Study: NCT00931879

Adverse event: Head trauma due to accidental fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient fell and suffered bruises and cuts to her face; received more than 25 stitches and wound care to her face. Later, patient experienced vomiting and headaches and later received a CAT scan which displayed an internal head bleed due to trauma.
Frequency: 1 affected / 19 at risk

Adverse event: Hospitilization due to low blood pressure and fainting
Serious: yes
Organ System: Cardiac disorders
Notes: Patient passed out in home, ER recorded BP as 63/48. During ER stay, patient had an EKG, MRI, ultrasound, and carotid doppler tests which all proved to be normal. Cause of fainting undetermined.
Frequency: 1 affected / 19 at risk

Adverse event: Overnight stay in ER for observation after experiencing chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Patient seen in ER after reporting feeling pain in chest that "radiated down her arm" and some pain in her back and abdomen. A nuclear stress test was performed and patient states that no blockages were found.
Frequency: 1 affected / 19 at risk

Adverse event: Planned surgery to treat Achalasia/Esophageal motility disorder
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient underwent a planned surgical procedure to treat Achalasia/Esophageal motility disorder. Procedure lasted 6 hours, and patient was under anesthesia for 7 hours. This was an in-patient procedure.
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient reports experiencing lower left quadrant pain with increased night sweats and low-grade fever. Patient seen at ER, where CAT scan revealed swollen lymph nodes in the small mesenteric bowel.
Frequency: 1 affected / 19 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Notes: Patient reports a bacterial infection and rash on abdomen and chest. Seen at dermatologist and prescribed prescription body wash, Z-pack, and skin culture.
Frequency: 1 affected / 19 at risk

Adverse event: Personal Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Rising from a seated position, patient fell. No dizziness, shortness of breath, or blurred vision noted. Patient did not receive any further medical attention.
Frequency: 1 affected / 19 at risk

Adverse event: Bladder Suspension with Sling
Serious: no
Organ System: Surgical and medical procedures
Notes: Patient underwent cystoscopy with transobturator sling. Not considered an emergency surgery.
Frequency: 1 affected / 19 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient suffered asthma-related bronchitis; prescribed prednisone, antibiotic, and inhaler.
Frequency: 1 affected / 19 at risk

Adverse event: Upper limb weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reports increased arm pain/weakness bilaterally. Ordered nerve conduction study on median, ulnar, and radial nerves bilaterally resulting in otherwise normal results.
Frequency: 1 affected / 19 at risk

Adverse event: Dry/Achy Eyes
Serious: no
Organ System: Eye disorders
Notes: Patient reports experiencing increased eye strain and very dry eyes. Patient seen at ophthalmologist; prescribed artificial tears to be take Q 4 hours.
Frequency: 1 affected / 19 at risk

Adverse event: Bells Palsy
Serious: no
Organ System: Nervous system disorders
Notes: During routine physical, patient showed signs and symptoms of having Bells Palsy. Patient also reports being recently diagnosed with genital herpes. Patient prescribed metrozol pack and valtrex.
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reports experiencing increased lower back pain. Went to ER, where x-rays revealed no significant findings. Pain attributed to soft tissue injury due to overactivity or arthritis. Received two shots of Dilaudid.
Frequency: 1 affected / 19 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Patients reports consistent higher than normal blood glucose levels. Patient instructed to continue to monitor levels.
Frequency: 1 affected / 19 at risk

Adverse event: Atypical Chest Pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Normal EKG, no evidence of myocardial infarction, normal stress test and echocardiogram and troponin normal
Frequency: 1 affected / 19 at risk

Adverse event: Emergency Surgery to relieve bile duct obstruction
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient went to ER reporting abdominal pain, losing 6 pounds, dark urine and clay-colored stool.CT scan found 2 stones in gallbladder - 1 occluding the common bile duct. An Endoscopic Retrograde Cholangiopancreatography removed both offending stones.
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient administered 5-day Z-pack; all symptoms subsided
Frequency: 1 affected / 19 at risk

Adverse event: Severe-Moderate Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient experienced severe to moderate diarrhea which was explained as "uncontrollable" at times
Frequency: 1 affected / 19 at risk

Adverse event: Dehyrdation/Severe Vomiting/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient went to ER for severe dehydration (administered 2 IV bags) and nausea (given Zofran). Patient went back to ER two weeks later for similar symptoms. Dehydration most likely due to vomiting and severe diarrhea
Frequency: 1 affected / 19 at risk

Adverse event: Personal Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient slipped in shower and struck right elbow against the shower wall. Patient seen at ER, where x-rays revealed no abnormalities.
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness/Fainting
Serious: no
Organ System: Nervous system disorders
Notes: While stopped at red light, patient reports feeling dizzy and then fainting causing her to strike another car. Bloodwork/CT done at ER with normal results. Cause of fainting undetermined.
Frequency: 1 affected / 19 at risk

Adverse event: Fainting/Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: While exiting a vehicle, patient reports fainting (no dizziness reported). Cause of fainting unknown.
Frequency: 1 affected / 19 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Patient reports experiencing significant increases in eye discharge. Patient reports seeing an ophthalmologist with no significant abnormalities noted.
Frequency: 1 affected / 19 at risk

Adverse event: Cranial/Facial Lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients reports sores on scalp and unhealing dark spots on facial skin. Patients also reports "stabbing" pain in left knee and left side of foot.
Frequency: 1 affected / 19 at risk