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"2024-05-09", "serious_pct": 6.5, "lot_display": "4492P", "volume_zscore": 7.34, "volume_flag": true, "date_span_days": 2291, "temporal_burst": false, "pct_of_vaccine_reports": 0.23, "rank_in_vaccine": 7, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 17.69, "oe_ratio": 0.509, "poisson_p": 0.9915364079606022, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "B9739", "lot_report_count": 135, "lot_serious_count": 2, "lot_death_count": 0, "date_min": "2018-05-18", "date_max": "2019-04-05", "serious_pct": 1.5, "lot_display": "B9739", "volume_zscore": 7.16, "volume_flag": true, "date_span_days": 322, "temporal_burst": false, "pct_of_vaccine_reports": 0.23, "rank_in_vaccine": 8, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 17.3, "oe_ratio": 0.116, "poisson_p": 0.9999994387497431, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "32GR4", "lot_report_count": 130, "lot_serious_count": 4, "lot_death_count": 0, "date_min": "2018-05-18", "date_max": "2019-06-28", "serious_pct": 3.1, "lot_display": "32GR4", "volume_zscore": 6.87, "volume_flag": true, "date_span_days": 406, "temporal_burst": false, "pct_of_vaccine_reports": 0.22, "rank_in_vaccine": 9, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 16.66, "oe_ratio": 0.24, "poisson_p": 0.9999460751976935, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "LT533", "lot_report_count": 127, "lot_serious_count": 9, "lot_death_count": 0, "date_min": "2018-04-25", "date_max": "2025-06-02", "serious_pct": 7.1, "lot_display": "LT533", "volume_zscore": 6.69, "volume_flag": true, "date_span_days": 2595, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 10, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 16.28, "oe_ratio": 0.553, "poisson_p": 0.9811436522376895, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "HG4P3", "lot_report_count": 126, "lot_serious_count": 8, "lot_death_count": 0, "date_min": "2018-04-12", "date_max": "2021-11-07", "serious_pct": 6.3, "lot_display": "HG4P3", "volume_zscore": 6.63, "volume_flag": true, "date_span_days": 1305, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 11, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 16.15, "oe_ratio": 0.495, "poisson_p": 0.990862308870136, "oe_note": "No lot-specific denominator 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"volume_zscore": 6.16, "volume_flag": true, "date_span_days": 874, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 13, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 15.13, "oe_ratio": 0.793, "poisson_p": 0.8237167538439347, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "XC534", "lot_report_count": 117, "lot_serious_count": 11, "lot_death_count": 1, "date_min": "2018-03-21", "date_max": "2021-09-14", "serious_pct": 9.4, "lot_display": "XC534", "volume_zscore": 6.1, "volume_flag": true, "date_span_days": 1273, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 14, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 15.0, "oe_ratio": 0.733, "poisson_p": 0.881535588470985, "oe_note": "No lot-specific denominator available — using 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5.8, "lot_display": "5NY3B", "volume_zscore": 6.34, "volume_flag": true, "date_span_days": 245, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 12, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 15.51, "oe_ratio": 0.451, "poisson_p": 0.9944921162768138, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "NX952", "lot_report_count": 118, "lot_serious_count": 12, "lot_death_count": 1, "date_min": "2018-01-30 00:00:00", "date_max": "2020-06-22 00:00:00", "serious_pct": 10.2, "lot_display": "NX952", "volume_zscore": 6.16, "volume_flag": true, "date_span_days": 874, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 13, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 15.13, "oe_ratio": 0.793, "poisson_p": 0.8237167538439347, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "XC534", "lot_report_count": 117, "lot_serious_count": 11, "lot_death_count": 1, "date_min": "2018-03-21 00:00:00", "date_max": "2021-09-14 00:00:00", "serious_pct": 9.4, "lot_display": "XC534", "volume_zscore": 6.1, "volume_flag": true, "date_span_days": 1273, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 14, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 15.0, "oe_ratio": 0.733, "poisson_p": 0.881535588470985, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "C523T", "lot_report_count": 112, "lot_serious_count": 4, "lot_death_count": 0, "date_min": "2018-04-06 00:00:00", "date_max": "2019-07-26 00:00:00", "serious_pct": 3.6, "lot_display": "C523T", "volume_zscore": 5.81, "volume_flag": true, "date_span_days": 476, "temporal_burst": false, "pct_of_vaccine_reports": 0.19, "rank_in_vaccine": 15, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 14.36, "oe_ratio": 0.279, "poisson_p": 0.9996449596016557, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "ZY3X4", "lot_report_count": 108, "lot_serious_count": 8, "lot_death_count": 0, "date_min": "2018-03-12 00:00:00", "date_max": "2021-02-22 00:00:00", "serious_pct": 