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TABLE 1

Characteristics of Prespecified Adverse Events

Medical SettingPostvaccination Risk Window, dFirst Episode in What Period?Primary Comparison Groupa
Uncommon or rare adverse event     
 Anaphylaxis ED, inpatient 0–2 First in 42 d Historic 
 Appendicitis ED, inpatient 1–42 First in 42 d Historic 
 Pancreatitis ED, inpatient 1–42 First ever Historic 
 GBS Outpatient, ED, inpatient 1–42 First in 42 d Historic 
 CIDP Outpatient, ED, inpatient 1–180 First ever Historic 
 Seizure ED, inpatient 0–42 First in 42 d and first ever Concurrent 
 Stroke ED, inpatient 0–42 First in 42 d Historic 
 VTE Outpatient, ED, inpatient 1–42 First in 1 y Historic 
Common adverse event     
 Allergic reactions Outpatient, ED, inpatient 0–2 for ED and inpatient,1–2 for outpatient First in 42 d Concurrent 
 Injection site reactions Outpatient, ED, inpatient 1–6 First in 42 d Concurrent 
 Nonspecific reactions Outpatient, ED, inpatient 0–6 First in 42 d Concurrent 
 Syncope Outpatient, ED, inpatient Day 0 First in 2 d Concurrent 
Medical SettingPostvaccination Risk Window, dFirst Episode in What Period?Primary Comparison Groupa
Uncommon or rare adverse event     
 Anaphylaxis ED, inpatient 0–2 First in 42 d Historic 
 Appendicitis ED, inpatient 1–42 First in 42 d Historic 
 Pancreatitis ED, inpatient 1–42 First ever Historic 
 GBS Outpatient, ED, inpatient 1–42 First in 42 d Historic 
 CIDP Outpatient, ED, inpatient 1–180 First ever Historic 
 Seizure ED, inpatient 0–42 First in 42 d and first ever Concurrent 
 Stroke ED, inpatient 0–42 First in 42 d Historic 
 VTE Outpatient, ED, inpatient 1–42 First in 1 y Historic 
Common adverse event     
 Allergic reactions Outpatient, ED, inpatient 0–2 for ED and inpatient,1–2 for outpatient First in 42 d Concurrent 
 Injection site reactions Outpatient, ED, inpatient 1–6 First in 42 d Concurrent 
 Nonspecific reactions Outpatient, ED, inpatient 0–6 First in 42 d Concurrent 
 Syncope Outpatient, ED, inpatient Day 0 First in 2 d Concurrent 
a

Concurrent comparison group: visits during which comparator vaccines were administered, with analytic strata defined by age (in 1-y increments), site, sex, and week of the vaccination visit. Two historic comparison groups (2007–2014) were used: general VSD population and vaccinated VSD population, vaccinated with comparator vaccines.

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