Background: The process of mass immunization against COVID-19 may be impacted by vaccine reluctance despite intense and ongoing efforts to boost vaccine coverage. The COVID-19 vaccine is a crucial component for controlling the pandemic. To the best of our knowledge, we did not come across any study presenting the post-vaccination side-effect profile among the Sudanese population. Developing strategies to improve the vaccine acceptability and uptake necessitate evidence-based reports about vaccine’s side effects and acceptance. In this regard, this study aimed at estimating the prevalence of COVID-19 vaccine side-effects among the general population in Sudan. Methodology: A cross-sectional web-based quantitative study was conducted among the general population aged ≥18 years and residing in the Khartoum state of Sudan. A 30-item survey tool recorded the demographics, chronic diseases, allergy to other vaccines and COVID-19 vaccine side-effects after the first, second and booster doses. The data on the onset and duration of side-effects after each dose were also recorded. The distribution of side-effect scores after each dose of COVID-19 vaccine was compared using appropriate statistical methods. Results: A total of 626 participants were approached for this study. There was a preponderance of females (57.7%), and 19% of respondents had chronic diseases. The vaccination rate against COVID-19 was 55.8% (n = 349/626). The prevalence of side-effects after the first, second and booster doses were 79.7, 48 and 69.4%, respectively. Pain at the injection site, headache, fatigue, exhaustion and fever were the common side-effects after the first and second doses, while pain at the injection site, fatigue, headache and muscle pain were frequently reported after the booster dose. Most of these side-effects appeared within 6 h and resolved within one or two days following the administration of the vaccine dose. The average side-effects scores were 4.1 ± 4.4 (n = 349), 2.2 ± 3.6 (n = 202) and 3.5 ± 4.1 (n = 36) after the first, second and booster doses, respectively. The female gender had significantly higher side-effects after primary and booster doses. The age group 18-24 years indicated higher side-effects after the first dose compared to participants with ages ranging from 31 to 40 years (p = 0.014). Patients with chronic disease indicated significantly higher (p = 0.043) side-effects compared to those without any comorbid illness. Conclusions: This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. However, these side-effects waned within 48 h. Pain at the injection site was the most common local side-effect, while fatigue, fever, headache and muscle pain were frequently reported systemic side-effects. The frequency of side-effects was more profound among females, young adults and those with comorbid conditions. These findings indicate that COVID-19 vaccines are safe and have side-effects as reported in the clinical trials of the vaccines. These results aid in addressing the ongoing challenges of vaccine hesitancy in the Sudanese population that is nurtured by widespread concerns over the safety profile. Full article

Local, national, and international health agencies have advocated multi-pronged public health strategies to limit infections and prevent deaths. The availability of safe and effective vaccines is critical in the control of a pandemic. Several adverse events have been reported globally following reception of different vaccines, with limited or no data from Africa. This cross-sectional epidemiological study investigated adverse events following COVID-19 vaccination in Africans from April–June, 2021 using a structured online questionnaire. Out of 1200 participants recruited, a total of 80.8% (n = 969) respondents from 35 countries, including 22 African countries and 13 countries where Africans live in the diaspora, reported adverse events. Over half of the vaccinees were male (53.0%) and frontline healthcare workers (55.7%), respectively. A total of 15.6% (n = 151) reported previous exposure to SARS-CoV-2, while about one-fourth, 24.8% (n = 240), reported different underlying health conditions prior to vaccination. Fatal cases were 5.1% (n = 49), while other significant heterogenous events were reported in three categories: very common, common, and uncommon, with the latter including enlarged lymph nodes 2.4% (n = 23), menstrual disorder 0.5% (n = 5), and increased libido 0.2% (n = 2). The study provided useful data for concerned authorities and institutions to prepare plans that will address issues related to COVID-19 vaccines. Full article

