Serious adverse events reported from the COVID-19 vaccines: A descriptive study based on WHO database

Abstract

Background: In the light of the current pandemic, the emergency approval of few COVID-19 vaccines seems to provide a ray of hope. However, their approval is solely based on limited data available from the clinical trials in a short period of time; thereby imposing a necessity to study the adverse events (AEs) associated with their use. This study therefore aims to assess the Serious Adverse Events (SAEs) associated with various COVID 19 vaccines reported in the WHO database (VigiBase). Methods: The data from VigiBase was analyzed to assess the reported SAEs linked to various COVID 19 vaccines. The duplicates in the data were removed and were analyzed on the basis of age, gender, and seriousness of adverse events at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level. Results: A total 103954 adverse events reported from 32044 subjects were taken for analysis. Of 32044 subjects, majority were females (80%). Also, a total of 28799 (27.7%) SAEs were reported from the 8007 individuals. Most of the SAEs were reported from Europe (83%), amongst females (79.4%) and between 18 to 64 years (80.74%) of age. Majority of SAEs (74%) were reported for BNT162b2 (Pfizer) vaccine. On system wise classification, general disorders (30%) were the commonest followed by nervous system (19.1%) and musculoskeletal (11.2%) disorders. In individual category, headache (8.1%) was the commonest, followed by pyrexia (7%) and fatigue (5.1%). The number of SAEs were reported with various vaccines were comparatively lesser as compared to the non-serious ones and incidence of death was low with all the vaccines candidates. Elderly (> 65 years) people reported more serious SAEs as compared to other age groups. Conclusion: The reported SAEs from the COVID 19 vaccines were in line with the data published in clinical trials. To link these SAEs to vaccines will need causality analysis and review of individual reports.

Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study

“…The first and the second doses of all types of vaccines considered in this study were well tolerated in Au/cIn-RD patients and in non-Au/cIn-RD. The majority of AEs recorded were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%), in accordance with a previously published study on the general population [19,20]. We underline that thrombosis events were not observed in our study population.…”

Analyzing the U.S. Post-marketing safety surveillance of COVID-19 vaccines

“…The percentage of the overall of death cases (4.3%) in our study (1,919 of 44,451) was higher than that of a previous VAERS-based study (1.3%) [10]. The median age at death was 80 years (most with co-morbidities), and a similar finding was reported in other countries [23]. We could not find any differences in the number of death cases between the most commonly used COVID-19 vaccines in the U.S. (i.e.…”

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

“…[13][14][15][16] In the absence of definite post-vaccination robust data on adverse events related to the COVID-19 vaccines, most of the studies conducted on COVID-19 vaccines are based on the data generated from these vaccines' clinical trials and on the data available in the VigiBase. [17][18][19] Since all COVID-19 vaccines are new drugs; hence it is essential to monitor their adverse events post-approval. Thus, we analyzed all the cardiovascular adverse events reported with COVID-19 vaccination in the WHO global pharmacovigilance database VigiBase and assessed any relationship between the adverse events with the vaccine.…”