Pneumococcal Disease
Conditions
Keywords
Pneumococcal conjugate vaccine
Brief summary
The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
Kaiser Permanente
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 3 Years
Healthy volunteers
Yes
Inclusion criteria
* Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.
Exclusion criteria
* Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3. | 53,902 |
| Total | 53,902 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age, Continuous | 63 days |
| Sex: Female, Male Female | 26274 Participants |
| Sex: Female, Male Male | 27628 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Abnormal involuntary movements | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Acute bronchiolitis due to RSV | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Acute otitis media | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Adverse drug reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Apnea | 3.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Apparent life threatening event infant | 2.50 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Asthma, unspecified, unspecified status | 0.23 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Bronchiolitis | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Bronchitis | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Bronchospasm | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Candidiasis of mouth | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Constipation | 0.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Croup | 0.59 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Dehydration | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Dermatitis | 0.26 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Dyspnea | 1.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Failure to thrive | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Fever | 1.38 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Fussy infant | 1.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Gastroenteritis | 0.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Hand, foot and mouth disease | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Hematoma | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Nausea and vomiting | 0.71 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Neonatal candida infection | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Other diseases of nasal cavity and sinuses | 0.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Other specified cardiac dysrhythmias | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Pneumonia | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Rash | 0.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Respiratory syncytial virus | 3.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Single seizure | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Stridor | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Umbilical hernia without obstruction/gangrene | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Unspecified septicemia | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Urinary tract infection | 3.30 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Urticaria | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Viral syndrome | 0.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Wheezing | 0.55 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.62mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.49mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.11mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.35mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.35mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.3mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.45mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.17mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.92mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.09mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.91mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Abnormal involuntary movements | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Acute bronchiolitis due to RSV | 2.65 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Acute febrile mucocutaneous lymph node syndrome | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Acute otitis media | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Acute pyelonephritis without RMN lesion | 1.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Apnea | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Apparent life threatening event infant | 2.50 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Asthma, unspecified, unspecified status | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Bronchiolitis | 1.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Bronchitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Candidiasis of mouth | 6.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Cellulitis and abscess of trunk | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Constipation | 0.30 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Croup | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Dehydration | 1.11 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Dermatitis | 0.46 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Dyspnea | 2.05 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Failure to thrive | 1.62 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Fever | 1.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Fussy infant | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Gastroenteritis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Lipoma of other specified sites | 0.46 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Methicillin susceptible Staphylococcus aureus | 4.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Nausea and vomiting | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Neonatal bradycardia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Other diseases of nasal cavity and sinuses | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Other specified cardiac dysrhythmias | 3.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Pilonidal cyst without mention of abscess | 2.36 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Pneumonia | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Rash | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Respiratory syncytial virus | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Single seizure | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Stridor | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Umbilical hernia without obstruction/gangrene | 2.50 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Unspecified bacterial pneumonia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Unspecified septicemia | 5.46 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Urinary tract infection | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Viral syndrome | 1.06 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Weakness | NA ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.91mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.86mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.11mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.42mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.88mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.79mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.42mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.46mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.88mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.93mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.9mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.11mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.09mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.34mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.92mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Apnea | 2.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Rash | 1.02 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Abnormal involuntary movements | 1.52 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Acute bronchiolitis due to RSV | 1.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Acute febrile mucocutaneous lymph node syndrome | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Acute otitis media | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Acute pyelonephritis without RMN lesion | 1.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Adverse drug reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Apparent life threatening event infant | 2.43 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Asthma, unspecified, unspecified status | 0.53 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Bronchiolitis | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Bronchitis | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Bronchospasm | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Candidiasis of mouth | 4.10 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Cellulitis and abscess of trunk | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Constipation | 0.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Croup | 0.58 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Dehydration | 1.00 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Dermatitis | 0.28 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Dyspnea | 1.58 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Failure to thrive | 1.