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Unsolicited Adverse Event

MedGen UID:
1791947
•Concept ID:
C5555506
•
Finding
Synonym: Unsolicited

Definition

An adverse event that is voluntarily reported by a healthcare professional, consumer, or patient outside of an organized data collection system. [from NCI]

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews,  VClinVar  
  • CROGVUnsolicited Adverse Event

Recent clinical studies

Etiology

Protective efficacy and safety of radiation-attenuated and chemo-attenuated Plasmodium Falciparum sporozoite vaccines against controlled and natural malaria infection: a systematic review and meta-analysis of randomized controlled trials.
Abuelazm MT, Elzeftawy MA, Kamal MA, Badr H, Gamal M, Aboulgheit M, Abdelazeem B, Abd-Elsalam S, Abouzid M
Infection 2024 Jun;52(3):707-722. Epub 2024 Feb 6 doi: 10.1007/s15010-024-02174-4. PMID: 38319556
Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, Bhatla N, Joshi S, Pimple S, Kawade A, Balasubramani L, Thomas A, Suri V, Lalwani S, Uday R, Kamath V, Mandal R, Rajeswar A, Peedicayil A, Poli UR, Banerjee D, Sankaranarayanan R, Basu P, Muwonge R, Gairola S, Dogar V, Rao H, Shaligram U
Lancet Oncol 2023 Dec;24(12):1321-1333. Epub 2023 Nov 7 doi: 10.1016/S1470-2045(23)00480-1. PMID: 37949086
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth.
Bayar E, MacIntyre DA, Sykes L, Mountain K, Parks TP, Lee PP, Bennett PR
Benef Microbes 2023 Mar 14;14(1):45-56. Epub 2023 Feb 23 doi: 10.3920/BM2022.0084. PMID: 36815494
Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial.
Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Köhn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group
Lancet Infect Dis 2022 Jan;22(1):97-109. Epub 2021 Sep 13 doi: 10.1016/S1473-3099(21)00125-0. PMID: 34529963Free PMC Article

Therapy

Protective efficacy and safety of radiation-attenuated and chemo-attenuated Plasmodium Falciparum sporozoite vaccines against controlled and natural malaria infection: a systematic review and meta-analysis of randomized controlled trials.
Abuelazm MT, Elzeftawy MA, Kamal MA, Badr H, Gamal M, Aboulgheit M, Abdelazeem B, Abd-Elsalam S, Abouzid M
Infection 2024 Jun;52(3):707-722. Epub 2024 Feb 6 doi: 10.1007/s15010-024-02174-4. PMID: 38319556
Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, Bhatla N, Joshi S, Pimple S, Kawade A, Balasubramani L, Thomas A, Suri V, Lalwani S, Uday R, Kamath V, Mandal R, Rajeswar A, Peedicayil A, Poli UR, Banerjee D, Sankaranarayanan R, Basu P, Muwonge R, Gairola S, Dogar V, Rao H, Shaligram U
Lancet Oncol 2023 Dec;24(12):1321-1333. Epub 2023 Nov 7 doi: 10.1016/S1470-2045(23)00480-1. PMID: 37949086
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth.
Bayar E, MacIntyre DA, Sykes L, Mountain K, Parks TP, Lee PP, Bennett PR
Benef Microbes 2023 Mar 14;14(1):45-56. Epub 2023 Feb 23 doi: 10.3920/BM2022.0084. PMID: 36815494
Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial.
Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Köhn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group
Lancet Infect Dis 2022 Jan;22(1):97-109. Epub 2021 Sep 13 doi: 10.1016/S1473-3099(21)00125-0. PMID: 34529963Free PMC Article

Prognosis

Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth.
Bayar E, MacIntyre DA, Sykes L, Mountain K, Parks TP, Lee PP, Bennett PR
Benef Microbes 2023 Mar 14;14(1):45-56. Epub 2023 Feb 23 doi: 10.3920/BM2022.0084. PMID: 36815494
Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial.
Perrett KP, Halperin SA, Nolan T, Carmona Martínez A, Martinón-Torres F, García-Sicilia J, Virta M, Vanderkooi OG, Zuccotti GV, Manzoni P, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Stranak Z, Merino Arribas JM, Cilleruelo Ortega MJ, Miranda-Valdivieso M, Arias Novas B, Ramos Amador JT, Omeñaca F, Baca M, Marchisio PG, Mesaros N
Vaccine 2020 Feb 18;38(8):2105-2114. Epub 2019 Nov 24 doi: 10.1016/j.vaccine.2019.10.104. PMID: 31776027

Clinical prediction guides

Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, Bhatla N, Joshi S, Pimple S, Kawade A, Balasubramani L, Thomas A, Suri V, Lalwani S, Uday R, Kamath V, Mandal R, Rajeswar A, Peedicayil A, Poli UR, Banerjee D, Sankaranarayanan R, Basu P, Muwonge R, Gairola S, Dogar V, Rao H, Shaligram U
Lancet Oncol 2023 Dec;24(12):1321-1333. Epub 2023 Nov 7 doi: 10.1016/S1470-2045(23)00480-1. PMID: 37949086
Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Müllner M, Tauber E, Ramsauer K, Baize S
Lancet 2023 Apr 15;401(10384):1267-1276. Epub 2023 Mar 16 doi: 10.1016/S0140-6736(23)00048-X. PMID: 36934733
Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth.
Bayar E, MacIntyre DA, Sykes L, Mountain K, Parks TP, Lee PP, Bennett PR
Benef Microbes 2023 Mar 14;14(1):45-56. Epub 2023 Feb 23 doi: 10.3920/BM2022.0084. PMID: 36815494
Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial.
Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Köhn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group
Lancet Infect Dis 2022 Jan;22(1):97-109. Epub 2021 Sep 13 doi: 10.1016/S1473-3099(21)00125-0. PMID: 34529963Free PMC Article
Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial.
Afolabi MO, Ishola D, Manno D, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Köhn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Greenwood B, Leyssen M, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group
Lancet Infect Dis 2022 Jan;22(1):110-122. Epub 2021 Sep 13 doi: 10.1016/S1473-3099(21)00128-6. PMID: 34529962Free PMC Article

Recent systematic reviews

Protective efficacy and safety of radiation-attenuated and chemo-attenuated Plasmodium Falciparum sporozoite vaccines against controlled and natural malaria infection: a systematic review and meta-analysis of randomized controlled trials.
Abuelazm MT, Elzeftawy MA, Kamal MA, Badr H, Gamal M, Aboulgheit M, Abdelazeem B, Abd-Elsalam S, Abouzid M
Infection 2024 Jun;52(3):707-722. Epub 2024 Feb 6 doi: 10.1007/s15010-024-02174-4. PMID: 38319556

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