Study: NCT01741012

Adverse event: Chest pain and arm pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Chest pain and arm pain due to atypical non cardiac chest pain and a pinched nerve affecting the arm
Frequency: 1 affected / 34 at risk

Adverse event: unplanned pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Unplanned pregnancy. Patient chose to terminate the pregnancy
Frequency: 1 affected / 34 at risk

Adverse event: nausea and vomiting with hypertensive crisis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea and vomiting due to gastritis with dehydration Hypertensive crisis due to non compliance with hypertension medications
Frequency: 1 affected / 34 at risk

Adverse event: unplanned pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: unplanned pregnancy. Patient chose voluntary termination of pregnancy
Frequency: 1 affected / 34 at risk

Adverse event: Chest pain and shortness of breath with left sided numbness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non cardiac chest pain due to fibromyalgia. Cardiac disease ruled out.
Frequency: 1 affected / 34 at risk

Adverse event: pain, swelling and discharge of the right breast
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Pain, swelling and discharge of the right breast due to a blocked duct
Frequency: 1 affected / 34 at risk

Adverse event: shortness of breath and itching after eating peanut butter
Serious: yes
Organ System: Immune system disorders
Notes: Allergic reaction to peanut butter.Pt had known allergy to peanuts
Frequency: 1 affected / 34 at risk

Adverse event: chest pain non cardiogenic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Chest pain radiating down left arm due to DJD (degenerative joint disease) of the Cervical spine with radiculopathy Cardiac work up negative
Frequency: 1 affected / 34 at risk

Adverse event: swollen left leg with ulcer
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Edema with superficial laceration which healed
Frequency: 1 affected / 34 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: There were 106 number of musculoskeletal non vaccine related adverse events in 34 patients
Frequency: 24 affected / 34 at risk

Adverse event: nervouus system
Serious: no
Organ System: Nervous system disorders
Notes: There were 102 Nervous system non vaccine related adverse events in 34 patients
Frequency: 25 affected / 34 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: There were 49 gastrointestinal non vaccine related adverse events in 18 patients
Frequency: 18 affected / 34 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Notes: There were 45 general disorder non vaccine related adverse events in 17 patients
Frequency: 17 affected / 34 at risk

Adverse event: dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: There were 45 dermatologic non vaccine related adverse events in 17
Frequency: 17 affected / 34 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Notes: There were 44 non vaccine related infectious adverse events in 21 patients
Frequency: 21 affected / 34 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: There were 29 respiratory non vaccine related adverse events in 12 patients
Frequency: 12 affected / 34 at risk

Adverse event: Angiopathy
Serious: no
Organ System: Vascular disorders
Notes: There were 18 vascular disorder non vaccine related adverse events in 10 patients
Frequency: 10 affected / 34 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: There were 8 metabolism and nutrition non vaccine related adverse events in 7 patients
Frequency: 7 affected / 34 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: There were 6 renal and urinary disorder non vaccine related adverse events in 6 people
Frequency: 6 affected / 34 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: There were 7 reproductive and breast non vaccine related adverse events in 6 patients
Frequency: 6 affected / 34 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: There were 12 psychiatric disorder non vaccine related adverse events in 5 patients
Frequency: 5 affected / 34 at risk

Adverse event: immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: There were 4 immune system disorder non vaccine related adverse events in 4 patients
Frequency: 4 affected / 34 at risk

Adverse event: Blood and Lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: There were 3 blood and lymphatic disorder non vaccine related adverse events in 3 patients
Frequency: 3 affected / 34 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: There were 4 ear and labyrinth disorder non vaccine related adverse events in 3 patients
Frequency: 3 affected / 34 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: There were 3 eye disorder non vaccine related adverse events in 3 patients
Frequency: 3 affected / 34 at risk

Adverse event: injury poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: There were 3 injury, poisoning and procedural complications in 3 patients
Frequency: 3 affected / 34 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Notes: There were 5 surgical and medical procedure non vaccine related adverse events in 3 patients
Frequency: 3 affected / 34 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: There were 2 cardiac disorder non vaccine related adverse events in 2 patients
Frequency: 2 affected / 34 at risk

Adverse event: neoplasms benign, malignant and unspecified (incl dysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: There were 2 neoplasms benign, malignant, and unspecified non vaccine related adverse events in 2 patients
Frequency: 2 affected / 34 at risk

Adverse event: Pregnancy , puerperium and perinatal conditions
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: There were 2 pregnancy, puerperium and perinatal condition non vaccine related adverse events in 2 patients
Frequency: 2 affected / 34 at risk

Adverse event: Hepatobiliary disorders-other
Serious: no
Organ System: Hepatobiliary disorders
Notes: There was one hepatobiliary disorder non vaccine related adverse event in one patient
Frequency: 1 affected / 34 at risk