Predictors for reactogenicity and humoral immunity to SARS-CoV-2 following infection and mRNA vaccination: A regularized, mixed-effects modelling approach.

Introduction: The influence of pre-existing humoral immunity, inter-individual demographic factors, and vaccine-associated reactogenicity on immunogenicity following COVID vaccination remains poorly understood. Methods: Ten-fold cross-validated least absolute shrinkage and selection operator (LASSO) and linear mixed effects models were used to evaluate symptoms experienced by COVID+ participants during natural infection and following SARS-CoV-2 mRNA vaccination along with demographics as predictors for antibody (AB) responses to recombinant spike protein in a longitudinal cohort study. Results: In previously infected individuals (n=33), AB were more durable and robust following primary vaccination when compared to natural infection alone. Higher AB were associated with experiencing dyspnea during natural infection, as was the total number of symptoms reported during the COVID-19 disease course. Both local and systemic symptoms following 1st and 2nd dose (n=49 and 48, respectively) of SARS-CoV-2 mRNA vaccines were predictive of higher AB after vaccination. Lastly, there was a significant temporal relationship between AB and days since infection or vaccination, suggesting that vaccination in COVID+ individuals is associated with a more robust immune response. Discussion: Experiencing systemic and local symptoms post-vaccine was suggestive of higher AB, which may confer greater protection.

Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system.

BACKGROUND: This study aimed to evaluate the reactogenicity effects of COVID-19 vaccines, used in Iran. METHODS: At least 1000 people were followed up with phone calls or self-report in a mobile application within 7 days after vaccination. Local and systemic reactogenicities were reported overall and by subgroups. RESULTS: The presence of one or more local and systemic adverse effects after the first dose of vaccines was 58.9% [(95% Confidence Intervals): 57.5-60.3)] and 60.5% (59.1-61.9), respectively. These rates were reduced to 53.8% (51.2-55.0) and 50.8% (48.8-52.7) for the second dose. The most common local adverse effect reported for all vaccines was pain in the injection site. During the first week after the first dose of vaccines, the frequency of the pain for Sinopharm, AZD1222, Sputnik V, and Barekat was 35.5%, 86.0%, 77.6%, and 30.9%, respectively. The same rates after the second dose were 27.3%, 66.5%, 63.9%, and 49.0%. The most common systemic adverse effect was fatigue. In the first dose, it was 30.3% for Sinopharm, 67.4% for AZD1222, 47.6% for Sputnik V, and 17.1% for Barekat. These rates were reduced to 24.6%, 37.1%, 36.5%, and 19.5%, in the second dose of vaccines. AZD1222 had the highest local and systemic adverse effects rates. The odds ratio of local adverse effects of the AZD1222 vaccine compared to the Sinopharm vaccine were 8.73 (95% CI 6.93-10.99) in the first dose and 4.14 (95% CI 3.32-5.17) in the second dose. Barekat and Sinopharm had the lowest frequency of local and systemic adverse effects. Compared to Sinopharm, systemic adverse effects were lower after the first dose of Barekat (OR = 0.56; 95% CI 0.46-0.67). Reactogenicity events were higher in women and younger people. Prior COVID-19 infection increased the odds of adverse effects only after the first dose of vaccines. CONCLUSIONS: Pain and fatigue were the most common reactogenicities of COVID-19 vaccination. Reactogenicities were less common after the second dose of the vaccines. The adverse effects of AZD1222 were greater than those of other vaccines.

Multimorbidity and Its Effect on Self-Reported Adverse Effects Following COVID-19 Vaccination.

