{
 "generated": "2026-10-09",
 "method": "#1 Observed-vs-expected (O/E) analysis for serious AESIs in VAERS, and the page\n/observed-vs-expected.html.\n\nExpected E = doses x (risk-window days / 365.25) x background incidence (per person-year)\nObserved O = US VAERS reports of the AESI with onset inside the risk window, vaccination in the\n            same period as the doses. O_adj adds reports with unknown onset in proportion.\nO/E with exact Poisson 95% CI on O. A sensitivity E uses the alternative background rate.\n\nHow to read it (printed on the page): VAERS under-reports most events, so O/E < 1 is the expected\nresult even for a vaccine that changes nothing and is NOT evidence of safety; O/E > 1 despite\nunder-reporting is a strong signal (this is how VAERS flagged myocarditis after mRNA vaccines and\nGBS after Shingrix/RSV vaccines, later confirmed in controlled studies). Reports are not\nconfirmed diagnoses (see the Brighton classification on the vaccine pages). Backgrounds are\ngeneral-population rates; vaccinees can differ (healthy-vaccinee effect, age mix).\n",
 "pairs": [
  {
   "vaccine": "influenza",
   "label": "Influenza",
   "aesi": "Guillain-Barr\u00e9 syndrome",
   "doses": 2714400000,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 1.68,
    "age_band": "all ages",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Guillain Barre, USA [27], age all ages"
   },
   "bg_sens": {
    "rate_per_100k_py": 1.72,
    "age_band": "all ages (age-standardised)",
    "sex": "all",
    "country": "US (VSD cohort)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)"
   },
   "E": 5243.752607802875,
   "E_sens": 5368.603860369611,
   "O": 1474,
   "O_adj": 1580.8002131060202,
   "reports_any_onset": 2013,
   "onset_known": 1877,
   "oe": 0.28109640371031996,
   "oe_lo": 0.2669277835143823,
   "oe_hi": 0.2958218266596751,
   "oe_adj": 0.30146353791628877,
   "oe_sens": 0.2745592780426381,
   "age_dist_in_window": {
    "1-4": 47,
    "18-49": 437,
    "50-64": 402,
    "65+": 473,
    "nan": 22,
    "5-17": 88,
    "<1": 5
   },
   "note": "All ages; flu vaccinees skew older, where GBS is commoner, so the all-age background may understate E."
  },
  {
   "vaccine": "influenza",
   "label": "Influenza",
   "aesi": "Bell's palsy / facial paralysis",
   "doses": 2714400000,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 25.2,
    "age_band": "all ages",
    "country": "US (Rochester, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Bell's Palsy, USA [22], age all ages"
   },
   "bg_sens": {
    "rate_per_100k_py": 52.7,
    "age_band": ">=70",
    "sex": "all",
    "country": "US (Rochester, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 78656.28911704312,
   "E_sens": 164491.5252566735,
   "O": 480,
   "O_adj": 502.62626262626264,
   "reports_any_onset": 622,
   "onset_known": 594,
   "oe": 0.0061024999448644765,
   "oe_lo": 0.005568711696153904,
   "oe_hi": 0.006673649947898595,
   "oe_adj": 0.006390159874925428,
   "oe_sens": 0.002918083465096486,
   "age_dist_in_window": {
    "50-64": 132,
    "65+": 83,
    "18-49": 186,
    "5-17": 52,
    "1-4": 13,
    "nan": 12,
    "<1": 2
   },
   "note": "Sensitivity uses the 70+ rate."
