INTRODUCTION: Ethiopia is the second most populous country in Africa. Ethiopia received most of its COVID-19 vaccines through donations. The Oxford AstraZeneca vaccine is the first to be donated to Ethiopia by the COVAX facility. Healthcare workers were the priority population that received the Oxford AstraZeneca COVID-19 vaccine. However, there was no nationwide study on the safety of the vaccine in Ethiopia. This study aimed to measure the prevalence and predictors of self-reported side effects of the Oxford AstraZeneca vaccine. MATERIALS AND METHODS: The study employed a cross-sectional design. A sample of healthcare workers who took Oxford AstraZeneca COVID-19 vaccine was drawn from four regions of Ethiopia; namely, Amhara, Oromia, Somali, and Southwest. Data were collected on sociodemographic characteristics, medical anamnesis, COVID-19 related anamnesis, and COVID-19 vaccine anamnesis via telephone interview. Descriptive and inferential analyses were done. The software, IBM SPSS Statistics v21.0, was used for analyses of data. RESULTS: Out of 384 people, 346 responded (response rate: 90.1%). Female accounted for 34.1% of the respondents. The mean age of the respondents was 31.0 years (Standard Deviation (SD) = 7.4). Nurses accounted for 43.7% of the respondents. The prevalence of at least one local- and systemic-side effect was 50.6 and 44.5%, respectively. The most frequent local- and systemic- side effect were injection site pain and headache, respectively. Both types of side effects mostly subsided in the first 3 days. A third of healthcare workers with side effects took at least one medication. Paracetamol followed by diclofenac sodium were taken by healthcare workers to overcome side effects. There was no independent predictor of local side effect. After controlling for age and chronic diseases, the odds of healthcare workers with COVID-19 like symptoms to experience systemic side effects was 1.38 (Confidence Interval (CI): 1.04-1.82) times more than that of healthcare workers without COVID-19 like symptoms. CONCLUSIONS: The prevalence of local- and systemic-side effects of the Oxford AstraZeneca COVID-19 vaccine was modest. As the symptoms were mostly common in the first 3 days, it is preferable to monitor healthcare workers at least in the first 3 days following the administration of the vaccine.

• Klíčová slova
• Africa, COVID-19 vaccine, Ethiopia, Healthcare workers, Oxford AstraZeneca, side effects,
• MeSH
• ChAdOx1 nCoV-19 * škodlivé účinky   MeSH
• COVID-19 * prevence a kontrola   MeSH
• dospělí MeSH
• lidé MeSH
• průřezové studie MeSH
• průzkumy a dotazníky MeSH
• zdravotnický personál MeSH
• zpráva o sobě MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Etiopie epidemiologie   MeSH
• Názvy látek
• ChAdOx1 nCoV-19 * MeSH

Healthcare workers were prioritized in vaccination campaigns globally because they are exposed to the highest risk of contamination by SARS-CoV-2. This study evaluated the self-reported post-vaccination side effects of inactivated (BBIBP-CorV and CoronaVac) and adenoviral vector-based (AZD1222, Gam-COVID-Vac and Ad26.COV2.S) vaccines among Algerian healthcare workers using a validated questionnaire. The final analysis included 721 healthcare workers, with a predominance of females (59.1%) and younger individuals 20-30 years old (39.4%). Less than half (49.1%) of the respondents reported at least one local side effect, while 53.8% reported at least one systemic side effect. These side effects were more prevalent among viral vector vaccinees than inactivated virus vaccinees. The most common local side effects were injection site pain (39%) and arm pain (25.4%), while fatigue (34.4%), fever (28.4%), headache (24.8%) and myalgia (22.7%) were the most prevalent systemic side effects. The side effects appeared earlier among inactivated virus vaccines recipients and generally lasted for 2 to 3 days for the two vaccinated groups. The risk factors associated with a higher prevalence of side effects included female gender, allergic individuals, individuals with regular medication, those who contracted the COVID-19 disease and those who received two doses for both inactivated and viral-based vaccines groups. Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.