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Fever | 1.39 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Fussy infant | 1.21 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Gastroenteritis | 0.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Hand, foot and mouth disease | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Hematoma | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Lipoma of other specified sites | 0.46 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Methicillin susceptible Staphylococcus aureus | 4.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Nausea and vomiting | 0.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Neonatal bradycardia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Neonatal candida infection | 1.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Other diseases of nasal cavity and sinuses | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Other specified cardiac dysrhythmias | 3.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Pilonidal cyst without mention of abscess | 2.36 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Pneumonia | 0.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Respiratory syncytial virus | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Single seizure | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Stridor | 0.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Umbilical hernia without obstruction/gangrene | 2.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Unspecified bacterial pneumonia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Unspecified septicemia | 3.03 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Urinary tract infection | 2.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Urticaria | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Viral syndrome | 0.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Wheezing | 0.55 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.59mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.86mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.1mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.19mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.35mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.42mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.29mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.11mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 1mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.16mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.19mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.4mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.65mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.1mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.91mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Abnormal involuntary movements | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Acute bronchiolitis due to RSV | 2.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Acute otitis media | 0.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Adverse drug reaction | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Apnea | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Apparent life threatening event infant | 0.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Asthma, unspecified, unspecified status | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Bronchiolitis | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Bronchitis | 1.16 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Bronchospasm | 1.24 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Candidiasis of mouth | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Constipation | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Croup | 0.87 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Dehydration | 1.03 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Dermatitis | 0.47 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Dyspnea | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Failure to thrive | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Fever | 1.15 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Fussy infant | 1.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Gastroenteritis | 1.05 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Hand, foot and mouth disease | 1.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Hematoma | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Nausea and vomiting | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Neonatal candida infection | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Other diseases of nasal cavity and sinuses | 2.92 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Pneumonia | 0.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Rash | 0.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Respiratory syncytial virus | 0.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Single seizure | 1.40 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Stridor | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Umbilical hernia without obstruction/gangrene | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Unspecified septicemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Urinary tract infection | 1.20 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Urticaria | 0.83 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Viral syndrome | 0.59 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Wheezing | 0.80 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.34mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.35mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.84mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.64mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.9mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.34mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.54mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Abnormal involuntary movements | 4.65 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Acute bronchiolitis due to RSV | 1.06 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Acute febrile mucocutaneous lymph node syndrome | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Acute otitis media | 0.53 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Acute pyelonephritis without RMN lesion | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Apnea | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Apparent life threatening event infant | 0.23 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Asthma with acute exacerbation | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Asthma, unspecified, unspecified status | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Bronchiolitis | 1.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Bronchitis | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Bronchospasm | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Cellulitis and abscess of trunk | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Constipation | 2.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Croup | 1.24 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Dehydration | 1.01 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Dermatitis | 1.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Dyspnea | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Failure to thrive | 1.16 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Fever | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Fussy infant | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Gastroenteritis | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Lipoma of other specified sites | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Methicillin susceptible Staphylococcus aureus | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Nausea and vomiting | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Other diseases of nasal cavity and sinuses | 0.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Other specified cardiac dysrhythmias | 2.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Pilonidal cyst without mention of abscess | 2.07 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Pneumonia | 0.78 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Rash | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Single seizure | 0.47 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Stridor | 3.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Umbilical hernia without obstruction/gangrene | 3.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Unspecified bacterial pneumonia | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Unspecified septicemia | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Urinary tract infection | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Urticaria | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Viral syndrome | 1.24 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Weakness | NA ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.19mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.8mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.92mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.76mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.91mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.34mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.4mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.8mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.