Vaccination has been a key protective behavior for COVID-19. This study investigated the clinical status of university professors administered the Vaxzevria COVID-19 vaccine, to monitor for any adverse reaction, and to understand attitude and hesitancy to vaccination. Data were collected through an online survey. The study received approval from the relevant ethics committee “Comitato Etico Campania Sud”. Multivariate logistic regressions were used to calculate significant predictors of the outcomes of interest. A gender and AB0 blood type difference in adverse vaccine reactions was found. The multivariate logistic regression model showed that female gender, city residence, blood type A+ and B−, and chronic underlying medical conditions or comorbidities were more strongly implicated in the occurrence of adverse reactions, whereas blood type 0 Rh+ or blood type A Rh− were protective factors of adverse reactions to the Vaxzevria vaccine. Both genders did not show serious adverse reactions to the Vaxzevria vaccine. Based on our results, we are able to support the hypothesis that AB0 blood type and gender difference appear as predictors of Vaxzevria COVID-19 vaccine reactogenicity. Furthermore, in the study population, the degree of concern and hesitation to undergo vaccination was minimal. Full article

The reported incidence of immediate hypersensitivity reactions (IHR) including anaphylaxis after COVID-19 vaccination is 10-fold higher than for other vaccines. Several patient groups are theorized to be at particular risk. Since specific vaccination guidelines for these patients are based on expert opinion, we performed a retrospective monocentric analysis of the tolerability of adenoviral vector and mRNA-based COVID-19 vaccines in a cohort of patients allegedly at high risk of IHR. Reactions were assessed immediately on-site by allergists during a monitored vaccination protocol and after 3–7 days through telephone interviews. The cohort included 196 patients (aged 12–84 years) with primary mast cell disease (pMCD, 50.5%), idiopathic anaphylaxis (IA, 19.9%), hereditary angioedema (HAE, 5.1%) or miscellaneous indications (24.5%). Twenty-five immediate reactions were observed in 221 vaccine doses (11.3%). Most occurred in IA or miscellaneous patients. None fulfilled anaphylaxis criteria and most were mild and self-limiting. Reaction occurrence was significantly associated with female sex. In total, 13.5% of pMCD patients reported mast cell activation-like symptoms within 72 h post-vaccination. All pediatric pMCD patients (n = 9, 12–18 years) tolerated both mRNA-based vaccine doses. In summary, adenoviral vector and mRNA-based COVID-19 vaccines were safe and well-tolerated in patients with pMCD, HAE, and IA. No anaphylaxis was observed. The mild and subjective nature of most reactions suggests a nocebo effect associated with vaccination in a medicalized setting. Patients with pMCD could experience mild flare-ups of mast cell activation-like symptoms, supporting antihistamine premedication. Full article

Concern has arisen about hypersensitivity reactions in patients with allergic reactions to drugs containing polyethylene glycol (PEG) or polysorbate 80 (PS80), excipients of currently available anti-SARS-CoV-2 mRNA vaccines. However, the actual utility of PEG and PS80 skin allergy testing is currently still debated. We retrospectively analyzed all cases of patients on whom we performed allergometric skin tests for PEG and PS80 in the context of a pre-vaccination screening (for patients with multiple hypersensitivity reactions to drugs for which these excipients were among the suspected agents) or following suspected hypersensitivity reactions to anti-SARS-CoV-2 vaccines. A total of 134 tests were performed for PEG and PS80, eight of which produced uninterpretable results (due to dermographism or non-specific reactions). Of the remaining 126 cases (85 pre-vaccinal and 41 post-vaccine reactions), 16 (12.7%) were positive for PEG and/or PS80. Stratifying by clinical indication, there were no statistically significant differences in the proportion of positive tests between patients evaluated in the context of the pre-vaccination screening and those evaluated after a vaccine reaction (10.6% vs. 17.1%, respectively, p = 0.306). Allergometric skin tests for PEG and PS80 in our case series resulted positive in an unexpectedly high proportion of patients, suggesting that testing for allergy to these two excipients should not be ignored in case of reasonable clinical suspicion. Full article

