The Impact of the Emotional Disposition of Healthcare Workers on the Expression of Adverse Events after Primary Vaccination against SARS-CoV-2.

Background and Objectives: Vaccination is one means of SARS-CoV-2 prevention and control. However, despite the effectiveness of vaccination, adverse reactions continue to require vigilance and monitoring. The researchers emphasize the possibility that some of the reported side effects may be psychological in origin. Based on this hypothesis, the main goal of this study was to evaluate the emotional dispositions of healthcare workers who experienced emotions before vaccination and adverse reactions after vaccination. Materials and Methods: This study was conducted between February and May 2021 in the Kaunas Clinics of the University of Health Sciences. A total of 2117 employees of the clinic departments who were vaccinated with two doses of the Pfizer-BioNTech vaccine participated in this study. Statistical analysis was performed on the data using IBM SPSS Statistics®. Results: Most participants (74.5%) experienced systemic (including local) adverse events; 16.5% experienced only local adverse events, and 9.1% experienced no adverse events. The frequency of systemic (including local) adverse events reduced with increasing age (p < 0.05). The main emotions that participants experienced before vaccination were anxiety (37.88%) and happiness (39.02%). Systemic (including local) adverse events occurred 1.26 times more frequently in women than men (77.44% vs. 61.6%, p < 0.05), while local adverse events occurred 1.4 times more often in male participants than in female participants (21.39% vs. 15.27%, p < 0.05). Among the respondents who did not experience adverse events, the most common emotion felt was happiness (25.5%), and most of the participants who experienced systemic (including local) adverse events felt anxiety (42.6%). Conclusions: The information about vaccination and potential adverse events should be targeted at younger persons. It is recommended that women, more than men, should receive professional counseling from psychologists or psychotherapists. The public dissemination of positive messages about the benefits and safety of vaccines prior to a vaccination campaign may alleviate the tension or anxiety felt regarding potential adverse events. Healthcare specialists-both those who work directly with vaccines and those who do not-should maintain a positive psychological attitude towards vaccination, as this can increase patient satisfaction with the benefits of vaccines.

Increasing Levels of Serum Anti-Spike S1-RBD IgG after 120 Days of the Pfizer-BioNTech-mRNA Second Dose Vaccination.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines, such as Pfizer-BioNTech, have demonstrated high efficacy; however, there is limited data on the duration of immune responses besides their relationships with age, gender, body mass index (BMI), and the presence of previous coronavirus disease-2019 (COVID-19) infection. This study aimed to evaluate SARS-COVID-19 Anti-Spike IgG levels after 30 days (one month) and 120 days (four months) of the 2nd dose of Pfizer-BioNTech vaccine given to medical students at Al-Iraqi University, Baghdad, Iraq. This study was performed after the obtainment of the acceptance and approval of the Medical College of Al-Iraqi University and the Iraqi Ministry of Health. Two groups of students were randomly picked up from the Medical College of Al-Iraqi University. They were completely vaccinated by administering two doses of Pfizer-BioNTech/0.5 ml for each dose. After taking their permission, 5 ml of their blood (one group after one month and the second group after four months of vaccination) was drawn in the Higher Education lab inside the Medical College of Al-Iraqi University. It took approximately four months to collect the samples (from October 2021 until February 2022). Following that, serological analysis was done for measuring the SARS-CoV-2 spike protein IgG by using Elabscience/SARS-CoV-2 spike protein IgG ELISA Kit (USA) (+ve <0.06) that was performed in the Higher Education lab of Medical College of Al-Iraqi University. Demographic data were also collected from participants, including age, gender, BMI, blood group, and the presence of previous COVID-19 infection. For statistical analysis, SPSS (version 26) and STATISTICA (version 12) were used to input, check, and analyze data. Standard approaches of frequencies and percentages were used for qualitative variables, while for quantitative variables, mean±standard deviation was used. A P-value of <0.05 was considered a significant plasma level of the SARS-COVID-19 Anti-Spike IgG. The study results showed that in group 1 (after one month of the 2nd dose), the male-female ratio was 62.2: 37.8, the mean age of the vaccinated students was 28.2000 years old, and the BMI was 25.5454 kg/m2 with 33.3% previously COVID-19 infected individuals. In group 2 (after four months of the 2nd dose), the male-female ratio was 44.4: 55.6, the mean age of the vaccinated students was 25.8444 years old , and the BMI was 24.7584 kg/m2 with 24.4% previously COVID-19 infected individuals. The plasma levels of SARS-COVID-19 Anti-Spike IgG after the 2nd dose of the Pfizer-BioNTech vaccine in group 1 (one month) and group 2 (four months) were statistically non-parametric. Once the independent two samples Mann-Whitney test was used, a significant difference (P<0.05) was observed in SARS-COVID-19 Anti-Spike IgG plasma levels after 30 days of the 2nd dose of the Pfizer-BioNTech vaccine administration, compared to the 120 days of administration. In conclusion, SARS-COVID-19 Anti-Spike IgG levels significantly increased in group 2 (four months after the 2nd dose of the Pfizer-BioNTech vaccine), compared to group 1 (one month after the 2nd dose of the Pfizer-BioNTech vaccine).

