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  1. Article ; Online: Daily COVID-19 symptom assessment over 28 days - findings from a daily direct-to-patient registry of COVID-19 positive patients.

    Brinkley, Emma / Knuth, Kendall / Kwon, Tom / Mack, Christina / Leister-Tebbe, Heidi / Bao, Weihand / Reynolds, Matthew W / Dreyer, Nancy

    Journal of patient-reported outcomes

    2023  Volume 7, Issue 1, Page(s) 128

    Abstract: In January 2021, 999 COVID-19 positive adults in the US enrolled in an online, direct-to-patient registry to describe daily symptom severity and progression over 28 days. The most commonly reported and persistent symptoms were fatigue, headache, ... ...

    Abstract In January 2021, 999 COVID-19 positive adults in the US enrolled in an online, direct-to-patient registry to describe daily symptom severity and progression over 28 days. The most commonly reported and persistent symptoms were fatigue, headache, decreased sense of taste, decreased sense of smell, and cough. Fast resolving symptoms included gastrointestinal symptoms (nausea, vomiting, diarrhea) and those related to fever and chills. While more than half (56%) of patients reported overall symptom improvement during the 28-day study period, 60% of patients were still reporting at least 1 COVID-19 symptom at the end of 28 days. Risk factors for experiencing symptoms for longer duration included at least one of the following: older age (> 60 years), higher BMI, lung disease, and receiving medication for hypertension. The study demonstrates the value of patient-reported data to provide important and timely insights to COVID-19 disease and symptom progression and the potential of using real-world data to inform clinical trial design and endpoints.
    MeSH term(s) Adult ; Humans ; COVID-19 ; SARS-CoV-2 ; Symptom Assessment ; Gastrointestinal Diseases ; Registries
    Language English
    Publishing date 2023-12-07
    Publishing country Germany
    Document type Journal Article
    ISSN 2509-8020
    ISSN (online) 2509-8020
    DOI 10.1186/s41687-023-00668-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: How frequent are acute reactions to COVID-19 vaccination and who is at risk?

    Dreyer, Nancy / Reynolds, Matthew W. / Albert, Lisa / Brinkley, Emma / Kwon, Tom / Mack, Christina / Toovey, Stephen

    Vaccine. 2022 Mar. 15, v. 40, no. 12

    2022  

    Abstract: Our objective was to describe and compare self-reported side effects ofCOVID-19 vaccinesin theUSA. Aweb-basedregistry enrolled volunteers who received a COVID-19 vaccine between March 19–July 15, 2021. We collected self-reported short-term side effects, ... ...

    Abstract Our objective was to describe and compare self-reported side effects ofCOVID-19 vaccinesin theUSA. Aweb-basedregistry enrolled volunteers who received a COVID-19 vaccine between March 19–July 15, 2021. We collected self-reported short-term side effects, medical consultation, hospitalization, and quality of life impact following completed vaccination regimens (Pfizer, Moderna, J&J). We recruited 6,966 volunteers who completed their full course of vaccination (median age 48 years, IQR 35.0–62.0; 83.6% female): Pfizer 3,486; Moderna 2,857; J&J 623. Few (3.1%) sought medical care for post-vaccination side effects. Hospitalization (n = 17; 0.3%) and severe allergic reactions (n = 39; 0.6%) also were rare. Those with autoimmune disease or lung disease were approximately twice as likely to seek medical care (adjusted odds ratio (aOR) 2.01, 95% CI:1.39; 2.92 and aOR 1.70, 95% CI: 1.12; .58 respectively). 92.4% of participantsreported ≥ 1side effect (median 3), with injection site reactions (78.9%), fatigue (70.3%), headache (49.0%) reported most frequently. More side effects were reported after the second dose of two-dose vaccines (medians: 1 vs. 2 for Pfizer and 1 vs. 3 for Moderna for first and second doses respectively) versus 3 for J&J's single-dose vaccine. For the employed, the median number of workdays missed was one. Diabetics and those vaccinated against influenza were substantially less likely to report 3 or more symptoms (aOR 0.68, 95% CI: 0.56;0.82] and aOR 0.82, 95% CI: 0.73;0.93, respectively). The total side effect burden was, not unexpectedly, greater with two-dose regimens but all three vaccines appear relatively safe. Very few subjects reported side effects serious enough to warrant medical care or reported post-vaccination hospitalization. While these findings do not address possible long-term effects, they do inform on their short-term safety and tolerability and will hopefully provide some reassurance and positively inform the benefit-risk and pharmacoeconomic assessment for all three vaccines. See Clinicaltrials.gov NCT04368065.
    Keywords COVID-19 infection ; adverse effects ; autoimmune diseases ; females ; headache ; influenza ; injection site ; odds ratio ; quality of life ; risk ; vaccination ; vaccines
    Language English
    Dates of publication 2022-0315
    Size p. 1904-1912.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2021.12.072
    Database NAL-Catalogue (AGRICOLA)

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1930: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Show issues

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  3. Article ; Online: How frequent are acute reactions to COVID-19 vaccination and who is at risk?