  },
  {
   "vaccine": "influenza",
   "label": "Influenza",
   "aesi": "Transverse myelitis",
   "doses": 2714400000,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 0.949,
    "age_band": "all ages",
    "country": "US (Olmsted County, MN; REP)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.05.016; PMC8118666",
    "location_in_source": "Results, TM paragraph (ref 29: Sechi E et al. Neurology 2019)"
   },
   "bg_sens": {
    "rate_per_100k_py": 4.9,
    "age_band": "26-62",
    "sex": "female",
    "country": "US (Northern California, Kaiser Permanente)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 2962.0959671457904,
   "E_sens": 15294.278439425054,
   "O": 214,
   "O_adj": 211.4724409448819,
   "reports_any_onset": 251,
   "onset_known": 254,
   "oe": 0.0722461400216569,
   "oe_lo": 0.06289018959393153,
   "oe_hi": 0.08260158853888619,
   "oe_adj": 0.07139283915525939,
   "oe_sens": 0.013992160587867834,
   "age_dist_in_window": {
    "1-4": 6,
    "18-49": 79,
    "50-64": 57,
    "nan": 3,
    "5-17": 22,
    "65+": 41,
    "<1": 6
   },
   "note": "Sensitivity: women 26-62 (highest US band)."
  },
  {
   "vaccine": "covid",
   "label": "COVID-19",
   "aesi": "Myocarditis / pericarditis",
   "doses": 663822575,
   "dose_source": "CDC COVID-19 Vaccinations in the United States, Jurisdiction (data.cdc.gov unsk-b7fc), location=US",
   "period": "2020-2022",
   "window": [
    0,
    7
   ],
   "bg": {
    "rate_per_100k_py": 20.63,
    "age_band": "all ages (age-standardised)",
    "country": "Pooled Europe (Denmark, France, Germany, Italy, Spain, Netherlands, UK; 10 databases)",
    "source": "Willame C et al. 2023 Vaccine (ACCESS project, EMA-funded, VAC4EU)",
    "doi_or_pmid": "10.1016/j.vaccine.2022.11.031; PMC9678835",
    "location_in_source": "Table 3, row 'Myocarditis or pericarditis', column 'GP & IN-OUTPATIENT'"
   },
   "bg_sens": {
    "rate_per_100k_py": 37,
    "age_band": "18-34",
    "sex": "male",
    "country": "Pooled: Australia, France, Germany, Japan, Netherlands, Spain, UK, US (random-effects meta-analysis)",
    "source": "Li X et al. 2021 BMJ (OHDSI network, 13 databases, 8 countries)"
   },
   "E": 2999.5147920054756,
   "E_sens": 5379.643592060233,
   "O": 3408,
   "O_adj": 3377.3203300825207,
   "reports_any_onset": 5284,
   "onset_known": 5332,
   "oe": 1.1361837618148272,
   "oe_lo": 1.0983546928001464,
   "oe_hi": 1.174983338439951,
   "oe_adj": 1.1259555509057664,
   "oe_sens": 0.6334992163848617,
   "age_dist_in_window": {
    "18-49": 1980,
    "5-17": 833,
    "50-64": 345,
    "65+": 210,
    "nan": 40,
    "1-4": 0
   },
   "note": "Background from European databases (no US all-age myocarditis rate found); sensitivity uses men 18-34. Doses to 28 Dec 2022."
