Analysis of COVID-19 Vaccine Adverse Drug Reactions Reported at Sultan Qaboos University Hospital

• Published in: Drug safety 2023-11, Vol.46 (11), p.1253-1254
• Main Authors: Al Riyami, I M, Al Busaidi, B H, Taher, H B, Al Zakwani, I S
• Format: Article
• Language: English
• Subjects: Cellular telephones; Chills; Clinical trials; COVID-19; COVID-19 vaccines; Data analysis; Disease transmission; Drug dosages; Hospitals; Patients; Side effects; Statistical analysis; Students; Surveys; Vaccines
• ISSN: 0114-5916; 1179-1942

Introduction: Both COVID-19 vaccines, Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOxl nCoV-19), have shown acceptable efficacy and safety profile in patients at the third phase of clinical trials. Given that both are relatively new, there were no reports of long-term adverse effect profiles (1-3) Aim: To report any suspected adverse drug reactions (ADRs) experienced by all vaccinated staff and students. Methods: This was an observational retrospective study, conducted during COVID-19 vaccination campaign that took place in a tertiary teaching hospital, Muscat, Oman. An online survey was generated, and was sent to all staff and students via email and through their mobile phones. An announcement message at the hospital website with a link to the survey was also made. Data analysis with descriptive statistics was done via STATA software. Results: In this study, 8,421 individuals reported being vaccinated with a total of 11,468 doses administered. A total of 8,014 patients' doses received the Pfizer-Biotech vaccine while 3,454 patients' doses received the Oxford-AstraZeneca brand. There were a total of 3,275 (38.8%) responses to the survey distributed and the majority of responses were completed by adults (47%) who were aged 12 to 30 years. A total of 741 individuals (22.6%) experienced an ADR after taking the vaccine and 67% (n = 498) of which were females. Majority of the ADRs reported were fever and chills (19.7%) followed by localized pain and swelling at the injection site (18.8%). Other ADRs were reported such as hair loss (0.5%) and one patient reported a clot in the right leg. Most responders (27%) considered their ADRs as mild while 25% of the responders considered them as severe. Conclusion: This observational retrospective study did demonstrate the most common side effects experienced by both COVID-19 vaccines used at SQUH in Oman; Oxford-AstraZeneca (ChAdOxl nCoV-19) and Pfizer-BioNTech (BNT162b2). It is crucial to observe for long term ADRs to the vaccines and a follow-up monitoring should be done to subjects to preclude any unwanted effects. Furthermore, spreading awareness to this type of vaccine is specifically recommended to enhance better uptake of the vaccine.