24 Supplemental Digital Content 2. Events of Interest Identification Algorithms 1. General flow chart for case identification algorithm

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Supplemental Digital Content 2. Events of Interest Identification Algorithms

1. General flow chart for case identification algorithm

Yes No

rule out

Identified as a pre-existing condition Apply case identification

criteria^a:

1. ICD-9 code(s) 2. Lab results 3. Medications

Exclusion criteria to rule out non- case ^b:

 Lab results (for aseptic meningitis and ITP only).

 ICD-9 code (for seizure and cerebellar ataxia)

For aseptic meningitis or ITP only:

Search for subsequent case identification criteria (code/lab result) in the observation window.

Apply case exclusion criteria to identify pre-existing conditions ^c: 1. ICD-9 code(s)

2. Lab Results 3. Medications

Not a pre-existing condition

If NOT ruled out, then proceed

For seizure and cerebellar ataxia: NOT a case Start

NOT a new case NOT a case

Newcase

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ITP: idiopathic thrombocytopenic purpura

ICD-9: International Classification of Diseases, 9^th Revision

Note:

The steps listed in the boxes with solid lines apply to all events of interest (EOI). The steps in the boxes of dotted lines apply only to the selected EOI.

2. Process for applying case identification algorithms

a: How to apply case identification criteria in the automated search queries.

 For seizure, allergic urticaria, and anaphylaxis: search 0-365 days after the vaccination date for the first occurrence. For meningococcal disease: search 15- 365 days after the vaccination date for the first occurrence. For all other events of interest: search 1-365 days after the vaccination date for the first occurrence.

 Search for all pre-specified International Classification of Disease – 9^th Revision (ICD-9) codes in all care settings (Outpatient, emergency department [ED], and Inpatient/Hospital). Search for all pre-specified abnormal test results in

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laboratory data, if applicable. Search for all pre-specified medications in outpatient medication dispense records, if applicable. Subjects identified by any of the pre-specified ICD-9 codes, abnormal test results, or medications will be considered potential new onset cases.

 The date of the first identified ICD-9 code/lab result (collection date)/medications dispense is defined as the index date of the case.

 The reference ranges for laboratory tests provided in this document are from the department of Pathology and Laboratory Medicine in Southern California

Permanente Medical Group (SCPMG). However, if a different reference range is used in the lab result (e.g. because a different measurement unit is used), then the reference range provided in the lab result will be used.

b: How to apply case rule out criteria to identify non-cases

 Search for case-rule out criteria based on all pre-specified ICD-9 codes in all clinical settings (Outpatient, ED, and Inpatient/Hospital) and all pre-specified test results in laboratory data during the periods listed in the individual EOI algorithms. Exclusion criteria are defined on the basis of an identified specific alternative cause or contradictory laboratory test.

 Subjects identified as having a case rule out criterion documented in a predefined period of their medical history will be considered not a case (non-case) of the EOI, and thus will be excluded from the list of potential new onset cases.

c: How to apply exclusion criteria to identify cases with pre-existing conditions

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 Search for all pre-specified ICD-9 codes (in all care settings, including

Outpatient, ED, and Inpatient/Hospital)/ lab tests (collection date) /medications (outpatient dispense date) any time between 3 years prior to the index date until the vaccination date (inclusive).

Exception: 1) Exclude day 0 for seizure, allergic urticaria, and anaphylaxis (because it is possible for vaccinees to experience these symptoms on the day of

vaccination). 2) Include 0-14 days following the vaccination for meningococcal disease.

 Subjects identified by any of the pre-specified ICD-9 codes, abnormal test results, or medications will be considered as having a pre-existing condition, and thus will be excluded from the list of potential new onset cases.

3. Algorithms

Neurological Events

1. Seizure (single event)

1) Case identification criteria:

a. ICD-9 code: 780.3x (seizure) in any care setting.

2) Case rule-out criteria: Exclude if 345.x (Epilepsy & Recurrent Seizure) is coded on the same day.