  },
  {
   "vaccine": "covid",
   "label": "COVID-19",
   "aesi": "Guillain-Barr\u00e9 syndrome",
   "doses": 663822575,
   "dose_source": "CDC COVID-19 Vaccinations in the United States, Jurisdiction (data.cdc.gov unsk-b7fc), location=US",
   "period": "2020-2022",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 1.68,
    "age_band": "all ages",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Guillain Barre, USA [27], age all ages"
   },
   "bg_sens": {
    "rate_per_100k_py": 3.25,
    "age_band": ">=60",
    "sex": "all",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 1282.3907157289525,
   "E_sens": 2480.815372689938,
   "O": 878,
   "O_adj": 874.2922297297297,
   "reports_any_onset": 1179,
   "onset_known": 1184,
   "oe": 0.6846587309398262,
   "oe_lo": 0.6401146293347207,
   "oe_hi": 0.7314854578195505,
   "oe_adj": 0.6817674356233573,
   "oe_sens": 0.35391589783966393,
   "age_dist_in_window": {
    "18-49": 285,
    "50-64": 302,
    "65+": 252,
    "5-17": 26,
    "nan": 11,
    "1-4": 2
   },
   "note": ""
  },
  {
   "vaccine": "covid",
   "label": "COVID-19",
   "aesi": "Cerebral venous sinus thrombosis",
   "doses": 663822575,
   "dose_source": "CDC COVID-19 Vaccinations in the United States, Jurisdiction (data.cdc.gov unsk-b7fc), location=US",
   "period": "2020-2022",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 2.85,
    "age_band": "all ages",
    "country": "US (HCUP National Inpatient Sample)",
    "source": "Payne AB et al. 2022 Res Pract Thromb Haemost (CDC)",
    "doi_or_pmid": "10.1002/rth2.12682; PMC8901465",
    "location_in_source": "Table 1, 2018 NIS column, all ages / all"
   },
   "bg_sens": {
    "rate_per_100k_py": 3.91,
    "age_band": "18-29",
    "sex": "female",
    "country": "US (HCUP National Inpatient Sample)",
    "source": "Payne AB et al. 2022 Res Pract Thromb Haemost (CDC)"
   },
   "E": 2175.4842498973303,
   "E_sens": 2984.6117252977415,
   "O": 298,
   "O_adj": 265.2127139364303,
   "reports_any_onset": 364,
   "onset_known": 409,
   "oe": 0.13698099630648386,
   "oe_lo": 0.12186834021626888,
   "oe_hi": 0.1534499421418175,
   "oe_adj": 0.12190973754415678,
   "oe_sens": 0.09984548324129895,
   "age_dist_in_window": {
    "18-49": 187,
    "5-17": 5,
    "50-64": 62,
    "65+": 41,
    "nan": 2,
    "1-4": 1
   },
   "note": "Sensitivity: women 18-29."
  },
  {
   "vaccine": "covid",
   "label": "COVID-19",
   "aesi": "Immune thrombocytopenia",
   "doses": 663822575,
   "dose_source": "CDC COVID-19 Vaccinations in the United States, Jurisdiction (data.cdc.gov unsk-b7fc), location=US",
   "period": "2020-2022",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 6.1,
    "age_band": "all ages (claims)",
    "country": "US (two private claims databases)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.05.016; PMC8118666",
    "location_in_source": "Results, ITP paragraph 1 (ref 107: Weycker D et al. J Med Econ 2020)"
   },
   "bg_sens": {
    "rate_per_100k_py": 13.7,
    "age_band": ">=65",
    "sex": "all",
    "country": "US (claims)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)"
   },
   "E": 4656.2996225872685,
   "E_sens": 10457.590955646816,
   "O": 376,
   "O_adj": 382.1138211382114,
   "reports_any_onset": 500,
   "onset_known": 492,
   "oe": 0.08075081727474315,
   "oe_lo": 0.07279401046649144,
   "oe_hi": 0.08933998474024542,
   "oe_adj": 0.08206383869384466,
   "oe_sens": 0.035954743458097314,
   "age_dist_in_window": {
    "18-49": 133,
    "50-64": 91,
    "nan": 4,
    "5-17": 30,
    "65+": 114,
    "<1": 0,
    "1-4": 4
   },
   "note": ""
  },
  {
   "vaccine": "covid",
   "label": "COVID-19",
   "aesi": "Bell's palsy / facial paralysis",
   "doses": 663822575,
   "dose_source": "CDC COVID-19 Vaccinations in the United States, Jurisdiction (data.cdc.gov unsk-b7fc), location=US",
   "period": "2020-2022",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 25.2,
    "age_band": "all ages",
    "country": "US (Rochester, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Bell's Palsy, USA [22], age all ages"
