| Unevaluable Event |
Other Serious |
2002 |
56 |
Male |
179 lb |
8/8/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Bladder Cancer Recurrent |
Life Threatening |
2/22/2011 |
70 |
Male |
105 lb |
9/5/2013 |
Physician |
Us |
|
| Urticaria |
|
3/3/2011 |
46 |
Female |
165 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Ventricular Arrhythmia |
Disability |
11/9/2011 |
89 |
Female |
|
7/12/2012 |
Other Health Professional |
Us |
|
| Mobility Decreased |
Hospitalization |
5/3/2012 |
69 |
Female |
187 lb |
1/18/2013 |
Consumer |
Ca |
|
| Gastrointestinal Haemorrhage |
Hospitalization |
6/27/2012 |
65 |
Female |
138 lb |
7/3/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vitello-intestinal Duct Remnant |
Hospitalization |
6/29/2012 |
53 |
Male |
184 lb |
7/11/2012 |
Pharmacist |
Us |
|
| Post Procedural Haemorrhage |
Hospitalization |
7/6/2012 |
76 |
Female |
132 lb |
8/1/2012 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toxicity To Various Agents |
Hospitalization |
8/18/2012 |
90 |
Female |
84 lb |
8/23/2012 |
Pharmacist |
Us |
|
| Sciatica |
Hospitalization |
6/30/2012 |
|
Male |
131 lb |
7/6/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thyroid Function Test Abnormal |
Hospitalization |
|
|
Female |
150 lb |
6/19/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
7/26/2012 |
65 |
Male |
135 lb |
8/2/2012 |
|
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Haemorrhagic Anaemia |
Hospitalization |
7/23/2012 |
74 |
|
228 lb |
8/2/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Torsade De Pointes |
Hospitalization |
7/13/2012 |
72 |
Female |
119 lb |
7/13/2012 |
Pharmacist |
Us |
|
| Haematuria |
Hospitalization |
7/14/2012 |
|
Male |
220 lb |
7/19/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lower Gastrointestinal Haemorrhage |
Hospitalization |
|
|
Male |
194 lb |
1/7/2013 |
Consumer |
Us |
|
| Tremor |
|
|
81 |
Female |
|
10/26/2012 |
Physician |
Us |
|
| Ophthalmic Herpes Zoster |
Other Serious |
2012 |
84 |
Male |
175 lb |
6/21/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rectal Haemorrhage |
Hospitalization |
8/24/2012 |
92 |
Female |
118 lb |
8/29/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sinus Bradycardia |
Hospitalization |
8/17/2012 |
76 |
Female |
168 lb |
8/29/2012 |
Pharmacist |
Us |
|
| Rectal Haemorrhage |
Hospitalization |
8/24/2012 |
92 |
Female |
118 lb |
8/29/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sinus Bradycardia |
Hospitalization |
8/17/2012 |
76 |
Female |
168 lb |
8/29/2012 |
Pharmacist |
Us |
|
| Partial Seizures |
Hospitalization |
7/8/2012 |
85 |
Female |
156 lb |
12/6/2012 |
Pharmacist |
Us |
|
| Respiratory Tract Infection Fungal |
Other Serious |
2012 |
|
Male |
|
12/27/2012 |
Physician |
Us |
|
| Vaginal Haemorrhage |
Hospitalization |
11/2012 |
39 |
Female |
168 lb |
2/20/2013 |
Physician |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Hospitalization |
2011 |
|
Female |
189 lb |
1/3/2013 |
Other Health Professional |
Us |
|
| Tumour Invasion |
Hospitalization |
10/12/2012 |
68 |
Male |
256 lb |
10/25/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Presyncope |
Hospitalization |
9/16/2012 |
71 |
Female |
200 lb |
9/27/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
10/3/2012 |
66 |
Male |
73 lb |
10/8/2012 |
Pharmacist |
Us |
|
| Mental Status Changes |
Hospitalization |
9/26/2012 |
89 |
Female |
|
9/28/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
10/3/2012 |
83 |
Male |
131 lb |
10/8/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Palpitations |
|
8/10/2012 |
58 |
Male |
175 lb |
12/12/2012 |
Consumer |
Us |
|
| Skin Disorder |
Disability |
11/28/2012 |
54 |
Female |
|
12/31/2012 |
Physician |
Us |
|
| Drug Effect Decreased |
|
|
55 |
Male |
236 lb |
12/18/2012 |
