Therefore, the WHO recommended post-marketing evaluation of the safety profile of all vaccines to uncover long-term and rare adverse events associated with the vaccine. However, severe or rare adverse events may not be identified in phase 3 trials due to limited sample size, inclusion criteria, and participants’ characteristics, which may differ from the population receiving the immunization. As vaccine distribution increases globally, the adverse effects should continue to be carefully monitored.ĬOVID-19 vaccine safety is a top priority to ensure that benefits exceed the risk. Furthermore, post-marketing studies showed a slight difference in the incidence and types of side effects reported by vaccinated individuals. In addition, severe adverse events have also been reported, such as appendicitis, hypersensitivity responses, acute myocardial infarction, and cerebrovascular accidents.
Pfizer-BioNTech Company has reported many COVID-19 vaccine reactions & adverse events, including some local reactions such as redness, swelling, and pain at the injection site and some systemic reactions such as fever, fatigue, headache, chills, vomiting, diarrhea, and new or worsening muscle/joint pain. On 23 August 2021, the US FDA approved the Pfizer vaccine making it the first approved COVID-19. On 11 December 2020, the Pfizer/BioNTech vaccine became the first to get FDA emergency use authorization. Worldwide mass efforts are in progress to develop COVID-19 vaccines and halt this pandemic by minimizing the spread and protecting human lives. 21, 2022, approximately 657,456 reported cases of COVID-19 and a total of 5659 deaths based on the department of health. Globally, as of May 21, 2022, over 524 million confirmed cases of COVID-19, including over 6.27 million deaths. This novel virus first appeared in December 2019 in China and later spread worldwide. Continuous monitoring and long-term studies are required to ensure vaccine safety.ĬOVID-19 infectious disease, the causative of the Coronavirus pandemic, is caused by different mutated types of Severe Acute Respiratory Syndrome Coronavirus 2(SARS-COV-2). COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. However, higher rates of allergic reactions were reported in this sample. In this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose.
Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Allergic reactions were reported by 12.7% of the participants furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. In total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years.
Data were analyzed using SPSS version 22. The Chi-square, Fisher’s exact, and McNemar’s tests were used to investigate significant relationships. MethodĪ questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, it is preferred by most recipients however, many people are concerned about the vaccine’s side effects. The Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA.
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