• Klíčová slova
• COVID-19, adenoviral-based vaccine, health workers, inactivated virus vaccine, side effects,
• MeSH
• bolest MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * epidemiologie   prevence a kontrola   MeSH
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• SARS-CoV-2 MeSH
• vakcína Janssen proti COVID-19 MeSH
• vakcíny proti chřipce * MeSH
• zdravotnický personál MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Alžírsko epidemiologie   MeSH
• Názvy látek
• ChAdOx1 nCoV-19 MeSH
• vakcína Janssen proti COVID-19 MeSH
• vakcíny proti chřipce * MeSH

Shortly after the worldwide initiation of vaccination against SARS-CoV-2, concerns emerged about a possible link between vaccination, severe thrombocytopenia, and the development of atypical venous thrombosis. Concerns were primarily about AstraZeneca (ChAdOx1 nCov-19), later Johnson & Johnson (Ad26.COV2.S), but cases of acute immune thrombocytopenic purpura (ITP) and bleeding without thrombosis and also atypical venous thrombosis after exposure to the messenger RNA-based vaccines produced by Pfizer-BioNTech and Moderna have been reported. Examination of the circumstances of these complications revealed that this is a similar mechanism to heparin-induced thrombocytopenia (HIT), a prothrombotic thrombocytopenic hypercoagulable disorder with venous and arterial thrombosis. HIT is caused by platelet-activating IgG antibodies directed against an antigen that is a macromolecular complex consisting of platelet factor 4 (PF4) and heparin. Naming this new entity vaccine-induced immune thrombotic thrombocytopenia (VITT) was suggested to avoid confusion with HIT. Patients had high levels of antibodies to the immune complex formed by PF 4 and the polyanionic component of the vaccine (double-stranded DNA). In patients with thrombosis at any vascular site after vaccination, accompanied by absolute or relative thrombocytopenia and systemic manifestations, HIT Ig ELISA assay to detect antibodies against PF4 and platelet-activating functional tests may be used for VITT recognition and differentiation from venous thromboembolic disease. Immune globulin impedes antibody-mediated platelet clearance and down-regulate platelet activation by immune complexes, as in HIT. It is prudent to choose from among the nonheparin antithrombotic agents - direct oral F.Xa inhibitors, direct thrombin inhibitors and indirect F.Xa inhibitors for the treatment of thrombosis.

• Klíčová slova
• PF4 platelet activation functional test, PF4-ELISA HIT assay, atypical venous thrombosis, cerebral venous thrombosis, heparin-induced thrombocytopenia (HIT), platelet factor 4, portal venous thrombosis, vaccine-induced immune thrombotic thrombocytopenia (VITT),
• MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * komplikace   MeSH
• idiopatická trombocytopenická purpura * etiologie   MeSH
• imunoglobulin G MeSH
• lidé MeSH
• SARS-CoV-2 MeSH
• trombocytopenie * chemicky indukované   diagnóza   MeSH
• trombocytový faktor 4 škodlivé účinky   MeSH
• trombóza * etiologie   MeSH
• vakcína Janssen proti COVID-19 MeSH
• vakcinace škodlivé účinky   MeSH
• vakcíny proti COVID-19 škodlivé účinky   MeSH
• vakcíny * škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• ChAdOx1 nCoV-19 MeSH
• imunoglobulin G MeSH
• trombocytový faktor 4 MeSH
• vakcína Janssen proti COVID-19 MeSH
• vakcíny proti COVID-19 MeSH
• vakcíny * MeSH