Consumer |
Us |
|
| Weight Decreased |
Other Serious |
9/2012 |
|
Male |
160 lb |
12/17/2012 |
Other Health Professional |
Us |
|
| Pancytopenia |
|
9/11/2012 |
72 |
Male |
|
12/14/2012 |
Pharmacist |
Us |
|
| Oedema Peripheral |
Disability |
2012 |
|
Male |
|
2/26/2013 |
Physician |
Us |
|
| Nasopharyngitis |
|
12/14/2012 |
86 |
Female |
|
4/4/2013 |
Consumer |
Us |
|
| Vesical Fistula |
Hospitalization |
10/22/2012 |
73 |
Female |
|
5/29/2013 |
Consumer |
Country Not Specified |
|
| Psoriasis |
|
|
|
Male |
209 lb |
1/28/2013 |
Consumer |
Country Not Specified |
|
| Injection Site Pain |
|
|
|
Male |
210 lb |
1/28/2013 |
Consumer |
Country Not Specified |
|
| Onychomycosis |
|
10/2011 |
55 |
Female |
|
1/28/2013 |
Consumer |
Country Not Specified |
|
| Injection Site Swelling |
|
|
|
Female |
|
1/28/2013 |
Other Health Professional |
Us |
|
| Urinary Tract Infection |
|
12/2011 |
|
Female |
139 lb |
1/28/2013 |
Physician |
Country Not Specified |
|
| Feeling Hot |
|
1/6/2012 |
51 |
Male |
170 lb |
1/28/2013 |
Physician |
Country Not Specified |
|
| Sinus Disorder |
|
|
|
Male |
|
1/28/2013 |
Physician |
Country Not Specified |
|
| Spinal Fusion Surgery |
Other Serious |
2010 |
|
Female |
154 lb |
1/31/2013 |
Physician |
Country Not Specified |
|
| Troponin Increased |
Hospitalization |
10/14/2012 |
81 |
Female |
106 lb |
10/25/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
12/4/2012 |
90 |
Female |
127 lb |
12/7/2012 |
Pharmacist |
Us |
|
| Unresponsive To Stimuli |
Hospitalization |
10/9/2012 |
94 |
Male |
152 lb |
11/1/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
10/20/2012 |
90 |
Female |
118 lb |
11/12/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Hospitalization |
10/17/2012 |
77 |
Female |
117 lb |
10/25/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyponatraemia |
Hospitalization |
10/10/2012 |
82 |
Female |
93 lb |
10/26/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Overdose |
Hospitalization |
12/24/2012 |
88 |
Female |
168 lb |
1/9/2013 |
Pharmacist |
Us |
|
| Urinary Tract Infection |
Hospitalization |
10/5/2012 |
75 |
Male |
160 lb |
|
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diverticulum Intestinal |
Hospitalization |
10/9/2012 |
92 |
Female |
155 lb |
10/16/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Bronchitis |
|
1/2/2012 |
71 |
Female |
210 lb |
1/28/2013 |
Consumer |
Country Not Specified |
|
| Visual Impairment |
|
|
83 |
Female |
|
2/6/2013 |
Physician |
Us |
|
| Nasopharyngitis |
|
2/2012 |
|
Male |
145 lb |
1/28/2013 |
Consumer |
Country Not Specified |
|
| Weight Increased |
|
2011 |
|
Female |
169 lb |
1/29/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nasopharyngitis |
Other Serious |
3/5/2012 |
59 |
Female |
192 lb |
1/29/2013 |
Physician |
Country Not Specified |
|
| Tenosynovitis Stenosans |
Other Serious |
2012 |
62 |
Female |
190 lb |
1/29/2013 |
Physician |
Us |
|
| Onychomycosis |
|
|
|
Female |
146 lb |
1/30/2013 |
Consumer |
Country Not Specified |
|
| Paraesthesia |
|
12/2/2012 |
53 |
Male |
180 lb |
2/1/2013 |
Consumer |
Country Not Specified |
|
| Pain In Extremity |
|
|
|
Female |
135 lb |
2/18/2013 |
Consumer |
Us |
|
| Pruritus |
|
|
|
Male |
240 lb |
2/18/2013 |
Consumer |
Country Not Specified |
|
| Laboratory Test Abnormal |
|
|
|
Female |
160 lb |
2/18/2013 |
Consumer |
Us |
|
| Pruritus |
|
|
|
Male |
203 lb |
2/18/2013 |
Consumer |
Country Not Specified |
|
| Low Density Lipoprotein Increased |
|
|
|
Male |
260 lb |
2/18/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
|
|
Male |
210 lb |
2/18/2013 |
Consumer |
Country Not Specified |
|
| Pruritus |
|
8/31/2012 |
60 |
Female |
160 lb |
2/18/2013 |
Consumer |
Country Not Specified |
|
| Skin Ulcer |
Other Serious |
12/16/2007 |
