Adverse Effects of Covid-19 Vaccine, an Observational Studymainly Focusing on the Cutaneous Reactions in Both Genders

Objective: COVID-19 caused a deleterious impact on the health care system globally.The roll out of vaccines seems to be the only effective way to curtail the spread of disease.The purpose of this study is to assess the dermatological adverse effect of post COVID-19vaccination on a gender basis. Methodology: This was an observational,cross-sectional,questionnaire-based survey conducted in Pakistan.The sample comprises 518 participants. The questionnaire was self-designed. The trial lasted six months, from August 1, 2022, until January 31, 2023. We used a non-probability sampling technique.Dermatological adverse effects like burning pain, redness, rashes, and lymphadenopathy at the injection site were recorded.Fever was also noted. All the participants have received booster shots or double doses of any one of CCOVID-19 vaccines, such as AstraZeneca, Pfizer, Sinovac, Sinopharm,Pakvac, etc. A p-value of less than 0.05 was considered statistically significant.Qualitative data was reported as frequency and percentage, and quantitativedata was reported as standard deviation and mean. Result(s): The study included 518 subjects, of whom 262 were males and 256 were females. The mean age of male is 42.70+/-14.05 years and female is 39.04+/-14.6years with a significant difference observed between them (p=0.004). The most common complaint among dermatological adverse effects after first was pain. 106(40.5%) male and 132(51.6%) female reported painwith a significant difference observed between them (p=0.011) followed by swelling which was reported by 92(35.1%) males and 120(46.9%) females with a significant difference observed between them (p=0.006).Burning was reported in 92(35.1%) male and 148(57.8%) female with a significant difference observed between them(p<0.001). Fever was also quite commonly reported in both male 116(44.3%) and female 178(69.5%) with significantdifference observed between them (p<0.001),Likewise post 2nd dose of vaccination, pain was most commonly noted in 90(34.4%) male and female 124(48.4%) female with significant difference observed between them (p=0.001). Moreover, burning was reported by 80(30.5%) malesand 132(51.6%) females with a significant difference observed between them (p<0.001). rashes were reported by76(29.0%) males and 100(39.1%) females with a significant difference observed between them (p=0.016), lymphadenopathy was also significantly associated with genders, (p<0.001). Conclusion(s): This study concluded that the burning pain,redness,rashes,and lymphadenopathywere the most prevalent side effects in male and female post 1st and 2ndCOVID-19 vaccination.Furthermore fever was also reported in majority of subjects.In addition to this higher percentage of side effects were recorded in females as comparedto males.Copyright © 2023 Lahore Medical And Dental College. All rights reserved.

Acute encephalomyelitis in a 52-year-old male post messenger ribonucleic acid severe acute respiratory syndrome coronavirus 2 vaccination: a case report.

BACKGROUND: Acute disseminated encephalomyelitis is a well-known, but rare, side effect of some vaccines, or symptom following a febrile illness. CASE: A 69-year-old, otherwise healthy Hispanic male presented with acute fever, confusion, and later progressive weakness after receiving the first dose of the mRNA-1273 (Moderna) severe acute respiratory syndrome coronavirus 2 vaccine. Considering the progressive deterioration of the patient, despite being on multiple immunosuppressive agents, a brain biopsy was obtained, which revealed nonspecific meningoencephalitis. CONCLUSION: In this case, we highlight the need for a regulatory framework to assist clinicians and patients with coverage of treatment for acute disseminated encephalomyelitis. The use of intravenous immunoglobulin in conjunction with glucocorticoids seems to be an effective treatment option.

Thrombocytopenia and pneumonitis associated with BNT16B2b2 mRNA COVID-19 vaccine: A case report.

An 80-year-old Japanese male patient with Behçet's disease presented with a seven-day history of fever, cough, and progressive shortness of breath after receiving a second dose of the BNT16B2b2 mRNA COVID-19 vaccine (Pfizer-BioNTech). The initial diagnosis was community-acquired pneumonia, and antibiotic treatment was started but proved ineffective. Twenty days after onset, his platelet count was significantly decreased. We suspected vaccine-induced pneumonitis and thrombocytopenia. After administration of prednisolone and intravenous immunoglobulin, and platelet transfusions, his platelet count normalized. The pneumonia symptoms improved three weeks after onset. Herein, we also summarize previous reports of cases of pneumonitis and thrombocytopenia associated with SARS-CoV-2 vaccination.

