key: cord-0745781-7rgh2tsc authors: Bukhari, Abrar E.; Almutlq, Malak M.; Bin Dakhil, Alhanouf A.; Alhetheli, Ghadah I.; Alfouzan, Sulaiman K.; Alqahtani, Mohammed A.; Aljalfan, Abdullah A.; Almutawa, Mohammed A.; Alsubaie, Fahad S.; Madani, Abdulaziz N. title: Cutaneous adverse reactions to coronavirus vaccines: A Saudi nationwide study date: 2022-03-25 journal: Dermatol Ther DOI: 10.1111/dth.15452 sha: f7c416aee128d77fe8703c512f8ac0bfbc0ccba6 doc_id: 745781 cord_uid: 7rgh2tsc The coronavirus vaccine was developed to help overcome the COVID‐19 crisis. This study aimed to identify the cutaneous side effects secondary to Pfizer‐BioNTech and Oxford‐AstraZeneca COVID‐19 vaccines in the general population of Saudi Arabia and to list the risk factors for the development of cutaneous side effects. This cross‐sectional study was conducted in 2021, self‐administered surveys were distributed electronically through social media, and telephonic interviews were conducted with a sample size of 1000 participants. Data analysis was performed using Statistical Package for the Social Sciences. A total of 1021 patients (229 male and 722 female) aged 12 years or older were included. While 833 participants were medically free, 188 had chronic illnesses. While 802 participants were not taking any medications, 219 were taking medications regularly. Oxford‐Astra Zeneca and Pfizer BioNTech vaccines were administered to 319 and 702 participants, respectively. One‐hundred and twenty‐five participants previously had COVID‐19 infection and 407 were exposed to a PCR positive case of COVID. Six hundred and fifty‐nine patients (64.5%) reported experiencing injection site reactions: 606 (59.4%) had injection site pain, 168 (16.5%) had injection site swelling, and 107 (10.5%) had injection site redness. Only 51 patients (5%) experienced cutaneous side effects after injection. A significant association was found between chronic illnesses and cutaneous side effects post‐vaccine (9% vs. 4.1%; p value = 0.005). Patients on medications showed a higher rate of symptoms (8.2% vs. 4.1%; p value = 0.005). Age, gender, vaccine types, and history of COVID‐19 infection were not significantly associated with cutaneous side effects post‐vaccine. trials of the Pfizer-BioNTech COVID-19 vaccine began in April of 2020; by November of 2020, the vaccine entered Phase III clinical trials. 3 Studies for the Oxford-AstraZeneca COVID-19 vaccine were carried out in 2020, and on December 30, 2020, the vaccine was first approved for use in the UK vaccination program. 4 A total of four vaccines have been approved in Saudi Arabia so far, these include the Pfizer-BioNTech, Moderna, Oxford-AstraZeneca, and Janssen vaccines. 5 Side effects have been listed, but most of these reports has been distributed by manufacturer-funded studies that have been observed by third parties and are in agreement with the parameters set by the drug authorities. 6 Thus, there is a shortage of independent studies on the safety of the vaccines, which may influence the vaccine acceptance by people and affect the uptake of the vaccine. To get away from this vicious cycle of the COVID-19 virus and its variants, we have to accelerate the vaccination process. 7 Vaccinations are critical for the prevention of infectious diseases; however, vaccines have side effects, many of which are cutaneous. Cutaneous adverse events reported in clinical and post-authorization trials include local injection-site reactions and local or generalized reactions beyond the injection site. Local injection-site reactions, both immediate or delayed (4 days after vaccination), are the most frequent manifestation. 8 Less frequent cutaneous reactions have been described including urticaria, maculopapular or morbilliform rash, pityriasis rosea-like rash, chilblain-like lesions, facial dermal filler reactions, reactivation of varicella-zoster virus, lichen planus, erythema multiforme, and non-specific hypersensitivity eruptions. 9 The objectives of our study are to identify the cutaneous side effects secondary to the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines among the general population of Saudi Arabia and to list the risk factors for the development of cutaneous side effects. This cross-sectional study was conducted from June 1, 2021, to September 30, 2021, to estimate the prevalence of cutaneous side effects of the COVID-19 vaccine among the general population of Saudi Arabia. Male and female adults and adolescents aged 12 years or older who were vaccinated with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccine in Saudi Arabia were included. Participants who did not complete the questionnaire and those who did not approve the informed consent were excluded. The convenience sampling technique was conducted by a combined method using self-administered surveys that were distributed electronically through social media platforms (WhatsApp and Twitter) and telephonic interviews with a sample size of 1000 participants. The questionnaire was categorized into four main sections: (i) demographic data including gender, age, and region; (ii) medical comorbidities and current medications; (iii) COVID-19-related history, including vaccination type, date and the number of doses, exposure to infected cases and previous infection; and (iv) vaccine side effects. The study was reviewed and approved by the Ethical Committee of the Imam Mohammad Ibn Saud Islamic University on June 1, 2021 (Project number: 81-2021). All participants provided informed consent and were able to decline participation at any stage. The data was kept confidential with the primary investigator and was used only for the purposes described in the study objectives. Participants have been anonymized by numerical listing. Data analysis was performed using Statistical Package for the Social Sciences (SPSS) 23rd version (SPSS Inc, IL). Frequency and percentages were used to display categorical variables. The Chi-square test was used to assess the presence of an association between categorical variables where the p-value of 0.05 was considered significant. A total of 1021 participants were included in this study. Table 1 displays the socio-demographic profile of the participants. Ninety-five (9.3%) of the participants were 12-18 years old, 886 (86.8%) of the participants were 19-60 years old, and 40 (3.9%) of the participants were older than 60 years old. As for the gender, 229 (29.3%) of the As of January 28, 2022, COVID-19 has infected more than 364 million people and taken more than 5.6 million lives. 10 The authors would like to thank all participants who took few minutes of their valuable time to fill out this questionnaire whether online or in a telephonic interview which helped them to contribute to medical literature and knowledge about COVID-19. The authors declare that there are no conflicts of interest. The primary investigator states that all data used in this study including: raw data, clean data, and figures are stored safely after participants' deidentification and are available upon requests. Coronavirus disease (COVID-19). 2022. Cited Impact of COVID-19 on the dental community: part I before vaccine (BV) Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 vaccine COVID-19 Vaccine Reactions & Adverse Events Group on Vaccine Hesitancy. 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