3) Exclusion criteria to identify pre-existing conditions:

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a. ICD-9 codes: The identification criteria + 345.x (Epilepsy & Recurrent Seizure) in any care setting.

2. Bell’s palsy

a. ICD-9 code: 351.0 (Bell's Palsy) in any care setting.

2) Case rule-out criteria: N/A

a. ICD-9 codes: same as the identification criteria.

3. Multiple sclerosis (including MS initially presenting as optic neuritis) 1) Case identification criteria:

a. ICD-9 code: 340 (MS), 377.3x (optic neuritis), 341.0 (Neuromyelitis optica, Devic's disease), 341.1 (Schilder’s disease), 341.8 (Other demyelinating diseases of central nerve system), 341.9 (CNS demyelination NOS) in any care setting.

b. Lab results: Positive cerebrospinal fluid (CSF) Oligoclonal Bands

Test CPT code KRMS code Reference range

CSF Oligoclonal Bands, CSF 83916 8229040 Negative

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8633001

b. Lab results: same as the identification criteria.

c. Medications: MS specific medications (≥1 dispense in outpatient setting).

Drug class GPI codes

Multiple Sclerosis Agents 624000xxxxxxxx 212000xxxxxxxx

Brand name NDC codes

Avonex 59627-0001-xx

59627-0002-xx 64370-0001-xx

Betaseron 53905-0523-xx

50419-0523-xx 50419-0522-xx 10130-0521-xx

Rebif 44087-0022-xx

44087-0044-xx 44087-8822-xx 52203-0022-xx

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52203-8822-xx 66303-0022-xx 66303-0044-xx 62195-0704-xx 62195-0705-xx Copaxone (glatiramer acetate) 00088-1153-xx 00480-6140-xx 10130-0126-xx 66914-1009-xx 68546-0317-xx Tysabri (natalizumab) 59075-0730-15 00409-9800-15 64406-0730-xx

Novantrone 44087-1520-01

50053-9393-xx 64370-0003-01

Extavia 00078-0569-12

Gilenya 00078-0607-xx

4. Guillain-Barre syndrome (GBS)

a. ICD-9 code: 357.0x (Guillain-Barre syndrome) in any care setting.

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5. Acute disseminated encephalomyelitis (ADEM), including other demyelinating encephalitis

a. ICD-9 code: 323 (Encephalitis, myelitis, and encephalomyelitis), 323.51 (Encephalomyelitis postimmunization), 323.61 (Infectious acute disseminated encephalomyelitis), 323.81 (Noninfectious acute disseminated encephalomyelitis), 323.9 (Unspecified cause) in any care setting.

6. Cerebellar ataxia

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a. ICD-9 code: 334.x (Spinocerebellar disease), 331.89 (Other cerebral degeneration, cerebral ataxia) in any care setting.

2) Case rule-out criteria: Exclude if 191.xx (Malignant neoplasm of brain) is found within 1 year before the index date.

7. Transverse myelitis

a. ICD-9 code: 341.2x (acute transverse myelitis), 323.52 (Myelitis postimmunization), 323.82 (Transverse myelitis NOS) in any care setting.

8. Brachial neuritis

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a. ICD-9 code: 353 (Nerve root and plexus disorders), 353.0 (Brachial plexus lesions), 353.5 (Parsonage-Turner Syndrome), 723.4 (brachial neuritis or radiculitis NOS) in any care setting.

9. Myasthenia gravis (including MG presenting as ptosis)

a. ICD-9 code: 358.0x (MG), 374.3x (Ptosis of eyelid) in any care setting.

b. Lab results: Elevated (positive) Acetylcholine receptor antibody

Acetylcholine receptor antibody (Anti-AChR)

84238 83519

8000100 8001002

Negative: ≤0.30 nmol/L Equivocal: 0.31-0.49 nmol/L Positive: ≥0.50 nmol/L

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b. Lab results: same as the identification criteria.