Vaccines for SAR-CoV-2 are the most effective preventive treatment able to reduce the risk of contracting the infection and experiencing worse outcomes whenever the infection is contracted. Despite their rarity, hypersensitivity reactions to the anti-SARS-CoV-2 vaccine have been described and could become the reason not to complete the vaccination. Desensitization protocols for other vaccines have been described and validated, while the use of this approach for anti-SARS-CoV-2 vaccines is still anecdotal. We herein describe our experience with 30 patients with previous allergic reactions to anti-SARS-CoV-2 vaccines or to any of their excipients, proving that they are effective and safe; only two patients experienced hypersensitivity reaction symptoms during the desensitization procedure. Moreover, in this article, we propose desensitization protocols for the most common anti-SARS-CoV-2 vaccines. Full article

The anti-SARS-CoV-2 vaccination has probably been the most effective tool for preventing the infection and negative outcomes of the COVID-19 disease, and therefore for interrupting the pandemic state. The first licensed SARS-CoV-2 vaccine was BNT162b2, an mRNA vaccine that has been widely used since the earliest stages of the global vaccination campaign. Since the beginning of the vaccination campaign, some cases of suspected allergic reactions to BNT162b2 have been described. Epidemiological data, however, have provided reassuring results of an extremely low prevalence of these hypersensitivity reactions to anti-SARS-CoV-2 vaccines. In this article, we describe the results of a survey carried out through the use of a questionnaire, administered to all the health personnel of our university hospital after the first two doses of the BNT162b2 vaccine, which investigated the development of adverse reactions after a vaccination. We analyzed the responses of 3112 subjects subjected to the first dose of the vaccine; among these, 1.8% developed symptoms compatible with allergic reactions and 0.9% with clinical manifestations of possible anaphylaxis. Only 10.3% of the subjects who had allergic reactions after the first injection experienced similar reactions after the second dose and none of them experienced anaphylaxis. In conclusion, the anti-SARS-CoV-2 vaccination is rarely associated with severe allergic reactions and the second dose of vaccine is safe for this group of patients. Full article

Adult-onset Still’s disease (AOSD)-like syndrome has rarely been reported as a complication of COVID-19 vaccination. This study reports a 31-year-old female patient who presented with fever, myalgia, arthralgia, pleuropericarditis, leukocytosis, and transaminitis following ChAdOx1 vaccination, and met Yamaguchi’s criteria. A PubMed literature search, performed up until March 2022, identified 10 such cases. A total of 11 cases, including the one in this report, developed AOSD-like syndrome after administration of the viral vector (ChAdOx1) vaccine (six patients) and mRNA vaccine (five patients: BNT162b2 in four and mRNA-1273 in one). There were four male and seven female patients, with their median (Q1, Q3) age and the onset of symptoms after vaccination being 36 years (29, 45) and 10 days (6, 13), respectively. Fever (100%), arthralgia/arthritis (90.9%), skin rashes (81.8%), and sore throat (81.8%) were the main clinical findings. Pericarditis (45.5%), myocarditis/cardiac dysfunction (36.4%), pleuritis (54.6%), and pulmonary infiltrations (36.4%) were also common. One patient developed macrophage activation syndrome. One patient responded well to non-steroidal anti-inflammatory drugs, and the other six showed a good response to high-dose corticosteroids alone. Of the remaining four patients, who showed partial responses to high dose corticosteroids, showed good responses to biological agents. AOSD-like syndrome following COVID-19 vaccination shared many similar clinical features and treatment outcomes to those of idiopathic AOSD (but with a higher prevalence of cardiopulmonary involvement in the former). Physicians should be aware of this extremely rare complication to achieve early diagnosis and provide proper management. Full article

