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Table 2 Adverse events of special interest (AESIs) and their risk windows.a

From: Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran

No

Body system

AESI

Risk interval (Days after vaccination)

1

Cardiac

Acute cardiovascular injury

D1-D42

2

Dermatologic

Chilblain like lesions

D1-D42

3

Dermatologic

Single organ cutaneous vasculitis

D1-D42

4

Dermatologic

Erythema multiforme

D1-D42

5

Endocrine

Pancreatitis

D1-14

6

Endocrine

Subacute thyroiditis

D1-42

7

Gastrointestinal

Acute liver injury

D1-D42

8

Hematologic

Coagulation disorder (thromboembolism)

D1-D42

9

Hematologic

Thrombocytopenia

D1-D42

10

Immunologic

Vaccine-associated enhanced disease

Unknown

11

Gastrointestinal

Respiratory

Anosmia, ageusia

Unknown

12

Immunologic

Anaphylaxis

D0-D7

13

Musculoskeletal

Acute aseptic arthritis

D1-D42

14

Musculoskeletal

Rhabdomyolysis

D1-D7

15

Neurologic

Acute disseminated encephalomyelitis

D1-D42

16

Neurologic

Bell’s palsy

D1-D42

17

Neurologic

Generalized convulsion

D1-D42

18

Neurologic

Guillain-Barré syndrome

D1-D42

19

Neurologic

Meningoencephalitis

D1-D42

20

Renal

Acute renal injury

D1-D42

21

Respiratory

Acute respiratory distress syndrome

D1-D42

22

Immunologic

Multisystem inflammatory syndrome in

children [Only for under 18 Y/O subgroup]

D1-D42

  1. aAdapted from WHO template (Reference No. [13])