COVID-19 Vaccine Side-Effects Surveillance

The study included all vaccinated female and male individuals in Saudi Arabia of any ethnicity, who were 12–96 years of age and spontaneously self-reported their side-effects through the Sehhaty app after receiving at least one dose of the three available COVID-19 vaccines: Pfizer–BioNTech (BNT162b2), Oxford–AstraZeneca (ChAdOx1-S), and/or Moderna (mRNA-1273) within 14 days of receiving COVID-19 vaccination over the period from 17th December 2020 to 31st December 2021 (7 (link)). The ICU records were considered post vaccine events if they happened within 14 days post COVID-19 vaccination. The exclusion criteria entailed individuals with wrong or missing data entry and/or misidentified unique IDs, individuals who are under 12 years or above 96 years old, those who did not receive COVID-19 vaccination, or who received COVID-19 vaccines other than Pfizer–BioNTech, Oxford–AstraZeneca or Moderna vaccines, and those who reported their side-effects outside of the 14-day window. We excluded those with pre-existing comorbidities and/or autoimmune diseases, as they could confound the results of the self-reported vaccines adverse events. The primary objective was to determine the patterns of minor side-effects: injection site (itchiness, pain, reaction, redness, swelling, and other), anxiety, dizziness, fever above or below 39°C, headache, hoarseness, itchiness other than injection site, loss of consciousness, nausea, heartburn, sleep disruption, and fatigue. In addition, we examined the pattern of reported major COVID-19 vaccine side-effects: seizures, shortness of breath, wheezing, swelling of lips, face, and throat, ICU admission, and loss of consciousness. The AEs were classified as local, systemic, or allergic, or as mild or moderate.

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Alkhalifah J.M., Al Seraihi A., Al-Tawfiq J.A., Alshehri B.F., Alhaluli A.H., Alsulais N.M., Alessa M.M., Seddiq W., Aljeri T., Qahtani M.H., Barry M, & Al-Otaiby M. (2023). Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study. Frontiers in Public Health, 11, 1043696.

Publication 2023

Anxiety Autoimmune diseases Chadox1 s Covid 19 Covid 19 vaccine Covid 19 vaccines pfizer biontech Ethnicity Face Fatigue Female Fever Headache Heartburn Hoarseness Lips Male Mrna 1273 Nausea Other Pain Pfizer biontech covid 19 vaccines Redness Seizures Shortness of breath Sleep Throat Vaccination Vaccines

Corresponding Organization : Ministry of Health

Other organizations : Johns Hopkins Medicine, Johns Hopkins University, Saudi Aramco Medical Services Organization, Indiana University – Purdue University Indianapolis, Harvard University, Brigham and Women's Hospital, Harvard Stem Cell Institute, University of Ottawa

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Variable analysis

independent variables

COVID-19 vaccine type (Pfizer–BioNTech, Oxford–AstraZeneca, or Moderna)

dependent variables

Minor side-effects (injection site reactions, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue)
Major side-effects (seizures, shortness of breath, wheezing, swelling of lips/face/throat, ICU admission, loss of consciousness)
Classification of adverse events (local, systemic, or allergic; mild or moderate)

control variables

Individuals aged 12-96 years
Individuals who received at least one dose of the three available COVID-19 vaccines
Individuals who self-reported side-effects through the Sehhaty app within 14 days of vaccination
Exclusion of individuals with wrong/missing data, under 12 or above 96 years old, did not receive the specified vaccines, reported side-effects outside the 14-day window, and those with pre-existing comorbidities/autoimmune diseases

positive controls

Not explicitly mentioned

negative controls

Not explicitly mentioned

Annotations

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