Vaccination is essential to manage the COVID-19 pandemic. Vaccination significantly protects against severe COVID-19, hospitalization and death; it also protects against symptomatic infection and reduces the risk of transmission to other people. Protection against the new SARS-CoV-2 variants may be lower, but protection against severe course and death remains high. Two mRNA vaccines (BNT162b2 and mRNA-1273) and two vector vaccines (AZD1222 and Ad26.COV2.S) are currently available in the Czech Republic. Vaccination of persons over 60 years of age and immunocompromised persons, who are demonstrably at the highest risk of a serious course of the disease, is of the utmost importance. In order to achieve adequate vaccination coverage, it is necessary to motivate other groups of people to be vaccinated, including children over 12 years of age and young adults. Vaccination is also recommended in pregnant women in the 2nd and 3rd trimesters and in breastfeeding women. For selected groups of vaccines, a third dose of vaccination is recommended (additional third dose 4 weeks after the second dose or a booster dose 8 to 12 months after the second dose). The side effects are usually mild, with serious complications (including anaphylaxis, thrombocytopenia with thrombosis syndrome, myocarditis, Guillain-Barré syndrome and capillary leak syndrome) being rare.

• MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * MeSH
• dítě MeSH
• infekční komplikace v těhotenství * MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• pandemie MeSH
• SARS-CoV-2 MeSH
• senioři MeSH
• těhotenství MeSH
• vakcína BNT162 MeSH
• vakcinace MeSH
• vakcíny proti COVID-19 MeSH
• Check Tag
• dítě MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• senioři MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• ChAdOx1 nCoV-19 MeSH
• vakcína BNT162 MeSH
• vakcíny proti COVID-19 MeSH

BACKGROUND: Venous thromboembolism (VTE)-including deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis (CVST)-may occur early after vaccination against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We sought to describe the site, clinical characteristics, and outcomes of VTE after vaccination against SARS-CoV-2. METHODS: In a prospective study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) platform, patients with VTE 4-30 days after vaccination against SARS-CoV-2 (1 February 2021 through 30 April 2021) were included. VTE patients recruited from the same centers into RIETE in the same months in 2018-2019 were selected as the reference group. All-cause mortality and major bleeding were the main study outcomes. RESULTS: As of 30 April 2020, 102 patients with post-vaccination VTEs had been identified (28 after adenovirus-based vaccination [ChAdOx1 nCov-19; AstraZeneca] and 74 after mRNA-based vaccination [mRNA-1273; Moderna, and BNT162b2; Pfizer]). Compared with 911 historical controls, patients with VTE after adenovirus-based vaccination more frequently had CVST (10.7% vs. 0.4%, p < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p < 0.001), and had higher 14-day mortality (14.3% vs. 0.7%; odds ratio [OR]: 25.1; 95% confidence interval [CI]: 6.7-94.9) and major bleeding rates (10.3% vs. 1.0%, OR: 12.03, 95% CI: 3.07-47.13). The site of thrombosis, accompanying thrombocytopenia, and 14-day mortality rates were not significantly different for patients with VTE after mRNA-based vaccination, compared with historical controls. CONCLUSIONS: Compared with historical controls, VTE after adenovirus-based vaccination against SARS-CoV-2 is accompanied by thrombocytopenia, occurs in unusual sites, and is associated with worse clinical outcomes.

• Klíčová slova
• COVID-19, SARS-CoV-2, vaccination, venous thromboembolism,
• MeSH
• časové faktory MeSH
• ChAdOx1 nCoV-19 aplikace a dávkování   škodlivé účinky   MeSH
• COVID-19 prevence a kontrola   MeSH
• hodnocení výsledků zdravotní péče MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• registrace * MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• trombocytopenie etiologie   MeSH
• vakcína BNT162 aplikace a dávkování   škodlivé účinky   MeSH
• vakcína firmy Moderna proti COVID-19 aplikace a dávkování   škodlivé účinky   MeSH
• vakcinace škodlivé účinky   mortalita   MeSH
• žilní tromboembolie etiologie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• ChAdOx1 nCoV-19 MeSH
• vakcína BNT162 MeSH
• vakcína firmy Moderna proti COVID-19 MeSH