Time frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Abnormal involuntary movements | 6.51 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Acute bronchiolitis due to RSV | 1.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Acute febrile mucocutaneous lymph node syndrome | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Acute otitis media | 0.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Acute pyelonephritis without RMN lesion | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Adverse drug reaction | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Apnea | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Apparent life threatening event infant | 0.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Asthma with acute exacerbation | 0.47 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Asthma, unspecified, unspecified status | 0.81 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Bronchiolitis | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Bronchitis | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Bronchospasm | 1.34 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Candidiasis of mouth | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Cellulitis and abscess of trunk | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Constipation | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Croup | 0.87 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Dehydration | 0.78 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Dermatitis | 0.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Dyspnea | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Failure to thrive | 1.16 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Fever | 1.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Fussy infant | 1.24 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Gastroenteritis | 1.03 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Hand, foot and mouth disease | 1.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Hematoma | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Lipoma of other specified sites | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Methicillin susceptible Staphylococcus aureus | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Nausea and vomiting | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Neonatal candida infection | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Other diseases of nasal cavity and sinuses | 2.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Other specified cardiac dysrhythmias | 2.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Pilonidal cyst without mention of abscess | 2.07 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Pneumonia | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Rash | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Respiratory syncytial virus | 0.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Single seizure | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Stridor | 3.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Umbilical hernia without obstruction/gangrene | 4.65 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Unspecified bacterial pneumonia | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Unspecified septicemia | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Urinary tract infection | 1.09 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Urticaria | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Viral syndrome | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Wheezing | 0.80 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.58mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.39mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.32mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.76mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.29mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.58mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.92mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.35mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.3mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.34mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.76mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.54mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Abnormal involuntary movements | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Acute bronchiolitis due to RSV | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Acute febrile mucocutaneous lymph node syndrome | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Acute otitis media | 0.90 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Acute pyelonephritis without RMN lesion | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Adverse drug reaction | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Apnea | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Apparent life threatening event infant | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Asthma, unspecified, unspecified status | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Bronchiolitis | 1.29 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Bronchitis | 0.42 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Bronchospasm | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Candidiasis of mouth | 0.25 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Cellulitis and abscess of trunk | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Constipation | 1.09 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Croup | 1.26 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Dehydration | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Dermatitis | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Dyspnea | 2.62 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Failure to thrive | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Fever | 1.07 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Fussy infant | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Gastroenteritis | 0.51 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Hand, foot and mouth disease | 1.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Hematoma | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Nausea and vomiting | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Neonatal candida infection | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Other diseases of nasal cavity and sinuses | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Other specified cardiac dysrhythmias | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Pneumonia | 1.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Rash | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Respiratory syncytial virus | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Single seizure | 1.15 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Stridor | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Umbilical hernia without obstruction/gangrene | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Unspecified septicemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Urinary tract infection | 1.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Urticaria | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Viral syndrome | 0.81 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Wheezing | 2.26 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.55mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.62mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.43mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.85mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.74mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.82mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.55mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.26mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.81mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.64mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.97mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.31mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Hand, foot and mouth disease | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Lipoma of other specified sites | 0.33 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Methicillin susceptible Staphylococcus aureus | 0.20 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Nausea and vomiting | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Other diseases of nasal cavity and sinuses | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Other specified cardiac dysrhythmias | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Pilonidal cyst without mention of abscess | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Pneumonia | 1.11 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Rash | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Respiratory syncytial virus | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Single seizure | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Stridor | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Umbilical hernia without obstruction/gangrene | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Unspecified bacterial pneumonia | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Unspecified septicemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Urinary tract infection | 0.39 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Viral syndrome | 0.25 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Wheezing | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Acute bronchiolitis due to RSV | 1.15 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Abnormal involuntary movements | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Acute febrile mucocutaneous lymph node syndrome | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Acute otitis media | 1.38 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Acute pyelonephritis without RMN lesion | 2.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Apnea | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Apparent life threatening event infant | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Asthma, unspecified, unspecified status | 0.39 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Bronchiolitis | 1.35 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Bronchitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Candidiasis of mouth | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Cellulitis and abscess of trunk | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Constipation | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Croup | 1.48 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Dehydration | 1.35 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Dermatitis | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Dyspnea | 0.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Failure to thrive | 1.15 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Fever | 0.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Fussy infant | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Gastroenteritis | NA ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.6mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.11mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.36mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.81mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.75mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.37mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.78mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.84mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.44mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.