7.4, "lot_display": "ZY3X4", "volume_zscore": 5.57, "volume_flag": true, "date_span_days": 1078, "temporal_burst": false, "pct_of_vaccine_reports": 0.18, "rank_in_vaccine": 16, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 13.84, "oe_ratio": 0.578, "poisson_p": 0.9654837836003799, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "9XC39", "lot_report_count": 105, "lot_serious_count": 8, "lot_death_count": 0, "date_min": "2017-12-12 00:00:00", "date_max": "2022-12-15 00:00:00", "serious_pct": 7.6, "lot_display": "9XC39", "volume_zscore": 5.4, "volume_flag": true, "date_span_days": 1829, "temporal_burst": false, "pct_of_vaccine_reports": 0.18, "rank_in_vaccine": 17, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 13.46, "oe_ratio": 0.594, "poisson_p": 0.9576190572278916, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "P3777", "lot_report_count": 100, "lot_serious_count": 7, "lot_death_count": 2, "date_min": "2017-12-24 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11.92, "oe_ratio": 0.252, "poisson_p": 0.9994411454929985, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "T5242", "lot_report_count": 92, "lot_serious_count": 2, "lot_death_count": 0, "date_min": "2018-02-22 00:00:00", "date_max": "2019-04-17 00:00:00", "serious_pct": 2.2, "lot_display": "T5242", "volume_zscore": 4.63, "volume_flag": true, "date_span_days": 419, "temporal_burst": false, "pct_of_vaccine_reports": 0.15, "rank_in_vaccine": 23, "vax_serious_background_rate": 0.12817904374364192, "expected_serious": 11.79, "oe_ratio": 0.17, "poisson_p": 0.9999030520561067, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "varicella", "vax_display": "Varicella", "lot_number": "37KL2", "lot_report_count": 91, "lot_serious_count": 1, 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"expected_serious": 14.26, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "7P5J5", "lot_report_count": 77, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2020-11-20 00:00:00", "date_max": "2023-05-16 00:00:00", "serious_pct": 0.0, "lot_display": "7P5J5", "volume_zscore": 6.29, "volume_flag": true, "date_span_days": 907, "temporal_burst": false, "pct_of_vaccine_reports": 0.28, "rank_in_vaccine": 5, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 14.08, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "H9FM5", "lot_report_count": 74, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2021-11-06 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"oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "Tdap", "lot_number": "U4612AA", "lot_report_count": 63, "lot_serious_count": 9, "lot_death_count": 0, "date_min": "2013-04-30 00:00:00", "date_max": "2019-12-24 00:00:00", "serious_pct": 14.3, "lot_display": "U4612AA", "volume_zscore": 4.96, "volume_flag": true, "date_span_days": 2429, "temporal_burst": false, "pct_of_vaccine_reports": 0.23, "rank_in_vaccine": 8, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 11.52, "oe_ratio": 0.781, "poisson_p": 0.8109423075530449, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "Tdap", "lot_number": "C2730AA", "lot_report_count": 62, "lot_serious_count": 24, "lot_death_count": 0, "date_min": "2007-03-29 00:00:00", "date_max": "2008-06-25 00:00:00", "serious_pct": 38.7, "lot_display": "C2730AA", "volume_zscore": 4.86, "volume_flag": true, "date_span_days": 454, "temporal_burst": false, "pct_of_vaccine_reports": 0.22, "rank_in_vaccine": 9, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 11.34, "oe_ratio": 2.116, "poisson_p": 0.0007010449748917118, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "42Y93", "lot_report_count": 61, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2024-09-27 00:00:00", "date_max": "2026-03-20 00:00:00", "serious_pct": 0.0, "lot_display": "42Y93", "volume_zscore": 4.76, "volume_flag": true, "date_span_days": 539, "temporal_burst": false, "pct_of_vaccine_reports": 0.22, "rank_in_vaccine": 10, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 11.16, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "3RT93", "lot_report_count": 59, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2024-05-21 00:00:00", "date_max": "2026-04-22 00:00:00", "serious_pct": 0.0, "lot_display": "3RT93", "volume_zscore": 4.57, "volume_flag": true, "date_span_days": 701, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 11, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.79, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "Td", "lot_number": "U7183AA", "lot_report_count": 59, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2022-05-06 00:00:00", "date_max": "2025-09-30 00:00:00", "serious_pct": 0.0, "lot_display": "U7183AA", "volume_zscore": 4.57, "volume_flag": true, "date_span_days": 1243, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 11, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.79, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "Tdap", "lot_number": "C2491AA", "lot_report_count": 59, "lot_serious_count": 23, "lot_death_count": 0, "date_min": "2006-06-13 00:00:00", "date_max": "2008-05-13 00:00:00", "serious_pct": 39.0, "lot_display": "C2491AA", "volume_zscore": 