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. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-022-01151-w.

COVID-19 vaccines-related adverse events and associated factors reported among adult Egyptians

“…29 Our study revealed that most of the post-COVID-19 vaccination adverse events were low to moderate in severity and were not severe enough to require hospitalization and usually resolved within a few days after vaccination and the same trend was reported in several studies. 15,22,25,29 The present study also showed that the reported adverse events were significantly higher among female participants and those who received AstraZeneca vaccination with multivariable-adjusted OR (95% CI) of 2.26 (1.67-3.08) and 4.31 (2.85-6.51), respectively. Gender differences were observed in different studies on different populations with females being more prone to report the occurrence of post-COVID-19 vaccination adverse events than males e.g., Menni and 20 Moreover, a two-phased randomized clinical trial that was conducted in China on Sinopharm vaccine, exhibited more common adverse events in females (55%) compared to males (45%).…”

“…However, a recent study in Netherlands reported that Pfizer-BioNTech was the most utilized vaccine type followed by AstraZeneca. 15 Despite that 84% of the Egyptian participants who received two doses of vaccine, 32% and 26.7 % of them, respectively, were hesitant and unwilling to receive a COVID-19 booster vaccine. The proportions were much higher than reported by Paul and Fancourt (2021) who found that among fully vaccinated adults in the UK only 4% were uncertain about receiving and 4% were unwilling to receive a COVID-19 booster vaccine.…”

More Than Three-Fourths of AstraZeneca (ChAdox1 COV-19) COVID-19 Vaccinated Individuals Develop Post Immunization Adverse Event in Northwest Ethiopia

“…Nevertheless, higher number of patients who took ChAdOx1 developed series AEFI compared to patients who took Moderna and Pfizer vaccine. 35 Another study finding indicate that among all immunized individuals more than half (58.1%) of the AEFI, and nearly half (49.5%) of severe adverse events were reported following ChAdOx1 vaccination compared to Moderna and Pfizer vaccines. 36 …”

Anti-NMDA receptor encephalitis and vaccination: A disproportionality analysis

“…This hypothesis is strengthened by a descriptive study of the frequency of adverse events reported after COVID-19 vaccination, where the rate of ADRs reported was lower with mRNA vaccines than with live non-replicating vaccines (rate of adverse effects reported after the first injection: 92.2% with ChAdOx1 nCov-19; 82.0% with Ad26COV2.S vs . 81.7% with mRNA-1273 and 45.2% with Bnt162b2) ( Kant et al, 2022 ).…”