Thrombotic Thrombocytopenic Purpura Following Pfizer-BioNTech COVID-19 Vaccination in a Patient With Multiple Myeloma: Case Report and Literature Review.

The vaccines developed to prevent infection and mitigate morbidity and mortality in patients with COVID-19 demonstrated high efficacy in clinical trials but were associated with adverse events, most of which were mild and transient. However, some adverse events were rather serious, with grave prognoses. Of note, a few cases of autoimmune hematological conditions such as thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenic purpura (ITP), and vaccine-induced immune thrombotic thrombocytopenia (VITT) were reported. TTP following Pfizer-BioNTech mRNA vaccination is exceptionally rare, with very scant literature. This case report describes an interesting case of a 61-year-old woman who presented 22 days after receiving the third dose of the Pfizer-BioNTech mRNA COVID-19 vaccine with malaise, bloody stools, and jaundice. Her medical history was significant for multiple myeloma previously treated with autologous bone marrow transplant and in remission with chemotherapy. She also had a history of chronic heart failure with preserved ejection fraction (HFpEF) and neuropathy treated with daily vitamins. The diagnosis was predicted by her classic presentation and was clinched by low ADAMTS13 activity. She was treated with plasmapheresis, steroids, and monoclonal antibodies. Intriguingly, her hospital stay was further complicated by an episode of generalized tonic-clonic seizure requiring intubation and mechanical ventilation for airway protection. Albeit infrequent, COVID-19 vaccine-associated TTP is associated with substantial morbidity and mortality. Hence, early diagnosis and treatment are essential in patients presenting with thrombocytopenia after COVID-19 vaccination.

Subacute thyroiditis following COVID-19 vaccination: Case presentation.

Background: Subacute thyroiditis (SAT) is an organ-specific disease that various drugs, including COVID-19 vaccines, can trigger. COVID-19 infection has been associated with thyroid gland damage and disease SARS-CoV-2 direct action, euthyroid sick syndrome, and immune-mediated mechanisms are all potential mechanisms of thyroid damage. It denotes thyroid gland inflammation, most commonly of viral origin, and belongs to the transitory, self-limiting thyroid gland diseases group, causing complications in approximately 15% of patients in the form of permanent hypothyroidism. Some authors say SAT is the most common thyroid disease associated with COVID-19.Purpose: The occurrence of SAT many weeks after administering the second COVID-19 vaccine is rare and has limited documentation in academic literature. This study aims to present the occurrence of SAT after administering the COVID-19 vaccine. We present the case of a 37-year-old man who developed SAT 23 days after receiving the second dose of Pfizer BioNTech's COVID-19 mRNA vaccine.Research design and study sample: Due to neck pain and an elevated body temperature (up to 38.2°C), a 37-year-old male subject presented for examination 23 days after receiving the second Pfizer BioNTech mRNA vaccine against SARS-CoV-2 viral infection. The patient denied ever having an autoimmune disease or any other disease. Painful neck palpation and a firm, slightly enlarged thyroid gland with no surrounding lymphadenopathy were identified during the exam. The heart rate was 104 beats per minute. All of the remaining physical findings were normal.Data collection and/or Analysis: Data collected during the disease are integral to the medical record.Results: Hematology and biochemistry analyses at the initial and follow-up visits revealed minor leukocytosis, normocytic anaemia, and thrombocytosis, followed by a mild increase in lactate dehydrogenase and decreased iron levels. The patient's thyroid function and morphology had recovered entirely from post-vaccine SAT.Conclusions: Results from this study emphasise the need for healthcare professionals to promptly report any case of SAT related to COVID-19 vaccination. Further investigation is warranted to understand the immunopathogenesis of COVID-19-associated thyroiditis and the impact of COVID-19 immunization on this condition.