56 |
Female |
|
3/8/2013 |
Consumer |
Country Not Specified |
|
| Upper Respiratory Tract Infection |
Hospitalization |
1/9/2013 |
69 |
Male |
192 lb |
4/26/2013 |
Physician |
Us |
|
| Pain |
|
|
75 |
Female |
121 lb |
3/25/2013 |
Consumer |
Us |
|
| Flushing |
Other Serious |
2011 |
|
Male |
215 lb |
4/8/2013 |
Consumer |
Country Not Specified |
|
| Drug Ineffective |
|
1/2013 |
81 |
Male |
161 lb |
4/4/2013 |
Consumer |
Us |
|
| Somnolence |
|
|
|
Male |
|
7/11/2013 |
Consumer |
Us |
|
| Myelodysplastic Syndrome |
Hospitalization |
11/15/2012 |
62 |
Male |
212 lb |
5/2/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
2/21/2013 |
93 |
Male |
174 lb |
2/28/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Death |
1/10/2013 |
85 |
Male |
205 lb |
1/24/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypokalaemia |
Hospitalization |
1/14/2013 |
88 |
Female |
159 lb |
1/17/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
1/15/2013 |
74 |
Male |
161 lb |
1/17/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
2/15/2013 |
82 |
Male |
188 lb |
2/19/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Occult Blood Positive |
Hospitalization |
1/21/2013 |
|
Female |
132 lb |
1/29/2013 |
Pharmacist |
Us |
|
| Respiratory Failure |
Hospitalization |
1/17/2013 |
69 |
Male |
194 lb |
1/25/2013 |
Pharmacist |
Us |
|
| Tachycardia |
Hospitalization |
1/23/2013 |
71 |
Male |
192 lb |
1/29/2013 |
Pharmacist |
Us |
|
| Somnolence |
Hospitalization |
2/5/2013 |
57 |
Female |
139 lb |
2/25/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Airway Obstruction |
Hospitalization |
2/25/2013 |
90 |
Male |
185 lb |
2/28/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetic Foot |
Hospitalization |
3/9/2013 |
67 |
Male |
|
5/16/2013 |
Consumer |
Us |
|
| Skin Burning Sensation |
Hospitalization |
2/4/2013 |
78 |
Male |
255 lb |
4/19/2013 |
Consumer |
Us |
|
| Pneumothorax |
Hospitalization |
|
62 |
Male |
|
5/1/2013 |
Consumer |
Country Not Specified |
|
| Respiratory Disorder |
Hospitalization |
4/29/2013 |
98 |
Female |
91 lb |
6/10/2013 |
Physician |
Us |
|
| Varices Oesophageal |
Hospitalization |
4/3/2013 |
77 |
Female |
90 lb |
6/19/2013 |
Physician |
Ca |
|
| Dyspnoea |
Other Serious |
|
|
NotSpecified |
327 lb |
|
|
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
6/17/2013 |
83 |
Male |
|
8/30/2013 |
Consumer |
Us |
|
| Wound Haemorrhage |
Hospitalization |
10/21/2012 |
76 |
Male |
198 lb |
10/30/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Tract Infection |
Hospitalization |
2011 |
|
Male |
205 lb |
5/23/2013 |
Physician |
Us |
|
| Oral Herpes |
|
10/2012 |
61 |
Female |
150 lb |
5/29/2013 |
Other Health Professional |
Us |
|
| Off Label Use |
|
|
66 |
Female |
140 lb |
5/31/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Hospitalization |
|
|
Female |
101 lb |
6/20/2013 |
Consumer |
Us |
|
| Parathyroid Gland Operation |
Other Serious |
1/2013 |
57 |
Female |
206 lb |
6/18/2013 |
Consumer |
Country Not Specified |
|
| Death |
Death |
3/14/2013 |
58 |
Male |
194 lb |
6/27/2013 |
Pharmacist |
Us |
|
| Unresponsive To Stimuli |
Life Threatening |
2/7/2013 |
84 |
Male |
190 lb |
4/3/2013 |
Pharmacist |
Us |
|
| Flushing |
|
|
|
Male |
164 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Wrong Technique In Drug Usage Process |
|
|
|
Male |
170 lb |
7/30/2013 |
Consumer |
Us |
|
| Skin Burning Sensation |
|
9/4/2012 |
62 |
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
|
|
Female |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Skin Burning Sensation |
|
|
|
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Paraesthesia |
|
9/11/2012 |
61 |
Male |
180 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Rash Pruritic |
|
8/2012 |
|
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