References:

1. Lee GM, Greene SK, Weintraub ES, Baggs J, Kulldorff M, Fireman BH, Baxter R, Jacobsen SJ, Irving S, Daley MF, Yin R, Naleway A, Nordin JD, Li L, McCarthy N, Vellozzi C, Destefano F, Lieu TA; Vaccine Safety Datalink Project. H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project. Am J Prev Med. 2011; 41(2):121-8.

2. Rowhani-Rahbar A, Klein NP, Lewis N, Fireman B, Ray P, Rasgon B, Black S, Klein JO, Baxter R. Immunization and Bell's Palsy in Children: A Case- Centered Analysis. Am J Epidemiol. 2012; 175(9):878-85.

3. Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP; CISA Network.

Recurrent Guillain-Barre syndrome following vaccination. Clin Infect Dis.

2012; 54(6):800-4.

4. Greene SK, Rett M, Weintraub ES, Li L, Yin R, Amato AA, et al. Risk of Confirmed Guillain-Barre Syndrome Following Receipt of Monovalent Inactivated Influenza A (H1N1) and Seasonal Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-2010. Am J Epidemiol. 2012;

175(11):1100-1109. Epub 2012 May.

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5. Bogliun G, Beghi E; Guillain-Barrè Syndrome Registry Study Group. Validity of hospital discharge diagnoses for public health surveillance of the Guillain- Barrè syndrome. Neurol Sci. 2002;23(3):113-7.

6. Langer-Gould A, Zhang JL, Chung J, Yeung Y, Waubant E, Yao J. Incidence of acquired CNS demyelinating syndromes in a multiethnic cohort of children.

Neurology. 2011;77(12):1143-8.

7. van der Maas NA, Bondt PE, de Melker H, Kemmeren JM. Acute cerebellar ataxia in the Netherlands: a study on the association with vaccinations and varicella zoster infection. Vaccine. 2009;27(13):1970-3.

8. Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010; 29(7):613-7.

9. Black S, Eskola J, Siegrist CA, Halsey N, Macdonald N, Law B, Miller E, Andrews N, Stowe J, Salmon D, Vannice K, Izurieta HS, Akhtar A, Gold M, Oselka G, Zuber P, Pfeifer D, Vellozzi C. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet. 2009; 374(9707):2115-22.

10. Zinman L, Thoma J, Kwong JC, Kopp A, Stukel TA, Juurlink DN. Safety of influenza vaccination in patients with myasthenia gravis: a population-based study. Muscle Nerve. 2009; 40(6):947-51.

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11. Klein NP, Ray P, Carpenter D, Hansen J, Lewis E, Fireman B, Black S, Galindo C, Schmidt J, Baxter R. Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies. Vaccine. 2010;

28(4):1062-8.

12. Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ.

Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012; 271(2):193-203.

Rheumatologic Events

10. Systemic lupus erythematosus (SLE)

a. ICD-9 code: 710.0 (Systemic lupus erythematosus) in any care setting.

11. Rheumatoid arthritis

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a. ICD-9 code: 714.xx (rheumatoid arthritis), 714.3x (juvenile rheumatoid arthritis, JRA) in any care setting.

12. Iridocyclitis (uveitis)

a. ICD-9 code: 364.0x (Acute and subacute iridocyclitis), 364.3x (Uveitis NOS) in any care setting.

References:

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2. Klein NP, Ray P, Carpenter D, Hansen J, Lewis E, Fireman B, Black S, Galindo C, Schmidt J, Baxter R. Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies. Vaccine. 2010; 28(4):1062-8.

Hematologic Events

13. Henoch-Schonlein purpura

a. ICD-9 code: 287.0 (Allergic purpura, purpura rheumatic, Henoch-Schonlein Purpura), 446.6x (Thrombotic microangiopathy) in any care setting.

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14. Idiopathic thrombocytopenic purpura (ITP)

a. ICD-9 code: 287.31(Idiopathic thrombocytopenic purpura) in any care setting.

2) Case rule-out criteria: Exclude if one normal platelet count result (≥ 100K) is found within +/- 2 weeks of the index date.

