Characteristics of Prespecified Adverse Events
| . | Medical Setting . | Postvaccination Risk Window, d . | First 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 Setting . | Postvaccination Risk Window, d . | First 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 |
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.