2008 |
|
Male |
160 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Oedema Peripheral |
|
9/9/2012 |
83 |
Male |
160 lb |
7/30/2013 |
Consumer |
Us |
|
| Oral Discomfort |
|
|
|
Male |
215 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Pruritus |
|
|
|
Female |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
|
|
Male |
185 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Generalised Erythema |
|
|
|
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Vulvovaginal Pruritus |
|
8/1/2012 |
74 |
Female |
110 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Pruritus |
|
11/2012 |
52 |
Female |
119 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Pruritus |
|
11/27/2012 |
56 |
Male |
141 lb |
7/30/2013 |
Consumer |
Us |
|
| Therapeutic Response Unexpected |
|
|
|
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Gastric Ulcer |
|
2011 |
|
Male |
150 lb |
7/30/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abdominal Discomfort |
|
|
|
Female |
137 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Skin Burning Sensation |
|
|
|
Male |
165 lb |
7/30/2013 |
Consumer |
Us |
|
| Tinnitus |
|
|
|
Female |
156 lb |
7/30/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Insomnia |
|
|
|
Female |
180 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Hypothyroidism |
|
|
|
Male |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Somnolence |
|
|
|
Female |
|
7/30/2013 |
Consumer |
Country Not Specified |
|
| Terminal Insomnia |
|
|
|
Male |
195 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Skin Burning Sensation |
|
|
|
Male |
250 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Upper Respiratory Tract Congestion |
|
|
|
Male |
175 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
7/15/2012 |
66 |
Female |
|
7/30/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pruritus |
|
|
|
Female |
198 lb |
7/30/2013 |
Consumer |
Us |
|
| Flushing |
|
|
|
Male |
180 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Product Physical Issue |
|
12/2012 |
78 |
Female |
145 lb |
7/30/2013 |
Consumer |
Us |
|
| Product Lot Number Issue |
|
|
|
Male |
235 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Product Lot Number Issue |
|
|
|
Female |
250 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Wrong Technique In Drug Usage Process |
|
|
|
Male |
215 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
|
|
Male |
230 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Flushing |
|
|
|
Male |
279 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Skin Burning Sensation |
|
2013 |
|
Male |
205 lb |
7/30/2013 |
Consumer |
Country Not Specified |
|
| Urinary Tract Infection |
Hospitalization |
3/6/2013 |
73 |
Female |
150 lb |
4/29/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
3/26/2013 |
77 |
Male |
226 lb |
4/4/2013 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vaginal Haemorrhage |
Hospitalization |
7/17/2013 |
78 |
Female |
180 lb |
7/24/2013 |
|
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Tachycardia |
Hospitalization |
6/2013 |
69 |
Male |
164 lb |
8/19/2013 |
Physician |
Country Not Specified |
|
| Pain In Extremity |
Other Serious |
2011 |
84 |
Female |
133 lb |
3/2/2012 |
|
Us |
|
| Weight Increased |
Other Serious |
2007 |
|
NotSpecified |
|
9/13/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
8/6/2009 |
64 |
Male |
249 lb |
9/13/2013 |
Other Health Professional |
Us |
|
| Wheezing |
Other Serious |
10/2003 |
|
Female |
226 lb |
12/20/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wheezing |
Hospitalization |
10/2003 |
83 |
Female |
226 lb |
8/8/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
2002 |
73 |
Female |
156 lb |
10/8/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|