The Incidence and Severity of COVID-19 Infection Post Vaccination in Saudi Arabia.

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). Presently, there is ongoing continuous research for more therapeutic options with a wide variety of vaccine availability. However, many people have worried about the vaccine's side effects. Hence, the current study was conducted to determine the prevalence of vaccinated individuals, side effects, and the rate of infectivity post vaccination including the three doses of vaccinations. Methods A cross-sectional questionnaire-based survey was conducted using Google Forms (Google, Inc., Mountain View, CA). Five hundred forty-three individuals participated and reported their status of COVID-19 infection, vaccination, and side effects. All the participants from Saudi Arabia received all the vaccine shots including the booster dose. Results Most of the Saudi nationals were fully vaccinated, and most received Pfizer vaccines for their first and second shots. Pain at the injection site was reported as the most common adverse effect followed by fever, headache, fatigue, and joint pain. Conclusion From the findings, it is concluded that most of the population of Saudi Arabia was vaccinated effectively. Pain at the injection site is identified as the primary adverse effect of vaccination. Most of the population is vaccinated with the Pfizer vaccine. Long-term side effect monitoring is recommended with large population studies to confirm the status of vaccines and adverse effects.

A Case of Acquired Aplastic Anemia after Severe Hepatitis- Probably Induced by the Pfizer/BioNTech Vaccine: A Case Report and Review of Literature.

INTRODUCTION: An important but rare adverse effect of vaccines is their association with autoimmune events, including hepatitis and aplastic anemia (AA). In this paper, we report a case of hepatitis followed by AA that occurred after the COVID-19 vaccine was administered. CASE REPORT: This paper focuses on a 30-year-old female who presented with acute hepatitis three weeks after receiving the second dose of the coronavirus Pfizer/BioNTech vaccine. After an extensive diagnostic evaluation was conducted that did not discover a specific cause, the Pfizer/BioNTech vaccine was suspected and the patient was treated with corticosteroids. One week after the onset of a liver disorder, the patient presented with gum bleeding and pancytopenia, and the diagnosis of AA was established via laboratory testing and bone marrow biopsy. After the diagnosis, the patient received immunosuppressive therapy using anti-lymphocyte serum (ATGAM) and CYCLOSPORINE A with progressive improvements in cytopenia. The important issue is whether AA is related to acute hepatitis or the coronavirus vaccine. CONCLUSION: Clinicians should be aware of the risk of both the possibility of acute hepatitis, AA, or both after receiving the COVID-19 vaccination. It is very hard to distinguish the cause of AA between vaccine- and hepatitis-related AA. Predicting who develops hepatic or myelo-complications after vaccination is difficult.

Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.

BACKGROUND: Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations. METHODS: We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri). RESULTS: The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP. CONCLUSION: We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.

Selection Effects and COVID-19 Mortality Risk after Pfizer vs. Moderna Vaccination: Evidence from Linked Mortality and Vaccination Records.