Platelet count 85049 8559000 ≥ 100K

Complete blood count (CBC) W/ Platelet 85025 8501500 ≥ 100K

a. ICD-9 codes: The identification criteria + 287 (Purpura and other hemorrhagic conditions), 287.0 (Allergic purpura), 287.1(Qualitative platelet defects), 287.2 (Other nonthrombocytopenic purpuras), 287.3x (Primary thrombocytopenia), 287.4 (Secondary thrombocytopenia), 287.5(Thrombocytopenia, unspecified), 287.8 (Other specified hemorrhagic conditions), or 287.9 (Unspecified hemorrhagic conditions) in any care setting.

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15. Autoimmune hemolytic anemia

a. ICD-9 code: 283.0 (Autoimmune hemolytic anemias) in any care setting.

a. ICD-9 codes: Same as the identification criteria.

References:

2. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence- based practice guideline for immune thrombocytopenia. Blood. 2011;

117(16):4190-207.

3. O'Leary ST, Glanz JM, McClure DL, Akhtar A, Daley MF, Nakasato C, Baxter R, Davis RL, Izurieta HS, Lieu TA, Ball R. The risk of immune thrombocytopenic

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purpura after vaccination in children and adolescents. Pediatrics. 2012;

129(2):248-55.

Endocrine Events

16. Hashimoto’s disease

a. ICD-9 code: 245.2x (Hashimoto’s disease) in any care setting.

b. Lab results: Abnormal results for at least two different tests (in the absence of ICD-9 code) within 2 weeks of each other--- Thyroid peroxidase antibody positive AND (elevated TSH OR decreased free T4).

Test CPT code KRMS code Reference range Thyroid peroxidase

antibody

86376 8637600 Less than 5.6 IU/mL

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TSH 84443 8348000 Age Reference range Source

1 -

10 yeas 0.66- 4.65 uIU/mL

CALIPER study¹

11-17 years 0.4- 4.00 IU/mL SCPMG Endocrinology

Consensus

Free T4 84439 8346000 Age Reference range Source

1 - 5 years 1.00 - 1.55 ng/dL CALIPER study¹ 6-10 years 0.93 - 1.47 ng/dL CALIPER study¹

>10 years 0.81 - 1.48 ng/dL CALIPER study¹

a. ICD-9 codes: The identification criteria + 245.x (Thyroiditis), 240.x (Simple and unspecified goiter), 244.9 (Unspecified hypothyroidism), 246.9 (Unspecified disorder of thyroid) in any care setting.

b. Lab results: Same as the identification criteria.

17. Juvenile diabetes mellitus (i.e., type 1 diabetes)

a. ICD-9 code: 250.x1, 250.x3 (Insulin dependent DM) in any care setting.

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b. ICD-9 code + Medication: 250.xx (Diabetes mellitus), excluding 250.x1 and 250.x3 + Insulin (≥ 1 dispense in outpatient setting).

Insulin 2710xxxxxxxxxx

Apidra

Apidra Solostar

00088-2500-xx 12854-0337-xx

00088-2502-xx 12854-0338-xx

Novolog 0169-7501-xx

0169-3303-xx 0169-6339-xx 54868-6054-xx NovoLog Mix 70/30

NovoLog Mix 70/30 FlexPen

NovoLog Mix Penfill

00169-3685-xx 54868-5201-xx 00420-3685-xx

00169-3696-xx 54868-5327-xx

00169-3682-xx 00420-3682-xx 00420-3303-xx

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Insulin NovoLog for injection

NovoLog insulin aspart injection

54868-2777-xx

00420-7501-xx

Humulin R Humulin R Pen

00002-8215-xx 00409-8215-xx 00409-2607-xx 00002-8501-xx 54868-3619-xx 62381-8217-xx

Humulin N 00002-8730-xx

00002-8315-xx 54868-1429-xx 62381-8317-xx Humulin 70/30

Humulin 70/30 Pen

00002-8715-xx

00002-8770-xx 62381-8770-xx 62381-7815-xx

Lantus 00088-2220-xx

00088-2219-xx 14608-0335-33 12854-0335-xx 12522-2220-03

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54868-4626-00 54868-5765-00 54868-6231-00 55045-3685-01