Vaccination against SARS-CoV-2 of adult allergic patients – experience from the Clinical Hospital Center Rijeka

SUMMARY. Introduction: In addition to preventive measures (wearing masks, hand hygiene, isolation), mass vaccination of the population remains the most effective means of combatting the COVID -19 pandemic. One of the serious hypersensitivity reactions to the vaccine is anaphylaxis. The aim of this study was to present the experience of the Clinical Hospital Center (CHC) Rijeka with screening and vaccination of patients at increased risk for anaphylaxis or similar severe allergic reaction to the SARS-CoV-2 vaccine. Participants and Methods: The study included data from all patients registered in the electronic consultation system of CHC Rijeka in 2021, in whom vaccination in hospital setting was indicated and who had received at least one dose of the vaccine against COVID -19 in the same year. The inquiry about the need for vaccination at the day hospital was made by a general practitioner, and the indication was made by a team of hospital allergologists. Only Pfizer's vaccine (Comirnaty®) was used for vaccination. Results: In 2021, a total of 451 patients were vaccinated based on the prior e-consultation. Of these, 138 received only the first dose of the vaccine, 308 received both doses, and five patients received three doses. The most common indication for in-hospital vaccination was a history of anaphylaxis or anaphylactoid reaction, in 330 (73.2%) patients. A total of 97 patients (21.5%) were referred for a history of non-anaphylactic allergic reaction, 17 (3.8%) for angioedema, and seven patients (1.6%) for other reasons. None of the patients vaccinated at the day hospital developed an anaphylactic reaction to the SARS-CoV-2 vaccine. A total of six patients reported mild reactions after vaccine administration. Conclusion: In the context of COVID -19 morbidity and mortality, the benefit of vaccination far outweighs the risk of anaphylaxis, which is readily treatable in the hospital setting. However, caution and prolonged monitoring is still warranted when vaccinating individuals with a history of anaphylaxis or allergy to any of the components of the administered vaccine. © 2022 Hrvatski Lijecnicki Zbor. All rights reserved.

Myths and misbelieves regarding COVID vaccines in India

Background: - COVID-19 is the most important public health problem of recent time. Many people require hospitalization after infection. COVID vaccination is the most effective way to prevent the disease. Due to extensive negative publicity through social media channels/platforms,significant number of individuals are not coming forward for vaccination. Therefore, study is needed to evaluate adverse effects associated with different vaccines available in India. Objectives: - To assess the adverse effects associated with COVID-19 vaccination and compare the side effect of two most commonly used COVID vaccines in India. Methods:- In the current report, a cross sectional study was conducted among beneficiaries of COVID-19 vaccines at the vaccination center of the LLRM Medical college, India. After institutional ethical clearance and informed consent, patients were asked about the symptoms they experienced after vaccination. A very simple random sampling approach was used to select beneficiaries. Information was collected on predesigned Google form and total 391 patients submitted the responses. Results:- Out of total respondents 77 % individuals reported one or more symptoms. Fever was reported to be most common problem (59.3%) followed by body ache (57.5%). Out of total beneficiaries, 68.3% experienced mild symptoms while 23% remain asymptomatic. Only few subjects reported moderate adverse effects (8.7%). None of the respondent reported severe and serious adverse effect. Conclusions:- Vaccine associated adverse effects were found less than 3 days and of mild variety in most of the beneficiaries. There was no difference in adverse effect profile of two commonly used vaccines in India. People must come forward for vaccination in mass without fearing of adverse effects of vaccines.

Small Fiber Neuropathy Associated With the Moderna SARS-CoV-2 Vaccine.

Efforts of controlling viral transmission began soon after the first cases of coronavirus disease 2019 (COVID-19) infections were identified. Initial efforts were related to contact precautions, hand hygiene, and mask-wearing; however, it was soon evident that a robust global immunization drive was the most effective way to curb disease transmission. In the United States, the first doses of COVID-19 vaccines were rolled out soon after the FDA granted emergency use authorization for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. What this also meant was that many of the routine phases that any new drug or vaccine goes through before being released publicly were bypassed. Over the past two years, various side effects and reactions have been seen after COVID-19 vaccine administration, the most common being local injection site events (e.g., pain, redness, swelling) and systemic effects (e.g., fatigue, headaches, myalgias). We report the case of a 64-year-old female who developed bilateral lower extremity numbness and tingling within weeks of receiving the third dose of Moderna SARS-CoV-2 vaccine. The patient underwent extensive testing to ascertain the diagnosis. She had negative autonomic testing and normal nerve conduction study/electromyography (EMG), which did not reveal large fiber neuropathy. Eventually, the patient underwent a skin biopsy, which revealed small fiber neuropathy. This case report highlights the importance of keeping a broad differential for rare side effects, such as small fiber neuropathy, that are currently being seen and reported in the literature.

