| Primary |
| Pyrexia |
36.8% |
| Drug Use For Unknown Indication |
17.7% |
| Teething |
15.9% |
| Product Used For Unknown Indication |
6.3% |
| Ear Infection |
4.0% |
| Immunisation |
3.2% |
| Malaise |
3.1% |
| Nasopharyngitis |
2.5% |
| Pain |
1.8% |
| Rhinorrhoea |
1.4% |
| Ear Pain |
1.2% |
| Prophylaxis |
1.1% |
| Cough |
0.8% |
| Gastrooesophageal Reflux Disease |
0.8% |
| Analgesic Therapy |
0.7% |
| Irritability |
0.7% |
| Bacterial Infection |
0.5% |
| Injection |
0.5% |
| Drooling |
0.5% |
| Hypersensitivity |
0.5% |
|
| Product Quality Issue |
42.0% |
| Vomiting |
14.1% |
| Transmission Of An Infectious Agent Via A Medicinal Product |
12.2% |
| Pyrexia |
8.7% |
| Weight Decreased |
2.8% |
| Viral Infection |
2.4% |
| Rash |
2.2% |
| Sudden Infant Death Syndrome |
2.0% |
| Wheezing |
1.9% |
| Autism |
1.5% |
| Renal Disorder |
1.3% |
| Respiratory Arrest |
1.3% |
| Somnolence |
1.3% |
| Drug Ineffective |
1.1% |
| Product Contamination |
1.1% |
| Rash Macular |
1.1% |
| Psychomotor Hyperactivity |
0.7% |
| Skin Discolouration |
0.7% |
| Urinary Tract Infection |
0.7% |
| White Blood Cell Count Increased |
0.7% |
|
| Secondary |
| Pyrexia |
38.3% |
| Drug Use For Unknown Indication |
20.5% |
| Teething |
12.4% |
| Product Used For Unknown Indication |
7.5% |
| Ear Infection |
4.6% |
| Malaise |
3.0% |
| Immunisation |
1.7% |
| Nasopharyngitis |
1.6% |
| Analgesic Therapy |
1.3% |
| Prophylaxis |
1.2% |
| Pain |
1.1% |
| Ear Pain |
1.1% |
| Injection |
1.1% |
| Irritability |
0.9% |
| Rhinorrhoea |
0.8% |
| Respiratory Disorder |
0.8% |
| Cough |
0.7% |
| Hypersensitivity |
0.6% |
| Gastrooesophageal Reflux Disease |
0.6% |
| Wheezing |
0.6% |
|
| Product Quality Issue |
42.9% |
| Transmission Of An Infectious Agent Via A Medicinal Product |
12.8% |
| Pyrexia |
10.9% |
| Vomiting |
10.4% |
| Wheezing |
4.6% |
| Respiratory Arrest |
2.7% |
| Weight Decreased |
2.5% |
| Wrong Drug Administered |
1.8% |
| Viral Infection |
1.4% |
| Rash |
1.1% |
| Productive Cough |
1.0% |
| Somnolence |
1.0% |
| Sudden Infant Death Syndrome |
1.0% |
| Autism |
0.9% |
| Kidney Infection |
0.9% |
| Skin Discolouration |
0.9% |
| Upper Respiratory Tract Infection |
0.9% |
| Urinary Tract Infection |
0.9% |
| Death |
0.8% |
| Renal Disorder |
0.8% |
|
| Concomitant |
| Pyrexia |
35.3% |
| Oropharyngeal Pain |
17.6% |
| Atrial Septal Defect Repair |
11.8% |
| Arterial Switch Operation |
5.9% |
| Cardiac Failure Congestive |
5.9% |
| Ear Infection |
5.9% |
| Haemolytic Uraemic Syndrome |
5.9% |
| Supplementation Therapy |
5.9% |
| Tricuspid Valve Repair |
5.9% |
|
| Pneumonia |
42.9% |
| Anhedonia |
14.3% |
| Petit Mal Epilepsy |
14.3% |
| Product Quality Issue |
14.3% |
| Thrombocytopenia |
14.3% |
|