Levemir 00169-3687-xx

00169-6439-xx 68258-8977-xx 54868-5883-xx 00420-3687-xx 00169-2312-xx 00169-3305-xx 00420-6439-xx

Humalog 00002-7510-xx

00002-7511-xx 00002-7512-xx 00002-7516-xx 00002-8793-xx 00002-8794-xx 00002-8797-xx 00002-8798-xx^ǂ

00002-8799-xx 00002-8725-xx 00409-2567-xx 54868-2746-xx 54868-4381-xx

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54868-5108-xx 54868-5899-xx 62381-8725-xx 62381-8793-xx 62381-8794-xx 62381-7511-xx 62381-7515-xx 62381-7516-xx

ǂThis NDC code is not covered by the Insulin GPI code 2710xxxxxxxxxx.

18. Grave’s disease

a. ICD-9 code: 242.0x (Toxic diffuse goiter, Graves' disease) in any care setting.

b. Medications: Grave’s disease specific medications (≥1 dispense in outpatient setting).

Antithyroid Agents 283000xxxxxxxx

Methimazole 00185-0205-xx

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00185-0210-xx 49884-0641-xx 49884-0640-xx 68773-0102-xx 68773-0104-xx 24236-0811-xx 24236-0989-xx 49884-0689-xx 68773-0101-xx 00615-6500-xx 00615-7613-xx 68071-0256-xx 55045-3455-xx 58016-0163-xx 68773-0110-xx 68773-0120-xx 66536-0101-xx 66536-0102-xx 66536-0103-xx 52152-0328-xx 52152-0329-xx 00179-1771-xx 00179-1822-xx 68084-0275-xx 68084-0276-xx

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63629-4331-xx 55567-0126-xx 54868-5135-xx 27280-0010-xx 26053-0223-xx 61392-0450-xx 57664-0459-xx 57664-0458-xx 51129-3005-xx 51129-3010-xx 51129-3609-xx Propylthiouracil (PTU) 42291-0550-xx 64725-0278-xx 24236-0204-xx 67253-0651-xx 24236-0430-xx 00615-7583-xx 00228-2348-xx 55045-2747-xx 67544-0966-xx 66267-0503-xx 00179-1630-xx 68258-9045-xx 34353-0033-xx 68258-9216-xx

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67228-0124-xx 61392-0468-xx 54868-1752-xx 00143-1480-xx 51129-3602-xx 51129-2120-xx 55154-7453-xx

a. ICD-9 codes: The identification criteria + 242.x (Thyrotoxicosis with or without goiter), 245.x (Thyroiditis), 240.x (Simple and unspecified goiter), in any care setting.

b. Medications: Same as the identification criteria.

References:

1. Chan MK, et al. Canadian Laboratory Initiative on Pediatric Reference Interval Database (CALIPER): Pediatric reference intervals for an integrated clinical chemistry and immunoassay analyzer, Abbot ARCHITECT ci8200 Clinical Biochemistry 2009; 42:885-891.

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Renal Events

19. Acute glomerulonephritis

a. ICD-9 code: 580.xx (Acute glomerulonephritis), 583.xx (Nephritis and nephropathy, not specified as acute or chronic) in any care setting.

a. ICD-9 codes: The identification criteria+ 582.xx (Chronic glomerulonephritis), 585.xx (Chronic kidney disease [CKD]) in any care setting.

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20. Nephrotic syndrome

a. ICD-9 code: 581.xx (Nephrotic syndrome) in any care setting.

a. ICD-9 codes: The identification criteria+ 582.xx (Chronic glomerulonephritis), 583.xx (Nephritis and nephropathy, not specified as acute or chronic), 585.xx (Chronic kidney disease [CKD]) in any care setting.