Prior research generally finds that the Pfizer-BioNTech (BNT162b2) and Moderna (mRNA1273) COVID-19 vaccines provide similar protection against mortality, sometimes with a Moderna advantage due to slower waning. However, most comparisons do not address selection effects for those who are vaccinated and with which vaccine. We report evidence on large selection effects, and use a novel method to control for these effects. Instead of directly studying COVID-19 mortality, we study the COVID-19 excess mortality percentage (CEMP), defined as the COVID-19 deaths divided by non-COVID-19 natural deaths for the same population, converted to a percentage. The CEMP measure uses non-COVID-19 natural deaths to proxy for population health and control for selection effects. We report the relative mortality risk (RMR) for each vaccine relative to the unvaccinated population and to the other vaccine, using linked mortality and vaccination records for all adults in Milwaukee County, Wisconsin, from 1 April 2021 through 30 June 2022. For two-dose vaccinees aged 60+, RMRs for Pfizer vaccinees were consistently over twice those for Moderna, and averaged 248% of Moderna (95% CI = 175%,353%). In the Omicron period, Pfizer RMR was 57% versus 23% for Moderna. Both vaccines demonstrated waning of two-dose effectiveness over time, especially for ages 60+. For booster recipients, the Pfizer-Moderna gap is much smaller and statistically insignificant. A possible explanation for the Moderna advantage for older persons is the higher Moderna dose of 100 µg, versus 30 µg for Pfizer. Younger persons (aged 18-59) were well-protected against death by two doses of either vaccine, and highly protected by three doses (no deaths among over 100,000 vaccinees). These results support the importance of a booster dose for ages 60+, especially for Pfizer recipients. They suggest, but do not prove, that a larger vaccine dose may be appropriate for older persons than for younger persons.

Side Effects Associated With Homologous and Heterologous COVID-19 Vaccines: A Cross-Sectional Study in Saudi Arabia.

BACKGROUND: Numerous studies on coronavirus disease 2019 (COVID-19) vaccination safety have been conducted in Saudi Arabia. Even though there is less evidence comparing the side effects of different vaccines and a few of them studied the side effects of mixing different platforms of vaccines. OBJECTIVES: This study aimed to evaluate the type and severity of adverse effects following COVID-19 vaccination based on the type and platform of received vaccine and to determine factors that contribute to the occurrence of these side effects. METHODS: This cross-sectional comparative study was conducted in Saudi Arabia from January to the end of February 2022 among COVID-19 vaccine recipients through an online survey. Based on the type of vaccines received, we categorized our participants into two groups - those who received two doses of either the Pfizer or the AstraZeneca COVID-19 vaccines, and those who received mixed vaccination regimen (one dose of Pfizer and one dose of AstraZeneca). RESULTS: The study included 1,340 participants, of which 56.3% received two doses of the Pfizer vaccine while (7%) received two doses of the AstraZeneca vaccine, and 8.8% received mixed vaccines (one dose of the Pfizer vaccine and one dose of the AstraZeneca vaccine). Pain at the injection site was the most frequent local symptom (37.9%) followed by swelling±redness (27.6%). The local adverse reactions were nearly equal in AstraZeneca and Pfizer vaccines, whereas these were significantly lower in those who received mixed doses (p<0.001). Fever was significantly higher in mixed vaccination regimens compared to other types (p<0.001). The male gender who received the Pfizer vaccine were at higher risk of developing an adverse reaction following vaccination. Unusual side effects (sleep disorders, menstrual irregularities, and symptoms suggestive of diabetic neuropathy) were also reported. CONCLUSION: The results suggest the overall safety of Pfizer and AstraZeneca vaccines as well as the mixed vaccination protocol. A heterologous regimen was associated with fewer side effects compared to homologous vaccines. Further studies are needed to assess the long-term side effects.

One-year dynamics of antibody titers after three doses of SARS-CoV-2 BNT162b2 vaccine.

BACKGROUND: A third dose of the BNT162b2 SARS-CoV-2 vaccine leads to a significant increase in antibody levels, however, concerns regarding the long-term persistence of this response exist. We assessed the humoral response for one year following vaccination. METHODS: A prospective study among immunocompetent healthcare workers (HCW) who received three doses of BNT162b2. anti-spike antibody titers were measured at six predefined timepoints, from before the second vaccine dose, and up to one year afterwards, which is 4-6 months after the third dose. HCW with a history of SARS-CoV-2 infection were excluded. RESULTS: Seventy-six HCW had all the six serological measurements. Antibody titers significantly increased shortly following the third vaccine dose, and while declining, remained higher from all previous measurements for up to six months. CONCLUSIONS: A third dose of BNT162b2 leads to a profound humoral response, which remains significantly higher than previous measurements, even after 6 months.