    Dreyer, Nancy / Reynolds, Matthew W / Albert, Lisa / Brinkley, Emma / Kwon, Tom / Mack, Christina / Toovey, Stephen

    Vaccine

    2022  Volume 40, Issue 12, Page(s) 1904–1912

    Abstract: Introduction: Our objective was to describe and compare self-reported side effects ofCOVID-19 vaccinesin theUSA.: Methods: Aweb-basedregistry enrolled volunteers who received a COVID-19 vaccine between March 19-July 15, 2021. We collected self- ... ...

    Abstract Introduction: Our objective was to describe and compare self-reported side effects ofCOVID-19 vaccinesin theUSA.
    Methods: Aweb-basedregistry enrolled volunteers who received a COVID-19 vaccine between March 19-July 15, 2021. We collected self-reported short-term side effects, medical consultation, hospitalization, and quality of life impact following completed vaccination regimens (Pfizer, Moderna, J&J).
    Results: We recruited 6,966 volunteers who completed their full course of vaccination (median age 48 years, IQR 35.0-62.0; 83.6% female): Pfizer 3,486; Moderna 2,857; J&J 623. Few (3.1%) sought medical care for post-vaccination side effects. Hospitalization (n = 17; 0.3%) and severe allergic reactions (n = 39; 0.6%) also were rare. Those with autoimmune disease or lung disease were approximately twice as likely to seek medical care (adjusted odds ratio (aOR) 2.01, 95% CI:1.39; 2.92 and aOR 1.70, 95% CI: 1.12; .58 respectively). 92.4% of participantsreported ≥ 1side effect (median 3), with injection site reactions (78.9%), fatigue (70.3%), headache (49.0%) reported most frequently. More side effects were reported after the second dose of two-dose vaccines (medians: 1 vs. 2 for Pfizer and 1 vs. 3 for Moderna for first and second doses respectively) versus 3 for J&J's single-dose vaccine. For the employed, the median number of workdays missed was one. Diabetics and those vaccinated against influenza were substantially less likely to report 3 or more symptoms (aOR 0.68, 95% CI: 0.56;0.82] and aOR 0.82, 95% CI: 0.73;0.93, respectively).
    Discussion: The total side effect burden was, not unexpectedly, greater with two-dose regimens but all three vaccines appear relatively safe. Very few subjects reported side effects serious enough to warrant medical care or reported post-vaccination hospitalization. While these findings do not address possible long-term effects, they do inform on their short-term safety and tolerability and will hopefully provide some reassurance and positively inform the benefit-risk and pharmacoeconomic assessment for all three vaccines. See Clinicaltrials.gov NCT04368065.
    MeSH term(s) COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/immunology ; Female ; Humans ; Male ; Middle Aged ; Quality of Life ; SARS-CoV-2 ; Vaccination/adverse effects
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2022-02-09
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2021.12.072
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1930: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Evaluating real-world COVID-19 vaccine effectiveness using a test-negative case-control design.

    Reynolds, Matthew W / Secora, Alex / Joules, Alice / Albert, Lisa / Brinkley, Emma / Kwon, Tom / Mack, Christina / Toovey, Stephen / Dreyer, Nancy A

    Journal of comparative effectiveness research

    2022  Volume 11, Issue 16, Page(s) 1161–1172

    Abstract: Aim: ...

    Abstract Aim:
    MeSH term(s) COVID-19/prevention & control ; COVID-19 Vaccines/therapeutic use ; Case-Control Studies ; Humans ; Vaccine Efficacy
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2022-09-23
    Publishing country England
    Document type Clinical Trial ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.2217/cer-2022-0069
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Evaluating Real-World COVID-19 Vaccine Effectiveness Using a Test-Negative Case-Control Design

    Reynolds, Matthew W / Secora, Alex / Joules, Alice / Albert, Lisa / Brinkley, Emma / Kwon, Tom / Mack, Christina D / Toovey, Stephen / Dreyer, Nancy

    medRxiv

    Abstract: It is important to assess the extent to which the real-world effectiveness of marketed vaccines is consistent with that observed in the clinical trials, and to characterize how well vaccines prevent COVID-19 symptoms. We conducted a modified test- ... ...