Introduction The coronavirus disease 2019 (COVID-19) vaccination has been suggested for those with comorbidities, although there are concerns regarding the vaccine's safety. This study aimed to compare the severity and incidence of post-vaccination side effects in people with and without comorbidities. Another aim of this study was also to look for the effect of multimorbidity on adverse events. Methods This observational study was conducted from November 2021 to February 2022. Data were collected from all over Pakistan using a self-administered online questionnaire that inquired about the subject's demographic, clinical, and COVID-19 vaccination profiles. Data analysis was done by using SPSS software version 22.0. (Chicago, IL, IBM Corp.). Results A total of 421 participants were included in the study, and 31.4% of individuals had underlying comorbidity. The overall mean age was 33 years (range: 13-85 years). This study included recipients of all major types of COVID-19 vaccines being used in Pakistan. Only 67.4% of the subjects had only underlying comorbidity, and hypertension was the most common one out of all comorbidities. Participants with comorbidities were not at a greater risk to produce vaccine-related adverse events when compared to those with no comorbidities. Comorbidity was also found to be statistically non-significant to the severity of the side effects. Only one subject with comorbidity produced a side effect and required hospitalization. Multimorbidity was not associated with a greater incidence of side effects. Multimorbidity was not significantly linked with the severity of the adverse effects, except muscle pain (p<0.05) and breathlessness (p<0.05). Conclusion It can be concluded that comorbidities do not affect the COVID-19 vaccine's reactogenicity but studies on an extensive scale should be conducted regarding individuals with multiple pre-existing comorbidities.

Reactogenicity of COVID-19 Vaccines in Patients With a History of COVID-19 Infection: A Survey Conducted in Pakistan.

Introduction As coronavirus disease 2019 (COVID-19) immunizations become more common, concerns about their safety and reactogenicity have grown. It is important to assess and analyze the post-vaccination side effects of several COVID-19 vaccines that have been licensed in Pakistan. Methods and results A comparative cross-sectional study was conducted between October 2021 and January 2022 to collect data on the side effects produced by different COVID-19 vaccines. An online survey was conducted to gather data on participants' demographics, clinical profiles, COVID-19 profiles as well as the intensity and side effects of COVID-19 vaccines. Statistical Package for the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY) was used to analyze the data collected. Out of 421 participants, 63.2% were males, 36.8% of participants received messenger RNA (mRNA) vaccine, 33.2% received viral vector vaccine, 29.9% received inactivated vaccine, and further 71.7% of the total subjects were completely immunized. The majority of the symptoms were mild to moderate in degree. Approximately, 0.7% of the individuals reported experiencing serious adverse effects. Injection site pain (35.9%) was noted to be the most remarkable post-vaccination side effect followed by fever (33.2%) and fatigue (23.1%). Prior COVID-19 infection was not associated with the severity of any COVID-19 vaccine-related side effect (p > 0.05), except dyspnea. Younger participants and the female gender were substantially linked to post-vaccination adverse effects. Conclusion In comparison to viral vector and inactivated vaccines, our data suggest that the mRNA-based vaccination causes more severe adverse effects, and the majority of them were mild to moderate in severity. Participants who had previously contracted COVID-19 were not at a higher risk of developing additional vaccine-related side effects.

Health Care Workers' Sick Leave due to COVID-19 Vaccination in Context With SARS-CoV-2 Infection and Quarantine-A Multicenter Cross-Sectional Survey.

Background: Reactogenicity of coronavirus disease 2019 (COVID-19) vaccines can result in inability to work. The object of this study was to evaluate health care workers' sick leave after COVID-19 vaccination and to compare it with sick leave due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and quarantine leave. Methods: A multicenter cross-sectional survey was conducted at Regensburg University Medical Center and 10 teaching hospitals in South-East Germany from July 28 to October 15, 2021. Results: Of 2662 participants, 2309 (91.8%) were fully vaccinated without a history of SARS-CoV-2 infection. Sick leave after first/second vaccination occurred in 239 (10.4%) and 539 (23.3%) participants. In multivariable logistic regression, the adjusted odds ratio for sick leave after first/second vaccination compared with BNT162b2 was 2.26/3.72 for mRNA-1237 (95% CI, 1.28-4.01/1.99-6.96) and 27.82/0.48 for ChAdOx1-S (95% CI, 19.12-40.48/0.24-0.96). The actual median sick leave (interquartile range [IQR]) was 1 (0-2) day after any vaccination. Two hundred fifty-one participants (9.4%) reported a history of SARS-CoV-2 infection (median sick leave [IQR] 14 [10-21] days), 353 (13.3%) were quarantined at least once (median quarantine leave [IQR], 14 [10-14] days). Sick leave due to SARS-CoV-2 infection (4642 days) and quarantine leave (4710 days) accounted for 7.7 times more loss of workforce than actual sick leave after first and second vaccination (1216 days) in all fully vaccinated participants. Conclusions: Sick leave after COVID-19 vaccination is frequent and is associated with the vaccine applied. COVID-19 vaccination should reduce the much higher proportion of loss of workforce due to SARS-CoV-2 infection and quarantine.