Study of the Side Effects of Pfizer and Oxford COVID-19 Vaccines in the Eastern Province of Saudi Arabia.

Background & Objective: The COVID-19 pandemic imposed global concern and became one of the deadliest pandemics of the twenty-first century. Several vaccines were developed against SARS-CoV-2 to counteract the effects of this virus. This study aims to determine the post-vaccination side effects of the most common COVID-19 vaccines used in the Eastern province of Saudi Arabia. Methods: This is a cross-sectional study using an online questionnaire distributed randomly through social media. Frequencies were calculated to determine participants' demographic information, vaccination details, and post-vaccination side effects. Univariate and multiple regression analysis were applied to test the association between individuals' willingness to receive a booster dose and different categorical variables. Results: A total of 1004 participants were included in the survey, of which 0.6%, 85.3% and 14.1% completed either one, two or three doses of the Pfizer mRNA vaccine and Oxford AstraZeneca vaccines, respectively. The similar common side effects between the first and the second doses were significantly associated with the type of vaccine received; these included fatigue (Pfizer 54.4%, Oxford 73.2%; p < 0.001), headache (Pfizer 33.2%, Oxford 44.7%; p = 0.002), and fever (Pfizer 25.1%, Oxford 57.6%; p < 0.001). Additionally, unusual side effects were also reported (palpitations and menstrual abnormalities). Getting SARS-CoV2 infection after vaccination was significantly associated with the type of vaccine received at the first dose (Chi-Square=5.496, p = 0.019). A statistically significant association was found between the individuals' willingness to receive a booster dose and their gender (Chi-Square = 39.493, p < 0.001), age (Chi-Square = 11.668, p = 0.02), presence of allergies (Chi-Square = 5.602, p = 0.018), and previous COVID-19 infection (Chi-Square = 9.495, p = 0.002). Conclusion: Despite the described side effects, further studies should be done to investigate the unusual and rare side effects to assess COVID-19 vaccines effectiveness and safety over longer period of time within a more diverse population.

Evaluation of Short-Term Symptoms Associated With COVID-19 Vaccines Used Among Adolescents in Saudi Arabia.

OBJECTIVES: Several government-sponsored reporting systems have stated mild to moderate side effects of COVID-19 vaccines. However, patient-reported data on COVID-19 vaccine-associated adverse effects in adolescents are lacking. Our objective was to assess the short-term side effects of Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 vaccinations among teenagers in Saudi Arabia. METHODS: A retrospective, cross-sectional study was conducted among individuals aged 12-18 years old who received one of the two mentioned vaccines between July 2021 and March 2022 in Riyadh, Saudi Arabia. RESULTS: The most common short-term side effects reported for COVID-19 vaccines among teenagers in our study were fatigue, pain at the site of injection, fever, chills, headache, nausea, and vomiting. Female participants, individuals who had a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and those who received two doses of the vaccine are at higher risk to develop side effects after getting the vaccine. Importantly, asthmatic participants have a higher incidence of COVID-19 vaccine side effects when compared to those with no history of chronic diseases. CONCLUSION: Our findings might enhance public trust in the COVID-19 vaccine, which could speed up the immunization procedure.