Anti-SARS-CoV-2 vaccines are safe and effective, also in individuals with allergic and immune-mediated diseases (IMDs). There are reports suggesting that vaccines may be able to trigger de-novo or exacerbate pre-existing IMDs in predisposed individuals. Eosinophilic granulomatosis with polyangiitis (EGPA) is a small-vessel vasculitis characterized by asthma, eosinophilia, and eosinophil-rich granulomatous inflammation in various tissues. We describe the case of a 63-year-old man who experienced cardiac, pulmonary, and neurological involvement one day after the administration of the booster dose of anti-SARS-CoV-2 vaccine (mRNA-1273). A diagnosis of EGPA was made and the patient was treated with high-dose steroids and cyclophosphamide, with a good clinical response. Interestingly, our patient had experienced a significant worsening of his pre-existing asthma six months earlier, just after the first two vaccine shots with the ChAdOx1 anti-SARS-CoV-2 vaccine. It is impossible to know whether our patient would have had developed EGPA following natural SARS-CoV-2 infection or at some point in his life regardless of infectious stimuli. Nevertheless, our report may suggest that caution should be paid during the administration of additional vaccine doses in individuals who experienced an increase in IMD severity that persisted over time following previous vaccine shots. Full article

Although serious adverse events have remained uncommon, cases of myocarditis induced by messenger RNA (mRNA) COVID-19 vaccines have been reported. Here, we presented a rare but potentially fatal disorder, hemophagocytic lymphohistiocytosis, in a 14-year-old previously healthy adolescent after BNT162b2 mRNA vaccination. The initial evaluation showed splenomegaly, pancytopenia, hyperferritinemia, and hypofibrinogenemia. Further examination revealed positive blood EBV DNA, and other infectious pathogen surveys were all negative. Hemophagocytosis was observed in the bone marrow aspiration and biopsy. HLH was confirmed and intravenous immunoglobulin (IVIG) and methylprednisolone pulse therapy were given. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) was set up for cardiopulmonary support for 3 days due to profound hypotension. The patient was kept on oral prednisolone treatment for 28 days with the following gradual tapering. The hemogram and inflammatory biomarkers gradually returned to normal, and the patient was discharged. The fulminant presentation of HLH in our case could be the net result of both acute immunostimulation after COVID-19 vaccination and EBV infection. Our case suggests that the immune activation after COVID-19 vaccination is likely to interfere with the adequate immune response to certain infectious pathogens, resulting in a hyperinflammatory syndrome. Full article

A 16-year-old Thai girl developed right facial palsy, a lower motor neuron lesion, and numbness 3 h after receiving the first dose of the BNT162b2 mRNA vaccine. Neurological examination showed the involvement of the right cranial nerves (CN) V, VII, IX, and X. Electrophysiological tests revealed the absence of an F wave response, suggesting a proximal demyelinating process. Magnetic resonance imaging of the brain demonstrated abnormal enhancement of the right CN VII. The cerebrospinal fluid profile on day 7 after the onset of symptoms was normal. The patient was diagnosed with polyneuritis cranialis, a rare variant of Guillain-Barre syndrome. She was successfully treated with intravenous immunoglobulin therapy. Full article

Kawasaki disease (KD) is a medium-vessel vasculitis that is typically presented during childhood; fewer than 100 cases of KD have been reported worldwide in adult patients who met the criteria according to the American College of Rheumatology. This study presents the case of an 18-year-old patient with no previous history of any disease, who presented atypical KD with liver and kidney dysfunction, with a good response to intravenous immunoglobulin therapy. The symptoms began 22 days after the application of the COVID-19 vaccine (nonreplicating viral vector Vaxzevria), and other conditions were ruled out. The term Adverse Events Following Immunization (AEFI)encompasses all the reactions that follow the application of any vaccine with no necessary causal relationship and can be due to the vaccine product, quality of the vaccine, immunization errors, or anxiety or just happen to be coincident events. These reactions should be reported so that clinicians can identify compatible cases and consider that the presentation of this disease, despite being atypical, can be manifested in adult patients. Likewise, case reports are an important basis for the pharmacovigilance of vaccines. Full article