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To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra Vaccine Recipients | Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente. |
| |
| Age-Matched Control | Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None administered in this study | Biological | N/A in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | Day 0 up to Day 60 post-vaccination |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Past receipt of Menactra vaccine
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28941623 | Derived | Hansen J, Zhang L, Klein NP, Robertson CA, Decker MD, Greenberg DP, Bassily E, Baxter R. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017 Dec 14;35(49 Pt B):6879-6884. doi: 10.1016/j.vaccine.2017.09.032. Epub 2017 Sep 21. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.
Study participant accrual occurred from 15 July 2005 through 14 April 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Menactra Vaccine Recipients | Kaiser Permanente members who received Menactra vaccine during the study period. Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice. |
| FG001 | Control Group | Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier. Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who received Menactra vaccine during the study period from the Kaiser Permanente databases.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Menactra Vaccine Recipients | Kaiser Permanente members who received Menactra vaccine during the study period. Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 60 post-vaccination |
|
Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Menactra Vaccine Recipients | Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases. None administered in this study: N/A in this study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia (Chronic, Precedes) | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Drector | Sanofi Pasteur Inc | RegistryContactus@sanofipasteur.com |
Not provided
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 up to Day 180 post-vaccination |
| Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | Day 0 up to Day 60 post-vaccination |
| Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room. | Day 0 up to Day 180 post-vaccination |
| Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | Day 0 up to Day 180 post-vaccination |
| Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | Day 0 up to Day 180 post-vaccination |
| Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined. | Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. | Day 0 up to 6 months post-vaccination |
| Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. | Day 0 up to 6 months post-vaccination |
| Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Only persons who received Menactra vaccine during the study period were included in this outcome. | Day 0 up to Determination of Pregnancy Outcome |
Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier. Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Gender | Gender information for 3 participants was not available in the database. | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Seasonality | Data represents participants receiving vaccine each season or time period shown. Some participants (49) had received more than one dose of Menactra vaccine are counted for each dose in the seasonality section. | Number | Participants |
|
Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study
| OG001 | Control Group | The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals. |
|
|
| Other Pre-specified | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 180 post-vaccination |
|
|
|
| Other Pre-specified | Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 60 post-vaccination |
|
|
|
| Other Pre-specified | Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room. | All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 180 post-vaccination |
|
|
|
| Other Pre-specified | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 180 post-vaccination |
|
|
|
| Other Pre-specified | Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room. | All persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 person-months | Day 0 up to Day 180 post-vaccination |
|
|
|
| Other Pre-specified | Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined. | Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. | Only all persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 doses | Day 0 up to 6 months post-vaccination |
|
|
|
| Other Pre-specified | Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined | Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. | Only persons who received Menactra vaccine during the study period were included in the analysis. | Posted | Number | Events per 1,000 doses | Day 0 up to 6 months post-vaccination |
|
|
|
| Other Pre-specified | Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination | Only persons who received Menactra vaccine during the study period were included in this outcome. | Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded. | Posted | Number | Paticipants | Day 0 up to Determination of Pregnancy Outcome |
|
|
|
| 273 |
| 31,561 |
| 0 |
| 31,558 |
| Idiopathic thrombocytopenic purpura (Precedes) | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Congenital Anomaly | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Congenital Heart Disease | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Sickle Cell Disease | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pectus Excavatum | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Febrile Illness | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Delirium Tremens | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Fatty Liver | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Transplant Rejection | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Abscess/Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Aseptic Meningitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Encephalitis due to Epstein-Barr Virus | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Viral Syndrome | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pelvic Inflammatory Disease | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Toxic Shock Syndrome | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Complications of Transplanted Organ | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Foreign Body | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Poisoning/Ingestion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Diabetes, Type 1 (New Onset) | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Diabetes, Type 