COVID-19 vaccine reactogenicity – A cohort event monitoring study in the Netherlands using patient reported outcomes

Abstract

Objectives To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. Design A web-based prospective cohort design using patient reported outcomes (PROs). Setting Any person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme. Participants 22,184 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 measures Factors that are associated with the occurrence of reactogenicity after COVID-19 vaccination. Results Compared 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. Conclusions This 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.

Adverse events and overall health and well-being after COVID-19 vaccination: interim results from the VAC4COVID cohort safety study

“…For example, a Dutch web-based cohort study reporting data up to 13 days after vaccination asked participants to indicate if they had experienced specific common vaccine adverse reactions. 20 The Dutch study reported a far higher 62.9% overall rate of reactogenicity AEs, similar to phase III vaccine trial findings.…”

“…Therefore, we expect the rate of AEs reported by our participants as mild to be lower than those reported in studies that did not use the same question format. For example, a Dutch web-based cohort study reporting data up to 13 days after vaccination asked participants to indicate if they had experienced specific common vaccine adverse reactions 20. The Dutch study reported a far higher 62.9% overall rate of reactogenicity AEs, similar to phase III vaccine trial findings.…”

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

“…Monitoring of vaccine safety (amongst others for the COVID-19 vaccines) allows for early detection of adverse reactions possibly linked to vaccination, thereby providing the first step in minimizing possible negative effects attributable to vaccines and allowing the provision of information about possible adverse reactions to vaccine recipients based on up-to-date data. This is achieved by The Netherlands Pharmacovigilance Centre Lareb through a spontaneous reporting system as well as longitudinal cohort event monitoring (CEM) studies ( 1 , 2 ). AEFIs are defined as any unintended medical occurrence after immunization which is not necessarily causally related to the application of the vaccine ( 3 ).…”

Tolerability and Reactogenicity Profile of mRNA SARS-Cov-2 Vaccines from a Mass Vaccination Campaign in a Tertiary Hospital: Between-Vaccine and Between-Population Prospective Observational Study (VigilVacCOVID Study)

“…A more recent Japanese study included 3254 HCPs vaccinated with BNT162b2 [11], and another recent Maltese study included 1480 HCPs vaccinated with BNT162b2 [36]. Another recent study, designed as a cohort event-monitoring study, included 22,184 participants vaccinated with BNT162b2, mRNA-1273, and other types of vaccines, such as Vaxzevria® [7]. Our results (in terms of proportions, severity, and types of reported AR) are in line with the results of these published studies.…”

“…The short-term safety of SARS-Cov-2 mRNA vaccines is reasonably well characterized from clinical trial data [1,2] and pharmacovigilance sources [3][4][5][6]. Real-world studies have been published beyond the controlled context of clinical trials [7][8][9][10][11][12]. It is important to continue to provide additional supporting evidence on the safety profile of SARS-CoV-2 vaccines, especially at a time characterized by severe distress and anxiety caused by the pandemic and the initial uncertainties surrounding vaccination.…”