References:

Pediatric and Pediatric Infectious Disease Events

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21. Aseptic meningitis

1) Case identification criteria (viral meningitis is NOT considered the EOI):

a. ICD-9 code: 322.9 (Meningitis, unspecified) in any care setting.

2) Case rule-out criteria: Exclude if any of the bacterial, mycobacterial, fungal culture, ^1-4 or viral test results in CSF are positive within +/- 2 weeks of the index date.

Test CPT code KRMS code

Bacterial culture, CSF 87070 8709014

Mycobacterial culture, CSF 87116 8710000

8701500

Fungal culture, CSF 87102 8710200

Viral culture, CSF 87254 8649605

Enterovirus PCR, Enterovirus molecular [87801D], CSF

87798 8649641

Herpes simplex, PCR, CSF [87529C] 87529 8649694 Epstein-Barr virus DNA, Quantitative

PCR, [87799B]

87799 8646640

Varicella Zoster, PCR, CSF[87798E] 87798 8649253 Meningoencephalitis Comprehensive

Panel [CSF] , Quest Description &

Test Code: 18957 (6031)

86695 (HSV-1) 86696 (HSV-2)

87610 (Influenza A&B Ab) 86727 (LCM IgG & IgM) 86765 (Measles IgG & IgM)

N/A, Order Manually

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86735 (Mumps IgG & IgM) 86787(Varicella Zoster Virus Antibody)

22. Asthma

a. ICD-9 code: 493.xx (asthma) in any care setting.

23. Allergic urticaria

a. ICD-9 code: 708.0 (Allergic urticaria) in any care setting.

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a. ICD-9 codes: 708.x (Urticaria) in any care setting.

24. Anaphylaxis

a. ICD-9 code: 995.0 (Anaphylaxis NOS or due to adverse effect of correct medicinal substance properly administered) in any care setting.

25. Meningococcal disease

a. ICD-9 code: 036.xx (Meningococcal infection), V02.59* (Other specified bacterial diseases, Meningococcal), 286.6 (Defibrination syndrome, purpura fulminans) in any care setting.

*The V02.59 code can be used for other bacterial infections. If evidence is found that this code is given for specified bacterial diseases other than meningococcal disease, the case will be excluded.

b. Lab results: Growth (positive) of Neisseria meningitides or N. meningitides in CSF, blood, urine, sputum, or sterile site.

Test CPT code KRMS code

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CSF culture, bacterial 87070 8709014 Blood culture, bacterial 87040 8709011 Urine culture, bacterial 87088

87086

8711000 8711010 Sputum culture, bacterial 87070 8709013 Sterile site culture, bacterial 87070 8709080

b. Lab results: Same as the identification criteria.

26. Intentional Injury

a. ICD-9 code: E950.xx--E959.xx (Suicide and self-inflicted injury) in any care setting.

References:

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3. Nigrovic LE, Kuppermann N, Malley R. Development and validation of a multivariable predictive model to distinguish bacterial from aseptic meningitis in children in the post-Haemophilus influenzae era. Pediatrics. 2002;110(4):712-9.

4. Nigrovic LE, Kuppermann N, Macias CG, et al; Pediatric Emergency Medicine Collaborative Research Committee of the American Academy of Pediatrics.

Clinical prediction rule for identifying children with cerebrospinal fluid pleocytosis at very low risk of bacterial meningitis. JAMA. 2007;297(1):52-60.

5. Dubos F, Moulin F, Gajdos V, De Suremain N, Biscardi S, Lebon P, Raymond J, Breart G, Gendrel D, Chalumeau M. Serum procalcitonin and other biologic markers to distinguish between bacterial and aseptic meningitis. J Pediatr.

2006;149(1):72-6.

6. Black S, Shinefield H, Ray P, Lewis E, Chen R, Glasser J, Hadler S, Hardy J, Rhodes P, Swint E, Davis R, Thompson R, Mullooly J, Marcy M, Vadheim C,

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Ward J, Rastogi S, Wise R. Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children: an analysis of the Vaccine Safety Datalink (VSD) Project. Pediatr Infect Dis J.

1997;16(5):500-3.