Time frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Acute pyelonephritis without RMN lesion | 3.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Abnormal involuntary movements | 2.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Acute bronchiolitis due to RSV | 1.10 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Acute febrile mucocutaneous lymph node syndrome | 4.92 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Acute otitis media | 0.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Adverse drug reaction | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Apnea | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Apparent life threatening event infant | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Asthma, unspecified, unspecified status | 0.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Bronchiolitis | 1.33 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Bronchitis | 0.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Bronchospasm | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Candidiasis of mouth | 0.39 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Cellulitis and abscess of trunk | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Constipation | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Croup | 1.29 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Dehydration | 1.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Dermatitis | 1.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Dyspnea | 0.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Failure to thrive | 1.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Fever | 1.05 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Fussy infant | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Gastroenteritis | 0.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Hand, foot and mouth disease | 1.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Hematoma | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Lipoma of other specified sites | 0.33 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Methicillin susceptible Staphylococcus aureus | 0.20 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Nausea and vomiting | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Neonatal candida infection | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Other diseases of nasal cavity and sinuses | 0.92 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Other specified cardiac dysrhythmias | 2.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Pilonidal cyst without mention of abscess | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Pneumonia | 1.10 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Rash | 0.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Respiratory syncytial virus | 0.42 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Single seizure | 0.91 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Stridor | 4.92 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Umbilical hernia without obstruction/gangrene | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Unspecified bacterial pneumonia | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Unspecified septicemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Urinary tract infection | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Urticaria | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Viral syndrome | 0.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Wheezing | 2.13 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.78mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.62mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.15mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.61mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.62mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.37mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.82mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.78mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.65mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.17mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.81mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.97mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.19mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Abnormal involuntary movements | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Acute bronchiolitis due to RSV | 0.27 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Acute otitis media | 2.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Acute pyelonephritis without RMN lesion | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Adverse drug reaction | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Apnea | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Apparent life threatening event infant | 0.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Asthma, unspecified, unspecified status | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Bronchiolitis | 0.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Bronchitis | 0.33 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Bronchospasm | 2.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Candidiasis of mouth | 0.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Constipation | 0.36 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Croup | 12.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Dehydration | 0.84 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Dermatitis | 0.36 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Dyspnea | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Failure to thrive | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Fever | 0.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Fussy infant | 0.67 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Gastroenteritis | 0.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Hematoma | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Methicillin susceptible Staphylococcus aureus | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Nausea and vomiting | 0.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Neonatal candida infection | 0.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Other diseases of nasal cavity and sinuses | 0.27 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Other specified cardiac dysrhythmias | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Pneumonia | 0.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Rash | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Respiratory syncytial virus | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Single seizure | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Stridor | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Subconjunctival hemorrhage | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Umbilical hernia without obstruction/gangrene | 0.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Unspecified septicemia | 0.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Urinary tract infection | 0.89 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Urticaria | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Viral syndrome | 0.83 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Weakness | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Wheezing | 0.84 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.61mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.42mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.36mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.37mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.19mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.75mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.83mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.12mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.26mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.83mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.74mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.62mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.
Time frame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Abnormal involuntary movements | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Acute bronchiolitis due to RSV | 0.46 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Acute febrile mucocutaneous lymph node syndrome | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Acute otitis media | 0.30 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Acute pyelonephritis without RMN lesion | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Alkalosis | 1.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Apparent life threatening event infant | 0.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Asthma, unspecified, unspecified status | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Bronchiolitis | 0.51 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Bronchitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Bronchospasm | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Candidiasis of mouth | 0.53 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Apnea | 0.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Cellulitis and abscess of trunk | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Constipation | 0.25 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Croup | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Dehydration | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Dermatitis | 0.25 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Dyspnea | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Failure to thrive | 0.87 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Fever | 0.28 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Fussy infant | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Gastroenteritis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Hypopotassemia | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Lipoma of other specified sites | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Methicillin susceptible Staphylococcus aureus | 1.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Nausea and vomiting | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Neonatal bradycardia | 0.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Neonatal candida infection | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Other diseases of nasal cavity and sinuses | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Other specified cardiac dysrhythmias | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Pilonidal cyst without mention of abscess | 7.22 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Pneumonia | 0.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Primary apnea of newborn | 0.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Rash | 0.22 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Respiratory syncytial virus | 0.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Retinopathy of prematurity stage 2 | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Single seizure | 1.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Stridor | 0.79 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Umbilical hernia without obstruction/gangrene | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Unspecified bacterial pneumonia | 3.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Unspecified septicemia | 1.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Urinary tract infection | 0.23 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Viral syndrome | 0.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Weakness | NA ratio |
