Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands

Abstract

Introduction: The rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).

Objective: The primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty^®, Moderna's Spikevax^®, AstraZeneca's Vaxzevria^® and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.

Methods: Patient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.

Results: Data of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.

Conclusions: The analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.

Fig. 1

Number of vaccines given at first and second dose, stratified for women and men, per vaccine brand. Vaccination data from the COVID-19 vaccination Information and Monitoring System (CIMS) until 07-10-2011. Data provided by the National Institute for Public Health and the Environment (RIVM)

Fig. 2

Flowchart of the number of participants in the study. *Only a single dose of the AstraZeneca, Pfizer or Moderna vaccine was administered to patients, possibly due to the protocol in the Netherlands for patients with previous COVID-19 infection [13] or the decision to not receive a second dose. ^#Active participants had not received a second dose at the time of data extraction but were still eligible to receive a second vaccine and continue in the study

Fig. 3

Percentages of participants who reported at least one of the following well-known systemic adverse events following immunization (AEFIs) after the first and second doses, stratified by age and sex: arthralgia, myalgia, nausea, pyrexia, headache, malaise, chills, fatigue, and fever (body temperature 38 °C or higher)

Fig. 4

Percentages of participants who reported a body temperature of 38.0 °C or higher after the first and second doses of a COVID-19 vaccine, stratified by age and sex

Fig. 5

Percentages of participants who reported at least one of the following well-known systemic adverse events following immunization (AEFIs) stratified by a history of COVID-19 prior to vaccination: arthralgia, myalgia, nausea, pyrexia, headache, malaise, chills, fatigue, and fever (body temperature 38 °C or higher)