4.57, "volume_flag": true, "date_span_days": 700, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 11, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.79, "oe_ratio": 2.132, "poisson_p": 0.0008135284066376422, "oe_note": "No lot-specific denominator 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"lot_display": "C2734AA", "volume_zscore": 4.48, "volume_flag": true, "date_span_days": 787, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 14, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.61, "oe_ratio": 1.885, "poisson_p": 0.006448778369285879, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "24T2N", "lot_report_count": 56, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2021-09-08 00:00:00", "date_max": "2023-06-30 00:00:00", "serious_pct": 0.0, "lot_display": "24T2N", "volume_zscore": 4.29, "volume_flag": true, "date_span_days": 660, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 16, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.24, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "D24G7", "lot_report_count": 56, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2020-09-21 00:00:00", "date_max": "2022-12-16 00:00:00", "serious_pct": 0.0, "lot_display": "D24G7", "volume_zscore": 4.29, "volume_flag": true, "date_span_days": 816, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 16, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.24, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "HB7L7", "lot_report_count": 56, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2019-08-19 00:00:00", "date_max": "2022-10-28 00:00:00", "serious_pct": 1.8, "lot_display": "HB7L7", "volume_zscore": 4.29, "volume_flag": true, "date_span_days": 1166, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 16, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.24, "oe_ratio": 0.098, "poisson_p": 0.9999642871503583, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "C5248AA", "lot_report_count": 55, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2017-08-07 00:00:00", "date_max": "2025-08-11 00:00:00", "serious_pct": 1.8, "lot_display": "C5248AA", "volume_zscore": 4.19, "volume_flag": true, "date_span_days": 2926, "temporal_burst": false, "pct_of_vaccine_reports": 0.2, "rank_in_vaccine": 19, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 10.06, "oe_ratio": 0.099, "poisson_p": 0.9999572439563225, "oe_note": "No lot-specific denominator available — using vaccine-wide serious 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"date_span_days": 698, "temporal_burst": false, "pct_of_vaccine_reports": 0.19, "rank_in_vaccine": 21, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 9.69, "oe_ratio": 0.103, "poisson_p": 0.999938100595582, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "E2L54", "lot_report_count": 53, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2021-10-04 00:00:00", "date_max": "2023-05-03 00:00:00", "serious_pct": 0.0, "lot_display": "E2L54", "volume_zscore": 4.0, "volume_flag": true, "date_span_days": 576, "temporal_burst": false, "pct_of_vaccine_reports": 0.19, "rank_in_vaccine": 21, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 9.69, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "H99J7", "lot_report_count": 52, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2022-04-02 00:00:00", "date_max": "2024-05-06 00:00:00", "serious_pct": 0.0, "lot_display": "H99J7", "volume_zscore": 3.91, "volume_flag": true, "date_span_days": 765, "temporal_burst": false, "pct_of_vaccine_reports": 0.19, "rank_in_vaccine": 23, "vax_serious_background_rate": 0.1828743078426405, "expected_serious": 9.51, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "dtap", "vax_display": "DTaP", "lot_number": "C5367AA", "lot_report_count": 51, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2019-03-15 00:00:00", "date_max": "2021-01-14 00:00:00", "serious_pct": 0.0, "lot_display": "C5367AA", "volume_zscore": 3.81, "volume_flag": true, "date_span_days": 671, "temporal_burst": 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"rank_in_vaccine": 15, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 2.43, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false } ], "flaggedLots_list": [ { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "0385AE", "lot_report_count": 272, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2012-10-26 00:00:00", "date_max": "2015-08-06 00:00:00", "serious_pct": 0.0, "lot_display": "0385AE", "volume_zscore": 12.49, "volume_flag": true, "date_span_days": 1014, "temporal_burst": false, "pct_of_vaccine_reports": 7.14, "rank_in_vaccine": 1, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 22.07, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "L016427", "lot_report_count": 203, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2015-11-03 00:00:00", "date_max": "2022-11-19 00:00:00", "serious_pct": 0.5, "lot_display": "L016427", "volume_zscore": 9.19, "volume_flag": true, "date_span_days": 2573, "temporal_burst": false, "pct_of_vaccine_reports": 5.33, "rank_in_vaccine": 2, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 16.47, "oe_ratio": 0.061, "poisson_p": 