    Abstract It is important to assess the extent to which the real-world effectiveness of marketed vaccines is consistent with that observed in the clinical trials, and to characterize how well vaccines prevent COVID-19 symptoms. We conducted a modified test-negative design (TND) to evaluate the RW effectiveness of three COVID-19 vaccines by leveraging data from an on-going, US community-based registry. Vaccine effectiveness was examined in two ways: considering cases who (1) tested positive for COVID-19 (695 cases, 1,786 controls) and who (2) tested positive with at least one moderate/severe COVID-19 symptom (165 cases, 2,316 controls). Any vaccination (full or partial) was associated with a 95% reduction in the odds of having a positive COVID-19 test [adjusted odds ratio (aOR) = 0.05 (95% confidence interval (CI): 0.04, 0.06)]. Full vaccination was associated with an aOR of 0.03 (95% CI: 0.03, 0.05) while partial vaccination had an aOR of 0.08 (95% CI: 0.06, 0.12). Any vaccination was associated with a 71% reduction in the odds of testing positive and having at least one moderate/severe symptom (aOR=0.29 (95% CI: 0.20, 0.40)). High effectiveness was observed across all three vaccine manufacturers both for prevention of positive COVID-19 test results and prevention of moderate/severe COVID-19 symptoms.
    Keywords covid19
    Language English
    Publishing date 2022-01-06
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2022.01.06.22268726
    Database COVID19

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  6. Article ; Online: How frequent are acute reactions to COVID-19 vaccination and who is at risk?

    Dreyer, Nancy A / Reynolds, Matthew W / Albert, Lisa M / Brinkley, Emma / Kwon, Tom / Mack, Christina D / Toovey, Stephen

    medRxiv

    Abstract: Introduction: Our objective was to describe and compare self-reported side effects of COVID-19 vaccines in the USA. Methods: A web-based registry enrolled volunteers who received a COVID-19 vaccine between March 19 and July 15, 2021. We collected self- ... ...

    Abstract Introduction: Our objective was to describe and compare self-reported side effects of COVID-19 vaccines in the USA. Methods: A web-based registry enrolled volunteers who received a COVID-19 vaccine between March 19 and July 15, 2021. We collected self-reported short-term side effects, medical consultation, hospitalization, and quality of life impact following completed vaccination regimens (Pfizer, Moderna, J&J). Results: We recruited 6,966 volunteers who completed their full course of vaccination (median age 48 years, IQR 35.0-62.0; 83.6% female): Pfizer 3,486; Moderna 2,857; J&J 623. Few (3.1%) sought medical care for post-vaccination side effects. Hospitalization (n=17; 0.3%) and severe allergic reactions (n=39; 0.6%) also were rare. Those with autoimmune disease or lung disease were approximately twice as likely to seek medical care (adjusted odds ratio (aOR) 2.01 [95% CI: 1.39;2.92] and 1.70 [95% CI: 1.12;2.58] respectively). 92.4% of participants reported >1 side effect (median 3), with injection site reactions (78.9%), fatigue (70.3%), headache (49.0%) reported most frequently. More side effects were reported after the second dose of two-dose vaccines (medians: 1 vs. 2 for Pfizer and 1 vs. 3 for Moderna for first and second doses respectively) versus 3 for J&J9s single-dose vaccine. For the employed, the median number of workdays missed was one. Diabetics and those vaccinated against influenza were substantially less likely to report >3 symptoms (aOR 0.68, 95% CI 0.56,0.82 and aOR 0.82, 95% CI 0.73,0.93, respectively.) Discussion: The total side effect burden was, not unexpectedly, greater with two-dose regimens but all three vaccines appear relatively safe. Very few subjects reported side effects serious enough to warrant medical care or reported post-vaccination hospitalization. While these findings do not address possible long-term effects, they do inform on their short-term safety and tolerability and will hopefully provide some reassurance and positively inform the benefit-risk and pharmacoeconomic assessment for all three vaccines. Clinicaltrials.gov NCT04368065
    Keywords covid19
    Language English
    Publishing date 2021-10-18
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2021.10.14.21265010
    Database COVID19

    Full text online

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