Central Retinal Vein Occlusion Following the First Dose of COVID Vaccine.

The reports of vascular adverse events in the eye following COVID-19 vaccination are infrequent. We report the case of a healthy male who developed central retinal vein occlusion in his left eye three days following administration of the first dose of Covishield vaccine. As the underlying systemic and ocular risk factors were absent and laboratory investigations were normal, vein occlusion appeared to probably result from the vaccine. The patient developed retinal hemorrhages and non-perfusion ischemic areas all over the fundus. The macular edema was reduced with intravitreal triamcinolone acetonide, but the visual gain was not much, which appears to be due to the time lag in his initial presentation to the Ophthalmology Department. A close watch should be kept for ophthalmic adverse events to have an early intervention.

Acute Extensive Deep Vein Thrombosis After Heterogeneous Administration of Moderna mRNA Booster Vaccine: A Case Report.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) struck the world in 2019 and led to the development of the multisystem coronavirus disease-2019 (COVID-19) causing a worldwide pandemic. Vaccines with boosters were developed due to novel mutations of SARS-CoV-2. Heterogeneous vaccination emerged with the perception that mixing vaccines can provide better protection. We present the case of a 68-year-old male patient who developed extensive acute deep vein thrombosis (DVT) of the left lower extremity, two weeks following the Moderna mRNA booster vaccine (mRNA-1273). His first two doses were AstraZeneca ChAdOx1-S [recombinant]. He was started on a heparin drip and prescribed rivaroxaban. We discuss the possible etiology of this DVT, the mechanism of action of the Moderna mRNA vaccine, the association of DVT with vaccine-induced inflammation, implications of heterogeneous vaccine combinations, and recommendations to advise people on possible thrombogenic adverse effects prior to mRNA vaccine administration.

Eruptive Angiomatosis Triggered by COVID-19 Vaccination.

Despite meeting strict standards of quality, safety, and effectiveness, rare systemic and cutaneous side effects of coronavirus disease 2019 (COVID-19) vaccinations continue to be reported throughout the world. We report a case of eruptive cherry angiomatosis in a female following her first dose of COVID-19 vaccination with subsequent crops appearing after the second dose. The biopsy revealed dilated capillaries within the superficial dermis consistent with the clinical diagnosis.

Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment.

PURPOSE: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment. PATIENTS AND METHODS: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose. RESULTS: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009). CONCLUSION: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS. GOV IDENTIFIER: NCT04932863.

COVID-19 Vaccine-Related Thrombosis: A Systematic Review and Exploratory Analysis.

Introduction: The World Health Organization declared the coronavirus disease 2019 (COVID-19) pandemic on March 11, 2020. Two vaccine types were developed using two different technologies: viral vectors and mRNA. Thrombosis is one of the most severe and atypical adverse effects of vaccines. This study aimed to analyze published cases of thrombosis after COVID-19 vaccinations to identify patients' features, potential pathophysiological mechanisms, timing of appearance of the adverse events, and other critical issues. Materials and Methods: We performed a systematic electronic search of scientific articles regarding COVID-19 vaccine-related thrombosis and its complications on the PubMed (MEDLINE) database and through manual searches. We selected 10 out of 50 articles from February 1 to May 5, 2021 and performed a descriptive analysis of the adverse events caused by the mRNA-based Pfizer and Moderna vaccines and the adenovirus-based AstraZeneca vaccine. Results: In the articles on the Pfizer and Moderna vaccines, the sample consisted of three male patients with age heterogeneity. The time from vaccination to admission was ≤3 days in all cases; all patients presented signs of petechiae/purpura at admission, with a low platelet count. In the studies on the AstraZeneca vaccine, the sample consisted of 58 individuals with a high age heterogeneity and a high female prevalence. Symptoms appeared around the ninth day, and headache was the most common symptom. The platelet count was below the lower limit of the normal range. All patients except one were positive for PF4 antibodies. The cerebral venous sinus was the most affected site. Death was the most prevalent outcome in all studies, except for one study in which most of the patients remained alive. Discussion: Vaccine-induced thrombotic thrombocytopenia (VITT) is an unknown nosological phenomenon secondary to inoculation with the COVID-19 vaccine. Several hypotheses have been formulated regarding its physiopathological mechanism. Recent studies have assumed a mechanism that is assimilable to heparin-induced thrombocytopenia, with protagonist antibodies against the PF4-polyanion complex. Viral DNA has a negative charge and can bind to PF4, causing VITT. New experimental studies have assumed that thrombosis is related to a soluble adenoviral protein spike variant, originating from splicing events, which cause important endothelial inflammatory events, and binding to endothelial cells expressing ACE2. Conclusion: Further studies are needed to better identify VITT's pathophysiological mechanisms and genetic, demographic, or clinical predisposition of high-risk patients, to investigate the correlation of VITT with the different vaccine types, and to test the significance of the findings.

SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis.

RATIONALE & OBJECTIVE: Recent studies showed that antibody titers after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the dialysis population are diminished as compared with the general population, suggesting the possible value of a third booster dose. We characterized the humoral response after 3 doses of the BNT162b2 vaccine in patients treated with either maintenance hemodialysis (HD) or peritoneal dialysis (PD). STUDY DESIGN: Case series. SETTING & PARTICIPANTS: 69 French patients (38 HD and 31 PD) treated at a single center who received 3 doses of the BNT162b2 vaccine. FINDINGS: Humoral response was evaluated using plasma levels of anti-SARS-CoV-2 spike protein S1 immunoglobulin measured after the second dose and at least 3 weeks after the third dose of the BNT162b2 vaccine. Patients (median age 68 years [interquartile range (IQR), 53-76 years], 65% men) had a median anti-S1 antibody level of 284 [IQR, 83-1190] AU/mL after the second dose, and 7,554 [IQR, 2,268-11,736] AU/mL after the third dose. Three patients were nonresponders (anti-S1 antibody level < 0.8 AU/mL), and 12 were weak responders (anti-S1 antibody level 0.8-50 AU/mL) after the second vaccine dose. After the third dose, 1 of the 3 initial nonresponders produced anti-spike antibody, and all the 12 initial weak responders increased their antibody levels. Patients with a greater increase in anti-S1 antibody levels after a third dose had lower antibody levels after the second dose, and a longer time interval between the second and the third dose. Adverse events did not seem to be more common or severe after a third vaccine dose. LIMITATIONS: Observational study, small sample size. Relationship between antibody levels and clinical outcomes is not well understood. CONCLUSIONS: A third dose of the BNT162b2 vaccine substantially increased antibody levels in patients receiving maintenance dialysis and appeared to be as well tolerated as a second dose.

Comparison of immunogenicity and reactogenicity of inactivated SARS-CoV-2 vaccine (CoronaVac) in previously SARS-CoV-2 infected and uninfected health care workers.

The effects of inactivated SARS-CoV-2 vaccine (CoronaVac) on previously naturally infected individuals are unknown. This study compared immunogenicity and reactogenicity of CoronaVac in once naturally infected health-care workers (HCWs) and uninfected HCWs. All HCWs were immunized with two doses of CoronaVac (600 U/0.5 ml) intramuscularly at a 28-day interval. Adverse reactions were obtained by web-based questionnaires or telephone calls seven days after each vaccine dose. Detection of antibody levels against the receptor-binding domain (RBD) of SARS-CoV-2 spike protein was done four weeks after the second dose of the vaccine. We enrolled 103 previously naturally infected and 627 uninfected HCWs. The mean time for vaccination after the first nasopharyngeal SARS-CoV-2 positivity was 64 days (range: 15-136 days) in previously naturally infected HCWs. Among the previously naturally infected HCWs, 41 (40%) were asymptomatic, 52 (50%) had mild upper respiratory tract infections, 10 (105) had pneumonia, and only 6 (5%) were hospitalized. Any reported adverse reactions, either from the first dose or the second dose of vaccine administration, did not differ between previously infected and uninfected HCWs. Anti-RBD antibody titers were obtained in 50 (51%) of 103 previously infected HCWs and 142 (23%) of 627 uninfected HCWs. Anti-RBD antibody titers were significantly higher in HCWs with a previous natural infection (median 1220 AU/ml, range: 202-10328 AU/mL) than in uninfected HCWs (median: 913 AU/ml, range: 2.8-15547 AU/mL, p = .032). CoronaVac administration was safe and may elicit higher antibody responses in previously naturally infected individuals.