1 (Prior Onset) | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Femoral Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Systemic Lupus Erythematosus (New dx, symptoms precede) | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Systemic Lupus Erythematosus (Prior onset) | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Temporomandibular Joint Disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cancer, Cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Cancer, Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Cancer, Ovarian | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Cancer, Pancreatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Benign lesion NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Cancer, R/O Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Hodgkin's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Lymphocytic Leukemia (Chronic, Precedes) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cranial Nerve Palsy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chronic Inflammatory Demyelinating Polyneuritis (Prior onset) | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Epilepsy (Hx of Seizure Disorder, possible seizure) | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Epilepsy (Seizure Event, w/hx of Seizure Disorder) | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Horner's Syndrome | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Syncope/LOC | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pregnancy | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pregnancy - Stillborn Delivery post Prolapsed Cord | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Psychiatric | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Suicidal Ideation/Attempt | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Renal Calculus | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| End-Stage Renal Disease | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Testicular Torsion | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Asthma/RAD | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Asphyxiation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Elective Procedure | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Inguinal Hernia/Repair | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Tooth disorder (Dental) | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Idiopathic Polycystic Splenomegaly | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumocystosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Genital pain (ER) |
|
| Hyperglycemia (ER) |
|
| Mononucleosis (ER) |
|
| Tympanic perforation (H) |
|
| Vomiting (ER) |
|
| Suicidal Ideation/Attempt (age 11-16 years; ER) |
|
| Elective procedure (age 11-16 years; H) |
|
| Febrile illness (age 11-16 years; ER) |
|
| Hives/Urticaria (age 11-16 years; C) |
|
| Mononucleosis (age 17-18 years; ER) |
|
| Otitis Externa (age 11-16 years; ER) |
|
| Vomiting (age 11-16 years; ER) |
|
| Allergy, drug (ER) |
|
| Benign lesion (H) |
|
| Congenital anomaly (H) |
|
| Cyst (H) |
|
| Fatigue (ER) |
|
| Insect bite (ER) |
|
| Musculoskeletal pain (ER) |
|
| Pelvic pain (ER) |
|
| Poisoning/Ingestion (H) |
|
| Post-operative complication (ER) |
|
| Post-operative complication (H) |
|
| Pregnancy delivery (H) |
|
| Psychiatric (ER) |
|
| Psychiatric (H) |
|
| Testicular pain (ER) |
|
| Tonsillitis (H) |
|
| Trauma (ER) |
|
| Vision disorder (H) |
|
| Well care/Reassurance/Follow-up (ER) |
|
| Allergic reaction (age 11-16 years; ER) |
|
| Benign lesion (age 11-16 years; H) |
|
| Congenital anomaly (age 11-16 years; H) |
|
| Cyst (age 11-16 years; H) |
|
| Pelvic pain (age 17-18 years; ER) |
|
| Post-operative complication (age 17-18 years; ER) |
|
| Psychiatric (age 11-16 years; H) |
|
| Psychiatric (age 17-18 years; ER) |
|
| Psychiatric (age 17-18 years; H) |
|
| Testicular pain (age 11-16 years; ER) |
|
| Tonsillitis (age 11-16 years; H) |
|
| Tonsillitis (age 17-18 years; ER) |
|
| Tonsillitis (age 17-18 years; H) |
|
| Trauma (age 11-16 years; ER) |
|
| Trauma (age 17-18 years; ER) |
|
| Trauma (age 19-29 years; ER) |
|
| Trauma (age 19-29 years; H) |
|
| Trauma (age 30-55 years; ER) |
|
| Trauma (age 30-55 years; H) |
|
| Well care/Reassurance/Follow-up (age 11-16 yrs;ER) |
|
| Well care/Reassurance/Follow-up (age 17-18 yrs;ER) |
|
| Title | Measurements |
|---|---|
|
| Appendicitis |
|
| Arrhythmia |
|
| Aseptic meningitis |
|
| Asphyxiation |
|
| Asthma/Reactive airway disease |
|
| Benign lesion |
|
| COPD |
|
| Cancer, Cervix |
|
| Cancer, Melanoma |
|
| Cancer, Ovarian |
|
| Cancer, Pancreatic |
|
| Cancer, Rule out cancer |
|
| Cholelithiasis |
|
| Chronic inflammatory demyelinating polyneuritis |
|
| Complications of transplanted organ |
|
| Congenital anomaly |
|
| Congenital heart disease |
|
| Constipation |
|
| Cranial nerve palsy |
|
| Cyst |
|
| Dehydration |
|
| Delirium tremens |
|
| Dental |
|
| Diabetes type I (Diagnosed after vaccination) |
|
| Diabetes type I (Diagnosed before vaccination) |
|
| Diarrhea |
|
| Elective procedure |
|
| Encephalitis |
|
| Encephalitis due to Epstein-Barr virus |
|
| End-stage renal disease |
|
| Epilepsy (Hx of seizure disorder possible seizure) |
|
| Epilepsy (Seizure event, w/hx of seizure disorder) |
|
| Fatty liver |
|
| Febrile illness |
|
| Femoral epiphysiolysis |
|
| Foreign body |
|
| Gastroesophageal reflux |
|
| Gastroenteritis |
|
| Hodgkin's disease |
|
| Horner's syndrome |
|
| Hydrocephalus |
|
| Hypertension |
|
| ITP (Diagnosed before vaccination) |
|
| Idiopathic polycystic splenomegaly |
|
| Inguinal hernia/repair |
|
| Kyphosis |
|
| Labyrinthitis |
|
| Lymphocytic leukemia (Chronic, diagnosed before) |
|
| Migraine |
|
| Osteomyelitis |
|
| Pancreatitis |
|
| Pectus excavatum |
|
| Pelvic inflammatory disease |
|
| Pharyngitis |
|
| Pneumocystosis |
|
| Pneumonia |
|
| Pneumothorax |
|
| Poisoning/ingestion |
|
| Pregnancy |
|
| Pregnancy - Stillborn delivery post prolapsed cord |
|
| Psychiatric |
|
| Plumonary embolism |
|
| Respiratory syncytial virus infection |
|
| Renal calculus |
|
| Scoliosis |
|
| Sickle cell disease |
|
| Sleep apnea |
|
| Splenomegaly |
|
| Suicidal ideation/attempt |
|
| Syncope/Loss of consciousness |
|
| SLE (Diagnosed after vaccination; symptoms before) |
|
| SLE (Diagnosed before vaccination) |
|
| Temporomandibular joint disorder |
|
| Testicular torsion |
|
| Thrombocytopenia (Chronic, diagnosed before vacc.) |
|
| Tonsillitis |
|
| Toxic shock syndrome |
|
| Transplant rejection |
|
| Trauma |
|
| Urinary tract infection |
|
| Viral syndrome |
|
| Title | Measurements |
|---|---|
|
| Early fetal death |
|
| Lost to follow up |
|