ArticleVaccine2022
COVID-19 vaccine reactogenicity - A cohort event monitoring study in the Netherlands using patient reported outcomes.
Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed, 43 citations in OpenAlex.
- Most COVID-19 vaccine adverse events detected within 48 hours in Ethiopia: implications for cohort event monitoring efficiency in resource-limited settings.European journal of clinical pharmacology · 2026Article
- Short-term safety and reactogenicity of same-day COVID-19 and influenza vaccination in very old, community-dwelling adults.European geriatric medicine · 2026Observational
- Inflammatory mediators of mRNA vaccine-induced adverse reactions in mice.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Article
- Comparison of Perceived Adverse Events After COVID-19 Vaccination Between Pregnant and NonPregnant Women Using Two Cohort Studies in the Netherlands.Birth defects research · 2025Article
- Article
- The association between coronavirus disease 2019 vaccination during pregnancy and neonatal health outcomes.Pediatric investigation · 2025Article
- A national pharmacovigilance centre perspective on pandemic preparedness -Frontiers in drug safety and regulation · 2025Article
- Innate immune response after BNT162b2 COVID-19 vaccination associates with reactogenicity.Vaccine: X · 2025Article
- Factors influencing adverse events following COVID-19 vaccination.Human vaccines & immunotherapeutics · 2024Article
- A scoping review of active, participant centred, digital adverse events following immunization (AEFI) surveillance of WHO approved COVID-19 vaccines: A Canadian immunization Research Network study.Human vaccines & immunotherapeutics · 2024Article
- A Texting- and Internet-Based Self-Reporting System for Enhanced Vaccine Safety Surveillance With Insights From a Large Integrated Health Care System in the United States: Prospective Cohort Study.JMIR mHealth and uHealth · 2024Article
- Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally.Vaccine: X · 2024Article
- Association between adverse events after COVID-19 vaccination and anti-SARS-CoV-2 antibody concentrations, the Netherlands, May 2021 to November 2022: a population-based prospective cohort study.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2024Article
- Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the "ilmiovaccinoCOVID19 collaborating group".Frontiers in drug safety and regulation · 2024Article
- Observational
- Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study.BMC medicine · 2023Observational
- Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system.BMC infectious diseases · 2023Article
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Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands.
designA web-based prospective cohort design using patient reported outcomes (PROs).
settingAny person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme.
participants22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination.
main outcome measuresFactors that are associated with the occurrence of reactogenicity after COVID-19 vaccination.
resultsCompared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50-60, 61-79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0-29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient.
conclusionsThis extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.