   },
   "bg_sens": {
    "rate_per_100k_py": 52.7,
    "age_band": ">=70",
    "sex": "all",
    "country": "US (Rochester, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 19235.86073593429,
   "E_sens": 40227.375427926076,
   "O": 4234,
   "O_adj": 4249.651237544198,
   "reports_any_onset": 6245,
   "onset_known": 6222,
   "oe": 0.2201097241305409,
   "oe_lo": 0.21352912454732148,
   "oe_hi": 0.22684156902531863,
   "oe_adj": 0.22092337306255672,
   "oe_sens": 0.10525170869240286,
   "age_dist_in_window": {
    "18-49": 1702,
    "5-17": 111,
    "50-64": 1305,
    "65+": 1043,
    "nan": 68,
    "1-4": 5
   },
   "note": ""
  },
  {
   "vaccine": "mmr",
   "label": "MMR / MMRV",
   "aesi": "Febrile seizure",
   "doses": 197158792,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    0,
    14
   ],
   "bg": {
    "rate_per_100k_py": 780.0,
    "age_band": "3-60 months (mean of girls and boys)",
    "country": "Denmark (national registers)",
    "source": "Christensen KJ et al. 2021 Acta Neurol Scand",
    "doi_or_pmid": "10.1111/ane.13420; PMC8178233",
    "location_in_source": "Results, paragraph 1"
   },
   "bg_sens": null,
   "E": 63155.58840246407,
   "E_sens": null,
   "O": 886,
   "O_adj": 889.7702127659575,
   "reports_any_onset": 944,
   "onset_known": 940,
   "oe": 0.014028845624141664,
   "oe_lo": 0.013120185730516952,
   "oe_hi": 0.014983852473991607,
   "oe_adj": 0.014088542839563543,
   "oe_sens": null,
   "age_dist_in_window": {
    "1-4": 842,
    "5-17": 23,
    "<1": 10,
    "nan": 11
   },
   "note": "Danish first-febrile-seizure rate at 3-60 months; MMR doses include some given to teens and adults, so E is overstated."
  },
  {
   "vaccine": "mmr",
   "label": "MMR / MMRV",
   "aesi": "Immune thrombocytopenia",
   "doses": 197158792,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 8.1,
    "age_band": "0-4",
    "country": "US (claims)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.05.016; PMC8118666",
    "location_in_source": "Results, ITP paragraph 1 (ref 107)"
   },
   "bg_sens": {
    "rate_per_100k_py": 8.8,
    "age_band": "<18",
    "sex": "all",
    "country": "US (commercial claims)",
    "source": "Gubernot D et al. 2021 Vaccine (FDA/CDC literature review of US rates)"
   },
   "E": 1836.3701858562627,
   "E_sens": 1995.068843893224,
   "O": 124,
   "O_adj": 132.58461538461538,
   "reports_any_onset": 139,
   "onset_known": 130,
   "oe": 0.06752451164533652,
   "oe_lo": 0.05616339521596893,
   "oe_hi": 0.08050899280988721,
   "oe_adj": 0.0721992855284752,
   "oe_sens": 0.062153243673548374,
   "age_dist_in_window": {
    "1-4": 109,
    "5-17": 12,
    "nan": 0,
    "18-49": 2,
    "50-64": 1
   },
   "note": "Children 0-4 (US claims)."
  },
  {
   "vaccine": "rotavirus",
   "label": "Rotavirus",
   "aesi": "Intussusception",
   "doses": 167131097,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    21
   ],
   "bg": {
    "rate_per_100k_py": 40.1,
    "age_band": "15-24 weeks",
    "country": "US (35 HCUP State Inpatient Databases, about 85% of birth cohort)",
    "source": "Tate JE et al. 2008 Pediatrics",
    "doi_or_pmid": "10.1542/peds.2007-1590; PMC2680116",
    "location_in_source": "Table 1, row 'Age 15-24 wk'"
   },
   "bg_sens": {
    "rate_per_100k_py": 11.6,
    "age_band": "6-14 weeks",
    "sex": "all",
    "country": "US (35 HCUP State Inpatient Databases, about 85% of birth cohort)",
    "source": "Tate JE et al. 2008 Pediatrics"
   },
   "E": 3853.2812261108834,
   "E_sens": 1114.664893338809,
   "O": 968,
   "O_adj": 802.2465753424658,
   "reports_any_onset": 1331,
   "onset_known": 1606,
   "oe": 0.25121446974608763,
   "oe_lo": 0.23563627644376692,
   "oe_hi": 0.26755192705286623,
   "oe_adj": 0.20819829341970278,
   "oe_sens": 0.8684224342084583,
   "age_dist_in_window": {
    "<1": 955,
    "nan": 13,
    "1-4": 0
   },
   "note": "Background by week of age: 15-24 weeks (doses 2-3); sensitivity 6-14 weeks (dose 1), which raises O/E."
