

Dilated sinusoids with extensive perisinusoidal hepatocyte dropout [n = 1]

Collapsed hepatic veins and decreased portal vein flow [n = 1]

Pulmonary thromboembolism [n = 1]

1 IVIG

1 Anticoagulants

(NOS, moderate)

1 survived

Tan et al. 2021 [77], United Kingdom

Retrospective case report, single centre

34

1 (100)

1 White (Caucasian)

1

1 CPT II deficiency

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Fever

1 Vomiting

1 SOB

1 Hematuria

1 Myalgia

1 Muscle weakness

1 Raised liver enzymes

1 Raised white blood cells

1 High creatine kinase

1 Low adjusted calcium

Not performed [n = 1]

Unremarkable [n = 1]

1 IV dextrose

1 Carbohydrate-rich diet

1 Paracetamol

(NOS, moderate)

1 survived

Waqar et al. 2021 [83], United States

Retrospective case report, single centre

69

0 (0)

1 White (Caucasian)

7

1 Hypertension

1 Chronic kidney disease

1 AIDS

1 Chronic hepatitis B

1 DVT

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Fatigue

1 SOB

1 Fever

1 Chills

1 Night sweats

1 Weight loss

1 Headaches

1 Vision changes

1 Cough

1 Sputum chest pain

1 Abdominal pain

1 Rash

1 Bleeding

1 Bruising

1 Oedema

1 Focal weakness

1 Changes in bowel or urinary habits

1 Anaemia

1 Thrombocytopenia

1 Raised liver enzymes

1 Raised bilirubin

1 High reticulocyte count

1 High LDH

Not performed [n = 1]

Unremarkable [n = 1]

1 Exchange transfusion

1 Steroid

1 Plasmapheresis

1 Rituximab

(NOS, moderate)

1 survived

Watanabe et al. 2022 [10], Japan

Retrospective case report, single centre

51

0 (0)

1 Asian

2

1 No medical history

Pfizer-BioNTech, dose 2 [n = 1]

New-onset [n = 1]

1 Fever

1 Genital bleeding

1 Petechia

1 DIC

1 Macrophage activation syndrome

1 Plasmacytoid dendritic cells

1 Thrombocytopenia

1 Reduced white blood cells

1 Pancytopenia

1 Raised liver enzymes

1 Raised bilirubin

1 High LDH

1 High CRP

1 High blood urea nitrogen

1 High creatinine

1 High D-dimer

1 High ferritin

Plasmacytoid dendritic cells [n = 1]

Not performed [n = 1]

1 Steroid

1 IVIG

(NOS, moderate)

1 survived

Wu et al. 2022 [28], United States

Retrospective case report, single centre

77

0 (0)

1 Hispanic

5

1 No medical history

Pfizer-BioNTech, dose 1 [n = 1]

New-onset [n = 1]

1 Muscle aches

1 Weakness

1 Fever

1 Pruritic and painful eruption on the right and left arms, chest and neck

1 Violaceous, poikilodermatous scaly plaques

1 Multiple vesicles and erythematous papules and patches on both thighs

1 High creatinine

1 Raised liver enzymes

1 Elevated anti-transcription intermediary factor 1γ antibody levels

Dermatomyositis [n = 1]

Unremarkable [n = 1]

1 IVIG

1 Steroid

1 Mycophenolate mofetil

(NOS, moderate)

1 survived

Yocum et al. 2021 [11], United States

Retrospective case reports, single centre

62

0 (0)

1 White (Caucasian)

37

1 Hypertension

1 Hyperlipidemia

1 Hypothyroidism

1 Gastroesophageal reflux disease

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Altered mental status

1 Petechiae

1 Vomiting

1 Acute kidney injury

1 Raised liver enzymes

1 Raised bilirubin

1 Raised white blood cells

1 High CRP

1 Thrombocytopenia

1 Low fibrinogen

1 High creatinine

1 High BUN

1 High LDH

1 Low Hb

1 High hs-cTnT

Not performed [n = 1]

Unremarkable [n = 1]

1 Intubation

1 Steroid

1 Hemodialysis

1 PRBCs

1 Plasma exchange

(NOS, moderate)

Outcome was not reported

Splanchnic vein thrombosis

Greinacher et al. 2021 [60], Germany and Austria

Retrospective case-series, multicenter

Median (IQR), 36 (22–49)

2 (18.2)

11 Whites (Caucasians)

Mean (SD), 9.3 (3.3)

8 No medical history

1 von Willebrand disease

1 Anticardiolipin antibodies

1 Factor V Leiden

Oxford Uni-AstraZeneca, dose 1 [n = 1]

Oxford Uni-AstraZeneca, dose not reported [n = 10]

New-onset [n = 11]

1 Fatigue

1 Myalgia

1 Headache

1 Chills

1 Fever

1 Nausea

1 Epigastric discomfort

1 Tachycardia

1 Gastrointestinal haemorrhage

1 Ascites

1 Raised liver enzymes

11 Thrombocytopenia

7 High D-dimer

1 High LDH

1 High CRP

1 Low Hb

5 High INR

5 High APTT

4 Low fibrinogen

11 Positive for antibodies directed against (PF4) antibodies

Cerebral venous thrombosis [n = 1]

Cerebral venous thrombosis [n = 9]

Intracranial hemorrhage [n = 1]

Splanchnic-vein thrombosis [n = 3]

Pulmonary embolisms [n = 3]

DIC [n = 5]

Other thromboses [n = 4]

1 Platelet concentrate

1 Antibiotics

1 Analgesics

5 Heparin

1 PRBCs

1 Prothrombin complex concentrates

1 Recombinant factor VIIa

1 Apixaban

(NOS, high)

5 survived

6 died

Muir et al. 2021 [50], United States

Retrospective case report, single centre

48

0 (0)

1 White (Caucasian)

14

1 No medical history

Johnson & Johnson COVID-19 vaccine, dose 1 [n = 1]

New-onset [n = 1]

1 Malaise

1 Abdominal pain

1 Anaemia

1 Headache

1 Thrombocytopenia

1 DIC

1 Low fibrinogen

1 High APTT

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Extensive splanchnic-vein thrombosis [n = 1]

Haemorrhagic stroke of the brain [n = 1]

New thrombus involving the right hepatic

and splenic veins [n = 1]

1 Heparin

1 Argatroban

1 IVIG

(NOS, high)

1 survived

Tiede et al. 2021 [48], Germany

Retrospective case-series, single centre

61

0 (0)

1 White (Caucasian)

6

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Fatigue

1 Thrombocytopenia

1 High D-dimer

1 Positive for antibodies directed against (PF4) antibodies

Not performed [n = 1]

Extensive splanchnic vein thrombosis [n = 1]

1 Argatroban

1 IVIG

1 Alteplase

1 Eculizumab

(NOS, moderate)

1 survived

van Dijk et al. 2022 [47], The Netherlands

Retrospective case report, single centre

61

0 (0)

1 White (Caucasian)

14

1 No medical history

Oxford Uni-AstraZeneca, dose 1 [n = 1]

New-onset [n = 1]

1 Abdominal pain

1 Nausea

1 Thrombocytopenia

1 High D-dimer

1 High CRP

Not performed [n = 1]

Extensive splanchnic vein thrombosis in the superior mesenteric vein, splenic vein and portal vein [n = 1]

1 Paracetamol

1 Rivaroxaban

1 IVIG

(NOS, moderate)

1 survived