Anticuerpos postvacunales frente a SARS-CoV-2 en una cohorte de trabajadores de un hospital general / Post-vaccination antibodies against SARS-CoV-2 in a cohort of workers of a general hospital

Introducción: El objetivo fue estimar la evolución de los niveles de anticuerpos anti-SARS-CoV-2 y los factores asociados, así como la incidencia de nuevas infecciones en el periodo de seguimiento.Método: Estudio de cohorte prospectivo de una muestra representativa de trabajadores del Hospital General Universitario de Castellón a los 8 meses de recibir la 2ª dosis de la vacuna Pfizer-BioNTech contra el SARS-CoV-2, mediante la determinación de anticuerpos IgG-S y IgG-NP, y la cumplimentación de un cuestionario. Se compararon los resultados con los del inicio de la cohorte en febrero de 2021. Se usó regresión lineal múltiple y regresión de Poisson. Resultados: Participaron 253 trabajadores de los 275 reclutados al inicio de la cohorte (92%). Todos mantenían niveles detectables de IgG-S, mediana de 691,5 UA/ml, disminu-yendo un 93,3% con respecto al inicio. Los descensos de IgG-S fueron mayores con la edad y la obesidad, y menores en aquellos con historia de COVID-19, IgG-S elevada inicial, prac-ticar ejercicio habitual y ser fumador. Tener IgG-NP se asoció positivamente con historia de COVID-19, tomar vitamina D, y disminuyó del 4,4% al 1,2%. Se produjeron 4 casos de COVID-19 en la cohorte, con una tasa de incidencia del 1,7%, con un fallecimiento en un participante con tratamiento inmunosupresor, solo un caso fue asintomático y no hubo reinfecciones. Conclusiones: Se produce un descenso general de los anticuerpos IgG-S e IgG-NP después de la segunda dosis de vacuna Pfizer-BioNTech, así como nuevas infecciones por SARS-CoV-2. Se recomienda dosis de recuerdo, mantener medidas protectoras y determinar el umbral de anticuerpos protectores de la vacunación (AU)

Introduction: The aim was to estimate the evolution of the levels of anti-SARS-CoV-2 an-tibodies, the associated factors, and the incidence of new infections during the follow-up period. Method: Prospective cohort study of a representative sample of workers at the General Uni-versity Hospital of Castellon 8 months after receiving the second dose of Pfizer-BioNTech vaccine against SARS-CoV-2, by determining IgG-S, IgG-NP, follow-up and response to a questionnaire. The results were compared with those at the start of the cohort in February 2021. Multivariate linear regression and Poisson regression were used. Results: A total of 253 workers participated out of the 275 in the start of the cohort. All had detectable levels of IgG-S, median 691% AU/ml, decreasing by 93.3% compared with the first study. The decline of IgG-S increased with age and obesity; and decreased with a COVID-19 previous history, regular exercise, and in smokers. IgG-NP was positively associ-ated with a history of COVID-19, taking vitamin D, and decreased from 4.4% to 1.2%. There were 4 new cases of COVID-19 in the cohort, with and incidence rate of 1.7%. One death occurred in a participant with immunosuppressive treatment, only one case was asymp-tomatic and no reinfections occurred Conclusions: A general decrease of IgG-S and IgG-NP antibodies after the second dose of Pfizer-BioNTech vaccine was observed in the cohort, as well as with new SARS-CoV-2 in-fections. Booster doses, maintaining protective measures and further determination of the protection threshold of vaccination are recommended (AU)

Multiple sites of thrombosis without thrombocytopenia after a second dose of Pfizer-BioNTech COVID-19 vaccine.

In the current international scientific panorama, rare cases of venous thrombotic complications following mRNA vaccine administration have been reported, consisting mainly of cerebral sinus thromboses and acute venous thromboembolism. The present paper describes the case of a 75-year-old woman in good health who developed cerebral venous thrombosis, deep venous thrombosis, and bilateral pulmonary emboli after receiving a second dose of Pfizer-BioNTech COVID-19 vaccine. A series of laboratory tests performed during hospitalization yielded interesting results, allowing us to exclude thrombophilic risk factors and to certify the absence of thrombocytopenia in the patient. Although COVID-19 vaccination is the most important tool in stopping the pandemic, pharmacovigilance is crucial for detecting potential multisystem thrombotic events, even for mRNA vaccines.

The Role of Existential Concerns in the Individual's Decisions regarding COVID-19 Vaccine Uptake: A Survey among Non-Vaccinated Italian Adults during the Third Wave of the Pandemic.