0.9999999296652605, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "L025738", "lot_report_count": 133, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2015-11-04 00:00:00", "date_max": "2017-05-02 00:00:00", "serious_pct": 0.8, "lot_display": "L025738", "volume_zscore": 5.85, "volume_flag": true, "date_span_days": 545, "temporal_burst": false, "pct_of_vaccine_reports": 3.49, "rank_in_vaccine": 3, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 10.79, "oe_ratio": 0.093, "poisson_p": 0.9999793954781712, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "K020216", "lot_report_count": 84, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2015-07-07 00:00:00", "date_max": "2016-03-24 00:00:00", "serious_pct": 1.2, "lot_display": "K020216", "volume_zscore": 3.5, "volume_flag": true, "date_span_days": 261, "temporal_burst": false, "pct_of_vaccine_reports": 2.2, "rank_in_vaccine": 4, "vax_serious_background_rate": 0.0811420832863108, 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"HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "L001441", "lot_report_count": 14, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2016-10-29 00:00:00", "date_max": "2016-10-30 00:00:00", "serious_pct": 0.0, "lot_display": "L001441", "volume_zscore": 0.15, "volume_flag": false, "date_span_days": 1, "temporal_burst": true, "pct_of_vaccine_reports": 0.37, "rank_in_vaccine": 57, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 1.14, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "R001084", "lot_report_count": 11, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2018-12-27 00:00:00", "date_max": "2019-01-25 00:00:00", "serious_pct": 0.0, "lot_display": "R001084", "volume_zscore": 0.01, "volume_flag": false, 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"vax_serious_background_rate": 0.0811420832863108, "expected_serious": 0.57, "oe_ratio": 7.018, "poisson_p": 0.0028002282968063925, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "1022F", "lot_report_count": 7, "lot_serious_count": 5, "lot_death_count": 0, "date_min": "2007-01-12 00:00:00", "date_max": "2008-03-19 00:00:00", "serious_pct": 71.4, "lot_display": "1022F", "volume_zscore": -0.18, "volume_flag": false, "date_span_days": 432, "temporal_burst": false, "pct_of_vaccine_reports": 0.18, "rank_in_vaccine": 133, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 0.57, "oe_ratio": 8.772, "poisson_p": 0.00031285867329066314, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "J010164", "lot_report_count": 7, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2016-10-29 00:00:00", "date_max": "2016-10-30 00:00:00", "serious_pct": 0.0, "lot_display": "J010164", "volume_zscore": -0.18, "volume_flag": false, "date_span_days": 1, "temporal_burst": true, "pct_of_vaccine_reports": 0.18, "rank_in_vaccine": 133, "vax_serious_background_rate": 0.0811420832863108, "expected_serious": 0.57, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-a", "vax_display": "Hepatitis A", "product_label": "HEP — Merck", "VAX_TYPE": "HEP", "lot_number": "0691U", "lot_report_count": 6, "lot_serious_count": 5, "lot_death_count": 0, "date_min": "2007-09-17 00:00:00", "date_max": "2011-09-26 00:00:00", 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0.49, "oe_ratio": 8.163, "poisson_p": 0.0016283936018138465, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true } ], "disproportionalitySignals": [ { "product_label": "HEP — Merck", "canonical_vaccine_id": "hepatitis-a", "lot_number": "T007984", "lot_display": "T007984", "meddra_pt": "Recalled product administered", "cases_in_lot": 4, "cases_other_lots": 0, "lot_report_count": 11, "prr": 2850.75, "prr_ci_low": 162.2317, "prr_ci_high": 50093.6466, "ror": 4560.6, "ror_ci_low": 225.173, "ror_ci_high": 92369.3092, "chi2": 1058.1904, "signal": true }, { "product_label": "HEP — Merck", "canonical_vaccine_id": "hepatitis-a", "lot_number": "K004810", "lot_display": "K004810", "meddra_pt": "Dyspepsia", "cases_in_lot": 3, "cases_other_lots": 1, "lot_report_count": 10, "prr": 806.4848, "prr_ci_low": 130.8143, "prr_ci_high": 4972.0691, "ror": 1182.3778, "ror_ci_low": 153.356, "ror_ci_high": 9116.1556, "chi2": 592.6548, "signal": 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"lot_report_count": 35, "prr": 188.85, "prr_ci_low": 41.6843, "prr_ci_high": 855.5811, "ror": 215.6857, "ror_ci_low": 44.1893, "ror_ci_high": 1052.7511, "chi2": 217.7024, "signal": true }, { "product_label": "HEP — Merck", "canonical_vaccine_id": "hepatitis-a", "lot_number": "1106AA", "lot_display": "1106AA", "meddra_pt": "No therapeutic response", "cases_in_lot": 3, "cases_other_lots": 5, "lot_report_count": 13, "prr": 172.6818, "prr_ci_low": 50.3148, "prr_ci_high": 592.6487, "ror": 229.9091, "ror_ci_low": 52.8251, "ror_ci_high": 1000.6267, "chi2": 225.2936, "signal": true }, { "product_label": "HEP — Merck", "canonical_vaccine_id": "hepatitis-a", "lot_number": "J007946", "lot_display": "J007946", "meddra_pt": "Drug dose omission", "cases_in_lot": 4, "cases_other_lots": 4, "lot_report_count": 35, "prr": 104.9167, "prr_ci_low": 29.6183, "prr_ci_high": 371.6449, "ror": 