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.2mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.79mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.16mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.26mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.09mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.83mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.74mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.79mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.25mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Abnormal involuntary movements | 1.23 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Acute bronchiolitis due to RSV | 0.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Acute febrile mucocutaneous lymph node syndrome | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Acute otitis media | 1.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Acute pyelonephritis without RMN lesion | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Adverse drug reaction | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Alkalosis | 1.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Apnea | 0.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Apparent life threatening event infant | 0.51 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Asthma with acute exacerbation | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Asthma, unspecified, unspecified status | 1.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Bronchiolitis | 0.71 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Bronchitis | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Bronchospasm | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Candidiasis of mouth | 0.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Cellulitis and abscess of trunk | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Constipation | 0.34 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Croup | 13.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Dehydration | 0.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Dermatitis | 0.35 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Dyspnea | 0.78 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Failure to thrive | 0.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Fever | 0.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Fussy infant | 0.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Gastroenteritis | 0.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Hematoma | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Hypopotassemia | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Lipoma of other specified sites | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Methicillin susceptible Staphylococcus aureus | 1.23 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Nausea and vomiting | 0.45 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Neonatal bradycardia | 0.18 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Neonatal candida infection | 0.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Other diseases of nasal cavity and sinuses | 0.30 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Other specified cardiac dysrhythmias | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Pilonidal cyst without mention of abscess | 7.22 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Pneumonia | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Primary apnea of newborn | 0.12 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Rash | 0.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Respiratory syncytial virus | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Retinopathy of prematurity stage 2 | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Single seizure | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Stridor | 0.49 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Subconjunctival hemorrhage | 1.97 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Umbilical hernia without obstruction/gangrene | 0.38 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Unspecified bacterial pneumonia | 3.93 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Unspecified septicemia | 1.09 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Urinary tract infection | 0.59 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Urticaria | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Viral syndrome | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Weakness | 0.98 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Wheezing | 0.84 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.2mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.79mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.09mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.4mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.36mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.61mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.38mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.71mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.97mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.26mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.85mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.09mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.99mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.77mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Abnormal involuntary movements | 1.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Acute bronchiolitis due to RSV | 1.27 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Acute febrile mucocutaneous lymph node syndrome | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Acute otitis media | 0.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Acute pyelonephritis without RMN lesion | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Adverse drug reaction | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Alkalosis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Apnea | 1.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Apparent life threatening event infant | 1.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Asthma with acute exacerbation | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Asthma, unspecified, unspecified status | 0.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Bronchiolitis | 0.89 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Bronchitis | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Bronchospasm | 1.20 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Candidiasis of mouth | 0.67 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Cellulitis and abscess of trunk | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Constipation | 0.81 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Croup | 0.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Dehydration | 0.96 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Dermatitis | 0.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Dyspnea | 1.37 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Failure to thrive | 3.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Fever | 1.17 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Fussy infant | 1.17 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Gastroenteritis | 0.73 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Hand, foot and mouth disease | 1.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Hematoma | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Nausea and vomiting | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Neonatal candida infection | 5.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Other diseases of nasal cavity and sinuses | 1.10 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Other specified cardiac dysrhythmias | 1.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Pneumonia | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Rash | 0.78 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Respiratory syncytial virus | 1.02 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Single seizure | 1.15 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Stridor | 4.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Umbilical hernia without obstruction/gangrene | 1.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Unspecified septicemia | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Urinary tract infection | 1.62 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Urticaria | 0.90 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Viral syndrome | 0.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Wheezing | 1.08 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.56mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.43mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.93mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.32mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.31mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.43mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.5mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.51mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.44mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.7mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.37mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.16mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.85mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.31mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.96mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.74mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.01mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.72mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Fussy infant | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Abnormal involuntary movements | 4.69 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Acute bronchiolitis due to RSV | 1.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Acute febrile mucocutaneous lymph node syndrome | 3.29 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Acute otitis media | 0.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Acute pyelonephritis without RMN lesion | 1.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Alkalosis | 6.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Apnea | 1.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Apparent life threatening event infant | 1.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Asthma with acute exacerbation | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Asthma, unspecified, unspecified status | 0.80 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Bronchiolitis | 1.55 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Bronchitis | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Bronchospasm | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Candidiasis of mouth | 4.22 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Cellulitis and abscess of trunk | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Constipation | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Croup | 1.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Dehydration | 1.17 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Dermatitis | 1.06 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Dyspnea | 0.