Recent studies have suggested that health constructs embraced by the Terror Management Theory (TMT) and the Basic Psychological Needs Theory (BPNT) may drive individuals' COVID-19 health-related decisions. This study examines the relationships between existential concerns (ECs; within the TMT), basic psychological needs (BPNs; within the BPNT) and COVID-19 vaccine hesitancy (VH), as well as the mediating role of negative attitudes toward COVID-19 vaccines. A cross-sectional survey was carried out from April to May 2021 on a sample of two hundred and eighty-seven adults (Mage = 36.04 ± 12.07; 59.9% females). Participants provided information regarding existential concerns, basic psychological needs, attitudes toward COVID-19 vaccines and vaccine hesitancy for Pfizer-BioNTech and AstraZeneca vaccines separately. Higher vaccine hesitancy (32.1%) and vaccine resistance (32.8%) rates were found for AstraZeneca than for Pfizer-BioNTech COVID-19 vaccine (22.3% and 10.1%, respectively). Structural equation modeling showed that existential concerns were related to Pfizer-BioNTech and AstraZeneca vaccine hesitancy both directly and indirectly through negative attitudes toward potential side effects of COVID-19 vaccines. The findings of the study confirm that the TMT is efficient in explaining COVID-19 vaccine hesitancy. Targeted efforts are needed to increase the acceptance of COVID-19 vaccines.

Vaccine Side Effects Following COVID-19 Vaccination Among the Residents of the UAE-An Observational Study.

COVID-19 vaccines have proven to be very safe in the clinical trials, however, there is less evidence comparing the safety of these vaccines in real-world settings. Therefore, we aim to investigate the nature and severity of the adverse effects reported and the differences based on the type of vaccine received. A survey was conducted among 1,878 adult (≥18 years) COVID-19 vaccine recipients through online survey platforms and telephonic interviews during March to September 2021. The factors potentially associated with the reported side effects like age, gender, ethnicity, comorbidities, and previous COVID-19 infection were analyzed based on the type of vaccine received. Differences in adverse events and the severity were compared between inactivated and mRNA vaccine recipients. The major adverse effects reported by the COVID-19 vaccine recipients were pain at the site of injection, fatigue and drowsiness, and headache followed by joint/muscle pain. The adverse effects were more common among recipients of mRNA Pfizer-BioNTech vaccine than among recipients of inactive Sinopharm vaccine with the odds ratio of 1.39 (95% CI 1.14-1.68). The average number of adverse effects reported between individuals who had received Sinopharm and Pfizer-BioNTech vaccines was 1.61 ± 2.08 and 2.20 ± 2.58, respectively, and the difference was statistically significant (p <0.001). Severe adverse effects after COVID-19 vaccinations were rare and 95% of the adverse effects reported after either an inactivated or mRNA vaccine were mild requiring no or home-based treatment. The study found that individuals less than 55 years of age, female gender, with history of one or more comorbid conditions, who had received mRNA Pfizer- BioNTech vaccine, and with history of COVID-19 infections are at higher odds of developing an adverse effect post COVID-19 vaccination compared to the others.

Adverse Events and Immunogenicity of mRNA-Based COVID-19 Vaccine among Healthcare Workers: A Single-Centre Experience.

Background and Objectives: The safety and effectiveness of vaccines are among the key priorities in COVID-19 pandemic management. Moreover, evidence-based data regarding vaccine safety and immunogenicity can play an important role in building the trust of the community regarding vaccination. The aim of this study was to investigate the safety and immunogenicity of Pfizer-BioNTech vaccine among healthcare workers in one hospital, 21 days after first dose. Materials and Methods: This study was conducted in the Hospital of the Lithuanian University of Health Sciences between February and March 2021. Hospital employees who arrived to receive the second dose of the Pfizer-BioNTech vaccine 21 days after the first one were invited to participate in the study: they were asked to complete an anonymous adverse events questionnaire and were offered a SARS-CoV-2 IgG/IgM rapid test. The study was performed at a single point, 21 days after the first dose of the vaccine. Results: Data of 4181 vaccine recipients were analysed. The first vaccine dose was associated with a 53.6% incidence of adverse events, mainly local reactions. Adverse events occurred more frequently in younger participants and women. Moderate adverse events were experienced by 1.4% of the vaccine recipients; 6.2% were incapacitated. Of the 3439 participants who performed a rapid IgG test, 94.5% were positive for IgG antibodies after the first vaccine dose. Seroconversion rates were lower in participants older than 47 years. Conclusions: Despite 1.4% moderate adverse events, no safety concerns or anaphylaxis were identified. The Pfizer-BioNTech vaccine induced an immune response in the overwhelming majority of recipients after a single dose. Younger participants experienced adverse events and were positive for IgG antibodies more frequently than older counterparts. It is important to mention that this study specifically considered short-term safety and reactions following vaccination and that long-term adverse effects were not investigated in the study. Thus, future research into both long-term adverse reactions and immune system programming is essential.