BACKGROUND: Patients with inflammatory bowel disease (IBD) on immune-modifying treatment could be at an increased risk for severe coronavirus disease 2019 (COVID-19); thus, data on the efficacy and safety of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted a prospective study of IBD patients vaccinated with BNT162b2, CX-024414, and ChAdOx1 nCoV-19 vaccines. The aim was to evaluate the rate and magnitude of seroconversion, assess the effect of different immune-modifying treatment modalities on the magnitude of anti-SARS-CoV-2 IgG antibody levels, and analyze the impact of anti-SARS-CoV-2 vaccination on the inflammatory biomarkers of IBD. METHODS: The study included 602 IBD patients and 168 immunocompetent health care workers serving as controls. Serum anti-SARS-CoV-2 IgG antibodies were measured by chemiluminescent microparticle immunoassay before the vaccination and 8 weeks after the vaccination. RESULTS: Of IBD patients, 82.2% were receiving biological treatment: most of them were treated with antitumor necrosis factor (TNF)-α inhibitors (48.5%), and just under half of them were treated with concomitant thiopurines or methotrexate, followed by vedolizumab (18.6%) and ustekinumab (15.1%). Only 8.1% of patients were on 5-aminosalicylates, and a minority (2.2%) were treatment-free. The postvaccine seropositivity rate among IBD patients and controls was 97.8% vs 100%. Median anti-SARS-CoV-2 IgG levels were lower among IBD recipients of ChAdOx1 nCoV-19 compared with 2 other vaccines (P < .0001) and control ChAdOx1 nCoV-19 recipients (P = .01). No correlation was found between serum trough levels and anti-SARS-CoV-2 IgG concentrations for any of the biological drugs used. The TNF-α inhibitors with concomitant immunosuppressive treatment but no other treatment modalities were associated with a lower postvaccination antibody response (P < .0001). When evaluating the laboratory activity of IBD by C-reactive protein and fecal calprotectin levels, no significant differences were found before the vaccination and 8 weeks after its completion. CONCLUSIONS: Our findings warrant particular attention to the anti-SARS-CoV-2 vaccination of IBD patients treated with TNF-α inhibitors with concomitant immunomodulators and show the priority of mRNA vaccines in this specific group of patients.

• Klíčová slova
• BNT162b2, COVID-19, CX-024414, ChAdOx1 nCoV-19, Inflammatory bowel disease, SARS-CoV-2, immunity, vaccination,
• MeSH
• C-reaktivní protein metabolismus   MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * prevence a kontrola   MeSH
• idiopatické střevní záněty * farmakoterapie   MeSH
• imunoglobulin G MeSH
• leukocytární L1-antigenní komplex MeSH
• lidé MeSH
• methotrexát MeSH
• prospektivní studie MeSH
• protilátky virové MeSH
• SARS-CoV-2 MeSH
• TNF-alfa metabolismus   MeSH
• tvorba protilátek MeSH
• ustekinumab MeSH
• vakcína BNT162 MeSH
• vakcinace MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• C-reaktivní protein MeSH
• ChAdOx1 nCoV-19 MeSH
• imunoglobulin G MeSH
• leukocytární L1-antigenní komplex MeSH
• methotrexát MeSH
• protilátky virové MeSH
• TNF-alfa MeSH
• ustekinumab MeSH
• vakcína BNT162 MeSH

Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (<55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs' prevalence and their potential risk factors; a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19-64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1-3 days, and the below 35 years-old group was the least affected age group. The SEs' frequency was insignificantly higher in females and previously infected participants; the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.

• Klíčová slova
• AZD1222, COVID-19, ChAdOx1 nCoV-19, Czech Republic, Germany, Oxford–AstraZeneca vaccine, drug-related side effects and adverse reactions, health personnel, mass vaccination,
• Publikační typ
• časopisecké články MeSH