  },
  {
   "vaccine": "hpv",
   "label": "HPV",
   "aesi": "Guillain-Barr\u00e9 syndrome",
   "doses": 177457602,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 0.81,
    "age_band": "<=17",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Guillain Barre, USA [27], age <=17"
   },
   "bg_sens": {
    "rate_per_100k_py": 1.34,
    "age_band": "18-39",
    "sex": "all",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 165.2869984952772,
   "E_sens": 273.4377505971253,
   "O": 112,
   "O_adj": 114.1,
   "reports_any_onset": 163,
   "onset_known": 160,
   "oe": 0.6776092555350033,
   "oe_lo": 0.5579413648508684,
   "oe_hi": 0.8153400117310865,
   "oe_adj": 0.6903144290762846,
   "oe_sens": 0.40959962461444227,
   "age_dist_in_window": {
    "18-49": 40,
    "5-17": 67,
    "50-64": 2,
    "nan": 3
   },
   "note": "Most doses go to ages 9-17."
  },
  {
   "vaccine": "meningococcal",
   "label": "Meningococcal",
   "aesi": "Guillain-Barr\u00e9 syndrome",
   "doses": 177573215,
   "dose_source": "HRSA VICP Monthly Statistics Report, updated 09/01/2026",
   "period": "2006-2024",
   "window": [
    1,
    42
   ],
   "bg": {
    "rate_per_100k_py": 0.81,
    "age_band": "<=17",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)",
    "doi_or_pmid": "10.1016/j.vaccine.2021.03.016; PMID 33846042; PMC7936550",
    "location_in_source": "Table 2, Guillain Barre, USA [27], age <=17"
   },
   "bg_sens": {
    "rate_per_100k_py": 1.34,
    "age_band": "18-39",
    "sex": "all",
    "country": "US (Olmsted County, MN)",
    "source": "Black SB et al. 2021 Vaccine (The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety)"
   },
   "E": 165.39468239014374,
   "E_sens": 273.6158943244353,
   "O": 187,
   "O_adj": 144.16299559471366,
   "reports_any_onset": 175,
   "onset_known": 227,
   "oe": 1.1306288527396076,
   "oe_lo": 0.9743798467766416,
   "oe_hi": 1.3048057585549129,
   "oe_adj": 0.8716301728168782,
   "oe_sens": 0.6834398288948375,
   "age_dist_in_window": {
    "18-49": 84,
    "5-17": 95,
    "nan": 4,
    "65+": 1,
    "<1": 2,
    "50-64": 1
   },
   "note": "Mostly adolescents."
  }
 ],
 "anaphylaxis": {
  "vsd_confirmed_per_million": 1.31,
  "vsd_source": "McNeil MM et al. 2016 J Allergy Clin Immunol (Vaccine Safety Datalink)",
  "rows": [
   {
    "vaccine": "influenza",
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    "reports_0_1_days": 560,
    "reporting_rate_per_million": 0.206307102858827
   },
   {
    "vaccine": "mmr",
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   },
   {
    "vaccine": "hpv",
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    "reporting_rate_per_million": 0.5353391397681572
   },
   {
    "vaccine": "dtap",
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   },
   {
    "vaccine": "hepatitis-b",
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    "reporting_rate_per_million": 0.2511388472711399
   },
   {
    "vaccine": "pcv",
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    "reporting_rate_per_million": 0.3608217095113276
   },
   {
    "vaccine": "meningococcal",
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    "reporting_rate_per_million": 0.47304431583333106
   }
  ]
 }
}