Table 1.
Prespecified Adverse Events Following 13-Valent Pneumococcal Conjugate Vaccination in Elderly ≥65 Years Old
| Adverse Event Group/Adverse Event | ICD-9 Codesa | ICD-9 Code Description | Exclude if Diagnosis Occurs in the Specified Period Before Vaccination in any Care Setting | Type of Encounter | Risk Window |
|---|---|---|---|---|---|
| Group 1. Cardiovascular events | |||||
| Acute myocardial infarction | 410 | Acute myocardial infarction | 12 mo | Inpatient and ED | 1–42 d |
| 411 | Other acute and subacute forms of ischemic heart disease | ||||
| Acute pericarditis; myocarditis | 420 | Acute pericarditis | 12 mo | Inpatient and ED | 1–42 d |
| 422.0 | Myocarditis in diseases classified elsewhere | ||||
| 422.90 | Acute myocarditis, unspecified | ||||
| 422.91 | Idiopathic myocarditis | ||||
| 422.99 | Other and unspecified acute myocarditis | ||||
| 429.0 | Myocarditis, unspecified | ||||
| Atrial fibrillation | 427.31 | Atrial fibrillation | 12 mo | Inpatient and ED | 1–42 d |
| Cardiomyopathy; heart failure (defined as heart failure code plus cardiomyopathy code) | 425.4 | Other primary cardiomyopathies, NOS | 12 mo | Inpatient and ED | 1–42 d |
| 425.8 | Cardiomyopathy in other diseases classified elsewhere | ||||
| 425.9 | Secondary cardiomyopathy, unspecified | ||||
| 429.3 | Cardiomegaly—dilation, hypertrophy, ventricular dilation | ||||
| 428.0 | Congestive heart failure, unspecified | ||||
| 428.1 | Left heart failure | ||||
| 428.2 | Systolic heart failure | ||||
| 428.4 | Combined systolic and diastolic heart failure | ||||
| 428.9 | Heart failure, unspecified | ||||
| Group 2. Bell’s palsy | 351.0 | Bell’s palsy | 12 mo | Outpatient, inpatient, and ED | 1–42 d |
| Group 3. Guillain-Barré syndrome | 357.0 | Acute infective polyneuritis Guillain-Barré syndrome Postinfectious polyneuritis | 12 mo Also exclude if 357.81 (chronic inflammatory demyelinating polyneuritis) |
Outpatient, inpatient, and ED | 1–42 d |
| Group 4. Syncope | 780.2 | Syncope and collapse | 30 d | Inpatient and ED | 0 d |
| Group 5. Erythema multiforme | 695.1 | Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis |
12 mo | Inpatient and ED | 1–42 d |
| Group 6. Thrombocytopenia | Lab value | Exclude if code below appears on same day as lab value | 12 mo | Outpatient, inpatient, and ED | 1–28 d |
| Thrombocytopenia I | 2 platelet counts of ≤50 000 within 7 d of each other (not necessarily consecutive) | Known illnesses causing thrombocytopenia: 140.0–208.0 (malignant neoplasms), 228 (hemangioma and lymphangioma, any site), 279 (disorders involving the immune mechanism), 283 (acquired hemolytic anemias), 284 (aplastic anemia and other bone marrow failure syndromes), 286.6 (defibrination syndrome), 570 (acute and subacute necrosis of liver), 571 (chronic liver disease and cirrhosis), 742.59 (other specified anomalies of spinal cord) | |||
| Thrombocytopenia II | 2 platelet counts of ≤100 000 within 7 d of each other (not necessarily consecutive) | Same as above | |||
| Group 7. Cellulitis and infection | 30 d | Outpatient, inpatient, and ED | 1–7 d | ||
| 682.3 | Cellulitis, upper arm and forearm | ||||
| 682.9 | Cellulitis, unspecified site | ||||
| 729.5 | Pain in limb | ||||
| 729.81 | Limb swelling | ||||
| 999.3 | Infection following infusion, infection, or vaccination | ||||
| 999.9 | Complication of medical care | ||||
| 289.3 | Lymphadenitis, unspecified, except mesenteric | ||||
| 683 | Acute lymphadenitis | ||||
| 785.6 | Enlargement of lymph nodes | ||||
| Group 8. Allergic reaction | 30 d | Outpatient, inpatient, and ED | 1–7 d | ||
| 995.2 | Adverse effects of drug | ||||
| 995.3 | Allergy, unspecified | ||||
| 708.0 | Allergic urticaria | ||||
| 708.1 | Idiopathic urticaria | ||||
| 708.9 | Urticaria, unspecified | ||||
| 995.1 | Angioneurotic edema | ||||
| 999.5 | Serum reaction | ||||
| Group 9. Anaphylaxis | 30 days | Outpatient, inpatient, and ED | 0–1 d | ||
| 999.4 | Anaphylactic shock due to serum | ||||
| 995.0 | Other anaphylactic shock | ||||
aFor 3-digit codes, include all fourth and fifth digits with that code; for 4-digit codes, include all fifth digits with that code.