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Failure to thrive | 1.35 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Fever | 1.30 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Gastroenteritis | 1.17 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Hand, foot and mouth disease | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Lipoma of other specified sites | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Methicillin susceptible Staphylococcus aureus | 1.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Nausea and vomiting | 0.47 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Neonatal bradycardia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Other diseases of nasal cavity and sinuses | 0.56 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Other specified cardiac dysrhythmias | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Pilonidal cyst without mention of abscess | 1.96 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Pneumonia | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Rash | 0.54 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Respiratory syncytial virus | 0.47 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Single seizure | 0.61 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Stridor | 1.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Subconjunctival hemorrhage | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Umbilical hernia without obstruction/gangrene | 2.66 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Unspecified bacterial pneumonia | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Unspecified septicemia | 2.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Urinary tract infection | 0.88 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Urticaria | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Viral syndrome | 0.87 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Wheezing | 0.94 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.26mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.4mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.2mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.41mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.59mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.1mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.93mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.56mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.79mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.46mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.92mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.4mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.93mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.82mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.59mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.85mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.33mid-p exact binomial method]
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.59mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.48mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.73mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.14mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.94mid-p exact binomial method
Primary
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Time frame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Cellulitis and abscess of trunk | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Other diseases of nasal cavity and sinuses | 1.01 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Abnormal involuntary movements | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Acute bronchiolitis due to RSV | 1.50 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Acute febrile mucocutaneous lymph node syndrome | 2.19 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Acute otitis media | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Acute pyelonephritis without RMN lesion | 2.07 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Adverse drug reaction | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Alkalosis | 6.57 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Apnea | 1.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Apparent life threatening event infant | 1.64 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Asthma with acute exacerbation | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Asthma, unspecified, unspecified status | 0.65 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Bronchiolitis | 0.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Bronchitis | 0.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Bronchospasm | 1.24 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Candidiasis of mouth | 1.36 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Constipation | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Croup | 0.95 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Dehydration | 0.99 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Dermatitis | 0.68 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Dyspnea | 1.13 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Failure to thrive | 1.43 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Fever | 1.16 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Fussy infant | 1.14 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Gastroenteritis | 0.77 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Hand, foot and mouth disease | 1.31 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Hematoma | 0.70 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Hypopotassemia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Lipoma of other specified sites | 0.75 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Methicillin susceptible Staphylococcus aureus | 1.41 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Nausea and vomiting | 0.85 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Neonatal bradycardia | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Neonatal candida infection | 5.63 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Other specified cardiac dysrhythmias | 3.05 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Pilonidal cyst without mention of abscess | 1.96 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Pneumonia | 0.83 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Primary apnea of newborn | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Rash | 0.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Respiratory syncytial virus | 0.94 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Retinopathy of prematurity stage 2 | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Single seizure | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Stomatitis | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Stridor | 1.74 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Subconjunctival hemorrhage | 3.76 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Umbilical hernia without obstruction/gangrene | 2.35 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Unspecified bacterial pneumonia | 2.82 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Unspecified septicemia | 1.72 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Urinary tract infection | 1.39 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Urticaria | 0.86 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Vaccines adverse reaction | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Viral syndrome | 0.67 ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Weakness | NA ratio |
| 13vPnC | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Wheezing | 1.09 ratio |
Comparison: Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.27mid-p exact binomial method
Comparison: Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.93mid-p exact binomial method
Comparison: Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.52mid-p exact binomial method
Comparison: Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.17mid-p exact binomial method
Comparison: Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.05mid-p exact binomial method
Comparison: Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.63mid-p exact binomial method
Comparison: Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.46mid-p exact binomial method
Comparison: Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.42mid-p exact binomial method
Comparison: Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.49mid-p exact binomial method
Comparison: Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.28mid-p exact binomial method
Comparison: Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.95mid-p exact binomial method
Comparison: Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.13mid-p exact binomial method
Comparison: Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.57mid-p exact binomial method
Comparison: Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.18mid-p exact binomial method
Comparison: Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.03mid-p exact binomial method
Comparison: Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.45mid-p exact binomial method
Comparison: Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.66mid-p exact binomial method
Comparison: Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.67mid-p exact binomial method
Comparison: Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.69mid-p exact binomial method
Comparison: Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.53mid-p exact binomial method
Comparison: Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.16mid-p exact binomial method
Comparison: Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.08mid-p exact binomial method
Comparison: Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.98mid-p exact binomial method
Comparison: Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.22mid-p exact binomial method
Comparison: Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.02mid-p exact binomial method
Comparison: Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.17mid-p exact binomial method
Comparison: Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.87mid-p exact binomial method
Comparison: Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.54mid-p exact binomial method
Comparison: Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.23mid-p exact binomial method
Comparison: Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.24mid-p exact binomial method
Comparison: Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.21mid-p exact binomial method
Comparison: Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.29mid-p exact binomial method
Comparison: Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.06mid-p exact binomial method
Comparison: Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.61mid-p exact binomial method
Comparison: Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.07mid-p exact binomial method
Comparison: Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: <0.01mid-p exact binomial method
Comparison: Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.04mid-p exact binomial method
Comparison: Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.p-value: 0.68mid-p exact binomial method