119.7619, "ror_ci_low": 30.957, "ror_ci_high": 463.3166, "chi2": 161.6252, "signal": true }, { "product_label": "HEP — 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"canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "151501", "lot_report_count": 29, "lot_serious_count": 5, "lot_death_count": 0, "date_min": "2016-05-31 00:00:00", "date_max": "2017-02-23 00:00:00", "serious_pct": 17.2, "lot_display": "151501", "volume_zscore": 3.84, "volume_flag": true, "date_span_days": 268, "temporal_burst": false, "pct_of_vaccine_reports": 0.28, "rank_in_vaccine": 13, "vax_serious_background_rate": 0.10546304411335086, "expected_serious": 3.06, "oe_ratio": 1.634, "poisson_p": 0.1949174296167645, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "5P2P7", "lot_report_count": 29, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2023-02-22 00:00:00", "date_max": "2026-04-06 00:00:00", "serious_pct": 0.0, "lot_display": "5P2P7", "volume_zscore": 3.84, "volume_flag": true, "date_span_days": 1139, "temporal_burst": false, "pct_of_vaccine_reports": 0.28, "rank_in_vaccine": 13, "vax_serious_background_rate": 0.10546304411335086, "expected_serious": 3.06, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "ABXB36AA", "lot_report_count": 29, "lot_serious_count": 1, "lot_death_count": 1, "date_min": "2021-09-10 00:00:00", "date_max": "2022-11-18 00:00:00", "serious_pct": 3.4, "lot_display": "ABXB36AA", "volume_zscore": 3.84, "volume_flag": true, "date_span_days": 434, "temporal_burst": false, "pct_of_vaccine_reports": 0.28, "rank_in_vaccine": 13, "vax_serious_background_rate": 0.10546304411335086, "expected_serious": 3.06, "oe_ratio": 0.327, "poisson_p": 0.9531123047800115, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background 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using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "XX33P", "lot_report_count": 28, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2023-05-16 00:00:00", "date_max": "2025-10-01 00:00:00", "serious_pct": 0.0, "lot_display": "XX33P", "volume_zscore": 3.66, "volume_flag": true, "date_span_days": 869, "temporal_burst": false, "pct_of_vaccine_reports": 0.27, "rank_in_vaccine": 17, "vax_serious_background_rate": 0.10546304411335086, "expected_serious": 2.95, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "3YB52", "lot_report_count": 27, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2022-08-08 00:00:00", "date_max": "2024-05-21 00:00:00", "serious_pct": 0.0, 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0.379, "poisson_p": 0.9286387304436139, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "PX7E2", "lot_report_count": 25, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2023-10-12 00:00:00", "date_max": "2025-10-05 00:00:00", "serious_pct": 4.0, "lot_display": "PX7E2", "volume_zscore": 3.12, "volume_flag": true, "date_span_days": 724, "temporal_burst": false, "pct_of_vaccine_reports": 0.24, "rank_in_vaccine": 27, "vax_serious_background_rate": 0.10546304411335086, "expected_serious": 2.64, "oe_ratio": 0.379, "poisson_p": 0.9286387304436139, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "meningococcal", "vax_display": "Meningococcal", "lot_number": "16D401", "lot_report_count": 14, "lot_serious_count": 1, 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using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "2553X", "lot_report_count": 21, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2024-09-12", "date_max": "2026-05-04", "serious_pct": 4.8, "lot_display": "2553X", "volume_zscore": 0.87, "volume_flag": false, "date_span_days": 599, "temporal_burst": false, "pct_of_vaccine_reports": 1.48, "rank_in_vaccine": 15, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 3.11, "oe_ratio": 0.322, "poisson_p": 0.9553990446597255, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "75C72", "lot_report_count": 19, "lot_serious_count": 1, "lot_death_count": 0, "date_min": "2019-12-31", "date_max": "2022-07-28", "serious_pct": 5.3, "lot_display": "75C72", 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false, "date_span_days": 527, "temporal_burst": false, "pct_of_vaccine_reports": 1.2, "rank_in_vaccine": 19, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 2.52, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "AHABB225AA", "lot_report_count": 17, "lot_serious_count": 7, "lot_death_count": 0, "date_min": "2012-04-11", "date_max": "2017-07-27", "serious_pct": 41.2, "lot_display": "AHABB225AA", "volume_zscore": 0.47, "volume_flag": false, "date_span_days": 1933, "temporal_burst": false, "pct_of_vaccine_reports": 1.2, "rank_in_vaccine": 19, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 2.52, "oe_ratio": 2.778, "poisson_p": 0.014751816972517973, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "429JJ", "lot_report_count": 16, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2024-04-30", "date_max": "2026-02-04", "serious_pct": 0.0, "lot_display": "429JJ", "volume_zscore": 0.37, "volume_flag": false, "date_span_days": 645, "temporal_burst": false, "pct_of_vaccine_reports": 1.13, "rank_in_vaccine": 21, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 2.37, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "A4XD4", "lot_report_count": 16, "lot_serious_count": 6, "lot_death_count": 0, "date_min": "2015-10-13", "date_max": "2017-10-11", "serious_pct": 37.5, "lot_display": "A4XD4", "volume_zscore": 0.37, "volume_flag": false, "date_span_days": 729, 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"canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "2KE55", "lot_report_count": 46, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2022-08-27 00:00:00", "date_max": "2024-04-17 00:00:00", "serious_pct": 0.0, "lot_display": "2KE55", "volume_zscore": 3.33, "volume_flag": true, "date_span_days": 599, "temporal_burst": false, "pct_of_vaccine_reports": 3.25, "rank_in_vaccine": 2, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 6.82, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "P2443", "lot_report_count": 45, "lot_serious_count": 2, "lot_death_count": 0, "date_min": "2025-04-23 00:00:00", "date_max": "2026-03-30 00:00:00", "serious_pct": 4.4, "lot_display": "P2443", "volume_zscore": 3.23, "volume_flag": true, "date_span_days": 341, 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"signal_flag": true }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "AHABB068AA", "lot_report_count": 8, "lot_serious_count": 5, "lot_death_count": 0, "date_min": "2007-02-12 00:00:00", "date_max": "2008-03-31 00:00:00", "serious_pct": 62.5, "lot_display": "AHABB068AA", "volume_zscore": -0.41, "volume_flag": false, "date_span_days": 413, "temporal_burst": false, "pct_of_vaccine_reports": 0.56, "rank_in_vaccine": 66, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 1.19, "oe_ratio": 4.202, "poisson_p": 0.00748858092639427, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "AHABB244AA", "lot_report_count": 8, "lot_serious_count": 5, "lot_death_count": 0, "date_min": "2013-01-18 00:00:00", "date_max": "2013-12-04 00:00:00", "serious_pct": 62.5, "lot_display": "AHABB244AA", 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denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "AHABA026AA", "lot_report_count": 4, "lot_serious_count": 3, "lot_death_count": 0, "date_min": "2006-01-27 00:00:00", "date_max": "2009-04-20 00:00:00", "serious_pct": 75.0, "lot_display": "AHABA026AA", "volume_zscore": -0.81, "volume_flag": false, "date_span_days": 1179, "temporal_burst": false, "pct_of_vaccine_reports": 0.28, "rank_in_vaccine": 99, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 0.59, "oe_ratio": 5.085, "poisson_p": 0.022138953364092866, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "lot_number": "AHABB036AA", "lot_report_count": 3, "lot_serious_count": 2, "lot_death_count": 0, "date_min": "2006-04-13 00:00:00", "date_max": "2007-03-12 00:00:00", "serious_pct": 66.7, "lot_display": "AHABB036AA", "volume_zscore": -0.91, "volume_flag": false, "date_span_days": 333, "temporal_burst": false, "pct_of_vaccine_reports": 0.21, "rank_in_vaccine": 107, "vax_serious_background_rate": 0.1483050847457627, "expected_serious": 0.44, "oe_ratio": 4.545, "poisson_p": 0.07258755364027641, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true } ], "disproportionalitySignals": [ { "canonical_vaccine_id": "hepatitis-b", "lot_number": "H3SG9", "lot_display": "H3SG9", "meddra_pt": "Accidental underdose", "cases_in_lot": 3, "cases_other_lots": 0, "lot_report_count": 24, "prr": 390.04, "prr_ci_low": 20.6873, "prr_ci_high": 7353.8441, "ror": 453.3721, "ror_ci_low": 22.7147, "ror_ci_high": 9049.0303, "chi2": 120.2562, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB030AA", "lot_display": "AHABB030AA", "meddra_pt": "Medication error", 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"canonical_vaccine_id": "hepatitis-b", "lot_number": "H3SG9", "lot_display": "H3SG9", "meddra_pt": "Underdose", "cases_in_lot": 3, "cases_other_lots": 1, "lot_report_count": 24, "prr": 130.0133, "prr_ci_low": 20.0095, "prr_ci_high": 844.771, "ror": 151.0155, "ror_ci_low": 21.2799, "ror_ci_high": 1071.7, "chi2": 89.0111, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "H3SG9", "lot_display": "H3SG9", "meddra_pt": "Product complaint", "cases_in_lot": 3, "cases_other_lots": 2, "lot_report_count": 24, "prr": 78.008, "prr_ci_low": 16.1626, "prr_ci_high": 376.5008, "ror": 90.5442, "ror_ci_low": 16.9089, "ror_ci_high": 484.8489, "chi2": 70.2697, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "H3SG9", "lot_display": "H3SG9", "meddra_pt": "Syringe issue", "cases_in_lot": 3, "cases_other_lots": 4, "lot_report_count": 24, "prr": 43.3378, "prr_ci_low": 11.3509, "prr_ci_high": 165.4636, "ror": 50.23, "ror_ci_low": 11.6607, "ror_ci_high": 216.3723, "chi2": 48.8629, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "P2443", "lot_display": "P2443", "meddra_pt": "Blood glucose decreased", "cases_in_lot": 3, "cases_other_lots": 2, "lot_report_count": 45, "prr": 41.7565, "prr_ci_low": 8.4624, "prr_ci_high": 206.0417, "ror": 45.1129, "ror_ci_low": 8.651, "ror_ci_high": 235.2536, "chi2": 35.7506, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB204BA", "lot_display": "AHABB204BA", "meddra_pt": "Oropharyngeal