Table 1.
Definitions of Primary and Secondary Adverse Events for a Vaccine Safety Datalink Recombinant Zoster Vaccine Safety Studya
| Adverse Event Group | ICD-9-CM Code(s) b , c | ICD-10-CM Code(s) b | Medical Setting | Postvaccination At-Risk Interval, days d |
|---|---|---|---|---|
| Primary adverse events | ||||
| Acute myocardial infarction | 410.x | I21.* | Inpatient | 1–42 |
| Stroke (both hemorrhagic and nonhemorrhagic) | 431 (hemorrhagic) 433.01, 433.11, 433.21, 433.31, 433.81, 433.91, 434.01, 434.11, 434.91 | I61.9 (hemorrhagic) I63.* | Inpatient | 1–42 |
| Supraventricular tachycardia | 427.0 | I47.1 | ED, inpatient | 1–42 |
| Polymyalgia rheumatica | 725 | M35.3 | Outpatient, ED, inpatient | 1–42 |
| Convulsion-associated terms excluding epilepsy | 780.3x | R56.0*, R56.9 | ED, inpatient | 1–42 |
| Bell’s palsy | 351.0 | G51.0 | Outpatient, ED, inpatient | 1–42 |
| Optic ischemic neuropathy | 377.41 | H47.01* | Outpatient, ED, inpatient | 1–42 |
| Giant cell arteritis | 446.5 | M31.6 | Outpatient, ED, inpatient | 1–42 |
| Anaphylaxis | 995.0, 999.42 | T78.2*, T80.52XD | Outpatient, ED, inpatient | 0–1 |
| GBS | 357.0 | G61.0 | Outpatient, ED, inpatient | 1–42 |
| Secondary adverse events | ||||
| Gout | 274.01, 274.00, 274.9 | M10.* | Outpatient, ED | 1–42 |
| Diagnoses consistent with systemic reactions | 780.60, 780.63, 729.1, 780.64, 787.0x, 780.7, 784.0, 339.89 | R50.9, R50.83, M79.1, R68.83, R11.*, R53.*, R51, G44.* | Outpatient, ED | 1–7 |
| Diagnoses consistent with local reactions | 682.3, 683, 729.5 | L03.113, L03.114, L03.119, L04.9, L04.2, M79.62* | Outpatient, ED | 1–7 |
| Any adverse reaction diagnosis, including systemic, local and nonspecific reactions | Any systemic or local reaction code (defined above) plus nonspecific codes 995.29, 979.6, 979.9, E949.6, E949.9 | Any systemic or local reaction code (defined above) plus nonspecific code T50.B9* | Outpatient, ED | 1–7 |
| Pneumonia | 052.1, 480.x, 487.0, 481, 482.x, 483.x, 485, 486 | J18.*, B01.2, J11.0*, J12.*, J13, J14, J15.*, J16.* | Inpatient | 1–42 |
| Keratitis | 370.0x, 370.2x, 370.40, 370.35, 370.31, 370.4x, 370.5x, 370.8, 370.9 | H16.0*, H16.1*, H16.20*, H16.23*, H16.25*, H16.29*, H16.3*, H16.8, H16.9 | Outpatient, ED | 1–42 |
| Uveitis and retinitis | 364.0x, 364.3, 363.0x, 363.1x, 363.2x, 362.84, 362.82, 362.85, 362.89 | H20.0*, H20.9, H30*, H35.82, H35.89 | Outpatient, ED | 1–42 |
| Zoster ocular disease | 053.2x, 052.7 | B02.3*, B01.81 | Outpatient, ED | 1–42 |
| Pericarditis | 420.9x | B33.23, I30* | Outpatient, ED, inpatient | 1–42 |
| Myocarditis | 422.9.x | B33.22, I40* | Outpatient, ED, inpatient | 1–42 |
| Urgent or emergency health-care visit for any reason | N/A | N/A | Urgent care, ED | 1–7 |
Abbreviations: ED, emergency department; GBS, Guillain-Barré syndrome; ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; N/A, not applicable; RZV, recombinant zoster vaccine; VSD, Vaccine Safety Datalink; ZVL, zoster vaccine live.
a January 2018–December 2019 for the RZV and well-person visit groups and January 2013–December 2017 for the historical ZVL group.
b Three-digit codes (e.g., 345) included those that started with those 3 digits and contained any additional fourth or fifth digit (e.g., 345.11); 4-digit codes included those that started with those 4 digits and had any fifth digit.
c ICD-9-CM–coded definitions were needed to identify events among historical ZVL vaccinees 365 days prior to vaccination, which overlapped with the ICD-9-CM era for some ZVL recipients.
d Outcomes were excluded if any of the ICD-9-CM or ICD-10-CM codes specifying that outcome were recorded during the 365 days prior to the index date, except for the anaphylaxis outcome. The anaphylaxis outcome was excluded if any of the codes defining that outcome were recorded in the 60 days prior to the index date.