Table 4.
List of the most frequently reported AEFIs (> 500).
| MedDRA PT | MedDRA SOC | Reports (N) |
|---|---|---|
| Pyrexia | General disorders and administration site conditions | 16,763 |
| Hyperpyrexia | General disorders and administration site conditions | 5,165 |
| Vaccination site pain | General disorders and administration site conditions | 2,898 |
| Headache | Nervous system disorders | 2,741 |
| Post-vaccinal Irritability | General disorders and administration site conditions | 2,687 |
| Morbilliform rash | Skin and subcutaneous tissue disorders | 2,494 |
| Pain | General disorders and administration site conditions | 2,161 |
| Injection site erythema | General disorders and administration site conditions | 2,083 |
| Vaccination site swelling | General disorders and administration site conditions | 2,039 |
| Somnolence | Nervous system disorders | 1,835 |
| Erythema | Skin and subcutaneous tissue disorders | 1,809 |
| Rash | Skin and subcutaneous tissue disorders | 1,679 |
| Crying | General disorders and administration site conditions | 1,515 |
| Urticaria | Skin and subcutaneous tissue disorders | 1,499 |
| Vomiting | Gastrointestinal disorders | 1,470 |
| Vaccination site reaction | General disorders and administration site conditions | 1,376 |
| Irritability | Psychiatric disorders | 1,295 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1,228 |
| Nasopharyngitis | Infections and infestations | 1,187 |
| Local reaction | General disorders and administration site conditions | 1,096 |
| Diarrhea | Gastrointestinal disorders | 1,094 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1,079 |
| Injection site pain | General disorders and administration site conditions | 1,062 |
| Asthenia | General disorders and administration site conditions | 1,048 |
| Restlessness | Psychiatric disorders | 1,011 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 989 |
| Nausea | Gastrointestinal disorders | 949 |
| Flushing | Vascular disorders | 921 |
| Agitation | Psychiatric disorders | 906 |
| Pruritus | Skin and subcutaneous tissue disorders | 853 |
| Decreased appetite | Metabolism and nutrition disorders | 824 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 754 |
| Lymphadenopathy | Blood and lymphatic system disorders | 700 |
| Swelling | General disorders and administration site conditions | 605 |
| Edema | General disorders and administration site conditions | 570 |
| Malaise | General disorders and administration site conditions | 559 |
| Abdominal pain | Gastrointestinal disorders | 556 |
| Hypotonia | Nervous system disorders | 548 |
| Vaccination site edema | General disorders and administration site conditions | 504 |
| Febrile convulsion | Nervous system disorders | 502 |