pain", "cases_in_lot": 3, "cases_other_lots": 15, "lot_report_count": 10, "prr": 28.8827, "prr_ci_low": 10.6601, "prr_ci_high": 78.2553, "ror": 41.8946, "ror_ci_low": 10.7101, "ror_ci_high": 163.8792, "chi2": 45.1832, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "2BA47", "lot_display": "2BA47", "meddra_pt": "Peripheral swelling", "cases_in_lot": 3, "cases_other_lots": 14, "lot_report_count": 13, "prr": 24.2069, "prr_ci_low": 8.5404, "prr_ci_high": 68.6117, "ror": 31.9425, "ror_ci_low": 8.5694, "ror_ci_high": 119.0659, "chi2": 35.9592, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "797K7", "lot_display": "797K7", "meddra_pt": "Unevaluable event", "cases_in_lot": 3, "cases_other_lots": 14, "lot_report_count": 13, "prr": 24.2069, "prr_ci_low": 8.5404, "prr_ci_high": 68.6117, "ror": 31.9425, "ror_ci_low": 8.5694, "ror_ci_high": 119.0659, "chi2": 35.9592, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB167BA", "lot_display": "AHABB167BA", "meddra_pt": "Throat tightness", "cases_in_lot": 3, "cases_other_lots": 17, "lot_report_count": 11, "prr": 23.4333, "prr_ci_low": 8.6455, "prr_ci_high": 63.5154, "ror": 32.6706, "ror_ci_low": 8.6311, "ror_ci_high": 123.6654, "chi2": 36.1705, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "H7RF2", "lot_display": "H7RF2", "meddra_pt": "Product storage error", "cases_in_lot": 4, "cases_other_lots": 7, "lot_report_count": 38, "prr": 21.2154, "prr_ci_low": 6.8907, "prr_ci_high": 65.3186, "ror": 23.8522, "ror_ci_low": 7.066, "ror_ci_high": 80.5155, "chi2": 36.0322, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "324BY", "lot_display": "324BY", "meddra_pt": "Product administered to patient of inappropriate age", "cases_in_lot": 12, "cases_other_lots": 42, "lot_report_count": 24, "prr": 16.3882, "prr_ci_low": 10.0276, "prr_ci_high": 26.7834, "ror": 31.7765, "ror_ci_low": 13.6996, "ror_ci_high": 73.7063, "chi2": 129.4581, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "M4B34", "lot_display": "M4B34", "meddra_pt": "Extra dose administered", "cases_in_lot": 4, "cases_other_lots": 20, "lot_report_count": 22, "prr": 13.3139, "prr_ci_low": 5.235, "prr_ci_high": 33.8603, "ror": 16.3092, "ror_ci_low": 5.3282, "ror_ci_high": 49.9212, "chi2": 27.0983, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "HZ9Z9", "lot_display": "HZ9Z9", "meddra_pt": "Hyperhidrosis", "cases_in_lot": 3, "cases_other_lots": 42, "lot_report_count": 8, "prr": 12.8928, "prr_ci_low": 5.3967, "prr_ci_high": 30.8009, "ror": 20.461, "ror_ci_low": 5.1759, "ror_ci_high": 80.8849, "chi2": 20.6051, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB189AB", "lot_display": "AHABB189AB", "meddra_pt": "Erythema", "cases_in_lot": 3, "cases_other_lots": 56, "lot_report_count": 7, "prr": 10.9181, "prr_ci_low": 4.7788, "prr_ci_high": 24.9447, "ror": 18.6323, "ror_ci_low": 4.4946, "ror_ci_high": 77.2392, "chi2": 17.5339, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "53AT5", "lot_display": "53AT5", "meddra_pt": "Loss of consciousness", "cases_in_lot": 3, "cases_other_lots": 34, "lot_report_count": 13, "prr": 10.1739, "prr_ci_low": 3.8749, "prr_ci_high": 26.7125, "ror": 13.2319, "ror_ci_low": 3.7682, "ror_ci_high": 46.4633, "chi2": 14.2382, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB223CA", "lot_display": "AHABB223CA", "meddra_pt": "Hypoaesthesia", "cases_in_lot": 3, "cases_other_lots": 48, "lot_report_count": 9, "prr": 10.1608, "prr_ci_low": 4.1777, "prr_ci_high": 24.7126, "ror": 15.0936, "ror_ci_low": 3.9893, "ror_ci_high": 57.107, "chi2": 15.2478, "signal": true }, { "canonical_vaccine_id": "hepatitis-b", "lot_number": "AHABB123AA", "lot_display": "AHABB123AA", "meddra_pt": "Dyspnoea", "cases_in_lot": 3, "cases_other_lots": 54, "lot_report_count": 8, "prr": 10.054, "prr_ci_low": 4.2572, "prr_ci_high": 23.7443, "ror": 15.8157, "ror_ci_low": 4.0299, "ror_ci_high": 62.0699, "chi2": 15.4349, "signal": true } ], "products": [ { "product": "HEPAB — Glaxosmithkline Biologicals", "vaxType": "HEPAB", "totalReports": 1407, "lotCount": 114, "flaggedLots": 8, "topLots": [ { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "product_label": "HEPAB — Glaxosmithkline Biologicals", "VAX_TYPE": "HEPAB", "lot_number": 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using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "product_label": "HEPAB — Glaxosmithkline Biologicals", "VAX_TYPE": "HEPAB", "lot_number": "H3SG9", "lot_report_count": 24, "lot_serious_count": 0, "lot_death_count": 0, "date_min": "2023-02-03 00:00:00", "date_max": "2025-02-21 00:00:00", "serious_pct": 0.0, "lot_display": "H3SG9", "volume_zscore": 1.15, "volume_flag": false, "date_span_days": 749, "temporal_burst": false, "pct_of_vaccine_reports": 1.71, "rank_in_vaccine": 11, "vax_serious_background_rate": 0.1457000710732054, "expected_serious": 3.5, "oe_ratio": 0.0, "poisson_p": 1.0, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": false }, { "canonical_vaccine_id": "hepatitis-b", "vax_display": "Hepatitis B", "product_label": "HEPAB — Glaxosmithkline Biologicals", "VAX_TYPE": "HEPAB", "lot_number": "J477Y", "lot_report_count": 23, 