A Safety Study For Prevenar 13 Among Chinese Children

Study Overview
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Brief Summary
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This is an observational study based on a population-based EHR database.

Detailed Description
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This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.

Official Title
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AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

Conditions
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Seizures, Urticaria and Angioedema, Apnea, Fever

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians. Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prevenar 13 cohort<br>This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after all doses | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after all doses | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after all doses | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 3 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after Dose 4 | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 Days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after all Doses | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 3 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 4 to 7 days after all doses | 
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. | 0 to 7 days after all doses | 
| Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 | IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 1 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 3 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 4 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. | 0 to 7 days after Dose 2 | 
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. | 0 to 3 days after Dose 2 |