The Association Between COVID-19 Pfizer Vaccine and The Reported Post-Vaccination Menstrual Changesi Citizen and Resident Women in KSA: Results of Riyadh Survey Study

Background: Pfizer vaccine has been approved for use in Saudi Arabia. Although the vaccine efficacy has been frequently addressed, little knowledge is available regarding the real-world post-vaccination menstrual disturbances. Objective: The aim was to evaluate the possible association between Pfizer vaccine and the post-vaccination menstrual irregularities among Saudi citizen and resident women. Subjects and methods: A self-administered validated questionnaire was used to obtain the data. It was distributed all over Riyadh City, KSA through social media and 731 females responded to the survey. Results: Overall, 50.9% of the participants reported a menstrual change after vaccination, in particular, those who received the 2 doses. There was a significant and positive correlation between the number of doses and the experience of menstrual changes being associated with the 2 dosed women. In details, 60.5% mentioned a menstrual delay, 30.4% reported early onset, and 9.1% mentioned a menstrual change other than in the date. 43.3% reported a decrease in the amount of menstrual flow, 34.9 % mentioned an increase. 62.4% declared an increase in the severity of pain while 11% reported a decrease. Interestingly, only 60.8% of the respondents mentioned the persistence of the menstrual changes each following cycle. However, the changes were positively correlated with the age and negatively associated with the marital status being less in married. Conclusion: It was concluded that the post-vaccination menstrual changes might be related to the age, marital status, and those receiving 2 doses and these changes could be related to the immune response frequently associated with vaccines. © 2022, Ain Shams University Faculty of Medicine. All rights reserved.

Patients with history of covid-19 had more side effects after the first dose of covid-19 vaccine.

INTRODUCTION: COVID-19 vaccination seems to be the most pertinent pharmacologic public health measure to control the pandemic. Reactogenicity symptoms were frequent in vaccine recipients mostly mild to moderate and commonly reported after the second dose. However, there is a lack of data in patients with a previous diagnosis of Covid-19. METHODS: We analysed side effects of 311 patients after the first dose of Pfizer-BioNTech COVID-19 vaccine, in a french university hospital. We compared patients with COVID-19 history to naive individuals. All the data collected are based on self-reported, including COVID-19 exposure status. RESULTS: Overall, 229 (74%) patients reported at least one side effect. Among participants with history of Covid-19, 95% reported at least one adverse event versus 70% in naive patients (p < 0.01). However, symptom intensity was not different between the 2 groups. CONCLUSION: Vaccine recipients with prior COVID-19 reported more, but no more serious, side effects than naive participants.

BCG Scar Local Skin Inflammation as a Novel Reaction Following mRNA COVID-19 Vaccines in Two International Healthcare Workers.

Bacillus Calmette-Guérin (BCG) local scar inflammatory reactions have been mostly associated with Kawasaki disease in children and less commonly with other viral infections (i.e., measles). BCG scar inflammation associated with or following vaccine administration has only been reported with the influenza vaccine. We describe the first reports in the literature of local BCG inflammation following two different available messenger ribonucleic acid (mRNA) anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) vaccines (mRNA-1273, and BNT162b2) in two young healthy physicians, one from Costa Rica, and another from the United States of America, with normal cell blood counts, flow cytometries, and negative for human immunodeficiency virus (HIV). In both cases, BCG scar inflammation appeared after 24 hours of vaccination of the second dose, without signs of reaction on the injection site, and resolved within four days. Dermoscopic findings in one case showed arborizing and comma-shaped vessels. Pharmacovigilance surveillance of BCG scar reactions following coronavirus disease 2019 (COVID-19) vaccines should be considered particularly in countries where BCG is part of their national immunization programs.