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rate.", "signal_flag": true }, { "canonical_vaccine_id": "polio", "vax_display": "Polio (IPV)", "product_label": "IPV (polio) — Sanofi Pasteur", "VAX_TYPE": "IPV", "lot_number": "M14771M", "lot_report_count": 5, "lot_serious_count": 3, "lot_death_count": 0, "date_min": "2016-09-20 00:00:00", "date_max": "2017-01-13 00:00:00", "serious_pct": 60.0, "lot_display": "M14771M", "volume_zscore": -0.56, "volume_flag": false, "date_span_days": 115, "temporal_burst": false, "pct_of_vaccine_reports": 0.38, "rank_in_vaccine": 59, "vax_serious_background_rate": 0.01598173515981735, "expected_serious": 0.08, "oe_ratio": 37.5, "poisson_p": 8.03735939961199e-05, "oe_note": "No lot-specific denominator available — using vaccine-wide serious background rate.", "signal_flag": true } ], "disproportionalitySignals": [ { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "A0298", "lot_display": "A0298", "meddra_pt": "Injection site discolouration", "cases_in_lot": 5, "cases_other_lots": 2, "lot_report_count": 6, "prr": 411.4, "prr_ci_low": 112.4058, "prr_ci_high": 1505.7051, "ror": 1916.2, "ror_ci_low": 214.3071, "ror_ci_high": 17133.462, "chi2": 630.7931, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "J13821", "lot_display": "J13821", "meddra_pt": "Incorrect storage of drug", "cases_in_lot": 48, "cases_other_lots": 3, "lot_report_count": 48, "prr": 358.3061, "prr_ci_low": 125.8116, "prr_ci_high": 1020.4408, "ror": 35017.0, "ror_ci_low": 1783.8008, "ror_ci_high": 687403.1459, "chi2": 1207.1786, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "A0298", "lot_display": "A0298", "meddra_pt": "Immediate post-injection reaction", "cases_in_lot": 3, "cases_other_lots": 4, "lot_report_count": 6, "prr": 145.4444, "prr_ci_low": 44.5569, "prr_ci_high": 474.7658, "ror": 289.8889, "ror_ci_low": 50.529, "ror_ci_high": 1663.1149, "chi2": 192.4672, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "W1B511M", "lot_display": "W1B511M", "meddra_pt": "Nasopharyngitis", "cases_in_lot": 3, "cases_other_lots": 1, "lot_report_count": 41, "prr": 70.7778, "prr_ci_low": 10.715, "prr_ci_high": 467.5236, "ror": 77.1212, "ror_ci_low": 11.0887, "ror_ci_high": 536.3724, "chi2": 46.7993, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "M14771M", "lot_display": "M14771M", "meddra_pt": "Injection site swelling", "cases_in_lot": 4, "cases_other_lots": 15, "lot_report_count": 5, "prr": 63.3871, "prr_ci_low": 32.2093, "prr_ci_high": 124.7441, "ror": 250.5484, "ror_ci_low": 36.9322, "ror_ci_high": 1699.7211, "chi2": 165.5233, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "Y1A212M", "lot_display": "Y1A212M", "meddra_pt": "Fall", "cases_in_lot": 3, "cases_other_lots": 5, "lot_report_count": 23, "prr": 34.2576, "prr_ci_low": 9.5449, "prr_ci_high": 122.9539, "ror": 39.9357, "ror_ci_low": 9.7557, "ror_ci_high": 163.4794, "chi2": 40.7297, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "W1C741M", "lot_display": "W1C741M", "meddra_pt": "Circumstance or information capable of leading to medication error", "cases_in_lot": 3, "cases_other_lots": 3, "lot_report_count": 42, "prr": 29.6047, "prr_ci_low": 6.9436, "prr_ci_high": 126.2229, "ror": 32.1392, "ror_ci_low": 7.0639, "ror_ci_high": 146.2273, "chi2": 28.83, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "M14771M", "lot_display": "M14771M", "meddra_pt": "Injection site erythema", "cases_in_lot": 4, "cases_other_lots": 36, "lot_report_count": 5, "prr": 26.9178, "prr_ci_low": 15.3464, "prr_ci_high": 47.2142, "ror": 104.6712, "ror_ci_low": 16.0202, "ror_ci_high": 683.889, "chi2": 76.2367, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "R1F801M", "lot_display": "R1F801M", "meddra_pt": "Product administered to patient of inappropriate age", "cases_in_lot": 3, "cases_other_lots": 15, "lot_report_count": 11, "prr": 24.5376, "prr_ci_low": 8.9271, "prr_ci_high": 67.4461, "ror": 34.2296, "ror_ci_low": 8.9469, "ror_ci_high": 130.9575, "chi2": 37.4502, "signal": true }, { "product_label": "IPV (polio) — Sanofi Pasteur", "canonical_vaccine_id": "polio", "lot_number": "Y1D03P1", "lot_display": "Y1D03P1", "meddra_pt": "Injection site pain", "cases_in_lot": 3, "cases_other_lots": 21, "lot_report_count": 15, "prr": 13.2267, "prr_ci_low": 4.7863, "prr_ci_high": 36.5513, "ror": 16.6502, "ror_ci_low": 4.7248, "ror_ci_high": 58.6761, "chi2": 18.6357, "signal": true } ] } ] } ], "meta": { "yearsProcessed": "2006–2026", "dataSource": "CDC/FDA VAERS", "generatedAt": "2026-10-28 18:38 UTC", "dataCurrentAsOf": "2026-10-28", "totalUniqueReports": 1194221, "reportsWithUsableLot": 1207107, "lotCoveragePct": 68.61, "totalLotsAnalyzed": 32339, "minLotReports": 3, "disproportionalitySignals": 28452, "caveat": "Lot number reporting in VAERS is voluntary and incomplete. Larger or more widely distributed lots naturally generate more reports. No public lot-specific dose denominators are available, so all analyses use within-vaccine comparisons or vaccine-wide background rates. Raw counts or rankings without context are misleading. Signals are hypothesis-generating only and require further investigation." } }