Evaluation of circulating leucocyte populations both in subjects with previous SARS-COV-2 infection and in healthy subjects after vaccination.

Innate immune mechanisms are central players in response to the binding of pathogens to pattern-recognition receptors providing a crucial initial block on viral replication. Moreover, innate immune response mobilizes cells of the cellular-mediated immune system, which develop into effector cells that promote viral clearance. Here, we observed circulating leukocyte T cell response in healthy subjects, COVID-19 infected, and in healthy vaccinated subjects. We found a significant CD8+ T cells (p < 0,05) decrease and an augmented CD4+/CD8+ ratio (p < 0,05) in COVID-19 infected group compared with vaccinated subjects. In addition, healthy vaccinated subjects have a significant increased expression of CD8+ T cells, and a reduction of CD4+/CD8+ ratio with respect to subjects previously COVID-19 infected. Central Memory and Terminal Effector Memory cells (TEMRA) increased after vaccine but not among groups.

Pfizer-BioNTech vaccine effectiveness against Sars-Cov-2 infection: Findings from a large observational study in Israel.

Development of an effective vaccine against Covid-19 is crucial to reducing infection. mRNA BNT162b2, developed and manufactured by Pfizer-BioNTech, was one of the first FDA-approved vaccinations reporting high efficacy (95%) and minimal side effects. Evaluating effectiveness of BNT162b2 in a general population has been made possible after the implementation of a nation-wide vaccination program in Israel. This retrospective cohort study was carried out in Maccabi HealthCare services, Israel among 1.6 million members aged 16 and over. The population was divided into those who were at least seven days post- second vaccination and those who had not been vaccinated. Number of days till the end of the study or Covid-19 infection, Covid-19-related hospitalization and mortality was calculated for each participant between 18.1.2021 to 25.4.2021. Participants who had reached day eight after second vaccination during the study period could contribute days to both groups. Vaccine efficacy (VE) was calculated using a conditional Poisson model, controlling for age group, gender, hypertension, diabetes and obesity, fitted within clusters defined by geographical statistical area and calendar week. BNT162b2 was found effective for the total population group for infection, hospitalization and mortality, with adjusted VE of 93·0% (CI:92·6-93·4%), 93·4% (CI:91·9-94·7%) and 91·1% (CI:86·5-94·1%) respectively. VE for infection was lower for participants aged 75 and over, and for those with hypertension, diabetes and obesity. This study strengthens the evidence that the Pfizer-BioNTech vaccination is effective in preventing infection, hospitalization and mortality.

Effectiveness of a Third Dose of BNT162b2 mRNA Vaccine.

A retrospective cohort study was carried out in a large Israeli health maintenance organization to determine vaccine effectiveness (VE) of a third dose of BNT162b2 vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Of nearly 1 million members receiving 2 doses of BNT162b2 in January-February 2021, infection rates (based on polymerase chain reaction results) were compared between those who received a third dose with those who did not during August-October 2021 (maximum, 70 days). Crude VE was 92.9% (95% confidence interval [CI], 92.6%-93.2%) and adjusted VE was 89.1% (95% CI, 87.5%-90.5%). We conclude that the third dose provides added protection against SARS-CoV-2 infection for those vaccinated 6 months ago.